Anti-KickBack |

HHS Fraud Enforcement Risk Tool Updated

October 25, 2023

The Department of Health & Human Services (“HHS-OIG”) just updated the 2023 Fraud Risk Indicator for the fourth quarter.

Based on information from False Claims Act settlements, HHS-OIG assesses the future trustworthiness of the settling parties to decide whether to exclude them from federal health care programs government’s primary civil tool for addressing health care fraud is the False Claims Act (“FCA”). Most FCA cases are resolved through settlement agreements in which the government alleges fraudulent conduct and typically the settling parties do not admit liability.

Depending on the facts and circumstances presented, OIG will usually pursue one of the following approaches when settling a health care fraud case: (1) exclusion; (2) heightened scrutiny; (3) integrity obligations; (4) take no further action; or (5) in the case of a good faith and cooperative self-disclosure, release 1128(b)(7) exclusion with no integrity obligations. OIG’s Risk Spectrum illustrates these approaches.

For more information on how OIG evaluates risk to the Federal health care programs and the criteria the OIG considers in evaluating exclusions in False Claims Act cases, see OIG’s April 18, 2016 notice.

For More Information

We hope this update is helpful. Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy Group.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

Leave a Comment » | Anti-KickBack, ASC, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Money Laundering | Permalink
Posted by Cynthia Marcotte Stamer

Sibley Hospital & Johns Hopkins Health System Pay $5 Million To Settle Stark Violations

April 19, 2023

Sibley Hospital (“Sibley”) and its parent company, Johns Hopkins Health System (“Johns Hopkins”) will pay the United States $5 million to resolve Physician Self-Referral Law, (commonly known as the “Stark Law”) allegations arising from claims that Sibley submitted to the Medicare Program, the Justice Department announced today.

The Stark Law prohibits a hospital from billing Medicare for certain services referred by physicians with whom the hospital has a financial relationship, unless that relationship satisfies one of the law’s statutory or regulatory exceptions. It is intended to ensure that medical decision-making is not influenced by improper financial incentives and instead is based on the best interests of the patient.

The new settlement resolves allegations that, from 2008 through 2011, Sibley violated the Stark Law by billing Medicare for services referred by ten cardiologists to whom Sibley was paying compensation that exceeded the fair market value of the services provided. These allegations arose out of conduct that Sibley and Johns Hopkins self-disclosed to the United States.

“Improper financial arrangements between hospitals and physicians can influence the type and amount of health care that is provided,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to holding accountable those who violate prohibitions designed to protect the integrity of physician decision-making.”

The high dollar settlement reminds other health care providers to ensure their own relationships with other health care providers comply with Stark, anti-kickback and other federal and state health care fraud laws.

More Information

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, billing, Child Care, Childcare, Childrens Health Insurance Program, Conditions of Participation, Corporate Compliance, DME, Doctor, E-Prescribing, false claims act, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Hospital, Laws, Life Sciences, Medicaid, Medicare, Medicare Advantage, OIG, pharmaceutical, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

4/21 Deadline For Comments On Proposed HIPAA Administrative Simplification Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification To Referral Certification and Authorization Transaction Standard

April 19, 2023

April 21 is the deadline to comment on the Centers for Medicare & Medicaid Services (CMS) National Standards Group (NSG) proposed rule that, if finalized, would adopt standards for “health care attachments” transactions, a standard for electronic signatures to be used in conjunction with health care attachments transactions, and a modification to the standard for the referral certification and authorization transaction (X12 278) published last December.

The April 21, 2023 deadline reflects a 30-day extension from the original deadline date of March 21, 2023. Comments must be received no later than 5 p.m. on April 21.

More Information

About the Author

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

FY 2022 Medicaid Fraud Conviction Increase, Other Data Shows Continued Robustness of Federal Medicaid Enforcement

March 10, 2023

Department of Health & Human Services Office of Inspector General (“OIG”) data showing a rise in Medicaid criminal convictions arising from fraud and patient abuse or neglect investigations and prosecutions during the 2022 fiscal year (“FY”) confirms the continued robustness of its Medicaid Fraud Control Units (MFCUs).

According to the just-released Medicaid Fraud Control Units Fiscal Year 2022 Annual Report convictions both for fraud and for patient abuse or neglect increased since FY 2020. In FY 2022, MFCUs achieved:

1,327 criminal convictions, an increase over the previous 2 years, but resulted in criminal recoveries of only $416 million; and
553 civil settlements and judgments resulting in civil recoveries of $641 million.

A Statistical Chart included in the Report provides a breakdown by state of the civil and criminal convictions and recoveries by nature of the offense.

While the Report reveals that civil and criminal recoveries from Medicaid criminal and civil enforcement dropped in FY 2022, the increase in convictions and other data sends a clear warning to health care providers and others that Medicaid fraud investigation and enforcement remains a key priority of the OIG and federal prosecutors.

Criminal Convictions

Total convictions resulting from MFCU cases continued to increase from the FY 2020 level but remained lower than in FY 2019. In FY 2022, MFCU cases resulted in 946 convictions for fraud and 381 convictions for patient abuse or neglect.
Exhibit 2 shows the total number of convictions during FYs 2018 through 2022. Although the proportion of patient abuse or neglect convictions to fraud convictions was similar to that in previous years, the total number of patient abuse or neglect
convictions also continued to increase from the FY 2020 level.

As in previous years, significantly more convictions for fraud involved Personal Care Services (PCS) attendants than any other provider type with fraud convictions of PCS attendants, accounting for 44 percent of the fraud convictions.

MFCU convictions related to the fraudulent billing of Medicaid, fraudulent activities of Medicaid providers involving drugs diverted from legal and medically necessary uses, regardless of whether Medicaid itself was billed and other “drug diversion” cases continued to increase from the FY 2020 level. Associated criminal recoveries from drug diversion cases totaled $18 million in FY 2022. Two States, Pennsylvania and Kentucky, accounted for 79 percent of the total convictions.

In FY 2022, convictions of nurse’s aides and of nurses or physician assistants accounted for 39 percent of the total 381 convictions for patient abuse or neglect.

Criminal and Civil Recoveries

While convictions rose, criminal recoveries decreased from $857 million in FY 2021 to $416 million in FY 2022. The Report attributes the drop in atypically large criminal recovery amounts realized in FY 2021 that resulted primarily from cases prosecuted by MFCUs in Virginia and Texas that produced a combined $714 million in criminal recoveries, 83 percent of the total reported criminal recoveries in FY 2021.

The Report points out that a single Texas criminal prosecution also significantly contributed to the total criminal recoveries in FY 2022. According to the Report, $82 million of the FY 2022 criminal recoveries resulted from the prosecution and conviction of the former head of Novus and Optimum Health Services, Bradley J. Harris and other defendants by the U.S. Attorney’s Office for the Northern District of Texas for defrauding the Medicare and Medicaid programs by among other actions:

Billing Medicare and Medicaid for hospice services that were (1) not provided, (2) not directed by a medical professional, and (3) provided to patients not eligible for hospice care; and
Using blank, pre-signed controlled substance prescriptions to distribute drugs without
physician input.

Recoveries from civil settlements and judgments also decreased in FY 2022, as did the total number of civil settlements and judgments associated with pharmaceutical manufacturers. In FY 2022, $395 million (62 percent) of the $641 million in civil recoveries derived from nonglobal cases. The remaining $246 million derived from global cases.

Appendixes to the report include a list of “beneficial” practices implemented by the MFCUs to prevent and discover these and other Medicaid abuses in various regions. Reviewing the granular statistics and these findings set forth in the Report provide valuable insights for health care providers, their leaders and advisors about these and other enforcement priorities and practices.

More Information

About the Author

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Anti-KickBack, ASC, Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Hospital, Medicaid, Medical Licensure, OIG | Permalink
Posted by Cynthia Marcotte Stamer

Ensure Health Care & Other Compliance Practices Updated For New DOJ Voluntary Disclosure Policy

February 24, 2023

Health care, life sciences and other organizations and their leaders generally recognize the need for effective compliance programs to mitigate their organizational and individual criminal liability risks for violations of the constantly widening plethora of federal health care, tax, marketing, labor and employment, antitrust, marketing, securities, cyber liability, safety, environmental and other laws.

To maintain and promote the effectiveness of these efforts, organizations and their leaders now need to consider the advisability of enhancements or other modifications of their organization’s Federal Sentencing Guideline and other compliance programs and practices in light of the new corporate criminal conduct Voluntary Self-Disclosure Policy (“VSD policy”) announced by the Department of Justice on February 23, 2023. Concurrently, organizations and their leaders also will want to monitor and respond promptly to Justice Department statements and congressional recommendations on proposed Guideline changes providing critical insights into the Justice Department’s planned interpretation and enforcement of federal criminal laws and the Guidelines against organizations and their leaders like those available here.

While the application of the VSP policy inherently requires subjective decision-making, the VSP policy and other emerging statements reinforce to organizations and their leaders the advisability of ensuring their organizations adopt and administer effective Federal Sentencing Guideline compliance programs for the ever-growing list of laws applicable to their organizations that carry potential felony and class A misdemeanor criminal liability and timely to investigate and self-disclose violations with the assistance of legal counsel in accordance with the Guideline requirements for liability mitigation to mitigate the potential liability exposure of the organization and its leader.

VSD Policy Standardizes USAO Sentencing Guideline Organization Liability Determinations

Chapter 8 of the Federal Sentencing Guidelines sets standards for the assessment of criminal liability and punishment against corporations, partnerships, labor unions, pension funds, trusts, non-profit entities, and governmental units (“organizations”) and their leaders for legal violations committed by the organization that carry felony or Class A misdemeanor liability or when the Federal Sentencing Guidelines impute criminal liability to the organization for criminal acts that an employee of the organization commits an act within the apparent scope of his employment.

The standards for organizational sentencing offer organizations the opportunity to mitigate their liability exposure if it can persuade the prosecuting U.S. attorneys office (“USAO”) it had in place and followed an effective compliance program, promptly reported the violation to the authorities, and that high-level leaders were not involved in the actual offense conduct. On the other hand, an organization’s lack of an effective compliance program, delay in investigation, cover-up or failure or delay of timely disclosure and failure to make prompt restitution for violations are aggravating factors that can increase its potential sanction.

According to the Justice Department, the Justice Department intends that the VSD policy ensure that organizations can rely on receiving the same treatment and benefits for voluntarily self-disclosing criminal conduct under the Federal Sentencing Guidelines organizational liability rules to any USAO no matter where the organization operates by setting “a nationwide standard” for how USAOs will determine whether an organization has made a voluntary self-disclosure and making transparent the specific, tangible benefits to an organization that the USAO will offer the organization for making a voluntary self-disclosure, fully cooperating, and remediating the criminal conduct.

In furtherance of this goal, the new VSD policy provides that a USAG will consider an organization to have made a VSD for purposes of the Federal Sentencing Guidelines if it becomes aware of misconduct by employees or agents before that misconduct is publicly reported or otherwise known to the DOJ, and discloses all relevant facts known to the company about the misconduct to USAO in a timely fashion before an imminent threat of disclosure or government investigation.

In the absence of any aggravating factor, the VSD policy calls for the USAG “significant benefits” to a corporation that voluntarily self-discloses criminal conduct committed by its employee or agent in accordance with the VSD policy, fully meets the other requirements of the VSD policy, fully cooperates and timely and appropriately remediates the criminal conduct including agreeing to pay all disgorgement, forfeiture, and restitution resulting from the misconduct. The promised significant benefits for organizations making a qualifying VSD include that the USAO:

Will not seek a guilty plea;
May choose not to impose any criminal penalty and in any event will not impose a criminal penalty that is greater than 50% below the low end of the United States Sentencing Guidelines (USSG) fine range; and
Will not seek the imposition of an independent compliance monitor if the company demonstrates that it has implemented and tested an effective compliance program.

The VSD policy identifies three aggravating factors that could warrant a USAO seeking a guilty plea even if the other requirements of the VSD policy are met:

If the misconduct poses a grave threat to national security, public health, or the environment;
If the misconduct is deeply pervasive throughout the company; or
If the misconduct involved the current executive management of the company.

The Justice Department says the presence of an aggravating factor does not necessarily mean that a guilty plea will be required. Rather, the USAO will assess the relevant facts and circumstances to determine the appropriate resolution. If a guilty plea is ultimately required, the Justice Department says the organization will still receive the other benefits under the VSD policy, including that the USAO will recommend a criminal penalty of at least a 50% and up to a 75% reduction off the low end of the USSG fine range, and that the USAO will not require the appointment of a monitor if the company has implemented and tested an effective compliance program.

In cases where a company is being jointly prosecuted by a USAO and another DOJ component, or where the misconduct reported by the company falls within the scope of conduct covered by VSD policies administered by other DOJ components, the USAO will coordinate with, or, if necessary, obtain approval from, the DOJ component responsible for the VSD policy specific to the reported misconduct when considering a potential resolution. Consistent with relevant provisions of the Justice Manual and as allowable under alternate VSD policies, the USAO may choose to apply any provision of an alternate VSD policy in addition to, or in place of, any provision of its policy.

VSD Policy Reenforces Necessity of Effective Compliance Program & Guideline Compliance

The stated goal of the VSD policy to incentivize companies to maintain effective compliance programs capable of identifying misconduct, expeditiously and voluntarily disclose and remediate misconduct, and cooperate fully with the government in corporate criminal investigations sends a strong message to organizations and their leaders to maintain and administer effective compliance programs and follow the VSD policy promptly when issues arise.

While the Justice Department touts the benefits of compliance with the VSD policy, its adoption also carries an implicit warning to organizations against failing to comply with its provisions.

With the Biden Administration accelerating enforcement of a wide range of federal laws carrying criminal liability, organizations and their leaders should heed this warning by auditing and enhancing their and their organization’s potential criminal exposures and the adequacy of their compliance policies, practices and documentation.

Because of the highly sensitive nature of this type of analysis for the organization and its leaders, before starting the review, and throughout its conduct organizations are urged to engage and seek guidance from qualified legal counsel to position their review for protection, within the scope of attorney, client privilege, and other evidentiary protections, as well as to maximize the benefit of the effort undertaken in the event of future investigations or enforcement.

Possessing an up-to-date understanding of material civil and criminal legal obligations and exposures is absolutely critical to the effectiveness of this review. With laws and regulations constantly changing, organizations and their leaders must establish a documented, provable culture of compliance. This starts with ensuring their organizations have adopted strong policies of compliance coupled with processes for monitoring and identifying laws carrying potential criminal liability, exposure or otherwise, requiring corporate compliance programs. Along with requirements to comply, leadership also must implement appropriate processes for auditing compliance as well as receiving and investigating complaints or other indicators that arguably put their organization or its leadership on notice of potential compliance concerns.

When implementing compliance procedures, for any specific law, organizations, and their leaders will also want to ensure that their processes and policies are designed to meet the seven criteria that Chapter 8 of the Federal Sentencing Guidelines outlines for establishing an “effective compliance program”

The maintenance and enforcement of compliance standards and procedures reasonably capable of reducing the prospect of criminal activity;
Oversight by high-level personnel;
Due care in delegating substantial discretionary authority;
Effective Communication to all levels of employees;
Reasonable steps to achieve compliance, which include systems for monitoring, auditing, and reporting suspected wrongdoing without fear of reprisal.
Consistent enforcement of compliance standards including disciplinary mechanisms; and
Reasonable steps to respond to and prevent further similar offenses upon detection of a violation.

Taking into account these criteria and the new VSP policy, organizations and their leaders also should ensure their organization has appropriate procedures and protocols for receiving, investigating and reports of potential violations and the organization’s timely and appropriate response in a manner that best positions the organization to demonstrate the culture of compliance, and other factors necessary to qualify for the maximum leniency under the guidelines. in a manner that best positions the organization to demonstrate the culture of compliance, and other factors necessary to qualify for the maximum leniency under the guidelines.

When designing and administering compliance investigations and responses, documentation and other evidence regarding actions taken, communications and deliberations, play a key role in deciding how the organization and its leaders will be treated under the VCD policy and the guidelines. For this reason, organizations should include appropriate procedures to determine when and how legal counsel will become involved to guide the process and allow for the use of attorney-client privilege to help protect, sensitive discussions along the way. Legal counsel also should assist in documenting the process and findings for presentation to the Justice Department and subsequent communications with it through resolution.

More Information

About the Author

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Anti-KickBack, ASC, Corporate Compliance, Employee Benefits, Employment, Federal Sentencing Guidelines, Health Care | Permalink
Posted by Cynthia Marcotte Stamer

Chiropractor, Modern Vascular Office-Based Labs and Modern Vascular Corporate Entities Face False Claims Act Prosecution

December 19, 2022

Three consolidated False Claims Act (“FCA”) lawsuits against chiropractor Yury Gampel (“Gampel”), 15 Modern Vascular office-based labs owned primarily by Gampel located across the United States, and five Modern Vascular-affiliated companies owned by Gampel alert other chiropractic, physician and other medical providers using office-based labs send a clear warning to other health care providers and suppliers for services covered or billed to Medicare, Medicaid, TRICARE or other federal health care programs about the necessity to ensure their arrangements don’t involve illegal financial relationships or transactions.

False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements

The Justice Department suit against the defendants alleges the defendants both arose from the defendants participation in arrangements involving the offering and payment of illegal remuneration in violation of the federal Anti-Kickback Statute (“AKS”) and that the claims for benefits made to Medicare and other federal programs for care provided involving the arrangement violated the FCA.

The AKS generally prohibits any person or entity from soliciting, receiving, offering, or paying any direct or indirect prohibited remuneration as an inducement or reward for referring, recommending, ordering, or arranging for the purchase of any item or service for which payment may be made in whole or in part by a federal health care program. Parties violating the AKS commit a felony punishable with a fine of up to $100,000, imprisonment for up to 10 years or both.

In addition to any criminal liability arising under the AKS, filing claims derived or involving transactions prohibited by the AKS also can trigger liability for violation of the FCA. The FCA makes it unlawful for any person to submit, directly or indirectly, false or fraudulent claims for payment to the Government by among other things:

Knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A) (the “presentment provision”); or
Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in violation of 31 U.S.C. § 3729(a)(1)(B).

The FCA defines the term “knowingly” under the FCA very broadly. As defined, “knowingly” means that a person, with respect to information, (i) has actual knowledge of the information, (ii) acts in deliberate ignorance of the truth or falsity of the information, or (iii) acts in reckless disregard of the truth or falsity of the information. 31 U.S.C. § 3729(b). No proof of specific intent to defraud is required to show that a person acted knowingly under the FCA.

Violations of the FCA subject the defendant to mandatory civil penalties per FCA violation, plus three times the amount of damages that the Government sustains as a result of the defendant’s actions. 31 U.S.C. § 3729(a). Under 42 U.S.C. § 1320a-7(b)(7), health care providers submitting claims to Medicare or other federal health care programs also can face exclusion from participation in federal health care programs for FCA violations.

Health care providers filing claims for Medicare or other federal health plans can violate the FCA by knowingly presenting or causing to be presented claims for items or services that the person knew or should have known were not medically necessary, or were false or fraudulent. 42 U.S.C. §§ 1320a-7a(a)(1).

Moreover, health care providers under the Medicare statute have an affirmative duty to familiarize themselves with the statutes, regulations, and guidelines regarding coverage for the Medicare services. As a condition of program participation, Medicare regulations require providers and suppliers to certify that:

The provider or supplier meets, and will continue to meet, the requirements of the Medicare statute and regulations, 42 C.F.R. § 424.516(a)(1), including that any claims and underlying transactions made in a claim for Medicare comply with the Federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all otherwise applicable conditions of participation in Medicare; and
The provider or supplier will not knowingly to present or cause to be presented a false or fraudulent claim for payment by Medicare, or to submit claims with deliberate ignorance or reckless disregard of their truth or falsity.

Additional certifications of continued compliance with these requirements also are required when claims are filed. Accordingly, since health care providers and suppliers are responsible for taking appropriate steps to familiarize themselves with the rules and regulations applicable to their claim and the transactions underlying it and certify in connection with the filing of the claim that the claim and its underlying transactions comply with the law, health care providers filing claims involving prohibited financial incentives or other transactions prohibited by law risk FCA liability.

Gampel, Modern Vascular FCA Complaint

Derived from the Justice Department’s assumption and consolidation of various qui tam lawsuits separately brought by various physicians, the United States filed its complaint in three consolidated lawsuits pending in the United States District Court for the District of Arizona under the qui tam, or whistleblower, provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733 (“FCA”) which allow a private citizen to sue on behalf of the government and share in any recovery. The United States is also entitled to intervene in the lawsuits, as it did in these cases.

The resulting consolidated three consolidated Justice Department lawsuits seek to recover treble damages and civil penalties, and under common law and equitable theories of recovery from defendants for their billing of Medicare, TRICARE and other federal health care programs for claims resulting from transactions involving prohibited remuneration offered and provided in violation of the AKS under Gampel’s alleged schemes Nobility Management LLC; Modern Vascular LLC; Modern Vascular of South Florida LLC; Modern Vascular Management LLC; Modern Vascular Management – East LLC; Modern Vascular Management – West LLC; Modern Vascular Institute LLC; Modern Vascular of Mesa LLC; Modern Vascular of Glendale LLC; Modern Vascular of Sun City LLC; Modern Vascular of Tucson LLC; San Antonio Vascular Specialists Corp. dba Modern Vascular; Fort Worth Vascular Specialists Corp. dba Modern Vascular; Modern Vascular of Denver LLC; Modern Vascular – Navajo LLC; Modern Vascular of Fairfax LLC; Modern Vascular of Houston LLC; Modern Vascular of Indianapolis LLC; Modern Vascular of Southaven LLC; Modern Vascular of St. Louis LLC; and Modern Vascular of Kansas LLC.

The Justice Department complaint alleges Defendant Yury Gampel, a chiropractor, is the founder and former Chief Executive Officer (“CEO”) of a franchise of office-based labs (“OBL”) located in Arizona, New Mexico, Colorado, Texas, Indiana, Kansas, Mississippi, Missouri, Tennessee, and Virginia operating under the name Modern Vascular (collectively, the “Modern Vascular OBLs”). The Modern Vascular OBLs – each its own separate legal entity – focus on the treatment of peripheral arterial disease (“PAD”), particularly through an aggressive use of vascular intervention procedures, such as angioplasty and atherectomy. The complaint claims Gampel and the Modern Vascular defendants designed and promoted the franchises that incorporated a package of management and other services provided by various Modern Vascular defendant companies.

Defendant Nobility Management, LLC, provides management services to the Modern Vascular OBLs. Defendants Modern Vascular Management, LLC; Modern Vascular Management – East, LLC; and Modern Vascular Management – West, LLC, offer
IT and management support to Modern Vascular OBLs. Defendants Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, are corporations controlled by Gampel that have various ownership interests in Modern Vascular OBLs. Through Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, and in his own capacity, Gampel is the majority owner of the Modern Vascular OBLs. (These entities that own and manage the Modern Vascular OBLs are referred to collectively below as “Modern Vascular Corporate.”)

The complaint alleges that Gampel and Modern Vascular Corporate designed and implemented a fraud scheme at Modern Vascular OBLs at the expense of patients and federal payors from at least January 1, 2018 through June 30, 2022. Among other things, the complaint charges Gampel and the Modern Vascular defendants offered physicians the opportunity to invest in Modern Vascular office-based labs to induce them to refer their Medicare and TRICARE patients to Modern Vascular for the treatment of peripheral arterial disease. More specifically, Gampel and Modern Vascular Corporate opened Modern Vascular OBLs in new markets where referring physicians and vascular surgeons had established relationships. Prior to opening an OBL in a particular location, Gampel sought out up to 20 local physicians – usually podiatrists and pain management physicians – who traditionally referred to vascular surgeons and offered each up to a two percent ownership interest in the OBL in order to induce the physicians to refer to the OBL. Gampel and Modern Vascular Corporate selected these particular physicians (hereinafter “physician investors”) to offer ownership investment because Gampel and Modern Vascular Corporate identified them as potential high-referral sources. Once they invested in an OBL, Gampel and Modern Vascular Corporate further required the physician-investors to make referrals to Modern Vascular OBLs as a condition for remaining as a physician-investor. The complaint also alleges that Gampel pressured vascular surgeons and interventional radiologists employed at the Modern Vascular office-based labs to increase the number of invasive surgical procedures performed by tracking procedures and setting aggressive weekly and monthly goals for such procedures. In particular, Gampel and Modern Vascular Corporate provided remuneration to physician investors in Modern Vascular OBLs to induce those investors to refer patients to the Modern Vascular OBL.

