Prescription Drugs |

CMS Likely To Tighten Audits & Reimbursement After OIG Says “Extremely High” Retail Pharmacy Billings To Medicare Part D Warrant Close Scrutiny

May 18, 2012

The Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) is recommending a “strong response” to improve Medicare Part D oversight of retail pharmacy prescriptions by the Centers for Medicare & Medicaid Services (CMS) based on findings of a recent study. See here. OIG says that “extremely high” prescription drug billings by many retail pharmacies merit scrutiny under medical necessity or other grounds.

Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. According to OIG, OIG has issued several reports that OIG has found that Part D had limited safeguards in place in the 6 years since Part D began.

In response to these concerns, OIG recently conducted a study based on an analysis of prescription drug event records. Sponsors send these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record has information about the pharmacy, prescriber, beneficiary, and drug. OIG analyzed all of the records for drugs billed by retail pharmacies in 2009 and developed eight measures to describe Part D billing and to identify pharmacies with questionable billing.

Based on this study, OIG reports that retail pharmacies each billed Part D an average of nearly $1 million for prescriptions in 2009. According to OIG, the study revealed “questionable billing” by more than 2,600 of these pharmacies. OIG reports that these pharmacies had ‘extremely high billing” for at least one of the eight measures developed and applied by OIG For example, many pharmacies billed what OIG characterized as “extremely high” dollar amounts or numbers of prescriptions per beneficiary or per prescriber. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.

Although OIG concedes that some of this billing may be legitimate, OIG believes that pharmacies that bill for extremely high amounts call for further scrutiny The OIG report expresses concern that these high dollar prescription drug billings could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary.

Accordingly, OIG is recommending that CMS: (1) strengthen the Medicare Drug Integrity Contractor’s monitoring of pharmacies and ability to identify pharmacies for further review, (2) provide additional guidance to sponsors on monitoring pharmacy billing, (3) require sponsors to refer potential fraud and abuse incidents that may warrant further investigation, (4) develop risk scores for pharmacies, (5) further strengthen its compliance plan audits, and (6) follow up on the pharmacies identified as having questionable billing. CMS concurred with four of the recommendations and partially concurred with the other two.

Private health plans and other payers are likely to review the study to determine whether it provides justification for closer scrutiny of prescription drug claims made to private payers.

Whether or not private health plans follow suit, retail pharmacies and other providers should anticipate that CMS will increase scrutiny and challenges of prescription drug charges submitted to Medicare Part D. Accordingly, retail pharmacies and the physician and other providers prescribing medications likely to be billed should tighten documentation and other procedures to defend against possible medical necessity and other challenges.

The continuing focus and success of federal health care fraud and related investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. The prosecutions of Giventer and Shavabskaya highlight that health care providers and their leaders need to manage prosecution risks under a broad range of laws in addition to focusing on management of the widely recognized exposures to prosecution under federal health care fraud laws,

Health Care Providers Must 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 proper 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 Legal Representation or More Information

If you need help 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 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 set up 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. 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

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:

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Posted by Cynthia Marcotte Stamer

Houston-Area Nurse Gets 97 Month Sentence For Role In $5.2 Million Medicare Fraud Scheme

May 18, 2012

A Houston-area home health nurse will serve a 97 month prison sentence for her participation in a $5.2 million Medicare fraud scheme according to a May 16, 2012 announcement by the Department of Justice, the Federal Bureau of Investigation and Department of Health and Human Service (HHS). The sentence is the latest in a growing series of reminders to health care providers and others of the growing risk of imprisonment and other consequences that can result from the submission of inappropriate Medicare or other health program claims.

Ezinne Ubani, the former director of nursing at Family Healthcare Group, a Houston home health care company, was sentenced by U.S. District Judge Nancy Atlas in the Southern District of Texas to 97 months in prison, followed by three years supervised release. Ubani also was ordered to pay $2.5 million in restitution jointly and severally with her codefendants. Ubani was convicted of one count of conspiracy to commit health care fraud and two counts of making false statements following a May 2011 trial.

According to the evidence presented at trial and in court documents, Family Healthcare Group purported to provide skilled nursing to Medicare beneficiaries. Family Healthcare Group paid co-conspirators to recruit Medicare beneficiaries for the purpose of filing claims with Medicare for skilled nursing that was medically unnecessary and/or not provided. The evidence showed that Ezinne Ubani falsified documents to support the fraudulent payments. After the Medicare beneficiaries were recruited, other co-conspirators fraudulently signed plans of care stating that the beneficiaries needed home health care when in fact they knew the beneficiaries were not home-bound and not in need of skilled nursing.

Ubani is the seventh defendant sentenced in connection with this scheme. Three other defendants, Clifford Ubani, Princewill Njoku and Cynthia Garza Williams, await sentencing in the Southern District of Texas.

Feds Continue To Turn Up HEAT on Health Care Fraud

The investigation and prosecution that lead to Ubani’s sentence are part of a growing number of prosecutions and convictions resulting from the federal HEAT Task Force. Empowered with new data mining, statistical profiling and other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions.

according to Justice Department officials, since their inception in March 2007, Medicare Fraud Strike Force operations in nine locations have charged more than 1,330 defendants who collectively have falsely billed the Medicare program for more than $4 billion. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012. Furthermore, this trend is likely to continue. Federal officials say the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers along side the ongoing investigatory and enforcement activities of the HEAT Task Force and other federal and state agencies.