The Justice Department charges that using this scheme, Defendants between January 1, 2018 and June 30, 2022 submitted, and caused to be submitted, tens of millions of dollars in false or fraudulent claims to Medicare, TRICARE and other federal health care programs by offering and providing illegal remuneration to health care providers to induce referrals to the Modern Vascular OBLs in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b. To induce referrals, Gampel and Modern Vascular Corporate provided remuneration to physician-investors in the form of equity ownership interests in an OBL, which also included distributions, the prospect of future distributions, and/or the prospect of a cash-out of the equity ownership amounts when
the Modern Vascular OBLs were sold. During the relevant time period, the Justice Department also claims Modern Vascular
OBLs received over $50 million from Medicare Part B alone for claims submitted for patients referred by physician-investors in violation of the FCA.

Warning To Other Heath Care Providers & Suppliers

In announcing its filing of the Gambrel FCA lawsuit, the Justice Department warned other federal health program providers and suppliers and their business partners, investors, employees and agents from violating the AKS, FCA or both in the provision of or billing of health care services or supplies. “As part of our mission to protect the American people, the FBI remains committed to safeguarding patients who rely on our healthcare systems,” said Deputy Assistant Director Aaron Tapp of the FBI’s Criminal Investigative Division. “The FBI and our law enforcement partners will continue to investigate those who abuse our healthcare systems, place patients at risk, and waste taxpayer dollars.”

This warning, along with the ever-lengthening list of federal criminal and civil prosecutions, convictions and settlements by the Justice Department, the Department of Health & Human Services Office of Inspector General and other agencies provide a strong warning to health care providers, suppliers and others involved in creating or administering transactions and other arrangements for the delivery and billing for health are to be billed to Medicare, Medicaid, TRICARE and other health care arrangements covered by the AKS, the FCA or other federal or state health care fraud laws to take well documented care to ensure the care delivery arrangement does not involve transactions prohibited under the AKS or other federal or state health care fraud transactions and the care billed qualifies for reimbursement before submitting the claim. Parties who know or suspect that they may have participated in an arrangement prohibited under these laws or submitted prohibited claims should contact experienced legal counsel within the scope of attorney-client privilege for assistance in reviewing those concerns and exploring options for correction or mitigation.

For More Information

If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.

An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”

For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see hereor contact Ms. Stamer directly.

Other Helpful Resources & Information

If you found this article of interest, you also may be interested in reviewing other Breaking News, articles and other resources available including:

NOTICE: Terms. These materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice, a substitute for legal advice, an offer or commitment to provide legal advice or an admission. The information and statements in these materials may not address all relevant issues or apply to any situation or circumstances. The author reserves the right to qualify or retract any of these statements at any time. and does not necessarily address all relevant issues. Because the law evolves and in ways that subsequent developments could impact the currency and completeness of this discussion. The author disclaims and has no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at any time. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication. Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein. ©2022 Cynthia Marcotte Stamer. Nonexclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, billing, compensation, Conditions of Participation, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, Health IT, Home Health, Hospice, Hospital, Hospital, Indian Health, Inpatient Rehabilitation Facility, Laboratory tests, Laws, long-term care, Medicaid, Medicaid Advantage, Medicare, Mergers and Acquisitions, nursing home, Outpatient, pain management, Pharmaceudical, Physician, Physician Licensing, Prescription Drugs, Reimbursement | Tagged: Anti-Kickback, Health Care Fraud, Health Care Reimbursement, Medicaid, Medicare, Office-based labs | Permalink
Posted by Cynthia Marcotte Stamer

6 Texas Physicians Face Federal Health Care Fraud Charges For Alleged Improper Kickbacks & Lab Testing Claims

May 29, 2022

The Department of Justice sent another strong warning to physicians and other health care provides not to violate the False Claims Act by making improper patient referrals in violation of the Anti-Kickback Statute and the Stark Law, billing federal health care programs for medically unnecessary laboratory testing or other services or both when charged six Texas physicians with federal health care fraud this week. The prosecution of the physicians for laboratory tests arranged and billed through management services organizations also reminds physicians and other providers that reliance upon management services or other third-party service providers generally does not protect a physician participating in prohibited laboratory or other testing, durable medical equipment, facility, physical therapy or other health care billing or referral arrangements from liability.

Charges Against Texas Physicians

This week, the Justice Department added the following six physicians as defendants to criminal charges filed in a False Claims Act complaint filed in January 2022 against former True Health Diagnostics LLC (THD) CEO Christopher Grottenthaler, former Boston Heart Diagnostics Corporation (BHD) CEO Susan Hertzberg, former LRH CEO Jeffrey Madison, and others:

Doyce Cartrett, Jr., M.D., of Silsbee, Texas, allegedly received over $320,000 from LRH and two management services organizations or “MSOs,” Ascend MSO of TX LLC (Ascend) and Eridanus MG LLC (Eridanus), in return for his referrals.
Elizabeth Seymour, M.D., of Corinth, Texas, allegedly received over $280,000 from two MSOs, Ascend and Eridanus, in return for her referrals.
Emanuel Paul “E.P.” Descant, II, M.D., of Spring, Texas, allegedly received over $125,000 from two MSOs, North Houston MSO and Tomball Medical Management Inc., in return for his referrals.
Frederick Brown, M.D., of Missouri City, Texas, allegedly received over $190,000 from two MSOs, Ascend and Indus MG LLC (Indus), in return for his referrals.
Heriberto Salinas, M.D., of Cleburne, Texas, allegedly received over $75,000 from two MSOs, Ascend and Herculis MG LLC (Herculis), in return for his referrals.
Hong Davis, M.D., of Lewisville, Texas, allegedly received over $70,000 from two MSOs, Ascend and Herculis, in return for her referrals.

The complaint in United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.) charges that small Texas hospitals including Rockdale Hospital dba Little River Healthcare (LRH), THD, BHD, the six physicians and others conspired to pay physicians to induce referrals to the hospitals for laboratory testing performed by THD or BHD. The charges stem from allegations made under the qui tam or whistleblower provisions of the False Claims Act by STF LLC by Felice Gersh, M.D. and Chris Riedel. The United States intervened in the qui tam action in December 2021.

The complaint alleges the charged hospitals paid a portion of their laboratory profits to recruiters, who in turn kicked back those funds to the referring physicians through MSOs allegedly set up by the recruiters to make payments to referring physicians. The Justice Department charges the alleged kickbacks were disguised as investment returns but actually were based on, and offered in exchange for, the physicians’ referrals. The complaint alleges that laboratory tests resulting from this referral scheme were billed to various federal health care programs, and that the claims not only were tainted by improper inducements but, in many cases, also involved tests that were not reasonable and necessary.

The Justice Department reports that before adding charges against the six physicians to the complaint this week, the Justice Department recovered more than $31 million relating to conduct involving BHD, THD and LRH, including False Claims Act settlements with 29 physicians, two health care executives and a laboratory company.

Health Care Fraud Liability Under False Claims Act, Anti-Kickback Statute, Stark Law

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally-funded programs. The Stark Law forbids a hospital or laboratory from billing Medicare for certain services referred by physicians that have a financial relationship with the hospital or laboratory. The Anti-Kickback Statute and the Stark Law seek to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.

The False Claims Act prohibits health care providers from billing federal health care programs for services resulting from referrals prohibited by the Anti-Kickback Statute or the Stark law.

Under the False Claims Act, a private party can file an action on behalf of the United States and receive a portion of the recovery. The False Claims Act also allows the Justice Department to intervene in such lawsuits and add claims and defendants, as happened in this litigation. The qui tam case is captioned United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.). If a defendant is found liable for violating the act, the United States may recover three times the amount of its losses plus applicable penalties.

The United States’ pursuit of this lawsuit illustrates the government’s emphasis on combating health care fraud generally with a special emphasis on physicians. For instance, U.S. Attorney Brit Featherston is quoted as saying, “Schemes that funnel health care referrals do not work without the participation of physicians. … They are not merely passive players in these elaborate schemes, but an integral part, without which the scheme could not exist. Our office is committed to rooting out health care fraud by pursuing all players involved the scheme, from the laboratories and their leaders to the marketers and the physicians who make it all possible. Naming these physicians in the complaint is evidence of that commitment.”

Given this clear warning, physicians and other prescribers, as well as recruiting, billing and management services organizations, laboratories and others involved in recruiting and marketing, providing or billing for laboratory or other services to double check the appropriateness of their referral and other practices keeping in mind that the Anti-Kickback Statute and Stark Law prohibitions against direct and indirect compensation can reach to a wide range of subtle value and benefits in addition to the obvious payment of cash or gifts delivered in a multitude of ways. The prosecution of these physicians for referrals made and compensation delivered under management services contracts also clearly warns physicians and other providers against expecting their reliance upon billing, management services or other staff or management service providers to shield them from liability if an improper referral or payment happens.

More Information

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.

Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.

Leave a Comment » | Anti-KickBack, billing, Centers For Disease Control, Conditions of Participation, DME, Doctor, Durable Medical Equipment, E-Prescribing, false claims act, Federal Sentencing Guidelines, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, healthcare, HHS, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Laboratory tests, Licensing, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Money Laundering, nursing home, OIG, Opiates, Pharmaceudical, Physician, Physician Licensing, Reimbursement, Stark, Substance Abuse | Tagged: Federal Sentencing Guidelines, Opiate, pain management, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Justice Department COVID & Other Health Care Fraud Enforcement Thriving Despite Pandemic Emergency

November 23, 2021

Federal health care fraud prosecution continues to thrive despite the ongoing COVID-19 health care emergency.

Recently announced prosecutions and other enforcement actions include Fraud & Abuse, False Claims Act and other health care fraud prosecutions commonly pursued by the Justice Department in recent decades as well as a host of new prosecutions of abuses of Covid-19 relief programs. Examples include:

These and other actions send a clear message to health care and life science organizations to continue vigorous health care fraud compliance and risk management activities as well as stay vigilant for signs of new audit and enforcement activities.

More Information

About the Author

Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.

As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

This involvement encompasses helping health care systems and organizations, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.

Author of a multitude of health industry and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Academic medicine, American Rescue Plan Act of 2021, Anti-KickBack, ASC, Centers For Disease Control, Conditions of Participation, Coronavirus, Corporate Compliance, Covid, COVID-19, Electronic Health Records, Employer, false claims act, Health Care, Health care coding, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, healthcare, HHS, Home Health, home health, Hospice, Hospital, hospitals, Life Sciences, long-term care, Medicaid, Medicaid Advantage, Medicare, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pandemic, Pharmacy, Physician, physician licensure, Reimbursement, retaliation, Skilled Nursing Facility, Stark, substance abuse treatment | Permalink
Posted by Cynthia Marcotte Stamer

CMS Updates COVID-19 Accelerated and Advance Payments FAQs

July 8, 2021

Providers that received COVID-19 accelerated and advance payments should read the Centers for Medicare and Medicaid Services (“CMS”) updated FAQs (PDF) about repayment of COVID-19 accelerated and advance payments to learn how recoupment works and how it affects the provider’s Medicare claims payment amounts.

The new FAQ updates the Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021 (PDF) guidance.

For more information and to follow future updates, see the COVID-19 Accelerated and Advance Payments webpage or contact the author of this update.

More Information

If you are interested in a more detailed description of this or other developments discussed in this article, see here.

If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.

Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.

Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.

A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

Leave a Comment » | Academic medicine, American Rescue Plan Act of 2021, Anti-KickBack, billing, Centers For Disease Control, compensation, Conditions of Participation, Coronavirus, Corporate Compliance, COVID-19, Doctor, E-Prescribing, Emergency Care, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Insurance, Health Plan, Health Plans, healthcare, HHS, Home Health, home health, Hospital, hospitals, Indian Health, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, OIG, Pandemic, Physician, public health, Reimbursement, Uncategorized | Tagged: COVID-19, Health Care, Health Care Fraud, Medicare, Physician, recoupment, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Key House Committee Votes To Advance HSA & Other Health Choice Reforms; Plans 7/17 Health Care Fraud Hearings

July 13, 2018

A flurry of activity in the House Ways & Means Committee and other Congressional committees over the past few weeks signals the advisability of keeping a close eye on health care and health benefit reform proposals this Summer in anticipation of both the Fall health benefit enrollment and renewal season and the mid-term November Congressional elections.

Certainly continued Congressional commitment to pursue reform is evident from the House Ways & Means Committee’s health care heavy agenda of hearings and votes that this week alone resulted in its voting in favor of 11 health care reform bills promising new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors. While it remains to be seen if the House and Senate can agree on any or all of these proposal, the bi-partisan sponsorship of many of these proposals and the intensity of the focus of the Committee and others in Congress reflects a strong interest in health care reform by both parties leading up to November that could impact health benefit and other health care choices for providers, employers and American families in the Fall annual enrollment season.

The legislation passed by the Ways & Means Committee this weeks include bills that would:

Provide relief for employers relief from the Obamacare’s employer mandate and delay for an additional year the effective date of the widely disliked “Cadillac Tax;”
Overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for healthcare flexible spending arrangement plans (HFSAs) that currently forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year;
Offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage using their subsidies; and
Expand expand the availability and usability of HSAs in a multitude of ways.

While the recurrent stalling of past reform efforts over the past few years calls into question whether any or all of these proposals can make it through the highly politicized and divided Congress, bi-partisian sponsorship of most of the bills reported out this week at least raises the possibility that some of these proposals enjoy sufficient bi-partisan support to potentially pass before the elections. With both parties viewing health care reform as a key issue in the upcoming elections, voter feedback on these proposals could play a big role in determining the prospects for passage this Summer.

Passage of any or all of these proposed reforms between now and year end likely will fuel the need for last minute reconsideration and potential adjustments in plan design choices of employers and other health plan sponsors and administrators, reconsideration of health benefit enrollment choices of individual Americans and their families and a reconsideration of practice billing and health plan participation decisions of physicians and other health care providers. Accordingly, health care providers, employers and other health plan sponsors, American taxpayers and their families and others impacted by health care and health benefit policies will want to carefully monitor these reforms as the Summer progresses:

To provide timely input to Congress on proposed reforms of particular benefit or concern;
To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

To learn more details about this proposed legislation, its potential implications or other related concerns, see here or contact the author.

About the Author

After holding hearings on health savings account reforms and passing a flurry of health care reform bills intended to give employers relief from two key Obamacare mandates, to allow Obamacare subsidy-eligible Americans the choice to use the subsidies to purchase health care coverage not offered by the Obamacare exchanges, and a host of bills that would expand availability and usability of health savings account (HSA) and health care flexible spending account (HFSA) programs this week, the House Ways and Means Committee will turn its attention to health care fraud oversight and reform next week by holding hearings Tuesday on those health concerns. Health care providers, employer and other health plan sponsors, individual Americans and their families, and others interested in health benefit and health care reform will want to keep a close eye on these and other developments as Congress continues to debate health care reform in the runup to the upcoming 2018 health benefit plan renewal and annual enrollment season and November’s mid-term elections.

Committee Approved 11 Health Care Reform Bills This Week

As a part of its health reform efforts this week, the Committee voted to advance 11 health care reform bills offering new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors.

Among the approved legislation is a bill that would provide key relief for employers from certain key Obamacare mandates that have been widely unpopular with employers. H.R. 4616, the “Employer Relief Act of 2018,” sponsored by Rep. Devin Nunes (R-CA) and Rep. Mike Kelly (R-PA), which would give employers sponsoring health plans for their employees retroactive relief from Obamacare’s onerous employer mandate and delay for an additional year the effective date of another Obamacare requirement that when effective, will forces employers to pay the 40 percent tax on amounts paid for employer sponsored health care coverage that exceeds cost limits specified in the Obamacare legislation commonly known as the “Cadillac Tax.” Relief from the Cadillac Tax is widely perceived as benefiting bother employers and their employees, as its provisions penalize employers for spending more for employee health coverage than limits specified in the Obamacare law. These provisions also are particularly viewed by many as unfair because rising health plan costs since Obamacare’s passage make it likely that many employers will incur the tax penalty simply by sponsoring relatively basic health plans meeting the Obamacare mandates.

In addition to H.R. 4616, the Committee also voted to approve H.R. 6313, the “Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018,” sponsored by Rep. Steve Stivers (R-OH), which would overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for HFSAs. Currently, this rule forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year. The bill would allow employers to eliminate this forfeiture requirement so that employees could carry over any remaining unused balances in their HFSAs at the end of the year to use in a later year.

The Committee also voted to advance legislation to offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage. H.R. 6311, the “Increasing Access to Lower Premium Plans Act of 2018,” sponsored by Chairman Peter Roskam (R-IL) and Rep. Michael C. Burgess, M.D. (R-TX), would provide individuals receiving subsidies to help purchase health care coverage through the Obamacare-created health insurance exchange the option to use their premium tax credit to purchase health care coverage from qualified plans offered outside of the exchanges. Currently, subsidies may only be used to purchase coverage from health plans offered through the exchange, which often are much more costly and offer substantially fewer coverage options and less provider choice. In addition, the bill would expand access to the lowest-premium plans available for all individuals purchasing coverage in the individual market and allows the premium tax credit to be used to offset the cost of such plans.

Along with these reforms, the Committee also voted to pass a host of bills that would expand the availability and usability of HSAs including:

H.R. 6301, the “Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act of 2018,” co-sponsored by Health Subcommittee Chairman Peter Roskam (R-IL) and Rep. Mike Thompson (D-CA), which seeks to expand access and enhance the utility of Health Savings Accounts (HSAs) by offering patients greater flexibility in designing their plan design while still being able to maintain their eligibility for HSA contributions.
H.R. 6305, the “Bipartisan HSA Improvement Act of 2018,” sponsored by Rep. Mike Kelly (R-PA) and Rep. Earl Blumenauer (D-OR), which also would expand HSA access and utility by allowing spouses to also make contributions to HSAs is their spouse has an FSA and lets employers offer certain services to employees through on-site or retail clinics.
H.R. 6317, the “Primary Care Enhancement Act of 2018,” co-sponsored by Rep. Erik Paulsen (R-MN) and Rep. Earl Blumenauer (D-OR), which seeks to protect HSA-eligible individuals who participate in a direct primary care (DPC) arrangement from losing their HSA-eligibility merely because of their participation in a DPC. In addition, it allows DPC provider fees to be covered with HSAs.
H.R. 6312, the “Personal Health Investment Today (PHIT) Act,” sponsored by Rep. Jason Smith (R-MO) and Rep. Ron Kind (D-WI), which seeks to fight obesity and promote wellness by allowing taxpayers to use tax-preferred accounts to pay costs of gym membership or exercise classes, children’s school sports programs and certain other wellness programs and activities.
H.R. 6309, the “Allowing Working Seniors to Keep Their Health Savings Accounts Act of 2018,” sponsored by Rep. Erik Paulsen (R-MN), which would expand HSA eligibility to include Medicare eligible seniors who are still in the workforce.
H.R.6199, the “Restoring Access to Medication Act of 2018,” sponsored by Rep. Lynn Jenkins (R-KS) and Rep. Grace Meng (D-NY), which would reverse Obamacare’s prohibition on using tax-favored health accounts to purchase over-the-counter medical products and would add feminine products to the list of qualified medical expenses for the purposes of these tax-favored health accounts.
H.R. 6306, the “Improve the Rules with Respect to Health Savings Accounts,” sponsored by Rep. Erik Paulsen (R-MN), which would increase the contribution limits for HSAs and further enhances flexibility in plans by allowing both spouses to contribute to make catch-up contributions to the same account and creating a new grace period for medical expenses incurred before the HSA was established.
H.R. 6314, the “Health Savings Act of 2018,” sponsored by Rep. Burgess (R-TX) and Rep. Roskam (R-IL), would expand eligibility and access to HSAs by allowing plans categorized as “catastrophic” and “bronze” in the exchanges to qualify for HSA contributions.

Committee Considers Health Care Fraud Next Week

The Committee next week will turn its attention to health care fraud by holding two hearings on Tuesday.

Tuesday morning, the Ways and Means Committee Oversight Subcommittee plans to hold a Hearing on Combating Fraud in Medicare: A Strategy for Success beginning at 10:00 AM Eastern Time; and
Tuesday afternoon, the Ways and Means Committee Subcommittee plans to hold a Hearing on Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program beginning at 2:00 PM.

Both hearings are scheduled to take place in Room 1100 Longworth and their proceedings will be live streamed on YouTube.

The Committee’s health care reform focus this week and next are reflective of the continued emphasis of members of Congress in both parties on health care reform legislation as they prepare for the impending mid-term elections in November. As a part of these efforts, the House and Senate already over the past several months have held a wide range of hearings in various committees and key votes on a multitude of reform proposals. Numerous other hearings and votes are planned over the next several months as Congressional leaders from both parties work to advance their health care agendas in anticipation of the upcoming elections.

Key health care and health benefit reform proposals that the Republican Majority has designated for priority consideration include:

Prescription drug costs by checking perceived negative effects of health industry and health plan consolidations involving large health insurers, pharmacy benefit management companies (PBMs), pharmacy companies and other health industry and health insurance organizations on health care costs and patient, plan sponsor and plan sponsor choice and health care quality;
Oversight and reform of existing STARK, anti-kickback and other federal health care rules and exemptions relied upon by PBMs and other health industry organizations;
Efforts to understand and address health care treatment, health care and coverage costs and related social concerns associated with mental health and opioid and other substance abuse conditions and their treatment;
Efforts promote health benefit and health care choice, affordability and coverage; improve patient and employer choice; promote broader health care access and quality; reduce counterproductive regulation; and other health insurance and care improvements through expanded availability of health savings accounts, direct primary care and other consumer directed health care options, association health plan and other program options, streamlining quality reporting and regulation, billing and coding, physician and other health care provider electronic billing and recordkeeping, and other provider, payer, employer, individual and other health insurance mandates and other federal health care and health plan rules; and
More.

Health care providers, employers and other health plan sponsors, American taxpayers and their families and others will want to carefully monitor these reforms as the Summer progresses:

To provide timely input to Congress on proposed reforms of particular benefit or concern;
To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

About the Author

Recognized repeatedly by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry, health and other benefit, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employer, associations, government and other health benefit sponsors and administrators, public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career.

Beyond her public policy and regulatory affairs involvement, Ms. Stamer also has extensive experience helping these and other clients to design and reform programs and practices; establish and administer compliance and risk management policies; comply with requirements, investigate and respond to government; accreditation and quality organizations; private litigation and other federal and state health care industry investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns. supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and employer and association group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients design, document and enforce plans, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

Leave a Comment » | Affordable Care Act, Anti-KickBack, Antitrust, Child Care, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Direct Primary Care, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, FDA, Fiduciary Responsibility, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Insurance, Health Insurance Exchange, Health IT, Health Plan, Health Plans, Health Policy, healthcare, HHS, Home Health, home health, Hospital, hospitals, managed care, Medicaid, Medical Licensure, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, Patient Empowerment, Pharmaceudical, Pharmacy, Physician, Preexisting Condition Insurance Plan, Prescription Drugs, Psychiatric, Public Policy, quality reporting, Reimbursement, Rural Health Care, substance abuse treatment, Tax, Tax-Exemption, Uncategorized, Veterans Health, Veterans Health Administration, Veterans Health Care | Permalink
Posted by Cynthia Marcotte Stamer

Physicians Pay $700,000 to Settle False Claims Act Violation Charges Arising from Financial Relationship with Drug Testing Lab

May 8, 2018

Three physicians are paying a total of $700,000 to settle Justice Department (DOJ) charges stemming from financial relationships with a drug testing lab. The settlement highlights the continuing need for providers to exercise care to avoid entering into financial arrangements with laboratories that DOJ, the Department of Health & Human Services Office of Inspector General (OIG) considers improper under federal health care fraud laws.

Dr. Robert Fetchero, D.O., Dr. Sridhar Pinnamaneni, M.D., and Dr. Thelma Green-Mack, M.D., separately agreed to settle allegations that they each received improper payments for referrals from Greensburg, Pennsylvania drug testing lab Universal Oral Fluid Laboratories, and caused false claims to be submitted to Medicare for drug testing services, United States Attorney Scott W. Brady announced yesterday.

The settlements announced resolve allegations that the settling physicians referred Medicare patients to Universal Oral Fluid Laboratories (“UOFL”) for drug testing services while engaged in a financial relationship with the lab. Specifically, UOFL paid the settling physicians to refer their patients to the lab for drug tests; UOFL then submitted claims to Medicare for the drug testing services from 2011 to 2014.

The settlements follow the earlier guilty plea on related charges of UOFL’s former medical director, Dr. John H. Johnson.

UOFL was owned and operated by William Hughes. The United States alleged that the financial arrangement between the settling physicians and UOFL violated the physician self-referral law, commonly known as the “Stark Law,” and the Anti-Kickback Statute, giving rise to liability under the False Claims Act. Pursuant to separately executed settlement agreements, Dr. Fetchero agreed to pay $200,000; Dr. Pinnamaneni agreed to pay $370,000; and Dr. Green-Mack agreed to pay $130,000.

The Stark Law forbids physicians from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless an exception applies. The Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of services covered by federal health care programs, such as Medicare. Violations of the Stark Law or Anti-Kickback Statute may give rise to civil liability for treble damages and penalties under the False Claims Act.

The settlements and underlying charges the resolve illustrate the risks that physicians and other providers run for participating in financial arrangements not structured to clearly meet applicable federal anti-kickback and STARK rules.

About the Author

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

May 8, 2018

HHS Picks Hargan As Acting HHS Secretary

October 11, 2017

President Trump has appointed Eric D. Hargan Acting Secretary of the U.S. Department of Health and Human Services (HHS).

Hargan, who was just sworn into office as Deputy Secretary of HHS on Oct. 6, 2017, takes over the duties of former Secretary Dr. Tom Price, who recently resigned in response to criticism about his expenditures for charter flights.

Before joining HHS, Mr. Hargan was an attorney, most recently a shareholder in Greenberg Traurig’s Chicago office in the Health and FDA Business department, where he focused his practice on transactions, healthcare regulations and government relations. He represented investors, companies, and individuals in healthcare investments and issues across the entire sector.

From 2003 to 2007, Mr. Hargan served at HHS in a variety of capacities, ultimately holding the position of Acting Deputy Secretary. During his tenure at HHS, Mr. Hargan also served as the Department’s Regulatory Policy Officer, overseeing the development and approval of all HHS, CMS, and FDA regulations and significant guidances.

Prior to this role, he served HHS as Deputy General Counsel. More recently, he was tapped by Governor Bruce Rauner to serve during transition as lead co-chair for Gov. Rauner’s Healthcare and Human Services committee.

During his time in Illinois, Mr. Hargan taught at Loyola Law School in Chicago, focusing on administrative law and healthcare regulations. He was a member of the U.S. government team at the inaugural U.S.-China Strategic Economic Dialogue in Beijing in 2006-2007, worked with the State Department’s Bureau of Arms Control to advance biosecurity in developing nations, and initiated and led the HHS team that developed the first responses to international food safety and importation issues in 2007.

He received his B.A. cum laude from Harvard University, and his J.D. from Columbia University Law School, where he was Senior Editor of the Columbia Law Review. Mr. Hargan also received a Certificate in International Law from the Parker School of Foreign and Comparative Law at Columbia University.

Before returning to Washington, D.C., Mr. Hargan lived in the suburbs of Chicago with his wife, Emily, and their two sons.

About The Author

Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management, disaster and other crisis preparedness and response, and other performance and operations management and compliance. Her experienced includes career long involvement in advising and defending health industry and other organizations about disaster and other crisis preparation, response and mitigation arising from natural and man-made disasters, government enforcement, financial distress, workplace emergencies and accidents, data breach and other cybersecurity and other events. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and publisher disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Centers For Disease Control, Childrens Health Insurance Program, Conditions of Participation, data breach, data security, DEA, Doctor, Electronic Medical Records, EMTALA, FDA, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Insurance Exchange, Health IT, Health Plan, Health Plans, healthcare, HHS, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, managed care, Meaningful Use, Medicaid, Medical Privacy, Medical Records, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, OCR, OIG, Outcomes Data, Outpatient, Peer Review, Pharmaceudical, Pharmacy, Physician, Preexisting Condition Insurance Plan, Prescription Drugs, Privacy, Prospective Payment, Psychiatric, public health, Public Policy, quality reporting, Reimbursement, Reproductive Rights, Rural Health Care, Skilled Nursing Facility, Stark, Substance Abuse, substance abuse treatment, Telemarketing, Telemedicine, Uncategorized, Wellness | Tagged: Affordable Care Act, controlled substance, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Health Care Reimbursement, Health Plans, HEAT, HHS, HIPAA, Hospital, Medicaid, Medicare, OCR, pain management, pharmacist, pharmacy, Physician, Physicians, Privacy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Christus Pays $12.24M Settlement Resolves False Claims Act Charges From “Donations” To New Mexico

September 11, 2017

CHRISTUS St. Vincent Regional Medical Center (St. Vincent) and its partner, CHRISTUS Health (CHRISTUS), have agreed to pay $12.24 million, plus interest to resolve charges by the U.S. Department of Justice (DOJ) and U.S Department of Health and Human Services Office of Inspector General (OIG) they violated the False Claims Act by making illegal donations to county governments that the counties used to fund the state share of Medicaid payments to the hospital. The settlement announced September 1, 2017 highlights the needs for States and private healthcare providers to use care to ensure that creative partnerships don’t violate federal Medicare or other program requirements as well as the risk that the False Claims Act or other whistleblower rules will incentivize disgruntled employees or other service providers to bring aggressive conduct to the attention of federal officials.

The settlement resolves allegations made in U.S. ex rel. Stepan v. Christus St. Vincent Regional Medical Center Corp. et al., Civil Action No. 11-cv-572 (D.N.M.) that St. Vincent and CHRISTUS allegedly caused the State of New Mexico to present false Medicaid claims in violation of the False Claims Act by making non-bona fide donations to the State of New Mexico that New Mexico improperly used to fulfill the requirement that the State pay 25% “matching” share to fund the New Mexico Sole Community Provider Program (SCP) between 2001 and 2009.

Under the now defunct SCP Program, federal law required that New Mexico fund 25% of the costs of the SCP program to qualify for reimbursement from the federal government for approximately 75 percent of its health care expenditures under the SCP program. Under federal law, New Mexico’s 25 percent “matching” share of SCP program payments had to consist of state or county funds, and not impermissible “donations” from private hospitals. Congress enacted this restriction on the use of private hospital funds to satisfy state Medicaid obligations to curb possible abuses and ensure that states have sufficient incentive to curb rising Medicaid costs.

The charges resolved by the settlement originally were brought in a qui tam lawsuit filed by a former Los Alamos County, New Mexico Indigent Healthcare Administrator . The whistleblower will receive $2.249 million as her share of the recovery in this case.

The prosecution and its settlement drive home both the importance for States receiving Medicaid funds and private health care partners providing services to patients reimbursed by these funds to use care to comply with all applicable program requirements, as well as the continuing risk of exposure and resulting liability from whistleblower claims brought by unhappy employees or others looking to use their knowledge of questionable conduct to realize profitable recoveries.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Leave a Comment » | Academic medicine, Anti-KickBack, Conditions of Participation, Corporate Compliance, Employment, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Reform, health care reimbursement, Hospital, Hospital, Medicaid, Uncategorized | Tagged: DOJ, false claims act, Health Care Fraud, HEAT, Medicaid, OIG, St. Vincent Christus, Whistleblower | Permalink
Posted by Cynthia Marcotte Stamer

CMS Proposes Cutbacks To Medicare Bundled Payment Program

August 15, 2017

A Centers for Medicare and Medicaid Services (CMS) proposed rule scheduled for publication in the August 18, 2017 Federal Register will propose to reduce the number of mandatory geographic areas for the joint bundled payment program and cancel the cardiac bundled payment program model for determining reimbursement of providers for care under Medicare as well as make other refinements to the bundled payment program scheduled to take effect in January.

Widely criticized by many providers including department of Health and Human Services Secretary Dr. Tom Price, the mandatory bundled payment program presently is scheduled to take effect in January, 2018 after multiple delays.

According to the advanced copy of the proposed rule released by CMS on August 15, 2017, the proposed rule will propose among other things the following changes to the bundled payment program:

Cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and rescind the regulations governing these models;
Revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model;
Make technical refinements and clarifications for certain payment, reconciliation and quality provisions; and
Increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.

Healthcare providers and others interested in the proposed changes should carefully review the proposed changes and provide feedback as soon as possible and no later than the October 17, 2017 deadline the proposed regulation sets for submitting comments.

About The Author

The author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

An American Bar Foundation, American College of Employee Benefits Counsel, and Texas Bar Foundation Fellow, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management and a broad range of other legal and operational concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.

If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates, publications, training program, advocacy and other initiatives available here.

Go here to register to receive other Solutions Law Press, Inc. updates and announcements about other upcoming briefings, training or other programs, products, services, and activities or to learn more about Solutions Law Press, Inc., its publications, programs and training, PROJECT COPE: Coalition on Patient Empowerment community service and education projects, event management and other resources and services.

For important information concerning this communication see here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Anti-KickBack, billing, Clinical pathway, Conditions of Participation, Consumer Driven Health Care, Corporate Compliance, Doctor, Electronic Medical Records, Evidence Based Medicine, false claims act, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Plan, Health Plans, healthcare, Hospital, Inpatient Rehabilitation Facility, Medicare, Medicare Fee Schedule, OIG, Physician, Prospective Payment, Reimbursement, Uncategorized | Tagged: Affordable Care Act, bundled payment program, CMS, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, HHS, Hospital, Hospitals, Medicaid, Medicare, OIG, physical therapy, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Healthcare Fraud Exposures Significant & Rising For Owners, Execs & Other Leaders

October 17, 2016

Owners, operators, and leaders of health care organizations face an ever-growing imperative to lock down compliance by the organization and its employees and agents both to protect their organizations and its investors and themselves personally against the criminal, civil and administrative sanctions that result when health care organizations or their people break the rules.

The Departmnet of Health and Human Services Office of Inspector General (OIG) and the Department of Justice (DOJ) increasingly are going after owners, operators and other leaders of healthcare organizations for participating in, failing to act to prevent or inadequately investigating and redressing fraud or other illegal conduct in their organizations or by members of their organization’s team. Leaders and owners need to learn the rules and what to do to manage their risk. Owners and leaders must get informed about their expectations and exposures and learn and take the right steps to adopt compliance plans, monitor and enforce compliance, investigate and redress concerns and deal with these responsibilities and risk

The latest slew of federal health care fraud prosecutions reported by DOJ and OIG during the first two weeks of October illustrate some of the risks owners and executives face when they, their organization or employees or agents violate these rules. DOJ and federal regulators like OIG have made clear that they construe these rules to require leaders both to abstain from violating these laws and to adopt and administer effective compliance plans, oversight and other actions to train and prevent their employees and agents from violating these rules. See, e.g., Practical Guidance for Health Care Governing Boards on Compliance Oversight.

Of course, owners and management leaders inevitably face significant financial loss and other fallout if their organizations or members of their teams are found to have violated federal or state health care fraud laws. Over the past decade, however, owners and leaders increasingly also face growing risks of personal prosecution when their organization or someone on their team breaks the rules.

Owners, executives or other leaders who may be tempted to underesktimate the significance of these warnings should note DOJ’s increasingly aggressive and heavy handed prosecution of owners, executives and other leaders who either directly participate in, or by failing to adopt or administer meaningful compliance and investigation practices, are perceived to have allowed, encouraged or facilitated employees or agents to engage in actions hat DOJ, OIG or other federal regulators consider fraudulent.

DOJ’s growing emphasis on holding health care executives accountable for health care fraud or other violations of federal health care and other laws is clearly reflected in the prosecutions and convictions it announced during the first two weeks of October clearly demonstrate the critical need for health care organization owners, officers and other leaders (executives) to safeguard themselves personally, as well as their organizations against becoming targeted or convicted of health care fraud or other violations of federal health care laws by ensuring their organization adopts and administers effective compliance programs and taking other meaningful, well-documented steps , efforts to ensure the effectiveness of these compliance efforts.

Federal criminal and civil health care fraud laws both prohibit owners, operators and executives from participating in or conspiring to violate federal anti-kickback, anti-referral, false claims and other health care fraud laws, as well as provide various mechanisms that impose liability against owners and executives that fail to adopt and administer appropriate compliance, audit and other oversight and enforcement processes and procedures. Since October 1, 2016, for instance, DOJ has announced the following healthcare charges, convictions and settlements involving owners and executives.

On October 4, 2016, a federal judge sentenced Bassem Kuran, the President and owner of Pennsylvania based a VIP Ambulance, Inc 10 months imprisonment followed by three years of supervised release, plus ordered him to pay $66,901.93 in restitution for making false statements to Medicare. See Ambulance Company Owner Sentenced To 10 Months In Prison;
On October 5, 2016, DOJ four California residents that operated Louisiana based Care Concepts, LLC, and California based Choice Home Medical Equipment and Supplies (Choice), Geoffrey and Marla Ricketts and Samuel and Sunyup Kim, are awaiting sentences of up to 10 years in prison, $250,000 fines, restitution liabilities, and three years’ supervised release for their health care fraud convictions relating to a $38 million fraud scheme centering around the distribution of “talking glucose meters” not medically needed and often not even requested. Four Californians Plead Guilty to Conspiracy to Commit Health Care Fraud;
On October 6, 2016, the owner of a medical supply company was sentenced to 60 months in prison for his role in a scheme that fraudulently billed more than $4 million to Medicare. Owner of Los Angeles Medical Supply Company Sentenced to 60 Months in Prison for Multimillion-Dollar Medicare Fraud Scheme;
On October 6, 2016. United States Attorney for the Western District of Missouri Tammy Dickinson and Missouri Attorney General Chris Koster announced the sentencing for federal health care fraud of a Springfield, Mo. man who operated four Family Medical Center clinics in southern Missouri. See Springfield Man Sentenced for Fraud Scheme to Overcharge Medicaid, Medicare at Four Clinics;
On October 6, 2016, DOJ announced the sentencing in federal court of the Los Angeles owner of a medical supply company to 5 years in prison for his role in a scheme that fraudulently billed more than $4 million to Medicare. See Owner of Los Angeles Medical Supply Company Sentenced to 60 Months in Prison for Multimillion-Dollar Medicare Fraud Scheme;
On October 7, 2016, a Tampa, Florida home health agency owner was convicted by a federal jury for her participation in a multimillion-dollar health care fraud and money laundering scheme. Owner of Florida Home Health Agency Convicted in Multimillion-Dollar Health Care Fraud Scheme;
On October 12, 2016, U.S. Attorney Josh J. Minkler announced the indictment of former Chief Executive Officer James Burkhart, former Indiana nursing home chain American Senior Communities (ASC) Chief Operating Officer Daniel Benson, for their alleged roles in a vast fraud, kickback, and money laundering scheme involving ASC. Former American Senior Communities executives indicted;
On October 13, 2016, the U.S. Attorney in Massachusetts announced the agreement of Haverhill-based skilled nursing facility operator Whittier Health Network, Inc., and its Director of Long Term Care, Leo Curtin, to pay $2.5 million to resolve allegations concerning inflated Medicare claims. See Nursing Home Operator and Director of Long Term Care to Pay $2.5 Million to Settle False Claims for Rehabilitation Therapy. See Nursing Home Operator and Director of Long Term Care to Pay $2.5 Million to Settle False Claims for Rehabilitation Therapy; and
On October 14, 2016, a federal district judge in the Northern District of Alabama sentenced the former chief executive of two non-profit health clinics for the poor and homeless to 18 years in prison for funneling millions in federal grant money to private companies he formed to contract with the clinics. See Former Non-Profit Health Clinics CEO Sentenced to 18 Years for Funneling Millions in Grant Money to Private Companies.

Of course, the costs and liabilities of federal criminal or civil investigations and prosecutions are only part of the challenges an organization and its leaders generally face when their healthcare organization or its actions are questioned under federal health care fraud or other laws. Whistleblower or other claims of employees and agents claiming to have been penalized for questioning practices, shareholder or other investor lawsuits, federal program disqualification, loss of position or reputation, the financial and other burdens of responding to and defending investigations and charges and a parade of other horribles that typically attend investigations and prosecutions also often exact a heavy toll on health care organization owners and leaders caught up in federal fraud investigations or prosecutions.

In the face of these growing risks, healthcare owners, executives and other leaders need a clear and up to date understanding of health care fraud laws and the obligations and expectations that these rules create not only for their organizations, but also increasingly them personally. Owners and other leaders need to understand the health care fraud rules, the ways that liability can attach not only to their organization but also themselves and their leaders under these rules, the burdens of proof and assumptions that create special challenges in responding to challenges or defending charges and actions and strategies they should take before, during, and after compliance issue or prosecution arises to strengthen their ability to defend or mitigate their and their organization’s liability exposures. As part of these efforts, owners and leaders not only should ensure that their organization adopt, train staff and others on and meaningfully administer up-to-date compliance programs in a manner that clearly documents the commitment of their organization and its leaders to compliance. Owners, executives and leaders also should become educated about the expectations of DOJ, HHS and other agencies and whistleblowers are likely to expect concerning their role and actions as owners and leaders both in establishing a clear expectation of compliance, as well as adopting, overseeing and enforcing practices and policies to maintain compliance, investigate and redress potential wrongdoing and otherwise maintain the compliance and culture expected and required under federal law. Owners and leaders should ensure that they and others in their organization are trained to recognize potential compliance issues, understand the steps they and their organization need to take when a potential compliance concern arises, and how to conduct and document investigations and other actions to strengthen their and their organization’s ability to defend against potential charges or other claims..

Owners, executives and other leaders also should anticipate, and prepare in advance for the likelihood that they and their organizations will need to respond investigations, suspected violations, whistleblower claims and other events that could create substantial exposure for their organizations and themselves personally. Leaders need to understand that the nature and risks associated with these potential health care fraud liabilities may make ill-advised commonly used settlement or other practices for resolving quickly disputes or other concerns. Owners and leaders bearing these responsibilities should seek specific advice and training about their responsibilities, as well as recommended strategies for investigating and responding to concerns that may carry or give rise to these risks. Most leaders also will want to ensure that their employment, shareholder and other agreements include sufficient flexibility and protections to protect the executive or other leader for termination, retaliation or other loss or injury for taking appropriate steps to investigate and respond to a compliance concern as well as plan in advance by arranging for their organization to provide indemnification, insurance or other coverage, and/or securing personally coverage to provide coverage needed to fund what often may be substantial legal fees arising out of investigation and defense of investigations, charges, or other actions and the corporate, employment and other fallout that often accompanies such events.

About The Author

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also is known for her experience in HIPAA and other privacy and data security and breach concerns. The scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates like the following:

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Clinical pathway, Conditions of Participation, Controlled Substances, Corporate Compliance, data breach, Disease Management, DME, Doctor, E-Prescribing, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Policy, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, hospitals, managed care, Medicaid, Medical Records, Medicare, Medicare Advantage, Medicare Fee Schedule, Money Laundering, Pharmaceudical, Pharmacy, Prospective Payment, Psychiatric, Public Policy, substance abuse treatment, Tax, Uncategorized | Tagged: Board Governance, Compliance, Directors and Officers, false claims act, Federal Sentencing Guidelines, Health Care Fraud, internal controls, Risk Management, STARK | Permalink
Posted by Cynthia Marcotte Stamer

CMS Publishes Final MACRA Rule

October 14, 2016

The Centers for Medicare and Medicaid Services (CMS) has released the 2398 page final rule implementing the Medicare Access & CHIP Reauthorization Act of 2105 (MACRA) reforms that Congress has adopted to replace the Sustainable Growth Rate (SGR) rules for determining physician and other clinician payments under Medicare with the new MACRA Quality Payment Program.

Despite widespread criticism by many physicians and clinicians about the MACRA reforms generally and the proposed regulations implemented in the final rules released today, CMS says the final rule establishes the primary regulatory structure to implement the MACRA reforms in a manner that will replace the current “flawed SGR payment system” with a “Quality Payment Program,” equip clinicians with the tools and flexibility to provide high-quality, and flexibility to provide high-quality, patient-centered care.

The sweeping final rule sets the 2017 performance period as a transition year for the 2019 Merit-Based Incentive Payment System payment year. Ultimately, however, physicians and other clinicians will need to choose between one of two options are having their compensation from Medicare determined under the new Quality Payment Program based on their evaluation of which program best fits their needs based on a thorough understanding and careful evaluation of the complex rules in the final regulations and any refinement to the rules that CMS subsequently issues:

Advanced Alternative Payment Models (APMs) or
The Merit-based Incentive Payment System (MIPS)

If a Clinician decides to participate in an Advanced APM, through Medicare Part B he or she may earn an incentive payment for participating in an innovative payment model.

If the clinician decides to participate in traditional Medicare Part B, then he will participate in MIPS where he earns a performance-based payment adjustment.

In order to position themselves to timely respond to the impending changes, conduct the evaluations necessary to determine which approach is likely to best fit their interests and timely act to submit the data, make elections, implement processes and complete other steps to prepare for and timely comply with the final rule, physicians, clinicians and others impacted by these rules must begin as soon as possible to carefully and systematically become educated about the provisions and terms of the final rule, to modify their processes and procedures to capture the data and administer the billing, coding and other functions necessary to evaluate options, timely submit data and make elections and come into compliance with the requirements of the final rules as they take effect while at the same time positioning themselves to adapt these arrangements in response to additional guidance that CMS and other anticipate will be forthcoming as CMS moves forward to full implementation of MACRA.

Solutions Law Press, Inc. is working to prepare additional summaries and other updates exploring certain key details of the lengthy and highly technical provisions of the final rules, as well as monitoring developments that might impact these rules. Stay tuned here for more details.

About The Author

Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates like the following:

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, billing, Centers For Disease Control, Clinical pathway, Conditions of Participation, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, HITECH Act, Home Health, Hospice, Hospital, Hospital, hospitals, Medicaid, Medicare, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

Tenet To Pay $513M For Anti-kickback Law Guilty Plea

October 3, 2016

Tenet Healthcare Corp. and two of its hospitals will pay $513 million and enter guilty pleas to resolve criminal charges and civil claims the hospitals illegally paid kickbacks for patient referrals, the U.S. Department of Justice Announce on Monday, October 2, 2016.

Atlanta Medical Center Inc. and North Fulton Medical Center Inc. were charged October 2 in a criminal information in federal court in Atlanta with conspiracy to defraud the United States by obstructing the lawful government functions of the Department of Health & Human Services (HHS) and to violate the Antikickback Statute (AKS), which, among other things, prohibits payments to induce the referral of patients for services paid for by federal health care programs.

Tenet HealthSystem Medical Inc. and its subsidiaries (collectively THSM) entered into a non-prosecution agreement (NPA) with the Criminal Division’s Fraud Section and the U.S. Attorney’s Office of the Northern District of Georgia related to the charges in the criminal information. THSM is the parent company of Atlanta Medical Center Inc., North Fulton Medical Center Inc., Spalding Regional Medical Center Inc. and Hilton Head Hospital, and employed their executives. THSM is a subsidiary of Tenet Healthcare Corporation. Under the terms of the NPA, THSM and Tenet will avoid prosecution if they, among other requirements, cooperate with the government’s ongoing investigation and enhance their compliance and ethics program and internal controls. Tenet has also agreed to retain an independent compliance monitor to address and reduce the risk of any recurrence of violations of the AKS by any entity owned in whole, or in part, by Tenet. The term of THSM’s and Tenet’s obligations under the NPA is three years, but the NPA may be extended for up to one year. the plea deal announced, the two Tenet subsidiaries have agreed to plead guilty to the charges alleged in the criminal information and will forfeit over $145 million to the United States – which represents the amount paid to Atlanta Medical Center Inc. and North Fulton Medical Center Inc. by the Medicare and Georgia Medicaid programs for services provided to patients referred as part of the scheme.

In the concurrently announced civil settlement, Tenet agreed to pay $368 million to the federal government, the state of Georgia and the state of South Carolina to resolve claims asserted in United States ex rel. Williams v. Health Mgmt. Assocs., Tenet Healthcare, et al., a lawsuit filed by Ralph D. Williams, a Georgia resident, in the Middle District of Georgia, under the federal and Georgia False Claims Acts. The acts permit whistleblowers to file suit for false claims against the government entities and to share in any recovery. The federal share of the civil settlement is $244,227,535.30, the state of Georgia will recover $122,880,339.70 and the state of South Carolina will recover $892,125. Mr. Williams’ share of the combined civil settlement amount is approximately $84.43 million.