Health Care Providers Must 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.

For More Information Or Assistance

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 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 » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, 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

Health Care Providers Get Nailed For Using False Statements To Defraud Medicaid, Bankruptcy Court

May 18, 2012

Two unrelated Federal felony prosecutions and convictions of Texas-based health care providers announced this week illustrate the risks that health care and other businesses and their leaders run for coloring the truth in health care billings, court filings or other dealings. The convictions highlight the advisability for health industry and other business leaders both to exercise care to avoid engaging in potentially actionable misrepresentations when signing billing, court pleadings or other official documents, as well as implement appropriate documentation and review procedures to minimize liability risks to their organizations and themselves that may arise from reliance upon represenations of staff or others which turn out to be untrue.

On May 16, 2012, Laredo, Texas dentist Dr. Carlos Armin Morales-Ryan and his wife orthodontist Dr. Nelia Patricia Garcia-Morales pleaded guilty to a criminal information admitting they made false statements on bills to Texas Medicaid. These guilty pleas follow the May 14, 2012 guilty plea entered by Michael Giventer to conspiracy to commit bankruptcy fraud by misrepresenting his ownership and control in health care businesses.

Texas Dentist/Orthodontist Couple Convicted of Making False Statements on Bills to Texas Medicaid

On May 16, 2012, dentist Morales-Ryan and his orthodontist wife Garcia-Morales pleaded guilty to a criminal information admitting they made false statements on bills to Texas Medicaid.

Morales-Ryan and Garcia-Morales owned and operated Orthogenesis International Centre, a Laredo dentistry and orthodontics business. A substantial portion of their business was targeted to rendering services to Medicaid-eligible children. Applicable Texas law and Medicaid regulations required the doctors to be present in their offices when services were rendered on Medicaid patients as a prerequisite to receiving payment for the services from Medicaid. Similar consumer protection laws and regulations are applicable to most types of physicians for many of the services they render in Texas, regardless of whether the patient is or is not a Medicaid beneficiary.

Morales-Ryan’s signed plea agreement states that though he and Garcia-Morales were in Hawaii on October 12, 2007, he falsely represented to Medicaid that he performed an evaluation and management of a new patient on that date claiming entitlement to payment. However, at the time he made this false representation to Medicaid, he and Garcia-Morales knew the statement was false and that neither of them performed that service on or about that date. Similarly, Garcia-Morales admitted that though she and Morales-Ryan were en route to the U.S. Virgin Islands on March 23, 2007, she falsely represented to Medicaid that she performed an orthodontic retention on that date claiming entitlement to payment. However, at the time she made this false representation to Medicaid, she and Morales-Ryan knew the statement was false and that neither of them performed an orthodontic retention on or about that date.

As a result of their plea agreements, they will be sentenced to five years probation and will pay restitution in the amount of $686,545 to the State of Texas Health and Human Services Commission – Office of Inspector General.

Court records reflect that this is not the first time Morales-Ryan has been in legal trouble. Morales-Ryan previously was convicted of 13 counts of practing medicine without a license for performing non-dentistry and non-non-oral and maxillofacial surgeriescosmetic surgery procedures including including: tummy tucks, liposuction, and breast augmentation. See here.

The Texas State Board of Dental Examiners previously suspended the license to practice dentistry of Morales-Ryanin Texas. See here.

Giventer Conspiracy To Commit Bankruptcy Plea

On May 14, 2012, Michael Giventer pleaded guilty to conspiracy to commit bankruptcy fraud. Giventer’s wife, Julia Shavabskaya, previously pleaded guilty to the same charge on April 30, 2012.

Justice Department officials charged that from on August, 2002 to July 2010, Giventer caused the incorporation of two business entities, Ambucare Inc. and Open Diagnostic Imaging Inc., as holding companies to receive income from clinics providing various forms of health care services to individuals who were covered by Workers’ Compensation insurance.

Ownership of both Ambucare and Open Diagnostic Imaging was placed solely in the name of Shvabskaya. Through these two companies, Giventer received income from a number of these clinics, such as Valley Center for Pain and Stress Management, Functional Pain Center, Palladium for Surgery and Valley Comprehensive Pain Management. Unrelated court records reflect that at least one of these organizations, Valley Center for Pain and Stress Management during the period was accused by insurer TML Intergovernmental Risk Pool of seeking worker’s compensation benefits for medically unnecessary services. Valley Comprehensive Pain Management v. TML Intergovernmental Risk Pool (May 19, 2004).

On November 4, 2005, Giventer filed for bankruptcy under chapter 7 in the Southern District of Texas. During the bankruptcy, Giventer was required to file under penalty of perjury various Schedules consisting of assets, debts, liabilities and a Statement of Financial Affairs in which he was required to disclose among other things, his income, debts, property and transfers of property. In some of the documents, Giventer indicated he did not own an interest in Ambucare, Open Diagnostic Imaging and other properties and assets. In truth, however Giventer controlled, managed and received income from these entities and made all decisions about how their income would be distributed. Shavabskaya falsely testified that she owned the companies and that Giventer did not own or operate them. Additionally, both Giventer and Shavabskaya knew and falsely denied under oath any ownership interest in these entities in order to deceive, frustrate and prevent creditors and the bankruptcy Trustee from identifying and collecting assets as part of the bankruptcy estate to be distributed for the benefit of creditors.