The Tenet investigations, enforcement actions and settlement demonstrate the continuing criminal and civil risks that health care organizations, individual providers and their employees and representatives run when engaging in aggressive marketing, billing or other practices under the Anti-kickback or other Federal health care fraud laws, as well as the role that employee and other whistleblowers with inside information often play in bringing actions and behaviors that provide the basis for prosecution of these and other charges or claims against healthcare organization and the health care providers, management and other individuals participating in or responsible for managing conduct to comply with these rules.

Health care organizations, their management, providers, and others participating in the planning, administration or oversight of transactions or other activities that could become subject to scrutiny or prosecution under these and other Federal or state healthcare laws should act proactively to manage their risks by using care to adopt and administer documented effective compliance plans and processes that prevent involvement in prohibited actions, to periodically conduct documented audits and other oversight to maintain demonstrated efforts to ensure their organizations and actions in operations comply with these requirements, continuously remain on the alert for and monitor transactions and arrangements in which they are involved for signs of potential violations or other risky conduct, to take prompt, well-documented corrective action to investigate and address as appropriate potential concerns including but not limited to the monitoring and investigation of employee complaints, performance, termination and other events for evidence of potential whistleblower or other concerns.

About The Author

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates like the following:

Leave a Comment » | Ambulatory care, Anti-KickBack, ASC, billing, Corporate Compliance, Doctor, Employer, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Policy, Hospital, hospitals, Medicaid, Medicare, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

OIG Modifies Past Ruling, Blesses Two New Medicare Co-Pay Financial Programs

January 4, 2016

Healthcare providers interested in or offering financial assistance with co-pays or other out-of-pocket charges to Medicare or Medicaid patients should review carefully two new and one modified opinion just published by the Department of Health and Human Services Office of Inspector General (OIG).

OIG generally interprets federal healthcare fraud laws as prohibiting healthcare providers from paying for or providing financial assistance with co-pay or other out-of-pocket costs for Medicare or Medicaid beneficiaries unless the arrangement Falls then an exemption approved by OIG.

In recent years the OIG increasingly has approved certain nearly defined co-pay or other financial assistance for him arrangements in a series of specific opinion letters. The three Advisory Opinions released today are the latest of these opinions. See Advisory Opinion 15-17 at http://go.usa.gov/c5ekz; Advisory Opinion 15-16 at http://go.usa.gov/c5e8C; and Modification of Advisory Opinion 06-04 http://go.usa.gov/c5e8W.

Healthcare providers reading these opinions must keep in mind the opinions only protect the parties who receive that opinion; other parties interested in offering financial assistance to Medicare or Medicaid beneficiaries with copayments or other out-of-pocket costs must get the OIG to issue them an opinion specifically blessing their proposed arrangement before moving forward to avoid risking triggering fraud enforcement.

While non parties cannot rely n opinions issued to others, health care providers offering or considering offering financial assistance carefully should review the guidance published in these opinions as a roadmap for designing and operating their own arrangements. Guidance in these opinions helps identify key criteria for qualification and enforcement.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years of experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

Examples of some of these recent health care related publications include:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Anti-KickBack, DME, Doctor, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, health care reimbursement, Home Health, Hospice, Hospital, Hospital, hospitals, Medicaid, Medicare, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Money Laundering, Nonprofits, OIG, Outpatient, Pharmacy, Physician, Prescription Drugs, Stark, Uncategorized | Tagged: Fianancial Assistance, Fraud & Abuse, Health Care Fraud, OIG, Rebate, STARK | Permalink
Posted by Cynthia Marcotte Stamer

Health Care Fraud Prosecutions Target Owners, Operators & Other Leaders

December 11, 2015

Lengthy prison sentences imposed against the five former owners and operators convicted or having plead guilty to involvement in health care fraud schemes carried out by their various health care organizations in the first 10 days of December drive home the growing effectiveness of the Departments of Justice, Health & Human Services and other federal state agencies at investigating and prosecuting health care fraud. Owners, operators and other leaders of health care organizations should administer well documented health care fraud compliance and other defensive actions to avoid becoming one of these lessons as a result of their involvement with their own organizations.

Mississippi Hospice Owner Gets 36 Months

On December 4, 2015; U.S. Attorney; Northern District of Mississippi that the owner-operator of Millstone Hospice in Grenada, Mississippi, Sandra Livingston on January 25, 2016 will begin serving a 36 month prison sentence imposed by a Federal judge on December 3, 2015 as part of her punishment for her health care fraud conviction. In addition to her prison sentence, Ms. Livingston also must serve three years of supervised release and pay $1,098,639 in restitution to the Medicare program.

Ms. Livingston previously pled guilty on July 30, 2015 to conspiracy to commit healthcare fraud in violation of 18 U.S.C. §§ 1347 & 1349. Ms. Livingston admitted that while she owned and operated Milestone Hospice in Grenada, Mississippi, Millstone Hospice used patient recruiters to solicit patients that were not hospice appropriate and then received more than $1 million of Medicare payments for fraudulent charges for these services submitted to Medicare. In announcing the sentence, Donald Alway, Special Agent in Charge of the FBI in Mississippi said “This scheme is particularly sickening because the defendant charged Medicare over a million dollars in services for “treating” folks who have no idea they were on hospice because they weren’t at the end of the lives.”

Ms. Livingston’s conviction is the third conviction as part of a joint effort by the United States Attorney’s Office, the U.S. Department of Health and Human Services Office of Inspector General, the Federal Bureau of Investigation, the Mississippi Attorney General’s Medicaid Fraud Control Unit and targeting fraudulent hospice providers who have billed Medicare and Medicaid for medically unnecessary services.

Southern California Ambulance Company Owners & Management Combined 168 Months Sentence

Following the Livingston sentencing, the Justice Department on December 7, 2015 announced the sentencing of the former owner, operator and managers of a Southern California ambulance company for their role in a fraud scheme that resulted in more than $1.5 million in fraudulent claims to Medicare.

U.S. District Judge S. James Otero of the Central District of California sentenced Yaroslav Proshak, aka Steven Proshakof Valley Village, California to serve 108 months in prison. On December 2, 2015, Judge Otero sentenced Emilia Zverev of Van Nuys, California; and Sharetta Michelle Wallace of Inglewood, California, to serve 36 months and 24 months in prison, respectively. In addition to their prison terms, Judge Otero ordered Zverev and Wallace to pay restitution jointly and severally with Proshak in the amount of $804,755.

The sentences are imposed for health care fraud convictions obtained last summer. On August 18, 2015 a federal jury in Los Angeles convicted Proshak, Zverev and Wallace of one count of conspiracy to commit health care fraud and five counts of health care fraud. Zverev and Wallace worked for ProMed Medical Transportation, an ambulance transportation company owned and operated by Proshak in the greater Los Angeles area that provided non-emergency services to Medicare beneficiaries, many of whom were dialysis patients. Zverev was the billing manager and Wallace supervised the ProMed EMTs.

The evidence at trial showed that between May 2008 and October 2010, the defendants conspired to bill Medicare for ambulance transportation services for individuals that did not need such services. The defendants also instructed ProMed EMTs to conceal the patients’ true medical conditions by altering paperwork and creating fraudulent documents to justify the services. During the course of the conspiracy, ProMed submitted at least $1.5 million in false and fraudulent claims to Medicare for medically unnecessary transportation services; Medicare paid at least $804,755 on those claims.

Pharmacy Owner Gets 108 Months Sentence

Subsequently on December 10, 2015, the Justice Department announced that U.S. District Judge Donald M. Middlebrooks sentenced Daniel Suarez to 108 months in prison, followed by three years of supervised release and ordered Suarez to pay $20,988,632 in restitution for pleading guilty to one count of conspiracy to commit health care fraud and wire fraud, in violation of Title 18, United States Code, Section 1349.

According to the court record, Suarez and his co-conspirators were the owners of eight separate pharmacies that submitted and caused the submission of false and fraudulent claims to Medicare that they provided pharmaceutical drugs pursuant to properly written prescriptions when, in fact, such items were not properly prescribed or actually provided to Medicare beneficiaries. This fraud was accomplished in part by the use of a number of patient recruiters who received kickbacks in return for referring Medicare Part D beneficiaries to the eight separate pharmacies that Suarez controlled. These patient recruiters then purchased the prescriptions for the medically unnecessary pharmaceutical items that the pharmacies billed to Medicare. Suarez placed the pharmacies he controlled in the names of co-conspirator family members. In total, Suarez and his co-conspirators submitted and caused the submission of more than $20 million in false claims to the Medicare Part D program. Suarez used the fraudulently obtained proceeds to benefit himself and his family, including the purchase of luxury automobiles (i.e.: a Rolls Royce Ghost, Bentley, Range Rover and Mercedes Benz S63 AMG).

Like the lengthy and ever growing list of convictions and sentencings of other owners, operators, management, marketing representatives and others charged with involvement in health care fraud, these sentences drive home the commitment and effectiveness of the Justice Department, the Department of Health & Human Resources Office of Inspector General, and other federal and state agencies to investigating and prosecuting health care organizations and their leaders or others acting on their behalf to inappropriately bill or otherwise defraud Medicare, Medicaid or other federal health care programs. These convictions and settlements are intended to and should send a strong message to other health care organizations and their owners, leaders and other representatives about the need to exercise care to avoid wrongful or questionable billing for health care services. As reflected in these prosecutions and sentences, health care organizations found guilty of engaging in health care fraud can expect crippling if not fatal restitution requirements, Medicare and other federal program participation exclusion and other serious consequences. However, these stiff organizational sanctions pale to the prison sentences, program exclusion, restitution and other punishment that individual owners, operators, management, and marketing or other staff generally incur when convicted of these schemes. In light of the heavy handed interpretation and enforcement of federal and state health care fraud rules, health care organization owners, operators, and others involved in the marketing, billing, delivery, recruitment or other elements of health care billed to Medicare, Medicaid or other public or private health care programs should exercise care both to verify that their practices comply with applicable requirements and that they carefully preserve the necessary documentation and other evidence to defend the actions of themselves and their organizations.

With health care fraud enforcement a key component of the federal government’s efforts to bring down health care costs and the continuing success of federal and state health care fraud investigation and enforcement efforts like those already achieved by the Justice Department against the 12 defendants that already pleaded guilty, health care providers providing substance abuse or other treatments reimbursed by federal or state programs should must ensure that their care and billings are appropriately delivered and documented to withstand almost inevitable government scrutiny of their operations and activities.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Other Helpful Resources & Other Information

Examples of some of these recent health care related publications include:

Leave a Comment » | Anti-KickBack, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Home Health, Hospice, Hospital, hospitals, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

Health Care Providers, Provide ACO, Reimbursement Reform Input To HHS

March 2, 2015

Physicians, nurses, hospitals and other health care providers, patients and others concerned about health care reimbursement and other health care reforms in the United States should sign up and participate in the new Health Care Payment Learning and Action Network (“Network”) the Department of Health and Human Services (HHS) is creating to help shape ongoing reform of the US health care delivery system to promote better care, smarter spending, and healthier people through the expansion of new health care payment models and other reforms. HHS is inviting private payers, employers, providers, patients, states, consumer groups, consumers, and other partners within the health care community to register here to participate in the Network activities including kickoff event scheduled for Wednesday, March 25, 2015.

HHS hopes cooperation through the Network will help the entire U.S. health care system match and exceed the following HHS goals for Medicare:

Tying 30 percent of payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and
Tying 50 percent of payments to alternative payment models by the end of 2018. The Network will also support the broader goal of tying the vast majority of payments in the health care system to quality or value.

As HHS moves forward to promote ACOs and other reforms, it is particularly important that providers and patients provide feedback and input about the goals and ideas HHS is promoting as solutions for “improving” health care. While HHS often touts consolidation of care into ACOs and other reimbursement strategies using government generated standards of quality as the best means of improving quality and cost-effectiveness, many patients, providers and others worry that HHS ACO and other reimbursement reforms as presently implemented or contemplated by HHS cut costs at the expense of patients by denying reimbursement or other access for effective care options based on cost or ignore other patient needs in the name of cost savings. Active, consistent participation in these and other opportunities for input is critical for those concerned about these and other issues to question and shape the goals, assumptions and actions HHS, Congress and others take to change the U.S. health care system.

HHS says most Network meetings will occur virtually by teleconference or webinar. In-person meetings will occur in the Washington D.C. area. HHS plans to hold the first live streaming of the kickoff event on Wednesday, March 25, 2015. HHS will share details through e-mails to those registered online to participate in the network. Individuals and organizations concerned about ACO and other HHS-lead health care reforms are urged to register and participate in the Network as one of the ways to help monitor and shape health care reform as lead by HHS.

About Project COPE: The Coalition On Patient Empowerment & Coalition on Responsible Health Policy

Do you have feedback or other experiences to share about medical debit, ACA or other health care challenges? Have ideas for helping improve our system, helping Americans cope with these and other health care challenges or other health care matters? Know other helpful resources or experiences that you are willing to share? Are you concerned about health care coverage or other health care and disability issues or policy concerns? Join the discussion and share your input by joining Project COPE: Coalition for Patient Empowerment here.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these needs is the purpose of

The Coalition and its Project COPE are founded and operate based on the belief that health care reform and policy must be patient focused, patient centric and patient empowering. The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up: Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can. Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process. Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist. The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye. Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families. While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining Project COPE: Coalition for Patient Empowerment here by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

Examples of some of these recent health care related publications include:

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Border Health, Centers For Disease Control, Conditions of Participation, Consumer Driven Health Care, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, FDA, Federal Health Center, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Policy, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, OIG, Outcomes Data, Patient Empowerment, Pharmacy, Physician, Prospective Payment, Public Policy, Rural Health Care, Stark, Telemedicine | Permalink
Posted by Cynthia Marcotte Stamer

Community Health Systems Professional Services Corporation & 3 Affiliated NM Hospitals Agree to $75 Million False Claims Act Settlement

February 3, 2015

Franklin, Tennessee based Community Health Systems Professional Services Corporation (CHSPSC) and three of its New Mexico affiliate hospitals- Eastern New Mexico Medical Center in Chaves County, Mimbres Memorial Hospital and Nursing Home in Luna County and Alta Vista Regional Medical Center in San Miguel County (collectively CHS) will pay the United States $75 million to settle Justice Department allegations that CHS violated the False Claims Act by illegally donating funds to county governments to use to fund the 25 percent “matching share” of the now discontinued New Mexico Sole Community Provider (SCP) program. The Justice Department action and resulting settlement highlight both the rising role of whistleblowers in helping Federal and state officials uncover potential False Claims Act or other health care fraud allegations and the Federal government’s continuing commitment to investigate and prosecute health care fraud charges against hospitals and other health care providers.

The Justice Department announced on February 3, 2015 that CHS had agreed to settle charges made by the Justice Department in United States ex rel. Baker v. Community Health Systems Professional Services Corporation, et al., Civ. Action No. 05-279 (D. N.M.). , that CHS violated the False Claims Act by providing illegal donations to New Mexico to use to pay its required portion of the SCP funding.

The New Mexico SCP program provided supplemental Medicaid funds to hospitals in mostly rural communities using a mix of federal and state funding. Under the program, the federal government reimbursed the state of New Mexico for approximately 75 percent of its health care expenditures under the SCP program provided that New Mexico provide state or county funds, and not impermissible “donations” from private hospitals, to fund the remaining 25 percent “matching” share of SCP program payments. Congress enacted the prohibition against the use of private hospital funds to fund the state’s required matching share of SCP program payments to curb possible abuses and ensure that states have sufficient incentive to curb rising Medicaid costs.

According to the Justice Department, CHS violated the False Claims Act from August 1, 2000 to December 31, 2010, by knowingly causing the state of New Mexico to present false claims to the United States for payments made to CHS under the SCP program by making improper donations to Chaves, Luna and San Miguel counties, which were then used by the counties, and later the state, to obtain federal matching payments. The government alleged that CHS concealed the true nature of these donations to avoid detection by federal and state authorities. The Justice Department additionally claimed that as a result of its scheme, CHS received SCP payments which were funded by the United States in the amount of three times CHS’ “donations.”

The prosecution leading to the settlement provides yet another example of the role of whistleblowers in helping the governing identify and prosecute fraud. The False Claims Act qui tam rules allow individuals to bring a lawsuit on behalf of the government and to share in the proceeds of the suit. The act also permits the government to intervene in and take over the lawsuit, as it did in this case as to some of Baker’s allegations. The United States did not intervene in Baker’s allegations as to SCP payments made to two other affiliated New Mexico hospitals, Carlsbad Medical Center and Lea Regional Medical Center. Today’s settlement also resolves these other allegations. Baker will receive $18,671,561 as his share of the government’s recovery.

In addition, the action and its settlement also affirms the Federal government’s continuing commitment to find and prosecute health care providers that it perceives violate the False Claims Act or other Federal health care fraud laws.

“Congress expressly intended that states and counties use their own money when seeking federal matching funds in order to encourage them to join the federal government in ensuring that Medicaid funds are spent on the needs of beneficiaries,” said Acting Assistant Attorney General for the Justice Department’s Civil Division Joyce R. Branda. “When private hospitals violate the rules against hospital donations funding the state share, that important protection of the Medicaid program is destroyed.”

“Hospitals that make provider donations with the expectation that they will receive a windfall from the Medicaid program threaten the integrity of the Medicaid program and will be held accountable,” said Special Agent in Charge Mike Fields for the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) Dallas region.

In the face of these continuing investigations and prosecutions, health care providers should continue to diligently work to comply with the False Claims Act and other federal and state health care fraud laws by tightening their internal controls and other compliance programs. As a key element of these efforts, health care providers should ensure that their human resources and other management carefully monitor employee, contractor and vendor complaints, concerns and other communications for potential signs of compliance concerns, retaliation or other indicators of the need to intervene to correct potential violations or other risks.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

Use New State Ebola Protocol Table In Ebola Prevention & Management Planning
Unpatched and Unsupported Software Triggers Latest HIPAA Security Breach Resolution Agreement
Congress Sends Bill To Fast Track FDA Ebola Treatment Review & HHS Declaration Gives Ebola Treatment Manufacturers Special Immunity
Former Center Texas Medical Center CFO Faces 5 Years After Guilty Plea To EHR Incentive Fraud Reminder To Manage Incentive Compliance
Preparing Privacy Compliance For Emergencies-Ebola Crisis Prompts HHS OCR To Share Guidance On HIPAA Privacy in Emergency Situations
IRS Issues Ebola-Related Tax Relief
Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants
OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases
10/10 Kidney Foundation Professional Symposium Offers 7.5 Hours CME/CEUs
Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle
Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement
Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts
CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule
Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors
Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants
OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases
Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle
Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement
Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts
CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule
Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements
Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years
Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date
NLRB Helps Union Force Another Health Care Employer To Recognize & Bargain With Union
Federal Health Care Fraud Enforcement Recouped Record $4.3 Billion in FY 2013
Former Houston Texas Physician Gets 70 Month Prison Sentence For Fraud Conviction
Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims
Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action
Medical Identity Theft/Fraud Convictions Highlight Need For Health Care Providers To Safeguard Health Information, Guard Against Fraud Schemes
Detroit-Area Foot Doctor Pleads Guilty to Medicare Fraud Scheme
Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges
Texas Physicians Get New Option For Resolving Some Medical Board Complaint
Broad-Reaching Prosecution Of Individuals Participating In Operations Of Companies Convicted Of Fraud Shows Risks Of Participation
Hospitals Can Expect CMS To Add Hospital Incident Reporting To Surveys In Response To OIG Report
Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians
DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing Functions, Urges Adoption of Written Policies & Agreements
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.

Leave a Comment » | Anti-KickBack, false claims act, Federal Health Center, Health Care Finance, Health Care Provider, Uncategorized | Tagged: false claims act, Health Care Fraud, OIG | Permalink
Posted by Cynthia Marcotte Stamer

Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years

April 4, 2014

Yesterday’s announcement of the exclusion of the operator and manager of the national dental chain, Small Smiles Dental Centers, from exclusion in Medicaid, Medicare and other federal health programs highlights the risks health care providers run by failing to comply with a Corporate Integrity Agreement.

Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services, announced April 3, 2014 that the operator and manager of the Small Smiles Dental Centers, CSHM, LLC (formerly known as FORBA Holdings and Church Street Health Management (CSHM), has signed an Exclusion Agreement that bars CSHM from participating in Medicare, Medicaid, and all other Federal health care programs for 5 years. Small Smiles Dental Centers provides services primarily to children on Medicaid.

Mr. Levinson said that this exclusion “makes clear to the provider community that OIG closely monitors our CIAs, critically evaluates providers’ representations and certifications, and will pursue exclusion actions against providers that fail to abide by their integrity agreement obligations.”

According to the announcement, the exclusion is based on CSHM’s alleged material breaches of its Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG).

CSHM’s corporate predecessor entered into the CIA in 2010, as part of the resolution of a False Claims Act case involving allegations that the company had provided dental services to children on Medicaid that were medically unnecessary or failed to meet professionally recognized standards of care.

On March 7, 2014, OIG issued a Notice of Exclusion to CSHM based upon numerous material breaches of its obligations under the CIA. CSHM failed to report serious quality-of-care reportable events, take corrective action, or make appropriate notifications of those events to the State dental boards as required by the CIA, OIG found. CSHM also failed to implement and maintain key quality-related policies and procedures, comply with internal quality and compliance review requirements, properly maintain a log of compliance disclosures, and perform training as required by the CIA. Finally, CSHM submitted a false certification from its Compliance Officer regarding its compliance with CIA obligations.

This exclusion marks the culmination of a series of alleged failures by CSHM and its corporate predecessors to comply with its CIA. Under the CIA, an independent quality monitor conducted more than 90 site visits and reviews to monitor CSHM’s compliance. Since the 2010 settlement, OIG repeatedly cited CSHM and took actions to address those violations, promote improved compliance, and maintain access to care for an underserved population. These actions included imposing financial penalties and forcing the divestiture of one of the company’s clinics.

Despite these actions, CSHM remained in material breach of its CIA and OIG issued Notices of Intent to Exclude to the company in December 2013 and January 2014. In such cases, providers get the chance to show OIG that they have cured, or are in the process of curing, the material breaches. CSHM represented to OIG that it would cure the material breaches. However, through meetings with CSHM and its Board of Directors and review of its written submissions, OIG determined that CSHM had failed to cure the material breaches and proceeded with the exclusion.

CSHM disputed OIG’s determination that it was in material breach of the CIA. However, under the Exclusion Agreement, CSHM now has waived its objections to these findings.

To minimize immediate disruption of care to the hundreds of thousands of children treated at CSHM clinics and to enable an orderly, controlled shutdown of the company or divestiture of its assets, the exclusion takes effect September 30, 2014. CSHM waived its right to appeal this exclusion in any judicial forum.

Until the exclusion goes into effect on September 30, 2014, an independent monitor will continue to monitor the quality of care being provided to patients at CSHM clinics. CSHM is required to inform patients at least 30 days before closing a clinic. CSHM is also required to keep State Medicaid agencies abreast of developments and provide monthly status reports to OIG. Any divestiture of assets by CSHM must be through bona fide, arms-length transactions to an entity that is not related to or affiliated with CSHM.

Beyond the implications for Small Smiles Dental Centers, the announced exclusion carries important implications for other health care providers. First, of course, the exclusion means that Small Smiles Dental Centers and CSHM as excluded providers are ineligible for hiring by other providers participating in Medicare or other Federal Health Programs. Second, the exclusion also highlights the advisability for other providers covered by CIAs not only to see to comply with their CIA and in the event the OIG questions of the adequacy of that compliance to look for opportunities to work with OIG to rectify alleged concerns as cooperatively as possible unless a high degree of certainty that the provider can prove that OIG’s concerns are unfounded.

For More Information Or Assistance

Board Certified in Labor & Employment Law, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters.

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Federal Health Program Exclusion, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

APDerm To Pay $150k To Settle 1st HIPAA Breach Rule Charges

December 27, 2013

A new settlement agreement announced by the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) shows health plans, health care providers, health care clearinghouses and their business associates the perils of failing to properly implement the necessary policies and procedures to comply with the breach notification requirements added to the Health Insurance Portability & Accountability Act of 1996 (HIPAA) added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 (ARRA).

APDerm Settlement Overview

Private dermatology practice, Adult & Pediatric Dermatology, P.C., (APDerm) has agreed to pay $150,000 and implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules. The APDerm Settlement marks the first settlement with a covered entity for not having policies and procedures in place to address the breach notification provisions of the HITECH Act.

According to its December 26, 2013 announcement of the settlement, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) opened an investigation of APDerm upon receiving a report that an unencrypted thumb drive containing the electronic protected health information (ePHI) of approximately 2,200 individuals was stolen from a vehicle of one its staff members. The thumb drive was never recovered. The investigation revealed that APDerm had not conducted an accurate and thorough analysis of the potential risks and vulnerabilities to the confidentiality of ePHI as part of its security management process. Further, APDerm did not fully comply with requirements of the Breach Notification Rule to have in place written policies and procedures and train workforce members.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

The APDerm settlement provides more evidence of the growing exposures that health care providers, health plans, health care clearinghouses and their business associates need to carefully and appropriately manage their HIPAA responsibilities. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website. It joins the growing list of settlement or resolution agreements under HIPAA announced by OCR.

The APDerm also is notable both as it settles the first ever charges against a covered entity for failing to adopt required Breach Notification policies and procedures and the relatively most settlement payment required in comparison to other announced settlement. Other settlements have been significantly higher. For instance, OCR required that Blue Cross Blue Shield of Tennessee (BCBST) to pay $1.5 million to resolve HIPAA violations charges.

In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s audit, investigation and enforcement actions, emerging litigation and other enforcement data, their own and reports of other security and privacy breaches and near misses, evolving rules and technology, and other developments to determine if additional steps are necessary or advisable. For tips, see here.

For Representation, Training & Other Resources

If you need assistance monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: Breach Notification, DOJ, Health Care, Health Care Fraud, HIPAA, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Reminder To Follow Confidentiality, Due Process When Conducting Peer Revew & Credentialing

December 16, 2013

Hospitals, physicians, health plans and others participating in credentialing and peer review activities need to use care to ensure that they and others involved in these matters understand and comply with the confidentiality requirements of the Health Care Quality Improvement Act and similar state laws.

Hospitals and their medical staffs, physician and other practice groups and other health care organizations commonly require or query the National Practitioner Data Bank (NPDB) established under HCQIA and other sensitive professional and personal when checking the backgrounds and credentials of physicians seeking admission to the medical staff, employment, staff privileges, participation in provider panels or other positions. These health care organizations and providers also frequently may receive inquiries from other health care providers or organizations seeking information about a provider who is applying for admission, employment or other status. Finally, medical staffs, practices and other health care organizations from time to time may conduct credentialing, peer review or other disciplinary activities, or quality assurance reviews that may involve the discussion of information about the conduct, quality, discipline or other credentials and qualifications of current or former physicians at their own or another health care organization.

The investigation or discipline of a physician and certain other information regarding potential performance or credentialing concerns about a physician or other health care worker often by necessity involves the receipt, sharing, or use of sensitive professional or personal information with credentialing, management, medical staff leadership or others involved in the investigation, review or process. When participating in any of these activities, all parties involved in the activities or providing input or participation in their conduct need to understand and be required to comply fully with all applicable confidentiality and privacy requirements. While participants in these processes often may feel great temptation to circumvent formal processes in the name of expediency, to share sensitive insight with special relationships or other inducements to cut corners on confidentiality, the participants in these activities and the organizations conducting the activities should take all necessary steps to ensure that the participants carefully comply with the confidentiality and privacy requirements and only obtain and share information as allowed by and in accordance with the procedures established by these rules.

The background check rules of the Fair Credit Reporting Act (FCRA) generally require that health care organizations, as well as other businesses, conducting background check or other investigations using third party data or investigators comply with the notice, consent and disclosures of the FCRA. Parties requesting or providing information as part of a credentialing, peer review or other investigation should ensure that the necessary disclosures, notices and consents have been obtained before requesting or sharing information. The fulfillment of these requirements should not be assumed as experience demonstrates that these requirements are commonly overlooked by many health care and other organizations engaged in these activities.

In addition to meeting the FCRA, HCQIA, most state peer review, and medical staff bylaws generally require that credentialing, peer review, quality assurance, and other performance and discipline activities be conducted in accordance with carefully prescribed rules, including specific requirements concerning the protection of the confidentiality of information about a provider. While relatively rare, violation of HCQIA’s confidentiality rules can create significant liability. For instance, after it self-disclosed conduct to the Department of Health & Human Services Office of Inspector General (OIG), The Queen’s Medical Center (QMC), Hawaii, agreed to pay $150,500 in civil money penalties for allegedly violating the NPDB in 2009.

Beyond the rare sanctions under HCQIA, failing to following the rules of HCQIA and state laws can undermine the defensibility of peer review and credentialing decisions by undermining the ability of participants in the process to rely upon the peer review privilege to protect deliberations and discussions conducted in connection with the peer review and credentialing process from discovery, as well as by providing evidence of bad faith, malice or other bad motivation or acts corrupted the process and determination. Beyond hurting the defensibility of the credentialing and peer review process, violations of confidentiality or other procedures often also give rise to antitrust, defamation, invasion of privacy, tortious interferences, and other damage claims by physicians who feel their ability to practice and reputations have been injured by alleged improper conduct in connection with a peer review, credentialing or quality assurance process.

Beyond avoiding giving rise to claims by the targeted physician or other health care provider, all participants in these processes also need to use care to properly protect any individually identifiable patient information. Records and information about a patient, his medical condition, payment history and other related patient data and information often involved in these activities typically qualifies as personal health information, the use, access, and disclosure of which is restricted by the Privacy Rules of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and state common law, HIPAA and other medical records privacy and confidentiality laws. In addition to the specific requirements of HIPAA and other medical information privacy laws, patient financial information and certain other sensitive information also may be protected by a broad range of federal and state laws protecting personal financial and other sensitive personal information, contractual rights created by privacy policies of the organizations involved or other laws.

Conducting proper credentialing, peer review and quality assurance activities is a critical aspect of the hiring and oversight of physicians and others providing care. As important as these requirements are, health care providers and organizations participating in these activities need to remember that the physicians who are subjected to these requirements also enjoy confidentiality, due process and other legal protections, which can create significant liability when violated. Consequently, health care organizations, physicians and members of management, and other staff and participants should use care to follow the proper procedures to ensure that physician rights to confidentiality, due process and other protections are honored as these activities are conducted.

Using care when discussing these concerns is equally important for a physician or other health care provider who is the subject of an investigation, credentialing, peer review, quality assurance or other activity. While a physician whose personal or professional conduct or credentials are questioned understandably feels a strong urge to defend him or herself through a campaign of communication or other actions, physicians on the receiving end also need to follow the process and restrict their discussions.

Cynthia Marcotte Stamer, for additional information or representation.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: CMS, compensation, DOJ, E-Prescribing, Fee Schedule, Health Care, Health Care Fraud, Home Care, home health, medical expense, Medicare, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Physician Fee Schedule, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

CMS Gives Providers Facing Fee Schedule Reduction For Unsuccessful EPrescribing Can Request Review Until 2/28

December 16, 2013

Physicians and other eligible professionals and group practices (who self-nominated for the 2012 and/or 2013 Electronic Prescribing (eRx) group practice reporting option) who were unsuccessful electronic prescribers under the 2012 or 2013 eRx Incentive Program can expect to receive notification from the Centers for Medicare & Medicaid Services (CMS) plans that CMS will have their 2014 eRx payment adjusted to 98.0% of his or her otherwise applicable Medicare Part B physician fee schedule (PFS) allowed charges amount for the specified services for all charges with dates of service from January 1–December 31, 2014.

Providers receiving these notices may wish to request a review of this planned adjustment under an informal review process for the 2014 eRx payment adjustment implemented by CMS. An informal review may be requested if the eligible professional or group practice receives notification from CMS confirming they will be subject to the 2014 eRx payment adjustment or they did not meet the requirements to avoid the 2014 eRx payment adjustment. CMS will accept nformal review requests through February 28, 2014.

Eligible professionals and group practices should submit their eRx informal review request via email to the informal review mailbox at eRxInformalReview@cms.hhs.gov.

Complete instructions on how to request an informal review are available in the 2014 eRx Payment Adjustment Informal Review Made Simple educational document.

Physicians or other health care providers who have questions about these or other e-prescribing or reimbursement concerns may contact the author of this update, Cynthia Marcotte Stamer, for additional information or representation.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: CMS, compensation, DOJ, E-Prescribing, Fee Schedule, Health Care, Health Care Fraud, Home Care, home health, medical expense, Medicare, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Physician Fee Schedule, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Update Mileage Reimbursement Policies, Communications For IRS 2014 Mileage Rates

December 10, 2013

Health care organizations should review the updated optional standard mileage rates and maximum standard automobile costs for purposes of claiming certain automobile allowances during 2014 recently released by the Internal Revenue Service (IRS) to determine and make the necessary arrangements to communicate and implement any changes in the rates that their business plans to use to reimburse employees and others for mileage. In addition, health care organizations also may want to consider sharing information about the updates to medical expense mileage reimbursement rates and other aspects of those rules in newsletters or other marketing communications to help empower those patients and their families to understand and use the new rates and rules to properly claim deductions that their families qualify for on their 2014 tax return for mileage incurred traveling for medical care.

Notice 2013-80, which is scheduled for official publication in Internal Revenue Bulletin 2013-52 on December 23, 2013, provides the optional 2014 standard mileage rates for taxpayers to use in computing the deductible costs of operating an automobile for business, charitable, medical or moving expense purposes. This notice also provides the amount taxpayers must use in calculating reductions to basis for depreciation taken under the business standard mileage rate, and the maximum standard automobile cost that may be used in computing the allowance under a fixed and variable rate (FAVR) plan. The IRS released an advanced copy of the Notice on December 6, 2013.

Many health care organizations reimburse doctors, management, home health, sales and marketing or other employees and other service providers for mileage and other automobile expenses under policies that use these IRS standard rates to calculate the reimbursement amounts. Reimbursement of employees based on these rate is not required. Because reimbursements in excess of the standard rates can create income tax recordkeeping and reporting challenges for the employer, the employee or both, however, most businesses use standard mileage reimbursement rates set at or below the IRS optional standard rates. Businesses facing financial or other challenges may want to reevaluate whether to continue to reimburse mileage and if so, the rate of reimbursement to use to do so.

When communicating with employees about the businesses’ policies for reimbursing business and moving expense mileage, businesses should take care to ensure that employees understand differences in the mileage reimbursement rates that apply to different categories of expenses. As an added service to employees, many human resources departments also may want to consider alerting employees to consult their tax advisor or take other steps to properly understand and retain documentation of mileage not only for business expense reimbursement, but also medical and moving purposes. The availability of this information can be helpful to empower workers and their families to understand and take proper advantage of rules for deducting these expenses even when the employer or its health plan does not reimburse the employee for the expenses.

In addition to reimbursements for workers, businesses also should consider the potential effects of the adjustments in the IRS optional standard mileage rates on the amounts they may bill their customers for mileage expenses as well as the amount that they should expect that their vendors and service providers may bill the business for mileage expenses under contracts that provide for reimbursement of those expenses. Businesses whose contracts with vendors or customers provide for reimbursement of mileage expenses using rates based on the IRS’ optional standard mileage rates should evaluate the effect of the announced adjustments on those mileage obligations to ensure that mileage expenses are properly anticipated, billed and paid.

Beyond dealing with their own policies for reimbursement and billing for mileage, many health care organizations may want to consider sharing information about the 2014 medical mileage reimbursement rates announced by the IRS with patients and their families. Many patients and their families may qualify to claim deductions for mileage for medical travel under IRS rules, but may not be aware of the adjusted rates or the proper procedures for identifying and documenting their medical mileage. While often negligible for families who are not suffering major illness requiring extensive commuting or travel, patients with chronic or serious medical conditions often can benefit from claiming these deductions properly. Communicating the new rates and other tips for keeping records and claiming the mileage deduction could be a significant and valued service to aid these families.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: compensation, DOJ, Health Care, Health Care Fraud, Home Care, home health, Hospital, medical expense, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Doc Sentenced to 15 Years for Health Care Fraud

November 16, 2013

Dr. Anthony Stevens Chase faces a 15 month sentence and must pay $360,293 in restitution after pleading guilty to two health care fraud counts.

On October 21, 2011, Jase pled guilty to two counts of health care fraud before Judge James J. Brady, for involvement in two nearly identical schemes to defraud Medicare.

The first conviction arose from Jase’s association Baton Rouge-based company Lobdale Medical Services, which was owned by Beatrice and Young Anyanwu. As part of the scheme to defraud, Sandra Parkman Thompson and others procured the names and personal information of Medicare beneficiaries in and around the New Orleans area and delivered these names to Jase, who then signed false and fraudulent prescriptions for power wheelchairs and other durable medical equipment for which the Medicare beneficiaries had no medical need. Thompson later delivered the fraudulent prescriptions to the Anyanwus, who submitted claims to Medicare through Lobdale Medical Services for the medically unnecessary equipment. The total billings to Medicare by Lobdale Medicare Services exceeded $1,000,000.

The second conviction arose from JASE’s involvement with a New Orleans-based durable medical equipment company known as Psalms 23-DME, which also paid Thompson to deliver prescriptions for wheelchairs and other durable medical equipment. Jase wrote prescriptions for beneficiaries whom he had never seen and who had no need for the equipment prescribed them. As a result, Psalms 23-DME billed Medicare for claims totaling $230,963 using JASE’s provider number.

Beatrice and Young Anyanwu pled guilty to the health care fraud scheme to defraud Medicare as well as the illegal remuneration conspiracy on August 14, 2012. Theywere sentenced February 1, 2013. Sandra Parkman Thompson was convicted after a jury trial on August 20, 2012. She was sentenced on March 14, 2013.

The investigation of Jase was conducted by the Department of Health and Human Services, Office of Inspector General, the Federal Bureau of Investigation, and the Louisiana Department of Justice. Announcing the sentence, acting U.S. Attorney Walt Green stated, “This case is a great example of how federal and state law enforcement work together on a daily basis to stamp out health care fraud by doctors and others who abuse our health care system in our state.”

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

DOL Extends Minimum Wage, Overtime Protections To Home Care Workers

September 18, 2013

Health care and other parties employing or otherwise engaging the services of home care workers should review and update their policies and practices for scheduling, tracking hours worked and paying these workers to ensure that they comply by January 1, 2015 with a new final rule announced by the U.S. Department of Labor’s Wage and Hour Division today (September 18, 2013). Today’s announcement of the regulatory changes means employers of home care workers can expect to see costs rise and also will join most other U.S. businesses that must worry about getting caught in minimum wage and overtime enforcement traps.

Under the new final rule, the Labor Department extends the Fair Labor Standards Act’s minimum wage and overtime protections to most of the nation’s direct care workers who provide essential home care assistance to elderly people and people with illnesses, injuries, or disabilities beginning January 1, 2015.

The new final rule generally will require that the approximately two million home care workers such as home health aides, personal care aides, and certified nursing assistants will qualify for minimum wage and overtime. Employers engaging these services also generally will need to keep records and comply with other FLSA requirements with respect to these workers as well.

In anticipation of the rollout of these new protections, the Labor Department is kicking off a public outreach campaign to educate home care workers and their employers about the rule change. The Department will be hosting five public webinars during the month of October and has created a new, dedicated web portal here with fact sheets, FAQs, interactive web tools, and other materials.

The Labor Department’s focus on home workers is an extension of its expanded regulation and enforcement efforts targeting a broad range of health care industry employers. Home care and other health industry employers should act to manage their rising exposures to minimum wage, overtime and other federal and state wage and hour law risks.

New Home Care Worker Rules Effective January 2015

The impending change in the treatment of home care workers is part of a larger commitment by the Obama Administration to both expansion and enforcement of the FLSA’s minimum wage and overtime provisions, and a specific program targeting employers in health care and related services industries.

The Obama Administration since taking office has conducted an aggressive campaign seeking to significantly increase the minimum wage under the FLSA and expand other protections. Along with this proactive regulatory agenda, the Obama Administration also specifically is aggressively targeting health care and other caregiver businesses in its enforcement and audit activities. See, e.g. Home health care company in Dallas agrees to pay 80 nurses more than $92,000 in back wages following US Labor Department investigation; US Department of Labor secures nearly $62,000 in back overtime wages for 21 health care employees in Pine Bluff, Ark.; US Department of Labor initiative targeted toward increasing FLSA compliance in New York’s health care industry; US Department of Labor initiative targeted toward residential health care industry in Connecticut and Rhode Island to increase FLSA compliance; Partners HealthCare Systems agrees to pay 700 employees more than $2.7 million in overtime back wages to resolve U.S. Labor Department lawsuit; US Labor Department sues Kentucky home health care provider to obtain more than $512,000 in back wages and damages for 22 employees; and Buffalo, Minn.-based home health care provider agrees to pay more than $150,000 in back wages following US Labor Department investigation.

Violation of wage and hour laws exposes health care and other employers to significant back pay awards, substantial civil penalties and, if the violation is found to be willful, even potential criminal liability. Because states all have their own wage and hour laws, employers may face liability under either or both laws. Coupled with these and other enforcement efforts against health and other caregiver businesses, today’s announcement reflects enforcement risks will continue to rise for employers of home care workers.

In light of the proposed regulatory changes and demonstrated willingness of the Labor Department and private plaintiffs to bring actions against employers violating these rules, health care and others employing home care workers should take well-documented steps to manage their risks. These employers should both confirm the adequacy of their practices under existing rules, as well as evaluate and begin preparing to respond to the proposed changes to these rules. In both cases, employers of home care or other health care workers are encouraged to critically evaluate their classification or workers, both with respect to their status as employees versus contractor or leased employees, as well as their characterization as exempt versus non-exempt for wage and hour law purposes. In addition, given the nature of the scheduled often worked by home care givers, their employers also generally should pay particular attention to the adequacy of practices for recordkeeping.

Enforcement Against Other Industries Shows Risks

Of course, the home care and health care industry are not the only industries that need to worry about FLSA enforcement. The Obama Administration is very aggressive in its enforcement of wage and hour and overtime laws generally. For instance, First Republic Bank recently paid $1,009,643.93 in overtime back wages for 392 First Republic Bank employees in California, Connecticut, Massachusetts, New York and Oregon after the Labor Department found the San Francisco-based bank wrongly classified the employees as exempt from the FLSA’s overtime and recordkeeping requirements, resulting in violations of the Fair Labor Standards Act’s overtime and record-keeping provisions. The Labor Department announced the settlement resulting in the payment on November 27, 2012. The settlement resulted from an investigation by the Labor Department that found the San Francisco-based bank wrongly classified the employees as exempt from overtime, resulting in violations of the FLSA’s overtime and record-keeping provisions.

The FLSA requires that covered, nonexempt employees be paid at least the federal minimum wage of $7.25 for all hours worked, plus time and one-half their regular rates, including commissions, bonuses and incentive pay, for hours worked beyond 40 per week. Employers also are required to maintain accurate time and payroll records.

While the FLSA provides an exemption from both minimum wage and overtime pay requirements for individuals employed in bona fide executive, administrative, professional and outside sales positions, as well as certain computer employees, job titles do not determine the applicability of this or other FLSA exemptions. In order for an exemption to apply, an employee’s specific job duties and salary must meet all the requirements of the department’s regulations. To qualify for exemption, employees generally must meet certain tests regarding their job duties and be paid on a salary basis at not less than $455 per week.

Investigators found that First Republic Bank failed to consider the FLSA’s criteria that allow certain administrative and professional employees to be exempt from receiving overtime pay. In fact, the employees were entitled to overtime compensation at one and one-half times their regular rates for hours worked over 40 in a week. Additionally, the bank failed to include bonus payments in nonexempt employees’ regular rates of pay when computing overtime compensation, in violation of the act. Record-keeping violations resulted from the employer’s failure to record the number of hours worked by the misclassified employees.

“It is essential that employers take the time to carefully assess the FLSA classification of their workforce,” said Secretary of Labor Hilda L. Solis in the Labor Department’s announcement of the settlement. “As this investigation demonstrates, improper classification results in improper wages and causes workers real economic harm.”

FLSA Violations Generally Costly; Enforcement Rising

The enforcement record of the Labor Department confirms that employers that improperly treat workers as exempt from the FLSA’s overtime, minimum wage and recordkeeping requirements run a big risk. The Labor Department and private plaintiffs alike regularly target employers that use aggressive worker classification or other pay practices to avoid paying minimum wage or overtime to workers. Under the Obama Administration, DOL officials have made it a priority to enforce overtime, record keeping, worker classification and other wage and hour law requirements. See e.g., Boston Furs Sued For $1M For Violations Of Fair Labor Standards Act; Record $2.3 Million+ Backpay Order; Minimum Wage, Overtime Risks Highlighted By Labor Department Strike Force Targeting Residential Care & Group Homes; Review & Strengthen Defensibility of Existing Worker Classification Practices In Light of Rising Congressional & Regulatory Scrutiny; 250 New Investigators, Renewed DOL Enforcement Emphasis Signal Rising Wage & Hour Risks For Employers; Quest Diagnostics, Inc. To Pay $688,000 In Overtime Backpay. In an effort to further promote compliance and enforcement of these rules, the Labor Department is using smart phone applications, social media and a host of other new tools to educate and recruit workers in its effort to find and prosecute violators. See, e.g. New Employee Smart Phone App New Tool In Labor Department’s Aggressive Wage & Hour Law Enforcement Campaign Against Restaurant & Other Employers. As a result of these effort, employers violating the FLSA now face heightened risk of enforcement from both the Labor Department and private litigation.

Employers Should Strengthen Practices For Defensibility

To minimize exposure under the FLSA, employers should review and document the defensibility of their existing practices for classifying and compensating workers under existing Federal and state wage and hour laws and take other actions to minimize their potential liability under applicable wages and hour laws. Steps advisable as part of this process include, but are not necessarily limited to:

Audit of each position current classified as exempt to assess its continued sustainability and to develop documentation justifying that characterization;
Audit characterization of workers obtained from staffing, employee leasing, independent contractor and other arrangements and implement contractual and other oversight arrangements to minimize risks that these relationships could create if workers are recharacterized as employed by the employer receiving these services;
Review the characterization of on-call and other time demands placed on employees to confirm that all compensable time is properly identified, tracked, documented, compensated and reported;
Review of existing practices for tracking compensable hours and paying non-exempt employees for compliance with applicable regulations and to identify opportunities to minimize costs and liabilities arising out of the regulatory mandates;
If the audit raises questions about the appropriateness of the classification of an employee as exempt, self-initiation of proper corrective action after consultation with qualified legal counsel;
Review of existing documentation and record keeping practices for hourly employees;
Exploration of available options and alternatives for calculating required wage payments to non-exempt employees; and
Re-engineering of work rules and other practices to minimize costs and liabilities as appropriate in light of the regulations and enforcement exposures.

Because of the potentially significant liability exposure, employers generally will want to consult with qualified legal counsel before starting their risk assessment and assess risks and claims within the scope of attorney-client privilege to help protect the ability to claim attorney-client privilege or other evidentiary protections to help shelter conversations or certain other sensitive risk activities from discovery under the rules of evidence.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

1 Comment | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Employer, Fair Labor Standards Act, FLSA, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

CMS To Host Provider Webinar To Celebrate National Health IT Week

September 13, 2013

In celebration of the third annual National Health IT Week is September 16-20, the Centers for Medicare & Medicaid Services (CMS) will host several webinars and launching new eHealth tools and resources that it intends to help providers participate in eHealth programs. These programs may be of interest to providers as well as payers who are interested in what providers are doing to use eHealth tools.

Details of Webinar

The eHealth Provider Webinar will be held on Thursday, September 19^th from 12:00 p.m. to 1:30 p.m. ET. CMS plans to present an overview of the eHealth programs and its eHealth initiative—an initiative that aligns health IT and electronic standards programs on:

Administrative Simplification
eRx Incentive Program
ICD-10
Quality Measurement

A portion of the webinar will also be dedicated to Q&A.

Registration Information

Space is limited. Register now to secure your spot for the eHealth Provider Webinar. Once registration is complete, you will receive a follow-up email with step-by-step instructions on how to log-in to the webinar. Listserv messages are sent prior to each webinar session with registration information.