Sentencing of both Giventer and Shavabskaya on the bankruptcy fraud conspiracy guilty pleas is scheduled on September 24, 2012. Each faces a maximum sentence of up to five years in federal prison and a fine up to $250,000.

Health Care Providers Must Act To Manage Risks

For Legal Representation or More Information

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

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Posted by Cynthia Marcotte Stamer

Texas Medical Supply Medical Supply Company Owner Convicted Of Violating Anti-Kickback Statute Could Get 5 Years

May 16, 2012

The owner of a Weslaco, Texas-area medical supply and diagnostic testing company faces sentencing on July 25, 2012 to five years in federal prison without parole and a $250,000 fine after pleading guilty to one count of conspiracy to violate the federal anti-kickback statute. The successful prosecution of Jose “Joe” Trevino is the latest in a growing list of criminal prosecutions and convictions by Federal officials under the Federal Anti-Kickback Statute.

The Anti-Kickback Statute

The Federal Anti-Kickback Statute prohibits individuals and entities from knowingly and willfully paying or offering to pay, as well as soliciting or receiving, remuneration (money or other things of value) in return for the referral of patients for medical services or items which are benefits under a federal health care program, such as Medicare or Medicaid. Violation of the Statute is a felony offense.

Trevino Conviction

Trevino pleaded guilty on April 24, 2012 to a one-count criminal information charging conspiracy to violate the anti-kickback statute. According to information presented by the United States at the April 24th hearing, Trevino is the owner of Med-Quick Diagnostics, a medical supply and diagnostic testing facility in Weslaco, Texas. From approximately September 2009 through April 2011, Federal officials charged that Trevino authorized thousands of dollars in illegal kickback payments to an area marketer, Alicia Vasquez, in exchange for Vasquez’s referrals of many Medicare and Medicaid patients to Med-Quick. Trevino paid the kickbacks to Vasquez through a third-party – referred to in the criminal information as “Person A.” The kickbacks were deposited into Person A’s bank account, from where the money was later diverted to Vasquez. Med-Quick subsequently billed Medicare and Medicaid hundreds of thousands of dollars for patients that were illegally referred by Vasquez.

Vasquez previously pleaded guilty to conspiracy and is awaiting sentencing.

Other Federal Anti-Kickback Statute Enforcement

The Trevino conviction is the latest in a growing list of Anti-Kickback Statute prosecutions. Federal enforcement of the Anti-Kickback Statute has increased. On April 19, 2012, for example, Federal prosecutors in Houston charged Floyd Leslie Brooks and Gwendolyn Kay Frank with conspiracy to violation the Anti-Kickback Statute in relation to the massive health care fraud conspiracy that allegedly billed the Medicare and Medicaid programs for more than $45 million.

That action followed the April 9, 2012 guilty plea of former Orthofix vice president of sales Thomas P. Guerrieri to violating the Anti-Kickback Statute in connection with the sale of bone growth stimulators. His sentencing is scheduled for July 11, 2012. He faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and forfeiture. See also, Nine Health Care Professionals, Including Five Doctors, Charged In Kickback Scheme.

Health Care Providers Must 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.

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 » | Anti-KickBack, Doctor, E-Prescribing, false claims act, Health Care, Health Care Fraud, Health Care Provider, Hospital, OIG, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Substance Abuse | Tagged: Anti-Kickback, 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

Texas Healthcare Operator’s Guilty Plea To Bankruptcy Fraud Conspiracy Highlights Broad Prosecution Risks

May 16, 2012

The recent guilty pleas of the former operator of Texas-based ambulance and imaging companies and his wife to conspiring to commit bankruptcy fraud shows the risks of misrepresentation in official documents, as well as the diverse range of tools and options that federal officials wield as part of their crusade against what they perceive as wrongdoers in the health care system.

Conspiracy To Commit Bankruptcy Plea

On May 14, 2012, Michael Giventer pleaded guilty to conspiracy to commit bankruptcy fraud. Giventer’s wife, Julia Shavabskaya, previously pleaded guilty to the same charge on April 30, 2012.

Health Care Providers Must Act To Manage Risks

For Legal Representation or More Information

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 » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, 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

Orthofix Medical Device Exec Awaits Sentencing After Pleading Guilty To Violating Anti-Kickback Law

April 10, 2012

The conviction today of a former vice president of sales of the medical device company Orthofix shows the risks that health care providers, medical device, Pharma, and other health care suppliers, and their leaders risk when engaging in consulting arrangements or other dealings that could raise scrutiny as aggressive under federal or state anti-kickback or other health care laws. The prosecution and conviction shows the advisability for health care suppliers, providers and their leaders to carefully evaluate proposed consulting and other arrangements between health care providers and health care providers for potential exposures to prosecution under Federal and State Anti-Kickback, STARK and other health care fraud and referral laws.

Thomas P. Guerrieri, former vice president of sales of medical device company Orthofix, now faces sentencing on July 11 after pleading guilty earlier today (April 10, 2012) to violating the Anti-Kickback statute. At sentencing, Guerrieri faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and forfeiture.