If you’d like to view past webinars, the PowerPoint presentations and recordings can now be accessed on the Resources page of the eHealth website. For more information about CMS’ eHealth Initiatives, visit the CMS eHealth website for the latest news and updates on CMS’ eHealth initiatives.

For More Information Or Assistance

If you need assistance responding to this invitation or with other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, CMS, eHealth, Health IT, HHS, HIPAA Privacy, Hospital, Physicians, Providers, Security | Permalink
Posted by Cynthia Marcotte Stamer

Tell HHS What You Think-Comment On HHS Strategic Plan Now!

September 9, 2013

Health care providers, health plans, employers and others concerned about the regulatory and enforcement activities of the Department of Health & Human Services (HHS) can make their concerns known by speaking up now. Share your input on the draft HHS strategic plan that will guide HHS’ regulatory and enforcement agenda for the next 4 years.

Every 4 years, HHS updates its strategic plan, which describes its work to address complex, multifaceted, and ever-evolving health and human service issues, including:

Health Care
Research and Innovation
Prevention and Wellness

HHS is inviting public input on the draft HHS Strategic Plan for FY 2014-2018. The comment period is open until October 15, 2013. Individuals or organizations wishing to respond to this invitation can read the HHS Strategic Plan FY 2014-2018 (Draft) and submit your comments several ways including:

Submit your comments online here
Via Email to: strategicplanning@hhs.gov
Via Fax: (202) 690-8252
U.S. Mail (not recommended as security screening results in significant delay.

For More Information Or Assistance

If you need assistance responding to this invitation for comment or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

OCR To Covered Entities: Learn From WellPoint $1.7 Settlement

July 12, 2013

WellPoint $1.7 M HIPAA Settlement Expensive Lesson On HIPAA Risks Of Leaving PHI Too Accessible In Web-Based Applications

With health care providers, health care organizations and others increasingly using Web-based applications and portals in operations and patient communications, managed care company WellPoint Inc. (WellPoint) is learning a $1.7 million lesson about the importance of ensuring Web-based applications and portals that allow access to members or other consumers protected health information (PHI) incorporate the administrative, technical and other security safeguards required by the Health Insurance Portability & Accountability Act (HIPAA) Privacy and Security rules.

The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced late yesterday (July 11, 2013) that WellPoint has agreed to pay $1.7 million to settle OCR charges that WellPoint violated the HIPAA Security Rule and left the electronic protected health information (ePHI) of 612,402 individuals accessible to unauthorized individuals over the Internet by failing to implement appropriate administrative and technical safeguards in its Web-based applications. See WellPoint HIPAA Settlement Press Release.

Web-based application use is increasingly popular among health care providers, health plans, employers and others. Health care providers use them for health care operations, as well as patient engagement and communication tools. Employers and health plans use them both in plan administration and as member tools.

The WellPoint settlement shows that managed care and other health insurers, health plans and their employer or other sponsors, health care providers, health care clearinghouses (Covered Entities) and their business associates can’t let their enthusiasm for the ease of use of these products to compromise the security of PHI.

Rather, health care providers and other Covered Entities, employer and other health plan sponsors, their business associates, and the Web and other technology developers, providers and consultants marketing products, services or other solutions to these organizations should learn from WellPoint’s hard lesson to ensure that current and future Web-based applications, portals and other information system components that are or could be used to provide access to PHI incorporate the Security Rule safeguards both when originally implemented and with each subsequent upgrade.

HIPAA Privacy, Security & Breach Notification Rules Require PHI Safeguards & Other Protections

The Breach Notification Rule added to HIPAA under the Health Information Technology for Economic and Clinical Health, or HITECH Act requires HIPAA-covered entities to notify OCR, affected individuals and the media promptly of a breach of “unsecured protected health information” (UPHI) impacting more than 500 individuals. For smaller breaches, the Breach Notification Rule still requires prompt notice to impacted individuals, but allows Covered Entities to disclose the breach to OCR as part of an annual breach report and to forego notification to the media. UPHI generally includes any PHI, whether or not ePHI that is not either secured or destroyed in the manner described by the Breach Notification Rules.

In addition to the Breach Notification Rule, most Covered Entities and their business associates also are subject to state laws or regulations that impose similar or additional breach notification and other standards and responsibilities on the protection of personal health or other data including required notification and other responses following a breach of the security of UPHI or other PHI.

WellPoint’s $1.7 HIPAA Security Mistake

WellPoint’s $1.7 million settlement lesson resulted from an OCR investigation started in response to a breach report WellPoint submitted to comply with the Breach Notification Rules.

According to OCR, the Breach Report indicated that security weaknesses in an online application database left the electronic protected health information (ePHI) of 612,402 individuals accessible to unauthorized individuals over the Internet.

OCR says its investigation indicated that WellPoint did not implement appropriate administrative and technical safeguards as required under the HIPAA Security Rule. According to OCR, WellPoint did not:

Adequately implement policies and procedures for authorizing access to the on-line application database;
Perform an appropriate technical evaluation in response to a software upgrade to its information systems; or
Have technical safeguards in place to verify the person or entity seeking access to electronic protected health information maintained in its application database.

As a result, OCR concluded that from October 23, 2009 until March 7, 2010, WellPoint impermissibly disclosed the ePHI of 612,402 individuals by allowing access to their ePHI maintained in the application database. This data included names, dates of birth, addresses, Social Security numbers, telephone numbers and health information.

Under the resulting WellPoint HIPAA Resolution Agreement, WellPoint must pay OCR a $1.7 million settlement payment as well as take a series of corrective actions to correct the deficiencies in its policies and practices that resulted in the reported breach to minimize future risks of breaches resulting from these deficient.

OCR Warns Learn From WellPoint’s Experience

All Covered Entities and their business associates and leaders should heed the lesson sent to them by OCR in announcing the WellPoint settlement and take appropriate steps other to ensure that appropriate policies and safeguards are adopted and applied in selecting and implementing future application or system upgrades, as well as review existing systems to ensure that the security of existing systems and applications have incorporated and apply the requisite safeguards.

OCR made clear that the WellPoint settlement is intended to send a message to Covered Entities and their business associates to ensure that these steps are appropriately taken. The settlement announcement states:

This case sends an important message to HIPAA-covered entities to take caution when implementing changes to their information systems, especially when those changes involve updates to Web-based applications or portals that are used to provide access to consumers’ health data using the Internet. Whether systems upgrades are conducted by covered entities or their business associates, HHS expects organizations to have in place reasonable and appropriate technical, administrative and physical safeguards to protect the confidentiality, integrity and availability of electronic protected health information – especially information that is accessible over the Internet.

The settlement announcement also reminds business associates that OCR will begin holding them directly accountable along with their Covered Entity clients for complying with many HIPAA requirements beginning in September, stating:

Beginning Sept. 23, 2013, liability for many of HIPAA’s requirements will extend directly to business associates that receive or store protected health information, such as contractors and subcontractors.

Take Documented Steps To Show You Hear OCR’s Messages

Covered entities and their business associates and leaders, and vendors and consultants offering services or products to them should take care to conduct careful and well-documented reviews and implement corrective actions necessary to show their applications and systems, policies and practices reflect their strong commitment and action to appropriately protect PHI in accordance with the expectations shown by the WellPoint HIPAA Resolution Agreement and other OCR settlements, OCR’s updated HIPAA regulations, and other OCR and industry information.

In addition to the guidance set forth in OCR’s Resolution Agreements with WellPoint and other Covered Entities, revisions to OCR’s Privacy and Security Rules in OCR’s 2013 restatement of its regulations here cause all Covered Entities and their business associates conduct a well-documented reassessment of the adequacy of their existing policies, systems and practices and steps taken to redress any uncovered gaps.

Among other things, the 2013 Regulations:

Revise OCR’s HIPAA regulations to reflect the HITECH Act’s amendment of HIPAA to add the contractors and subcontractors of health plans, health care providers and health care clearinghouses that qualify as business associates to the parties directly responsible for complying with and subject to HIPAA’s civil and criminal penalties for violating HIPAA’s Privacy, Security, and Breach Notification rules;
Update previous interim regulations implementing HITECH Act breach notification rules that require Covered Entities including business associates to give specific notifications to individuals whose PHI is breached, HHS and in some cases, the media when a breach of unsecured information happens;
Update interim enforcement guidance OCR previously published to implement increased penalties and other changes to HIPAA’s civil and criminal sanctions enacted by the HITECH Act;
Implement HITECH Act amendments to HIPAA that tighten the conditions under which Covered Entities are allowed to use or disclose PHI for marketing and fundraising purposes and prohibit Covered Entities from selling an individual’s health information without getting the individual’s authorization in the manner required by the 2013 Regulations;
Update OCR’s rules about the individual rights that HIPAA requires that Covered Entities to afford to individuals who are the subject of PHI used or possessed by a Covered Entity to reflect tightened requirements enacted by the HITECH Act that allow individuals to order their health care provider not to share information about their treatment with health plans when the individual pays cash for the care and to clarify that individuals can require Covered Entities to provide electronic PHI in electronic form;
Revise the regulations to reflect amendments to HIPAA made as part of the Genetic Information Nondiscrimination Act of 2008 (GINA) which added genetic information to the definition of PHI protected under the HIPAA Privacy Rule and prohibits health plans from using or disclosing genetic information for underwriting purposes; and
Clarifies and revises other provisions to reflect other interpretations and information guidance that OCR has issued since HIPAA was passed and to make certain other changes that OCR found appropriate based on its experience administering and enforcing the rules.

Covered Entities were required to begin complying with most of these rule changes earlier this year. However, delayed compliance dates in the 2013 Regulations allowed Covered Entities and Business Associates to delay updates to pre-existing business associate agreements and the date that OCR would begin enforcing many of the HIPAA Rules directly against business associates to September 23, 2013.

Even without the necessity Settlements like that involving WellPoint, these 2013 Regulations make it imperative that Covered Entities to take the necessary steps to conduct an appropriate and well-documented review and update as needed their systems, policies and practices, business associate agreements, training and documentation.

With self-disclosures of breaches mandated by the Breach Notification Rules and OCR audits and enforcement rising, careful documentation of these activities and its analysis is necessary so that Covered Entities can be in a position to show OCR that the risk assessments required by the Security Rules was conducted as well as the efforts and commitment of the Covered Entity or business associate in the event of a breach investigation or audit. Yesterday’s WellPoint HIPAA announcement is just the latest in an ever-growing list of examples of the expensive consequences that can result if a Covered Entity or business associate cannot produce this documentation in response to an OCR audit or investigation. See, e.g. OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website; Providence To Pay $100000 & Implement Other Safeguards. In contrast, the OCR website also provides a multitude of examples showing how the ability to produce documentation and other evidence showing diligent efforts to comply has helped other covered entities that fall under OCR investigation to avoid or mitigate serious sanctions.

Coupled with statements by OCR about its intolerance, the WellPoint and other settlements provide a strong warning to covered entities of the need to carefully and appropriately manage their HIPAA encryption and other Privacy and Security responsibilities. Covered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures.

In response to the 2013 Regulations and these expanding exposures, all Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions against WellPoint and others, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable. Covered Entities and business associates should document this review in a manner that both reflects the scope and diligence of their activities including relevant considerations and decision-making about identified potential susceptibilities and reasoning about the adequacy of safeguards and other solutions.

Because this review is likely to uncover existing or past deficiencies or breaches, most covered entities and business associates will want to discuss with qualified legal counsel the planned assessment within the scope of attorney-client privilege to understand when and how to conduct the assessment to preserve options to claim attorney-client privilege to protect sensitive work product or discussions that may result in the course of the investigation within the attorney-client communication, work product or other evidentiary privileges, evaluation of the adequacy and appropriateness of the audit and resulting investigations and its documentation, and other assistance in strengthening the defensibility of compliance and risk management activities.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other human resources, employee benefit, or other compliance, risk management, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Nationally recognized for her extensive work, publications and leadership on HIPAA and other privacy and data security concerns, Ms. Stamer has extensive experience representing, advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical and other privacy and data security, employment, employee benefits, and to handle other compliance and risk management policies and practices; to investigate and respond to OCR and other enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health care providers, health plans and their sponsors, their workforces, professional associations and others.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Anti-KickBack, DME, Doctor, E-Prescribing, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, Money Laundering, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: Health Care Providers, Health Plans, HIPAA, HIPAA Privacy, HIPAA Security, OCR, Privacy, WellPoint | Permalink
Posted by Cynthia Marcotte Stamer

Hollywood Pavillion & Other Fraud Convictions Show Individuals Risk Prison Time For Health Care Fraud Involvement

July 6, 2013

Convictions Show Growing Fraud Enforcement Risks Reach Broadly To Broad Range Of Actors

Do you love your health care organization enough to go to jail? With federal and state prosecutors stepping up health care fraud investigation and enforcement, this is a question that individuals leading, working or investing in health care organizations increasingly need to seriously consider.

As federal and state officials continue to ramp up their war on health care fraud, the ever-growing list of criminal convictions of individuals found to have participate in or tolerated prohibited billing, referral or other activities prohibited under federal or state health care fraud laws are intended to both punish the guilty and send a strong message to others throughout the industry: Don’t Do The Crime If You Don’t Want To Serve The Time!

Hollywood Pavilion Convictions

The July 28 federal jury conviction of four individuals for their involvement in nearly $70 million of fraudulent Medicare billings by Hollywood Pavilion (HP), a Miami-area mental health care hospital is the latest case in point. The successful prosecutions shows again the readiness of the Justice Department to prosecute individuals at all levels of organizations for their participation in health care fraud activities even after obtaining criminal convictions, civil settlements, and program disqualification or other administrative consequences against the health care organizations, their leaders, employees and others that participate illegal schemes that defraud federal health care programs like Medicare, private health insurance plans or both.

In the verdicts announced July 28 stemmed from the Justice Department’s prosecution of the former Chief Executive Officer, the former in-patient clinical director, former head of intensive outpatient care and former director of physical therapy for various health care fraud, wire fraud and other charges for their participation in a massive scheme that attempted to defraud the United States of approximately $70 million by taking advantage of Medicare beneficiaries.

Federal officials originally announced charges against the four defendants as part of high-profile sting and takedown by the Medicare Fraud Strike Force of 91 individuals across the nation for their alleged involvement in submitting approximately $430 million in false billings to federal health care programs. See Indictment of 91 Shows Growing Heath Care Fraud Enforcement Risk.

The convictions resulted after the Justice Department tried the defendants with illegally paying bribes to a network of patient recruiters, falsifying documents and other criminal conduct in violation of federal health care fraud, wire fraud and other laws. Based on evidence presented at trial, the federal jury found:

Karen Kallen-Zury, 59, and Daisy Miller, 44, each guilty of one count of conspiracy to commit wire fraud and health care fraud, five substantive counts of wire fraud and two substantive counts of health care fraud;
Michele Petrie, 64, guilty of one count of conspiracy to commit wire fraud and health care fraud and three substantive counts of wire fraud;
Kallen-Zury, Miller, Petrie and a fourth defendant, Christian Coloma, 49, of one count of conspiracy to pay bribes in connection with Medicare; and
Kallen-Zury and Coloma also each guilty of five substantive counts of paying bribes.

The convictions resulted after Federal prosecutors charged the four defendants and one other individual with participating and aiding HP to illegally bill Medicare for nearly $70 million for services that were not properly rendered, for patients that did not qualify for the services being billed and for claims for patients procured through bribes and kickbacks from at least 2003 through at least August 2012.

At trial, Federal prosecutors claimed that the defendants and their co-conspirators caused the submission of false and fraudulent claims to Medicare through HP, a state-licensed psychiatric hospital located in Hollywood that purportedly provided, among other things, inpatient psychiatric care and intensive outpatient psychiatric care. Prosecutors claimed the defendants paid illegal bribes and kickbacks to patient brokers in order to obtain Medicare beneficiaries as patients at HP who did not qualify for psychiatric treatment, then illegally submitted claims to Medicare for those patients who were procured through bribes and kickbacks.

Among other things, Federal prosecutors charged and introduced evidence that:

Karen Kallen-Zury, the CEO and registered agent of HP, attempted to conceal the payment of bribes and kickbacks by creating false documents to make it appear as if legitimate services were being rendered;
Miller, the clinical director of HP’s inpatient facility, and Petrie, the head of HP’s intensive outpatient program, facilitated the payment of bribes to patient recruiters and oversaw the fraudulent admissions and treatment of unqualified patients;
Coloma, the director of physical therapy for an entity associated with HP, facilitated the payment of bribes and kickbacks, and he supervised the creation of false documents to conceal the bribery scheme.

All four defendants now are awaiting sentencing.

Zealous Investigation & Prosecution Part of National Anti-Health Care Fraud Campaign

These and other convictions provide tangible proof of the growing success of the efforts to zealously investigate and prosecute health fraud by the Justice Department, HHS and other federal officials under their joint the Health Care Fraud Prevention & Enforcement Action Team (HEAT), Medicare Fraud Strike Force and other anti-fraud efforts. The joint Department of Justice-HHS Medicare Fraud Strike Force that lead to these charges and convictions is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since its announcement, the Strike Force has used the combined resources of agents from the FBI, HHS-Office of Inspector General (HHS-OIG), multiple Medicaid Fraud Control Units, and other state and local law enforcement agencies to investigate and prosecute a rising number of organizations and individuals throughout the industry for alleged violations of Federal health care fraud prohibitions.

In recent years, Congress has amended the False Claims Act and enacted other reforms that give the Justice Department and other federal officials working in these anti-fraud efforts new tools that they are using to strengthen the effectiveness of their anti-fraud investigation and prosecution efforts. See Health Care Fraud Enforcement Packs New Heat.

Empowered by these and other new tools, the Justice Department and other participants in the HEAT and Medicare Fraud Strike Force increasingly are successful in prosecuting and convicting health care providers and others for participating in activities and schemes that violate federal or state health care fraud, referral, anti-kickback or other federal or state laws. See, e.g., North Texas Medical Supply Company Owner Indicted For Health Care Fraud Now Also Charged With Immigration Fraud; Former Houston Texas Physician Gets 70 Month Prison Sentence For Fraud Conviction; Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims; Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action; Detroit-Area Foot Doctor Pleads Guilty to Medicare Fraud Scheme; Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges. Indeed, since the jury rendered its July 28 verdict, Justice Department officials already have announced several other prosecutorial successes. See, e.g.,Los Angeles Medical Supply Company Owner Sentenced to Five Years in Prison for $8.4 Million Medicare Fraud Scheme; Los Angeles-Area Doctor and Patient Recruiter Plead Guilty to Participating in a Power Wheelchair Scheme That Defrauded Medicare of Over $10.1 Million; Owner of Rehabilitation Facility Pleads Guilty to Mail Fraud Charge; Local Oncology Practice Sentenced To Pay Millions for Medicare Fraud.

In addition to criminal prosecutions, the HHS Centers for Medicare and Medicaid Services, working with the HHS-OIG, are using a wide range of new and old tools in their campaign against what they perceive as fraudulent providers and to deter other perceived aggressiveness by health care providers and organizations. See e.g., U.S. to use software to crack down on Medicare, Medicaid, CHIP fraud; Health Care Fraud Enforcement Packs New Heat; OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct; OIG Launch of Health Care Fraud “Most Wanted” List Sign of Enforcement Risks; CMS Delegated Lead Responsibility For Development of New Affordable Care Act-Required Medicare Self-Referral Disclosure Protocol; HHS announces Rules Implementing Tools Added By Affordable Care Act to Prevent Federal Health Program Fraud.

The effectiveness of these Federal efforts to deter, find and prosecute false claims and other perceived abuses of Federal health care law has been significantly strengthened since Congress passed the Patient Protection & Affordable Care Act (Affordable Care Act). Among other things, ACA empowered HHS to:

Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.

See HHS announces Rules Implementing Tools Added By Affordable Care Act to Prevent Federal Health Program Fraud.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in wielding these and other tools against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Anti-KickBack, DME, Doctor, E-Prescribing, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, Money Laundering, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

55 Hospitals To Pay $35M+ To Settle FCA Claims Charges On Kyphoplasty Procedures

July 6, 2013

Whistleblowers Played A Big Role, Collectively Will Receive $5.5 Million From Settlement Proceeds

Fifty-five hospitals in 21 states will pay a total of more than $34 million to settle Justice Department allegations that the health care facilities submitted false claims to Medicare for a minimally-invasive procedure used to treat certain spinal fractures that often are due to osteoporosis known as “kyphoplasty.”

The settlement stems from charges by the Justice Department and Department of Health & Human Services (HHS) Office of Inspector General (OIG) that the settling hospitals frequently billed Medicare for performing kyphoplasty procedures on the more costly inpatient basis, rather than an outpatient basis, in order to increase their Medicare billings when the kyphoplasty could have been performed safely and effectively as an outpatient procedure without any need for a more costly hospital admission.

With the settlements announced July 1, the Justice Department says it has now reached settlements with more than 100 hospitals totaling approximately $75 million to resolve allegations that they mischarged Medicare for kyphoplasty procedures. Justice Department officials credited whistleblowers with helping it to identify the charged misconduct in virtually all of the cases. They collectively will receive an estimated $5.5 million of the total of $34 million to be paid under the settlements.

55 Settlements Impact Systems & Providers Across The Nation

According to the Justice Department’s July 1 announcement of the settlements, the settling facilities, and the amounts they have agreed to pay, include 23 hospitals affiliated with HCA Inc., Nashville, TN, who have agreed to pay a total of $7,145,842.72. These include:

Aventura Hospital & Medical Center, Aventura, FL
Capital Regional Medical Center, Tallahassee, FL
Coliseum Medical Center, Macon, GA
Coliseum Northside Hospital, Macon, GA
Conroe Regional Medical Center, Conroe, TX
Denton Regional Medical Center, Denton, TX
Doctors Hospital of Sarasota, Sarasota, FL
Edmond Regional Medical Center, Edmond, OK
Fawcett Memorial Hospital, Port Charlotte, FL
Fort Walton Beach Medical Center, Fort Walton Beach, FL
Garden Park Medical Center, Gulf Port, MS
JFK Medical Center, Atlantis, FL
Los Robles Regional Medical Center, Thousand Oaks, CA
North Florida Regional Medical Center, Gainesville, FL
Northlake Medical Center, Tucker, GA
Oklahoma University Medical Center, Oklahoma City, OK
Palmyra Medical Center, Albany, GA
Redmond Regional Medical Center, Rome, GA
Southwest Florida Regional Medical Center, Fort Myers, FL
St. Lucie Medical Center, Port Saint Lucie, FL
Summit Medical Center, Hermitage, TN
Sunrise Hospital & Medical Center, Las Vegas, NV
Wesley Medical Center, Wichita, KS

Also 6 hospitals affiliated with Lifepoint Hospitals, Inc., Brentwood, TN, have agreed to pay a total of $2,522,502.69. These include:

Andalusia Regional Hospital, Andalusia, AL
Jackson Purchase Medical Center, Mayfield, KY
Lake Cumberland Regional Hospital, Somerset, KY
Minden Medical Center, Minden, LA
Russellville Hospital, Russellville, AL
Western Plains Medical Complex, Dodge City, KS

Also, 5 hospitals affiliated with Trinity Health, Livonia, MI, have agreed to pay a total of $3,910,017.53. These include:

Mercy Medical Center, – Dubuque, Dubuque, IA
Mercy Medical Center – Sioux City, Sioux City, IA
St. Joseph Mercy Hospital, Pontiac, MI
Mercy Health Partners, Muskegon, MI
Mount Carmel New Albany Surgical Hospital, New Albany, OH

Justice Department officials also report that 4hospitals affiliated with Morton Plant Mease BayCare Health System, Clearwater, FL, have agreed to pay a total of $2,378,325.45. These include:

Morton Plant Hospital, Clearwater, FL
Morton Plant North Bay Hospital, New Port Richey, FL
Mease Dunedin Hospital, Dunedin, FL
Mease Countryside Hospital, Safety Harbor, FL

Justice Department officials also say 3 hospitals affiliated with Baptist Memorial Health Care Corporation, Memphis, TN, have agreed to pay a total of $691,168. These are:

Baptist Memorial Hospital-Golden Triangle, North Columbus, MS
Baptist Memorial Hospital-Collierville, Collierville, TN
Baptist Memorial Hospital-Memphis, Memphis, TN

In addition, Justice Department officials say 2 hospitals affiliated with Covenant Health, Knoxville, TN, have agreed to pay a total of $1,845,641.74. These are Parkwest Medical Center in Knoxville, TN and Methodist Medical Center of Oak Ridge in Oak Ridge, TN.

Meanwhile, 2 hospitals affiliated with Bayhealth Medical Center, Newark, DE, also reportedly have agreed to pay a total of $1,115,306.37. These are Bayhealth Kent General Hospital, Dover, DE and Bayhealth Milford Memorial Hospital, Milford, DE.

In addition to these hospitals, the following facilities have agreed to pay the following settlements:

Atrium Medical Center, Middletown, OH, has agreed to pay $4,232,992.50
Altru Health System, Grand Forks, ND, has agreed to pay $1,492,690
Cedars Sinai Medical Center, Los Angeles, CA, has agreed to pay $1,485,846
Des Peres Hospital, St. Louis, MO, has agreed to pay $900,000
Mount Sinai Medical Center, Miami, FL, has agreed to pay $1,846,194.00
New England Baptist Hospital, Boston, MA, has agreed to pay $374,814.48
St. Anne’s Hospital, Fall River, MA, has agreed to pay $552,745
The Queen’s Medical Center, Honolulu, HI, has agreed to pay $1,055,249.57
Trover Health System, Madisonville, KY, has agreed to pay $1,162,837
Wayne Memorial Hospital, Goldsboro, NC, has agreed to pay $1,250,000.

In addition to today’s settlement, the government previously settled with Medtronic Spine LLC, the corporate successor to Kyphon Inc., for $75 million to settle allegations that the company defrauded Medicare by counseling hospital providers to perform kyphoplasty procedures as inpatient rather than outpatient procedures.

According to Tom O’Donnell, Special Agent in Charge of the Office of Investigations of the HHS-OIG New York Regional Office, “The settlements related to kyphoplasty billing that have been reached with over 100 hospitals represent one of the largest and most successful multi-party health care investigations in the nation.”

While these settlements relate specifically to kyphoplasty procedures, they send a message impacting all procedures and practice areas that they risk OIG and/or Justice Department prosecution if procedures are performed in a most costly manner to increase reimbursement which is not medically necessary. Justice Department officials warned health care providers that Justice and OIG will act “Whenever hospitals knowingly overcharge Medicare, critically needed resources are wasted and health costs are driven up.”

Whistleblower Involvement Played Big Role

As in other recently announced settlement agreements, see e.g., Whistleblower Collects $2.7 M of $14.5M Sound Inpatient Physicians Overbilling Settlement, whistleblower involvement played a key role in helping OIG and Justice to identify and prosecute the alleged misconduct.

According to the Justice Department, all but four of the settling facilities announced today were named as defendants in a qui tam, or whistleblower, lawsuit brought under the False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States and receive a portion of the proceeds of any settlement or judgment awarded against a defendant. The lawsuit was filed in federal district court in Buffalo, N.Y., by Craig Patrick and Charles Bates. Mr. Patrick is a former reimbursement manager for Kyphon, and Mr. Bates was formerly a regional sales manager for Kyphon in Birmingham, Ala. The whistleblowers will receive a total of approximately $5.5 million from the settlements.

Mitigate Risks With Effective Oversight of Both Documentation & Operations

As Acting Assistant Attorney General for the Civil Division Stuart F. Delery noted in the settlement announcement. “Physicians who participate in Medicare and other federal health care programs must document and bill for their services accurately and honestly.” With qui tam and other whistleblower participation, the Justice Department, HHS and other federal and state fraud investigators go beyond merely challenging whether the medical record documentation supports the charges billed to question whether the medical record itself accurately reflects the care in fact delivered by relying upon testimony of employees or other “insiders” often with an axe to grind against the provider.

To mitigate these exposures, health care providers clearly should work diligently both to ensure that their billing and other compliance programs accurately, honestly and completely document the care provided and code and bill for those services in accordance with the currently applicable federal program rules. While these compliance and risk management programs are indispensable components of any effective health care fraud compliance program, health care providers also should recognize that the effectiveness of their health care fraud and other compliance program also may depend on the effectiveness of their operational and workforce oversight and management. Along with effective billing and other fraud detection and compliance programs, providers also need effective medical quality and records documentation, provider and workforce performance and management, investigations and other management programs.

As a key element of these activities, providers should constantly be on watch for evidence of gaps between the medical and billing documentation and the factual realities looking at broad range of sources. Providers should target these activities to cover both specific medical documentation, coding and care, and other operational indicators that could show a problem. With qui tam and other whistleblower claims rising, however, providers should keep in mind that mere auditing of records and billing patterns alone often fails to uncover key evidence of potential concerns.

To help identify potential areas of scrutiny, providers should carefully monitor and examine the adequacy of their compliance and risk management agreements against corporate integrity agreements with other providers who have reached settlements with the Department of Justice, HHS Office of Inspector General or other agencies like the TranS1 Inc. Corporate Integrity Agreement .

Health care providers also should take into account a plethora of other potential indicators including but not limited to peer review and quality assurance data, deficient as well as inexplicably exceptional medical record or other record keeping documentation, hotline, exist interview and other workforce feedback, disagreements among providers in patterns of care, political and interpersonal differences, and a host of other indicators that could show a valid compliance concern or a developing hostility that could become the incentive for a whistleblower or other complaint. Providers should document these and other efforts to investigate, monitor and redress potential concerns In addition, providers also should guard against qui tam, retaliation and other claims by ensuring that their human resources, peer review, credentialing, background and other investigations, privacy and other operational activities are designed, documented to be both legally compliant and defensible.

For More Information Or Assistance

Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: false claims act, HEAT, Hospitals, Medicaid Fraud, Medicare Fraud, Overbillng, Physicians, qui tam, Upcoding | Permalink
Posted by Cynthia Marcotte Stamer

Whistleblower Collects $2.7 M of $14.5M Sound Inpatient Physicians Overbilling Settlement

July 6, 2013

Former employee-turned Whistleblower Craig Thomas will collect $2.7 million out of the $14.5 million settlement that Sound Inpatient Physicians Inc. (SIP) will pay $14.5 million to settle allegations that it overbilled Medicare and other federal health care programs under a settlement announced by the Justice Department on July 3, 2013. The SIP announcement comes the same day the Justice Department announced medical device manufacturer TranS1 Inc., now known as Baxano Surgical Inc., will pay $6 million to resolve whistleblower-prompted FCA allegations that TranS1 Inc. caused health care providers to submit false claims to Medicare and other federal health care programs for minimally-invasive spine surgeries.

Both the SIP and TranS1 Inc. charges and settlement clearly show the ever-growing risk of Justice Department prosecution that providers face when billing Medicare or other government programs for care beyond the level delivered and documented in the medical record. The litigation and resulting settlement also show the too-often underappreciated rule that employees, vendors and other whistleblowing insiders increasingly play in the initiation and success of these prosecutions and how they impact the ability of providers charged with fraud to prove they have billed Medicare or other federal health plans accurately and honestly for services actually delivered in the manner documented in the record and in accordance with applicable Federal program rules.

To mitigate these exposures, health care providers both should strengthen their health care medical record documentation, billing and other fraud and compliance programs and their employee, vendor and other workforce relations and management processes.

Former SIP Employee’s Qui Tam Claim Prompted Suit

The settlement resolves charges that SIP fraudulently inflated billings to government programs brought in U.S. ex rel. Craig Thomas v. Sound Inpatient Physicians, Inc. and Robert A. Bessler, Civil Action No. C09-5301RBL (W.D. Wash.) that initially came to the government’s attention through a lawsuit filed by former SIP employee, Craig Thomas, under the qui tam, or whistleblower, provisions of the False Claims Act (FCA). The FCA allows private citizens to bring civil actions on behalf of the government and share in any recovery. Thomas will receive $2.7 million of the $14.5 million settlement for exposing Sound Physicians’ inflated claims.

In the lawsuit, the Justice Department alleged that SIP, a Tacoma, Washington-based employer of more than 700 hospitalists and post-acute physicians at 70 hospitals and a growing network of post-acute facilities in 22 states, between 2004 and 2012, knowingly submitted inflated claims to federal health benefits programs for its hospitalist employees for higher and more expensive levels of service than documented by hospitalists in patient medical records.

The SIP civil settlement illustrates the growing reliance on whistleblowers and other FCA tools by the Federal government in its rising campaign against false claims and other health care fraud by physicians, hospitals and other health care providers under the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative announced in May 2009 by Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius. Since January 2009, the Justice Department claims to have recovered a total of more than $14.7 billion through FCA cases, with more than $10.7 billion of that amount recovered in cases involving fraud against federal health care programs.

TranS1 Inc. Whistleblower Gets $1M+ Out of $6M Settlement

Whistleblower claims also prompted the charges and settlement announced against medical device manufacturer TranS1 Inc. The Justice Department announced July 3 that TranS1 Inc. has agreed to pay the United States $6 million to resolve allegations under the FCA. Whistleblower Kevin Ryan, whose qui tam claim prompted the investigation that lead to the settlement will collect $1,020,000 from the settlement.

The settlement resolves Justice Department charges developed out of the qui tam action of a former employee that TranS1 knowingly caused health care providers to submit claims with incorrect diagnosis or procedure codes for minimally-invasive spine fusion surgeries using Trans1’s AxiaLIF System. That device was developed as alternative to invasive spine fusion surgeries. The United States alleges that TranS1 improperly counseled physicians and hospitals to bill for the AxiaLIF System by using incorrect and inaccurate codes intended for more invasive spine fusion surgeries. The Justice Department alleged that, as a result, health care providers received greater reimbursement than they were entitled to for performing the minimally-invasive AxiaLIF procedures.

The Justice Department also claimed TranS1 knowingly paid illegal remuneration to certain physicians for participating in speaker programs and consultant meetings intended to induce them to use TranS1 products, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and thereby caused false claims to be submitted to federal health care programs. The Anti-Kickback Statute prohibits offering or paying remuneration to induce referrals of items or services covered by federally-funded programs and is intended to ensure that a physician’s medical judgments are not compromised by improper financial incentives and are based solely on the best interests of the patient.

In addition, the Justice Department alleged that TranS1 promoted the sale and use of its AxiaLIF System for uses that were not approved or cleared by the U.S. Food and Drug Administration, including use in certain procedures to treat complex spine deformity, and which were thus not covered by federal health care programs.

“A medical device manufacturer violates the law when it advises physicians and hospitals to report the wrong codes to federal health insurance programs in order to increase reimbursement rates,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “Health care providers are required to bill federal health care programs truthfully for the work they perform.”

As part of the settlement, TranS1 has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.

Mitigate Risks With Effective Oversight of Both Documentation & Operations

For More Information Or Assistance

About Solutions Law Press

OIG Urges CMS To Step Up Efforts To Recover “Overpayments”

July 2, 2013

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) is recommending that the Centers for Medicare & Medicaid Services (CMS) step-up efforts to collect Medicare overpayments to providers currently considered uncollectable because the provider has failed to repay overpayments identified and demanded by CMS six or more months after CMS demands repayment. The recommendations made in OIG’s Medicare’s Currently Not Collectible Overpayments Report (Report) reflect the ever-growing emphasis of HHS on reducing Medicare and other federal program costs by aggressive enforcement of Medicare and other federal regulations against providers. While CMS has not concurred with all of OIG’s recommendations in the Report, providers can expect CMS to further tighten its overpayment processes in response to these and other OIG recommendations.

According to the Report, CMS identifies billions of dollars in alleged Medicare overpayments to health care providers each year. In fiscal year (FY) 2010, overpayments totaled $9.6 billion. While CMS identifies these amounts, the Report notes that CMS does not recover all overpayments. Under CMS current accounting policies, CMS classifies overpayments for which the provider has not repaid at least 6 months after the due date on the Medicare demand letter as “currently not collectible” (CNC). CMS does not report these CNC amounts in CMS’s annual financial statements because it considers these amounts unlikely to be recovered.

The Report summaries the results of an OIG study of these CNC amounts. In the study, OIG requested details from CMS about CNC overpayments in FY 2010 and summary financial data for FYs 2007 to 2010. CMS provided most of the data from its Healthcare Integrated General Ledger Accounting System (HIGLAS). OIG also surveyed CMS and all its claims processing contractors to identify (1) hindrances to debt collection and (2) strategies to reduce the number and dollar amount of overpayments that become CNC.

According to the Report, CMS reported $543 million in new CNC overpayments across all contractors in FY 2010. However, CMS provided detailed information on $69 million in CNC overpayments for only seven contractors. Citing contractor transitions, CMS did not provide detailed data for the remaining 32 contractors. For 54 percent of CNC overpayments associated with the seven contractors, the provider type was missing in HIGLAS. For the seven contractors, 97 percent of FY 2010 CNC overpayments were not recovered. According to contractors, inaccurate provider contact information delays or prevents some overpayment demand letters from reaching providers. In addition, CMS and contractors reported that expanding the types of provider identifiers used to recover payments could improve debt collection efforts.

Based on these findings, OIG recommended that CMS should:

Ensure the HIGLAS variable for provider type is populated for all overpayments,
Ensure that demand letters are mailed to the contacts and addresses identified by the provider, and
Use tax identification numbers and provider transaction access numbers in addition to national provider numbers for the collection of overpayments.

According to OIG, CMS partially concurred with the first recommendation, did not agree with our second recommendation, and concurred with our third recommendation. Accordingly, at minimum, providers should expect that CMS will step up use of tax identification and provider transaction access numbers in tracking down and collecting overpayments demanded by OIG.

The Report is just one of a plethora of activities that OIG, CMS and other HHS agencies, alone or in conjunction with the Department of Justice and other federal and state agencies are conducting in their campaign to control Medicare and other federal program costs by targeting provider reimbursements.With health care fraud and other billing audits and enforcement rising, hospitals and other health care providers should heed these reports as continuing reminders to tighten their billing practices to ensure defensibility in the event of an audit or other enforcement action.

For More Information Or Assistance

About Solutions Law Press

OCR Makes Technical Corrections To HIPAA Omnibus Final Rule; September 2013 Enforcement Deadline Looming

June 7, 2013

The Department of Health & Human Services Office of Civil Rights (OCR) is publishing Technical Corrections (Technical Corrections) to the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notifications Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Rule) previously published on January 25, 2013. The Technical Corrections will appear in the June 7, 2013 Federal Register. Physicians, hospitals, clinics and other health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates should take into account the Technical Corrections as they rush to update business associate agreements, policies, practices, training and other HIPAA compliance to comply with the Omnibus Rule changes by the September 2013 deadline.

Technical Corrections To Omnibus Rule Released

OCR published the Omnibus Rule to implement changes to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (“the HIPAA Rules”) enacted by the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”) and section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008, as well as to address public comment received on the interim final Breach Notification Rule and to other changes to the HIPAA Rules. The Technical Corrections are scheduled for publication in the Federal Register on June 7, 2013.

The Technical Corrections correct various typographical errors and other oversights in the Omnibus Regulations as originally published. While many of these corrections have limited material impact, certain corrections do have substantive implications. For instance, by correcting errors in references to other provisions of the Omnibus Regulations, the Technical Corrections clarify that the authority of OCR to extend the time pursuant to § 160.508(c)(5) for violations before February 18, 2009 also applies to violations occurring on or after February 18, 2009, as there is for violations occurring prior to February 18, 2009.

Covered Entities and their business associates will need to review and take into account the Technical Corrections as they work to review and update their policies and practices for handling and disclosing personally identifiable health care information (“PHI”) in response to the Omnibus Rule.

Get Moving To Update HIPAA Compliance For New Omnibus Rule Requirements As Amended By Technical Corrections

Covered Entities and their business associates have a lot to accomplish between now and September to update their business associates and comply with other changes made by the Omnibus Rule by its September 2013 deadline. Among other things, the Omnibus Regulations:

Revise OCR’s HIPAA regulations to reflect the HITECH Act’s amendment of HIPAA to add the contractors and subcontractors of health plans, health care providers and health care clearinghouses that qualify as business associates to the parties directly responsible for complying with and subject to HIPAA’s civil and criminal penalties for violating HIPAA’s Privacy, Security, and Breach Notification rules;
Update previous interim regulations implementing HITECH Act breach notification rules that require Covered Entities including business associates to give specific notifications to individuals whose PHI is breached, HHS and in some cases, the media when a breach of unsecured information happens;
Update interim enforcement guidance OCR previously published to implement increased penalties and other changes to HIPAA’s civil and criminal sanctions enacted by the HITECH Act;
Implement HITECH Act amendments to HIPAA that tighten the conditions under which Covered Entities are allowed to use or disclose PHI for marketing and fundraising purposes and prohibit Covered Entities from selling an individual’s health information without getting the individual’s authorization in the way required by the Omnibus Regulations;
Update OCR’s rules about the individual rights that HIPAA requires that Covered Entities to afford to individuals who are the subject of PHI used or possessed by a Covered Entity to reflect tightened requirements enacted by the HITECH Act that allow individuals to order their health care provider not to share information about their treatment with health plans when the individual pays cash for the care and to clarify that individuals can require Covered Entities to provide electronic PHI in electronic form;
Revise the regulations to reflect amendments to HIPAA made as part of the Genetic Information Nondiscrimination Act of 2008 (GINA) which added genetic information to the definition of PHI protected under the HIPAA Privacy Rule and prohibits health plans from using or disclosing genetic information for underwriting purposes; and
Clarifies and revises other provisions to reflect other interpretations and information guidance that OCR has issued since HIPAA was passed and to make certain other changes that OCR found appropriate based on its experience administering and enforcing the rules.

Liability & Enforcement Risks Heighten Need To Act To Review & Update Policies & Practices

The restated rules in the Omnibus Rule make it imperative that Covered Entities review the revised rules carefully and updated their policies, practices, business associate agreements, training and documentation to comply with the updated requirements and other enforcement and liability risks. OCR even prior to the regulations has aggressively investigated and enforced the HIPAA requirements. See, e.g., OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website; Providence To Pay $100000 & Implement Other Safeguards.

Coupled with statements by OCR about its intolerance, the HONI and other settlements provide a strong warning to covered entities of the need to carefully and appropriately manage their HIPAA encryption and other Privacy and Security responsibilities. Covered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures.

All Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable. In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if tightening their policies, practices, documentation or training is necessary or advisable.

For More Information Or Assistance

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experience with health plan privacy and data security matters, Ms. Stamer serves as the scribe for the ABA JCEB Annual Technical Session meeting with OCR each May and has worked, spoken and published extensively on these and other privacy and data security concerns and controls. Extensively published and a popular speaker on HIPAA and other data security matters, Ms. Stamer works extensively with health care providers, health plans, employers, insurance and financial services, technology and other clients on privacy, data seurity and other privacy and cybercrime concerns. She also serves as the Scribe for the ABA JCEB Agency Techical Sessions Meetings with the Office of Civil Rights which occur each May in Washington, D.C.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Acute Care, CMS, Hospital, Medicare, PPS, Prospective Payment, Skilled Nursing, SNF | Permalink
Posted by Cynthia Marcotte Stamer

National Provider Calls: Medicare Shared Savings Program Application Process — Register Now

May 24, 2013

Medicare Fee For Service (FFS) providers and others interested in participating in Accountable Care Organizations (ACOs) should consider participating in the two National Provider Calls that the Centers for Medicare & Medicaid Services (CMS) plans to host on the Medicare Shared Savings Program (Shared Savings Program) outlined in final regulations published October 20, 2011 of the Affordable Care Act.

On Thursday, June 20, CMS subject matter experts will provide an overview and updates to the Shared Savings Program application process for the January 1, 2014 start date. A question and answer session will follow the presentations.
On Thursday, July 18, CMS subject matter experts will be available to answer questions about the Shared Savings Program and application process for the January 1, 2014 start date.

The Shared Savings Program Application web page has important information, dates, and materials on the application process. CMS encourages call participants to review the application and materials before the call.

To receive call-in information, interested participants must register for the call on the CMS Upcoming National Provider Calls registration website. Registration will close at 12pm on the day of the call or when available space has been filled. Since CMS says it will make no exceptions, interested persons should plan to register as soon as possible.

Following the conference calls, CMS plans to post the presentation on the FFS National Provider Calls web page. In addition, a link to the slide presentation will be emailed to all registrants on the day of the call.

CMS says certain continuing education credit may be awarded for participation in certain CMS National Provider Calls. Visit the Continuing Education Credit Information web page to learn more.

For More Information Or Assistance

About Solutions Law Press

Former White House Cybersecurity Coordinator Schmidt, Stamer & Others Share Key HIPAA & Other Privacy & Data Security Insights 5/21 In LA

May 3, 2013

SLP Readers Get Discount: Go to
blocked::http://securitysummitla.eventbrite.com/” href=”http://securitysummitla.eventbrite.com/” data-mce-href=”http://securitysummitla.eventbrite.com/”://securitysummitla.eventbrite.com/ and enter Promotional Code: Health_Summit_125

Former White House Cybersecurity Coordinator Howard Schmidt and Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer are two of an impressive lineup of leaders scheduled to share key HIPAA & other privacy and data security compliance and risk management strategies at the Healthcare HITECH Privacy and Security Summit at the Fifth Annual Information Security Summit on May 21 in Los Angeles. The program offers essential insights for hospitals, physicians, and other health care providers, health plans and insurers, employers and other health plan sponsors, fiduciaries and administrators, their business associates and other business partners and others on what their organizations should do to cope with the rapidly changing and expanding privacy and data security obligations of HIPAA and other federal and state laws.

With the rapidly approaching and privacy and data breach penalties and enforcement rising, health care providers, health plans, health care clearinghouses and their business associates must get moving to update business associate contracts, policies and notices and processes to meet changing HIPAA rules while managing ongoing compliance and risks.

Former Cybersecurity Coordinator Schmidt Keynotes

The Healthcare HITECH Privacy and Security Summit will bring together leaders in Privacy and Security within government and private industry for a day of collaboration, networking and presentations by leading Privacy and Security professionals sharing who HIPAA covered entities and business associates need to know to comply with new HITECH rules and OCR investigations.

Stamer Speaks On Latest HIPAA Rules & Developments

Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer will help lay the foundation for the workshop by briefing participants on changes made to HIPAA rules by the new Omnibus HIPAA Rulemaking changes that the Office of Civil Rights (OCR) plans to start enforcing in September, 2013.

Armed with the latest insights from serving as the scribe for the ABA JCEB annual agency meeting with the Office of Civil Rights (OCR), Ms. Stamer, a practicing attorney and widely published author and speaker, will discuss required changes and other recommended steps and strategies that covered entities and their business associates should take to maintain HIPAA compliance and manage HIPAA and other related risks in light of the Omnibus HIPAA Rulemaking changes, new OCR guidance for health care providers about disclosures to avert threats to health or safety, recent audit and enforcement activities and other changing risks and responsibilities including:

The latest on OCR’s regulatory guidance, audit and investigation and enforcement rules, actions and strategies and their implications on covered entities and business associates;
Changes to breach notification rules and their implications on covered entities and their business associates;
Practical implications of new rules on who is covered and their responsibilities;
Required and recommended updates to policies, business associate and other agreements, privacy notices and other HIPAA compliance arrangements;
Effective training and other risk management strategies;
Planning for, investigating and mitigating PHI privacy breaches and other compliance concerns under new rules other selected events; and
Other selected strategies for coordinating HIPAA and other privacy and data breach responsibilities and risk management; and
Participant questions.

For a complete agenda, to register, to get details on sponsorship or for other information, see here.

For More Information Or Assistance

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Border Health, Childrens Health Insurance Program, Consumer Driven Health Care, Corporate Compliance, DME, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Breach Notification, Data Breach, Data Security PHI, HIPAA, personal financial information, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

CMS Proposes To Further Tighten Medicare Provider Enrollment Rules

May 1, 2013

The proposed rule would also strengthen certain provider enrollment provisions including allowing HHS to deny enrollment of providers affiliated with an entity that has unpaid Medicare debt, deny or revoke billing privileges for individuals with felony convictions, and revoke privileges for providers and suppliers who are abusing their billing privileges.