Federal prosecutors charged that while serving as vice-president of sales at Orthofix, a manufacturer and provider of bone growth stimulator devices, Guerrieri facilitated signing up a surgeon in New York to a “consulting” agreement with the company to induce the surgeon to prescribe the company’s bone growth stimulators. According to federal officials, the company paid the surgeon tens of thousands of dollars when he provided little or no consulting services in return. Federal officials charged that although the surgeon was supposed to document his services in time sheets provided to the company, the company paid him monthly consulting fees for years even though Guerrieri did not fill out these forms or provide any legitimate consulting services.

Federal officials charged that after the surgeon became concerned about increased government scrutiny of consulting arrangements such as his in 2007, the surgeon, Guerrieri, and a territory manager for the company decided to create and backdate time sheets going back to 2006 to make it seem as though the surgeon filled out these forms contemporaneously and performed legitimate consulting services. In addition, at the surgeon’s request, Guerrieri and the territory manager obtained a letter from the company’s general counsel indicating that the surgeon was compliant under his consulting agreement, which was not true. Federal officials had charged that Guerrieri did these things to induce the surgeon to continue to order bone growth stimulators from the company.

Federal officials also charged that Guerrieri and others executed a scheme to pay Michael Cobb, a RI physician’s assistant, for each bone growth stimulator ordered by Cobb. The surgeon had delegated to Cobb the choice of which stimulator his patients received. For years, the device company paid Cobb $50-$100 for each stimulator that his surgeon prescribed. In Sept. 2008, the device company issued a policy expressly prohibiting any payments to anyone who works for a surgeon that prescribes the company’s products. Guerrieri and others worried that if they could no longer pay Cobb under the new policy, the company might lose Cobb’s business. Thus, Guerrieri, and others, devised a scheme where Cobb continued to be paid for each order, but the payments were made by a vendor of the device company, making it more difficult to trace the paper trail back to the device company. Cobb is also charged with violating the Anti-Kickback law. Cobb’s plea hearing is set for April 19, 2012. The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to show the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must Act To Manage Risks

While media attention has focused most heavily on federal fraudulent claims enforcement, the conviction of Guerrieri and the prosecution of Cobb show that federal officials also remain committed to enforcement of the Anti-Kickback and STARK laws.

In light of the heightened enforcement risks, health care providers and others conducting business that may be affected by these laws should exercise care to adopt and administer effective policies to keep up compliance with these and other requirements. Health care providers and suppliers should consider auditing the adequacy of existing practices, tightening training, oversight and controls on marketing, consulting, referral and other business transactions, billing and other regulated conduct. In addition to constantly reviewing and enforcing policies designed to maintain compliance with these requirements, health care providers and suppliers also should consistently recommunicate and reaffirm their commitment to compliance to workforce members and constituents and take other appropriate steps to help prevent, detect and timely redress anti-kickback and other prohibited referrals and 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 » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: aniti-kickback, 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, STARK | Permalink
Posted by Cynthia Marcotte Stamer

Health Care Providers Also Should Guard Against Rising Exposures To State Health Care Fraud & Other Enforcement Risks

April 9, 2012

With all the media hype over federal health care fraud enforcement and prosecution, the growing emphasis and success of state regulators in finding and prosecuting health care fraud often goes relatively unnoticed. Health care providers concerned with managing their risks should exercise care to properly recognize and manage these state law exposures to promote an effective fraud compliance and risk management program.

Driven both by federal program mandates and daunting state health care entitlement program budget expenditures, state regulators and law enforcement teams across the United States increasingly are active and vital participants in the expanding federal and state war against health care fraud and other health care provider misconduct.

Highlights of some of the more significant state health care fraud enforcement activities over the past month include:

On April 4, a Gwinnett County Georgia Grand Jury indicted the former owner of a company known as Diversified Family Solutions and three employees for unlawfully obtaining approximately $980,000.00 in Medicaid payments through a fraudulent billing scheme. See Owner and Employees of Metro Atlanta Mental Health Services Company Indicted for Stealing Nearly $1 Million from Medicaid
In a series of announcements made on April 4-5, 2012, 9 states and the federal government announced a massive settlement with WellCare Health Plans, Inc., which resolves Medicare Fraud allegations against Wellcare by the states and federal regulators. See e.g., Indiana Medicaid to receive $922K in WellCare settlement; Connecticut Benefits From Settlement With WellCare on Medicaid Fraud Charges; Florida Recovers More Than $54 Million From WellCare in Medicaid Fraud Settlement
On April 5, 2012, the Oklahoma Attorney General announced that an Oklahoma City counselor has been named in a multicounty grand jury indictment unsealed in Oklahoma County District Court. Vickie Rhea Yearwood, 53, a licensed professional counselor through Beacon Pointe LLC and Specialized Alternatives for Families and Youth, was indicted on two counts of Medicaid fraud. See, OKC Counselor Indicted for Medicaid Fraud
On April 4, 2012, Attorney General Eric T. Schneiderman announced the arrests and indictment of four ringleaders of a massive scheme to distribute black market prescription HIV drugs and defraud the Medicaid Program of $155 million. After an investigation code-named “Operation Black Market Meds,” the Attorney General’s Medicaid Fraud Control Unit shut down an illegal operation that was distributing HIV prescription drugs obtained on the black market through MOMS pharmacy, a high-volume pharmacy with satellites in Suffolk County and Brooklyn. MOMS, and its parent company Allion Healthcare, then dispensed the illegally obtained drugs to Medicaid recipients, and billed the New York State Medicaid program for these un-sellable drugs. See, A.G. Schneiderman Announces Arrests in $274 Million Black Market Prescription Drug Operation
On April 3, 2012, Tennessee officials announced charges against a Montgomery County woman for TennCare fraud in a case involving prescription drugs. See, Montgomery County Woman Charged With Tenncare Drug Fraud
On March 30, 2012, Massachusetts officials announced that a medical testing company will pay $20 million in restitution to resolve allegations of an elaborate kickback scheme that cost the Massachusetts Medicaid program (MassHealth) millions of dollars for unnecessary urine drug screens. See, Calloway Laboratories Pays $20 Million to Resolve Allegations of Kickbacks and Fraud on State Medicaid Program
On March 27, 2012, Texas Attorney General announced a Texas court’s approval of “The largest recovery of taxpayer funds in a Texas civil Medicaid fraud case.”Under an agreed final judgment entered this morning, Johnson & Johnson and its subsidiaries must pay $158 million to resolve the State’s enforcement action charging Janssen Pharmaceutica with defrauding the taxpayer-funded Texas Medicaid program. See, Statement Regarding Final Agreed Judgment in State’s Medicaid Fraud Case Against Johnson & Johnson

Between March 22 and March 27, 2012, the Tennessee Department of Finance & Administration filed charges against a variety of individuals for TennCare fraud arising out of alleged misrepresentations and billings for prescription drugs to get healthcare benefits. See, Williamson County Woman Charged With TennCare Fraud ; Two Mid-State Residents Charged With TennCare Fraud Involving Prescription Drugs Two Women Plead Guilty To TennCare Drug Fraud
On March 22, 2012, Louisiana Attorney General Buddy Caldwell announced the trial setting in the state’s lawsuit against more than 100 drug manufacturers beginning on n March 4, 2013, June 17, 2013, and October 7, 2013. See Trial Dates Set in Cases Against Drug Manufacturers
On March 22, 2012, the Georgia Attorney General announced the sentencing of Leetra Dometric Langston to five years of probation and restitution for following his plea to one count of Medicaid Fraud for his role in a scheme involving a businesses that purported to be a residential treatment program for homeless teenage girls. Langston was the last of three defendants to plead guilty to the scheme. See Final Defendant Pleads Guilty to Medicaid Fraud in Scheme Involving Homeless and Pregnant Teenagers
On March 22, 2012, Louisiana announced that a Delhi woman has been arrested and charged with three-counts of Exploitation of the Infirmed. Delhi Woman Arrested for Exploitation of the Infirmed
On March 21, 2012, Oklahoma Attorney General Scott Pruitt’s Medicaid Fraud Control Unit announced it filed charges against the owner of a Midwest City youth counseling agency for billing services to children that parents say didn’t happen. See, AG Pruitt Charges MWC Counselor with Medicaid Fraud
On March 20, 2012, Alabama Attorney General Luther Strange announced that a former bookkeeper employed by a Wetumpka nursing home was sentenced to prison for the theft of $115,734 of residents’ funds from the facility. See, AG Announces Prison Sentence Of Former Bookkeeper For Theft Of $115,734 From Wetumpka Nursing Home
On March 19, 2012, the Tennessee Department of Finance & Administration brought charges against a Davidson County woman is charged with TennCare fraud involving “doctor shopping,” or using TennCare to go to multiple doctors in a short time period to obtain controlled substances. See, Davidson Co. Woman Charged With TennCare “Doctor Shopping”
On March 19, 2012, Tennessee Department of Finance & Administration charged an Anderson County woman is charged with TennCare fraud for using TennCare benefits to pay for what officials say was a fraudulent prescription. See, Anderson County Woman Charged With TennCare Fraud
On March 19, 2012, Wisconsin Attorney General J.B. Van Hollen announced that Wisconsin has joined other states and the federal government and reached an agreement in principle with KV Pharmaceutical Company to settle allegations that the company failed to tell the Centers for Medicare and Medicaid Services that two unapproved products did not qualify for coverage under federal and state health care programs. See, St. Louis-based KV Pharmaceutical to Settle Medicaid False Claims Allegations
On March 16, 2012, Attorney General Jeffrey S. Chiesa announced that the owner of a now-defunct Newark mental health and substance abuse counseling center was sentenced to state prison after being convicted of defrauding Medicaid. See, Former Owner of Counseling Center Sentenced to State Prison for Defrauding Medicaid
On March 15, 2012, Ohio Attorney General Mike DeWine said that Alicia K. Mahone, of Cleveland, was convicted of billing for home health care not provided for $20,000. Mahone regularly submitted bills, from April to December 2010, to the Ohio Department of Job and Family Services claiming to have provided 35 hours of patient care to a Medicaid recipient, while only having provided 15 hours. See, Attorney General DeWine Announces Conviction in Medicaid Billing Fraud
Also on March 15, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a certified nursing assistant who worked at a Livingston nursing home was charged with allegedly conspiring to take a photograph of an elderly resident’s genitalia and have the photograph posted on Facebook. Her friend, and co-defendant, was charged on March 14 in the alleged scheme. See, Certified Nursing Assistant Among Two Charged with Invasion of Privacy After Photo of a Nursing Home Resident’s Genitalia Posted on Facebook
On March 13, 2012, Arizona Attorney General Tom Horne announced that a Glendale man has been sentenced to prison and probation for prescription drug fraud. See, Horne Announces Prison Sentence For Glendale Man Convicted Of Prescription Drug Fraud
Also on March 13, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a former Matawan doctor pleaded guilty to dispensing controlled dangerous substances by writing prescriptions for medically unnecessary pharmaceutical narcotics in return for cash payments. See, Former Matawan Doctor Pleads Guilty to Dispensing Pharmaceutical Narcotics for Cash
On March 13, 2012, Arizona Attorney General Tom Horne announced that a guilty verdict in the health care fraud trial of Julianne Mari Lane, a home health worker in Tucson. See, Home Health Care Worker Convicted For Fraud Of Vulnerable Adult
On March 13, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a Newark pharmacist has pleaded guilty for his role in a scheme in which pharmacy owners and employees purchased prescriptions including HIV/AIDS drugs from indigent patients so Medicaid could be billed for medications that were never actually dispensed. See, Essex County Pharmacist Pleads Guilty to Medicaid Fraud in False Billing Scheme
On March 7, 2012, Michigan Attorney General Bill Schuette, Michigan Department of Human Services Director Maura D. Corrigan and U.S. Department of Health and Human Services, Office of Inspector General announced that the Attorney General’s Public Integrity Unit charged a former City of Detroit employee with one felony count of fraud. See, Schuette, Corrigan Announce Fraud Charge against Ex-City of Detroit DHS Social Worker
On March 7, 2012, Ohio Attorney General Mike DeWine announced that Janet Root, 35, was sentenced for theft of patient funds at the Arcadia Nursing Center in Coolville, Ohio. Root was sentenced to five years of community control and ordered to pay $31,471 in restitution. She also received a nine-year suspended sentence after she pled guilty last November to four counts of Theft from the Elderly, fourth-degree felonies, and two counts of Forgery, fourth-degree felonies. See, Attorney General DeWine Announces Sentencing in Theft from Nursing Center Residents
On March 7, 2012, Maryland Attorney General Douglas F. Gansler today announced that Maryland, along with multiple states and the federal government, has reached agreements with K-V Pharmaceutical Company to settle allegations that the company caused false claims to be submitted to the Medicaid program. Under the K-V agreement, K-V will pay the states and the federal government a total of $17 million to compensate Medicaid and various federal health care programs for the violations. The federal share of the settlement is $10,158,695, and the states’ share of the settlement is $6,841,305. Maryland will receive $36,377. See, AG Gansler Secures Settlement with K-V Pharmaceutical
Also on March 7, 2012, Maryland Attorney General Douglas F. Gansler announced Dava Pharmaceuticals, Inc. agreement, (“Dava”) had agreed to a settlement of the State’s allegations that Dava failed to pay required rebates to the Medicaid program. Dava will pay $11 million to Medicaid and other government health care programs. Maryland will receive $7,054 from the settlement. See, AG Gansler Secures Recovery from Dava Pharmaceuticals, Inc.

This lengthy and growing list of state prosecution and other enforcement actions encompass both fraudulent billing activities of the nature commonly drawing the attention of federal health care fraud enforcement teams, as well as a wide range of other misconduct often not targeted by federal investigators.

Coupled with the growth and success of federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. When taking these efforts, the lengthy and growing list of successful state prosecutions show the need for health care providers and payers to make sure their compliance and risk management activities provide adequate protection of their organizations and people against both the highly publicized federal health care fraud war, and the much quieter, but equally active state health care fraud effort.

Health Care Providers Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal and state officials in investigating and taking action against health care providers and organizations, health care providers should constantly work to keep up and strengthen their defensive shield against health care fraud.

Among other things, health care providers 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

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Posted by Cynthia Marcotte Stamer

Halfway House Owner Gets 24 Months Imprisonment For Health Care Fraud & Kickback Conviction

March 14, 2012

Broward County, Florida halfway house owner and operator Barry Nash was sentenced to to 24 months in prison followed by three years of supervised relief for his role in a Medicare fraud kickback scheme that funneled patients through a fraudulent mental health company, the Department of Justice, the FBI and the Department of Health and Human Services (HHS) announced today (March 13, 2012).

Nash pleaded guilty on Jan. 9, 2012, to one count of conspiracy to commit health care fraud. In his guilty plea, Nash admitted that, in exchange for illegal health care kickbacks, he agreed to refer Medicare beneficiaries who resided at Starter House to American Therapeutic Corporation (ATC) and American Sleep Institute (ASI), a company related to ATC. Nash knew that ATC and ASI fraudulently billed Medicare for partial hospitalization program (PHP) services and sleep treatment purportedly provided to his referrals.

PHP is a form of intensive mental health treatment.

According to court documents, ATC’s principals paid kickbacks to owners and operators of assisted living facilities and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, the patients received a portion of those kickbacks. Throughout the course of the ATC conspiracy, millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries who did not qualify for PHP services.

Ultimately, the Justice Department alledges ATC and ASI billed Medicare for more than $200 million in medically unnecessary services.

According to the plea agreement, Nash’s participation in the fraud resulted in more than $959,901 in fraudulent billing to the Medicare program.

ATC, its management company Medlink Professional Management Group Inc., and various owners, managers, doctors, therapists, patient brokers and marketers of ATC, Medlink and ASI, were charged with various health care fraud, kickback, money laundering and other offenses in two indictments unsealed on Feb. 15, 2011. ATC, Medlink and nine of the individual defendants have pleaded guilty or have been convicted at trial. Other defendants are scheduled for trial April 9, 2012, before U.S. District Judge Patricia A. Seitz.

Feds Continue To Turn Up HEAT on Health Care Fraud

The prosecution of Nash and other defendants charged in connection with the Florida mental health investigation are one of a growing number of prosecutions and convictions resulting from the federal HEAT Task Force health care fraud enforcement efforts empowered with new data mining, statistical profiling and other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws. Using these new tools, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012.

Health Care Providers Must 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.

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

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Posted by Cynthia Marcotte Stamer

Comment Period Extended To 3/21 On Proposed Extension Of Minimum Wage, Overtime To In-Home Caregivers

March 9, 2012

The U.S. Department of Labor’s Wage and Hour Division (WHD) has extended until March 12 the comment period for its proposed rule to provide minimum wage and overtime protections for nearly 2 million workers who provide in-home care services. See here.

In December, 2011, the WHD published a proposed rule that would expand minimum wage and overtime protections to all home care workers employed by third parties, such as staffing agencies. It also would clarify that individuals performing skilled in-home care work are entitled to minimum wage and overtime pay. However, individuals engaged by families for true companionship or fellowship activities, such as visiting with friends or pursuing hobbies, still would be considered “companions” and not be required to meet the act’s labor standards provisions. See Notice of Proposed Rulemaking [1] (NPRM).

Among other things, the NPRM proposes to revise the companionship and live-in worker regulations under the Fair Labor Standards Act (FLSA):

To more clearly define the tasks that may be performed by an exempt companion;
To limit the companionship exemption to companions employed only by the family or household using the services; and
To provide that third party employers, such as in-home care staffing agencies, could not claim the companionship exemption or the overtime exemption for live-in domestic workers, even if the employee is jointly employed by the third party and the family or household.

When Congress expanded protections to “domestic service” workers in 1974, it exempted casual babysitters and companions for the aged and inform from both the minimum wage and overtime pay requirements of the FLSA and exempted live-in domestic workers from the overtime pay requirement only. While WHD has left regulations governing this exemption substantially unchanged since first issued in 1975, it now believes the in-home care service industry. workers employed by in-home care staffing agencies are not the workers that Congress envisioned in enacting the companionship exemption (i.e., neighbors performing elder sitting).

As a result of these determines, WHD is moving to modify its existing rules to broaden protections for professionally employed home care workers as well as outreaching to inform employers and workers about the requirements that it perceives employers of these workers must meet.

The proposed tightening of regulations for home health workers follows a general toughening by WHD of its regulation and enforcement of wage and hour laws in the health care industry. 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.

Many have expressed concerns about the potential added costs that changes proposed in the NPRM would trigger in providing in home health and companion care for aging and disabled family members. The extension of the comment deadline provides added time for members of the public concerned about these rules to share their input.

Whether or not the proposed rule is adopted, the growing aggressiveness of the WHD and private plaintiffs to bring actions against employers violating minimum wage and overtime rules means 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 modifications 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 frequently worked by home care givers, their employers also generally should pay particular attention to the adequacy of practices for recordkeeping.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related workforce, 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 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

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Posted by Cynthia Marcotte Stamer

2 Doctors, 4 Nurses Join 11 Defendants Charged in $20M Home Health Fraud, Kickback, Money Laundering & Tax Evasion Sting

March 8, 2012

Federal officials continued their battle against health care fraud in the home health care industry, federal prosecutors added two physicians and four registered nurses to the growing list of defendants indicted for their participation in what federal prosecutors claim was a Chicago area home health care fraud scam that allegedly swindled Medicare of at least $20 million over five years. The Justice Department’s announcement of the new Chicago indictments follows their February 28, 2012 announcement of indictments against a Dallas-area physician, his medical practice office manager and five home health agency owners on charges of submitting more than $375 million in fraudulent Medicare claims for home health services.

Chicago Home Health Fraud Sting

With the new indictments announced in Chicago today, a total of 12 defendants are now face federal criminal charges in connection with a health care fraud investigation into the operations of two suburban Chicago home health care businesses operated by the initial defendant, Jacinto “John” Gabriel, Jr. Federal officials charge that 9 of the 11 new defendants allegedly conspired with Gabriel to bill millions of dollars in false claims for reimbursement of home health care services purportedly provided to Medicare beneficiaries, which federal official allege never were provided or were not medically necessary. Prosecutors claim Gabriel and his co-schemers allegedly used the proceeds for various purposes, including: using cash to gamble at casinos in the Chicago area and Las Vegas, and to buy automobiles, jewelry and real estate in the United States and the Philippines; to perpetuate the businesses by paying his employees and providing them with gifts, and to bribe physicians and pay kickbacks to others in exchange for patient referrals.

Gabriel, who has no formal medical training, medical degrees, or licenses to practice as a health care professional, initially was arrested and charged alone in a 15-count indictment last summer. Following the issuance of a superseding indictment on March 7, he now is charged with one count of health care fraud conspiracy, 43 counts of health care fraud, 11 counts of money laundering, and four counts of federal income tax evasion.

According to the indictment, Gabriel did not identify himself as an owner, but in fact exercised ownership and control over Perpetual Home Health, Inc., based in Oak Forest, and Legacy Home Healthcare Services, which was located on the city’s north side. Both firms now have ceased operating and no longer receive Medicare payments. Between May 2006 and January 2011, federal prosecutors allege Perpetual submitted more than 14,000 Medicare claims seeking reimbursement for services allegedly provided to beneficiaries. As a result of those claims, Perpetual received more than $38 million in Medicare payments. Between 2008 and January 2011, Legacy submitted more than 2,000 claims for Medicare reimbursement and received more than $6 million. Neither Perpetual nor Legacy had any sources of revenue other than Medicare funds, the indictment states.

In addition to the charges against Gabriel, the 69-count superseding indictment returned March 7, 2012 by a federal grand jury charges:

Jassy Gabriel, Gabriel’s brother, the nominal majority owner of Perpetual and its president, as well as a registered nurse faces one count of health care fraud conspiracy and one count of filing a false federal income tax return;
Stella Lubaton, a registered nurse who was minority owner, officer and administrator of Perpetual with one count of health care fraud conspiracy, 16 counts of health care fraud, one count of filing a false federal income tax return, and one count of violating the medical anti-kickback statute;
Nessli Reyes, a registered nurse who was President and a part-owner of Legacy with one count of health care fraud conspiracy and nine counts of health care fraud;
Charito Dela Torre, a physician charged with one count of health care fraud conspiracy, 12 counts of health care fraud, and three counts of federal income tax evasion;
Ricardo Gonzales, a physician charged with one count of health care fraud conspiracy, 19 counts of health care fraud, and one count of violating the medical anti-kickback statute;
Rosalie Gonzales, a registered nurse and Ricardo Gonzales’ daughter, charged with one count of violating the medical anti-kickback statute;
Perpetual data entry employees James Davis, Francis Galang, and Michael Pacis each face one count each of health care fraud conspiracy;
Regelina “Queenie” David,a Perpetual quality assurance employee, faces charges of one count of health care fraud conspiracy;
Kennedy Lomillo, who provided bookkeeping and payroll services to Perpetual and prepared a corporate tax return for Perpetual, as well as an individual return for Lubaton, was charged with two counts of aiding and abetting the preparation of false income tax returns; and
The indictment also seeks forfeiture of $20 million against the Gabriel brothers and Lubaton.

Federal officials charge that as part of the conspiracy, Gabriel, acting in various combinations with the nine co-conspirator, allegedly obtained personal information of Medicare beneficiaries to bill Medicare without the beneficiaries’ knowledge or consent; paid bribes and kickbacks in cash and by check, directly and indirectly, to physicians and others in exchange for referrals of patients to Perpetual and Legacy; created false patient files to support fraudulent Medicare claims and submitted false claims based on those records; used Medicare proceeds to pay themselves and others who assisted in carrying out the scheme; and concealed the fraud proceeds by directing Perpetual and Legacy to issue checks payable to fictitious entities, John Gabriel’s friends and associates.

Among other details, the indictment alleges that John and Jassy Gabriel, Lubaton, and Reyes authorized Perpetual and Legacy to pay various amounts, ranging between $200 and $800, to employees and others, including indirectly to Ricardo Gonzales, for each patient they referred and enrolled in home health care services. John Gabriel and others also cold-called Medicare beneficiaries to try to persuade them to enroll with Perpetual and Legacy.

As part of allegedly falsifying patient records, John Gabriel directed Perpetual and Legacy employees, including Davis, Galang, and Pacis, to systematically complete standard forms by listing the same false diagnoses, including arthropathy (joint disease) and hypertension, which enabled them to claim a higher level of Medicare reimbursement, according to the charges.

In addition to the fraud counts, the money laundering charges allege that between October and December 2010, Gabriel cashed 11 checks in amounts under $10,000 — usually $9,000 and all involving fraud proceeds — to avoid federal currency transaction reporting requirements.

The four tax evasion counts against John Gabriel allege that for calendar years 2006 through 2009, he failed to pay taxes totaling approximately $889,062 on gross income totaling more than $2.82 million. The three tax evasion counts against Dela Torre allege that for calendar years 2005 through 2007, she failed to pay taxes totaling approximately $158,405 on gross income totaling more than $560,000.

Lubaton was charged with filing a false tax return for 2007 for allegedly failing to report all of her income, which was in excess of the $546,442 that she reported, and Lomillo was charged with aiding and abetting the preparation of her false return. Jassy Gabriel was charged with filing a false tax return for 2007 for allegedly failing to report all of his adjusted gross income, which exceeded the $603,974 that he reported, and Lomillo was charged with aiding and abetting the preparation of his false return.

Health care fraud conspiracy and each count of health care fraud carries a maximum penalty of 10 years in prison and a maximum fine of $250,000, or an alternate fine totaling twice the loss or twice the gain, whichever is greater, as well as mandatory restitution. Each count of money laundering carries a maximum 20-year prison term and a maximum fine of $500,000. Violating the medical anti-kickback statute carries a maximum penalty of