Since provider enrollment is the gateway to Medicare, CMS routinely evaluates its provider enrollment policies, and has implemented new safeguards as a result of the Affordable Care Act. In the February 2011 final screening rule (72 FR 5862). CMS identified additional changes in enrollment policy that would increase the integrity of the Medicare program. Now, CMS is proposing include the following provisions:

Add the ability to deny the enrollment of providers, suppliers and owners affiliated with an entity that has unpaid Medicare debt. This proposal would prevent individuals and entities from being able to incur substantial debt to Medicare, leave the Medicare program and then re-enroll as a new business to avoid repayment of the outstanding Medicare debt. We are proposing that CMS would only enroll individuals or entities if they repay the debt or enter into a repayment plan, if they are otherwise eligible for the program.
Deny enrollment or revoke the billing privileges of a provider or supplier if a managing employee has been convicted of certain felony offenses. This provision ensures that CMS can block or remove bad actors from the Medicare program to protect beneficiaries and safeguard the Medicare Trust Fund.
Permit CMS to revoke billing privileges of providers and suppliers that have a pattern or practice of billing for services that do not meet Medicare requirements. This proposal is intended to address providers and suppliers that regularly submit inaccurate claims in such a way that it poses a risk to the Medicare program.
Make the effective date of billing privileges consistent across certain provider and supplier types. Most practitioners and practitioner groups may only submit bills as of the filing date of their enrollment application. CMS is proposing to eliminate ambulance suppliers’ current ability to bill for up to a year prior to enrollment in the Medicare program. CMS is also proposing to require that ambulance providers and other provider and supplier types submit any claims within 60 days of revocation of billing privileges, consistent with the requirements for practitioners and practitioner groups.

For More Information Or Assistance

About Solutions Law Press

HHS Proposes Increasing Health Care Fraud Reporting Rewards To Up To $9.9 Million

May 1, 2013

The Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) plans to increase rewards paid to Medicare beneficiaries and others whose tips about suspected fraud lead to the successful recovery of funds to as high as $9.9 million. Secretary Kathleen Sebelius announced proposed regulations that would increase the penalties on April 24. In addition, a new funding opportunity released this month supports the expansion of Senior Medicare Patrol (SMP) activities to educate Medicare beneficiaries on how to prevent, detect and report Medicare fraud, waste and abuse.

The Obama Administration has made health care fraud prosecutions and settlement a key element of its health care cost containment plan. Over the last three years, the administration claims its enforcement efforts have recovered over $14.9 billion in fraud, some of which resulted from fraud reporting by individuals.

Summary Of The SMP Incentive Reward Program Proposals

The SMP is a national, volunteer-based program that empowers Medicare beneficiaries to prevent and report Medicare fraud, waste, and abuse. Since 1997, HHS reports more than 7,000 referrals have been made to CMS and the Office of the Inspector General (OIG) for investigation since 1998.

Under the proposed changes, CMS is proposing to increase the potential reward amount for information that leads to a recovery of Medicare funds from 10 percent to 15 percent of the final amount collected. HHS currently offers a reward of 10 percent up to $1,000 under the current incentive reward program. In changes are modeled on an IRS program that has returned $2 billion in fraud since 2003, HHS proposes to increase the portion of the recovery on which CMS will pay a reward up to the first $66 million recovered – this means an individual could receive a reward of $9.9 million if CMS recovers $66 million or more.

HHS began paying rewards to individuals who reported tips that led to the recovery of funds in 1998. According to HHS, to date, HHS has recovered approximately $3.5 million as a result of this program and paid just $16,000 for 18 rewards. The proposed changes are similar to the IRS whistleblower program that has resulted in recoveries of over $2 billion since 2003.

To expand the SMP program’s capacity to reach more Medicare beneficiaries, the Administration for Community Living issued a new funding opportunity. Each of the current 54 SMP projects is eligible for varying funding levels, up to a total of $7.3 million across the program.

HHS says thhese proposed changes will support the administration’s comprehensive approach to program integrity, including the work being done with the Health Care Fraud Prevention and Enforcement Action Team, a joint effort between HHS and the Department of Justice to fight health care fraud. The Obama Administration credits this joint effort with recovering a record $4.2 billion in taxpayer dollars in fiscal year 2012.

The proposed increase in the reward for blowing the whistle on health care fraud is intended to fuel further reports by beneficiaries, workers and others of suspected health care fraud. Health care providers should share any concerns about the proposed increase in the rewards as well as review and tighten their health care fraud prevention and risk management to defend against rising exposures.

For more details, read a fact sheet on the proposed rule available here for more details.

For More Information Or Assistance

About Solutions Law Press

CMS Proposes Changes To Accute Care Hospital & Skilled Nursing Facility Propective Payment Rules

May 1, 2013

Acute care hospitals and skilled nursing facilities participating in Medicare should review proposed changes to key Medicare reimbursement rules and act quickly to share feedback on any provisions of significant concern.

The Centers For Medicare & Medicaid Services (CMS) is proposing changes to its Prospective Payment Systems and other reimbursement key reimbursement rules for Hospitals and Skilled Nursing Facilities for Fiscal Year (FY) 2014. Advance copies of the proposed rules were made available May 1.

CMS’ proposed rules on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014 are scheduled for official publication on May 1, 2013.

CMS’ proposed rules on Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Long Term Care Hospital Prospective Payment System, etc. are scheduled for official publication on May 10, 2013.

Acute care hospitals and skilled nursing facilities should evaluate the implications of the proposed changes and provide relevant feedback as necessary to CMS.

For More Information Or Assistance

About Solutions Law Press

OCR Shares New Tools to Educate Consumers and Providers about HIPAA Privacy and Security

April 30, 2013

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has developed an array of new tools to educate consumers and health care providers about the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.

Many consumers are unfamiliar with their rights under the HIPAA Privacy Rule. With that in mind, OCR has posted a series of factsheets, also available in eight languages, to inform consumers about their rights under the HIPAA Privacy Rule. These materials are available on OCR’s website here.

The fact sheets compliment a set of seven consumer-facing videos released earlier this year on OCR’s YouTube channel. An additional video, The HIPAA Security Rule, has been designed for providers in small practices and offers an overview of how to establish basic safeguards to protect patient information and comply with the Security Rule’s requirements. The videos are available on the HHS OCR YouTube Channel at here.

OCR has also launched three modules for health care providers on compliance with various aspects of the HIPAA Privacy and Security Rules, available at Medscape.org:

Patient Privacy: A Guide for Providers at here;
HIPAA and You: Building a Culture of Compliance here; and
Examining Compliance with the HIPAA Privacy Rule here.

The Medscape modules offer free Continuing Medical Education (CME) credits for physicians and Continuing Education (CE) credits for health care professionals.

For More Information Or Assistance

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Covered Entities, Data, Health Care, Health Plans, HIPAA, HIPAA Audits, OCR, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

Amgen Settlement Highlights Anti-Kickback Exposures From Whistleblowers, Need For Effective Compliance & Risk Management

April 22, 2013

California-based biotechnology giant Amgen, Inc. has agreed to pay $24,9 Million to resolve Justice Department False Claims Act charges that the biotechnology giant violated the False Claims Act by paying illegal kickbacks to long-term care pharmacy providers to promote the sale of its Aranesp and other products. The settlement announced by the Justice Department on April 16, 2013 is the latest in a series of settlements resulting from efforts by Federal officials to target pharmaceutical and other providers for violating federal anti-kickback and other health care fraud laws brought by the Justice Department. See Amgen to Pay U.S. $24.9 Million to Resolve False Claims Act Allegations. It highlights the growing risk of civil prosecution that pharmaceutical companies face for offering or providing prohibited kickbacks, as well as the growing role of whistleblowers in civil prosecutions under the anti-kickback law.

Amgen Settlement Highlights

The Amgen Settlement Agreement resolves Federal allegations that Amgen paid illegal kickbacks to long-term care pharmacy providers Omnicare Inc., PharMerica Corporation and Kindred Healthcare Inc. in return for implementing “therapeutic interchange” programs designed to switch Medicare and Medicaid beneficiaries from a competitor drug to Aranesp, which Amgen manufactures.

The government alleged that the kickbacks took the form of performance-based rebates tied to market-share or volume thresholds. The government also charged that, as part of the therapeutic interchange program, Amgen distributed materials to consultant pharmacists and nursing home staff encouraging the use of Aranesp for patients who did not have anemia associated with chronic renal failure.

The Amgen Settlement Agreement resolves a civil lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the United States and share in any recovery. The False Claims Act suit in the U.S. District Court for the District of South Carolina is captioned United States ex rel. Kurnik v. Amgen Inc., et al.

When announcing the settlement, Justice Department officials emphasized federal officials’ commitment to pursuing pharmaceutical companies for paying illegal kickbacks to secure drug sales. “We will continue to pursue pharmaceutical companies that pay kickbacks to long-term care pharmacy providers to influence drug prescribing decisions,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “Patients in skilled nursing facilities deserve care that is free of improper financial influences.”

The Settlement Agreement and lawsuit that it resolves also show the key role that whistleblowers can play in these types of prosecutions. Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud. The Amgen Settlement and other recent prosecutions and settlement show that Federal officials are acting on this promise and that whistleblowers increasingly are helping them to do so.

As this trend continues, pharmaceutical companies and other health care providers subject to the anti-kickback and other health care fraud laws will need to review their existing and former practices to identify pre-existing and ongoing exposures, and decide what steps to take, if any, to mitigate these risks. In addition to considering what corrective actions, if any are needed generally, these organizations also should consider the workforce management and other internal controls that will help promote compliance with these policies and manage potential whistleblower and other liabilities.

In addition to working to promote compliance with the False Claims Act and other health care laws, pharmaceutical companies and health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns. These processes and policies should involve but not be limited to hotlines and other processes for reporting suspected fraud or other misconduct. Most companies also should consider adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and coöperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith.

For More Information Or Assistance

For help reviewing and updating your Stark Law, Anti-Kickback Statute, or other health care compliance, workforce, internal controls and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872. To review and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Anti-KickBack, Controlled Substances, Corporate Compliance, Evidence Based Medicine, false claims act, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Medicaid, Medicare, OIG, Pharmacy, Prescription Drugs, Reimbursement | Tagged: FDA, Federal Sentencing Guidelines, Food and Drug, GlaxoSmithKiine, Health Care, Health Care Fraud, Health Care Fraud Task Force, Pharma, Pharmaceudical | Permalink
Posted by Cynthia Marcotte Stamer

HHS Publishes Medicaid Expansion Final Regs, Invites Public Comment

April 1, 2013

The Department of Health & Human Services (HHS) has published its final rule with a request for comments that provides, effective January 1, 2014, the federal government will pay 100 percent of the cost of certain newly eligible adult Medicaid beneficiaries. These payments will be in effect through 2016, phasing down to a permanent 90 percent matching rate by 2020. The Affordable Care Act authorizes states to expand Medicaid to adult Americans under age 65 with income of up to 133 percent of the federal poverty level (approximately $15,000 for a single adult in 2012) and provides unprecedented federal funding for these states.

Under the Affordable Care Act, states that cover the new adult group in Medicaid will have 100 percent of the costs of newly eligible Americans paid for by the federal government in 2014, 2015, and 2016. The federal government’s contribution is then phased-down gradually to 90 percent by 2020, and remains there permanently. For states that had coverage expansions in effect prior to enactment of the Affordable Care Act, the rule also provides information about the availability of an increased FMAP for certain adults who are not newly eligible.

For the full text of the final rule, see http://www.ofr.gov/inspection.aspx.

For More Information Or Assistance

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Covered Entities, Data, Health Care, Health Plans, HIPAA, HIPAA Audits, OCR, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

Hospitals with 2012 CMS Adverse Complaint Inspection Reports in AHCJ Data Bank Should Prepare Response

March 27, 2013

Acute-care and critical access hospitals that had adverse complaint inspections in 2012 by the Centers for Medicare & Medicaid Services (CMS) may want to prepare to respond to press and public inquiries. The Association of Health Care Journalists (AHCJ) updated its website, healthcareinspectionreports.com, to include details about deficiencies cited during complaint inspections at acute-care and critical access hospitals throughout the United States since January 1, 2011 obtained from CMS.

Although AHCJ cautions in its website that the posted data should not be used to rank hospitals because of omissions and limitations in the data, hospitals with posted reports in the data bank should expect that the reports on their hospital may draw the attention of the media, patients, health plans and others.

AHCJ publishes the reports, which historically have not been easily accessible to the general public. AHCJ cautions that the data is not necessarily complete and should not be used to rank hospitals within a state. AHCJ says data on acute-care and critical hospital access hospitals is incomplete because CMS has just begun gathering this data and releasing it in electronic format. AHCJ also says some reports are missing narrative details. Beyond that, CMS acknowledges that other reports that should appear may not. It does not include results of routine inspections or those of psychiatric hospitals or long-term care hospitals. It also does not include hospital responses to deficiencies cited during inspections. Those can be obtained by filing a request with a hospital or the U.S. Centers for Medicare and Medicaid Services (CMS).AHCJ to make future iterations of this data more complete. At this time, this data should not be used to rank hospitals within a state or between states. It can be used to review issues identified at hospitals during recent inspections.

Subject to these limitations, an individual wishing to review the available data can click on a state on the map will retrieve a list of all hospitals with their violations grouped together.

In anticipation of potential media or public review and reaction to the AHCJ website posting, hospitals with adverse reports posted on the website should consider acting proactively. Hospitals should consult with counsel and their public relations team to plan and prepare a factually accurate response to the shared reports and other suitable mitigation activities.

For More Information Or Assistance

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: health care quality, Health Plans, Hospitals, Public Relations | Permalink
Posted by Cynthia Marcotte Stamer

OCR Invites Comments On Plans to Survey HIPAA Covered Entities Audited Under 2012 HIPAA Audit Program

March 25, 2013

The Department of Health & Human Services (HHS) Office of Civil Rights (OCR) wants to ask the 115 health plans, health care clearinghouses, and health care providers (covered entities) that OCR audited in 2012 for compliance with Privacy and Security Rules of the Health Insurance Portability & Accountability Act (HIPAA) under its HIPAA Audit Program to share feedback about their experience. The planned survey announcement follows OCR’s recent released of restated HIPAA Privacy & Security Rules scheduled to take effect in September, 2013 and as OCR continues and expanding its HIPAA Audit Program in 2013. All together, the signs are clear that covered entities should update and strengthen their HIPAA compliance and risk management practices to withstand the tightened rules and enforcement.

OCR initiated the HIPAA Audit Program in 2012 to comply with Section 13411 of the Health Information Technology for Economic and Clinical Health Act’s requirement that it audit covered entity and business associate compliance with the HIPAA privacy, security, and breach notification rules. While it continues its HIPAA Audit Program in 2013, OCR also is evaluating the effectiveness of the HIPAA Audit Program audits in 2012.

To this end, OCR currently is conducting a review of the HIPAA Audit program to determine its efficacy in assessing the HIPAA compliance efforts of covered entities. As part of that review, OCR plans to ask covered entities audited under the HIPAA Audit Program in 2012 to complete an online survey about their experience. In anticipation of its conduct of the proposed surveys, OCR is inviting public comment on the burden to Covered Entities to complete the planned online survey, which OCR estimates will take two hours to complete through May 20, 2013. According to OCR, the survey will gather information on the effect of the audits on the audited entities and the entities’ opinions about the audit process. The online survey will be used to:

Measure the effect of the HIPAA Audit program on covered entities;
Gauge their attitudes towards the audit overall and in regards to major audit program features, such as the document request, communications received, the on-site visit, the audit report findings and recommendations;
Obtain estimates of costs incurred by covered entities, in time and money, spent responding to audit-related requests;
Seek feedback on the effect of the HIPAA Audit program on the day-to-day business operations; and
Assess whether improvements in HIPAA compliance were achieved as a result of the Audit program.

OCR says it will use the information, opinions, and comments collected using the online survey to produce recommendations for improving the HIPAA Audit program.

For instructions to comment or more details, see here.

For More Information Or Assistance

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Covered Entities, Data, Health Care, Health Plans, HIPAA, HIPAA Audits, OCR, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

On Health Reform Law’s 3rd Anniversary, Test Your Reform Knowledge

March 21, 2013

March 21, 2013 is the 3rd Anniversary of the Affordable Care Act. With the 2014 rollout of the next round of reforms approaching, the Kaiser Family Foundation invites you to take its latest interactive quiz to test your knowledge about what’s in – and what’s not in – the health reform law and encourage your friends and family to do the same. You can compare your knowledge with others and share your results on Facebook and Twitter. The quiz also includes links to more information about specific provisions of the law.

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Affordable Care Act, Health Care Reform | Permalink
Posted by Cynthia Marcotte Stamer

Maintaining Patient Problem List Under Meaningful Use Core Measure 3 To Support Patient Care

March 16, 2013

ONC is sharing resources to help health care providers see the value of and effectively incorporate and use active patient problem lists as part of the electronic health records systems (EHRs).

Meaningful Use Core Measure 3 calls for physicians and other eligible professionals to design their electronic health record systems to incorporate and maintain an up-to-date problem list of current and active diagnoses of patients.

The requirement reflects ONC’s determination that accurate active problem lists and the fast overview of patient history’s they provide are a “mainstay” of efficient and effective primary care. Effective active patient problem lists in EHRs make this information available to all clinic staff and the on-call team improves the efficiency and effectiveness of the care team.

To support this goal, the requirement that Meaningful Use Core Measure 3 calls for more than 80 percent of all unique patients seen by the eligible professional have at least one entry or an sign that no problems are known for the patient recorded as structured data.

Review the requirements of Core Measure 3 and access other tips and resources for developing and using effective patient problem lists in EHRs here.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

1 Comment | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: EHR, Health Care, Meaningful Use | Permalink
Posted by Cynthia Marcotte Stamer

CMS 2nd Recalculation Medicare Readmission Penalties In 6 Months Cuts Overall Penalties By $10M

March 15, 2013

The Centers for Medicare & Medicaid Services (CMS)for the second time in six months has corrected errors in its calculation of Medicare readmission penalties imposed against more than 1,000 hospitals imposed under the Medicare Hospital Readmission Reduction Program.

Under the Medicare Readmission Reduction Program, CMS is penalizing hospitals whose readmissions within 30 days following their discharge of heart attack, heart failure and pneumonia patients exceed the rate CMS expects based on their patient risks with the loss of up to 1 percent of their regular payments. This maximum penalty ramps is slated to rise to up to 2 percent in October and 3 percent in 2014.

While some hospital’s penalties went up and most went down, the net effect of the recalculation back to the program’s origination last October is a $10 million reduction in the overall penalties resulting in an adjusted total of $280 million for 2013.

An updated chart of the corrected readmission penalties prepared by Kaiser Health News is available here.

Part of new CMS “quality” provisions, the readmission penalties have prompted widespread concern by many hospital and other health care leaders as penalizing hospitals for readmissions beyond their control. Supports of the penalties say that the penalties can encourage hospitals to provide better quality and reduce costs by emphasizing appropriate discharge planning.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Health Care Fraud, Medicaid Fraud, Medicare, Medicare Fraud Task Force, readmissions penalty | Permalink
Posted by Cynthia Marcotte Stamer

Par Pharmaceutical Pays $45 Million For Illegal Off-Label Marketing Of Megace ES

March 11, 2013

New Jersey-based Par Pharmaceutical Companies Inc. (Par) must pay more than will pay $45 million to resolve their criminal and civil liability under its March 5, 2013 guilty plea to illegally promoting off-label uses of the prescription drug Megace ES in violation of Food and Drug Administration (FDA) rules and wrongfully promoting and billing Medicare for its use. The Par guilty plea followed a guilty plea by Par’s Chief Executive Officer Paul V. Campanelli earlier in the day in a New Jersey federal court.

Par also entered into a civil settlement that resolved three lawsuits filed under the whistleblower provisions of the False Claims Act, which let private parties to file suit on behalf of the United States and obtain part of the government’s recovery. The civil lawsuits filed in New Jersey are U.S. ex rel. McKeen and Combs v. Par Pharma ceutical, et al., U.S. ex rel. Thompson v. Par Pharmaceutical, et al., and U.S. ex rel. Elliott & Lundstrom v. Bristol-M yers Squibb, Par Pharma ceutical, et al. As part of today’s resolution, relators McKeen and Combs will receive $4.4 million. The actions provide another example of the growing role of whistleblowers to the success of federal health care fraud detection and enforcement efforts.

Par Criminal & Charges

The Federal Food, Drug and Cosmetic Act (FDCA) requires companies such as Par to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be distributed in interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.

Par pleaded guilty to a federal a criminal misdemeanor violation of these rules by misbranding Megace ES in violation of the FDCA. Megace ES, a megestrol acetate drug product was approved by the FDA to treat anorexia, cachexia, or other significant weight loss suffered by patients with AIDS. Federal prosecutors charged that Megace ES distributed nationwide by Par was criminally misbranded because its FDA-approved labeling lacked adequate directions for use in the treatment of non-AIDS-related geriatric wasting, a use that was intended by Par but never approved by the FDA.

Federal Judge Judge Arleo fined Par $18 million and ordered $4.5 million in criminal forfeiture. Par also entered into a civil settlement agreement to settle associated civil liability.

The civil settlement agreement requires Par to pay $22.5 million to the federal government and various states to resolve claims arising from its off-label marketing. The civil settlement resolves allegations that Par, by promoting the sale and use of Megace ES for uses that were not FDA-approved and not covered by Federal health care programs, caused false claims to be submitted to these programs. The United States further alleged that Par deliberately and improperly targeted sales to elderly nursing home residents with weight loss, whether or not such patients suffered from AIDS, and launched a long-term care sales force to market to this population. During this marketing campaign, the government charged Par was aware of adverse side effects associated with the use of megestrol acetate in elderly patients, including an increased risk of deep vein thrombosis, toxic reactions in elderly patients with impaired renal function, and mortality. The United States alleged that Par made unsubstantiated and misleading representations about the superiority of Megace ES over generic megestrol acetate for elderly patients to encourage providers to switch patients from generic megestrol acetate to MegaceES, despite having conducted no well-controlled studies to support a claim of greater efficacy for Megace ES.

As part of plea agreement and corporate integrity agreements reached to resolve its civil and criminal charges, Par committed to the Department of Justice, the Department of Health & Human Services (HHS) and its Office of Inspector General. Par to implement several compliance measures and annually provide the U.S. Attorney’s Office and other agencies with certain reports.

The plea agreement and corporate integrity agreement include provisions that require Par to implement changes to the way it does business. The plea agreement and agreement prohibit Par from providing compensation to sales representatives or their managers based on the volume of sale of Megace ES, and in the corporate integrity agreement, based on the volume of Megace ES and any branded successor megestrol acetate drug.

The agreements also dictate individual accountability of Par’s board and executives. Under the agreement, Par is also required to change its executive compensation program to permit the company to recoup annual bonuses from covered executives if they, or their subordinates, engage in significant misconduct. Company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales representatives may not be paid incentive compensation for the drug involved in the case, or successor branded versions of that drug. For instance, the plea agreement requires Par give the Justice Department a sworn certification from its chief executive officer that the company has not unlawfully marketed any of its pharmaceutical products.

Par Prosecutions Part Of Larger Aggressive Health Care Fraud Enforcement

The Par civil and criminal charges were brought as part of the ongoing war against health care fraud conducted by federal and state officials. Its announcement is just one of high-profile health care fraud charges, settlements and convictions announced by the Justice Department in the first seven days of March. See, e.g., Health Care Clinic Director Pleads Guilty in Miami for Role in $63 Million Health Care Fraud Scheme; Orange County Doctor Convicted of Six Counts of Health Care Fraud in Multi-Million Dollar Scam involving Durable Medical Equipment; Manhattan U.S. Attorney Sues Park Avenue Medical Associates for Medicare Billing Fraud; Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing; Doctor gets 50 Month Sentence for Health Care Fraud & Tax Evasion; and Nelson County, Kentucky Drug Store Owner Charged With Health Care Fraud and Wire Fraud.

Already a lead federal enforcement priority for more than a decade, the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2012 (FY2012 Report) documents that DOJ and HHS health care fraud enforcement activities scored big in 2012, and that qui tam whistleblowers played a big part and shared big in the profits. See Federal Health Care Fraud & Abuse Recovery of $4.2 Billion In FY 2012 Shows Enforcement Risks Growing.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges. Along with a broad health care fraud enforcement and compliance programs, these efforts should include targeted efforts to prevent and manage fraud and other whistleblower claims by employees, business partners and others.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: FDA, Health Care Fraud, Medicaid Fraud, Medicare, Medicare Fraud Task Force, Off Label | Permalink
Posted by Cynthia Marcotte Stamer

For More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

Criminal Convictions

Criminal and Civil Recoveries

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements

Gampel, Modern Vascular FCA Complaint

Warning To Other Heath Care Providers & Suppliers

For More Information

Other Helpful Resources & Information

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this: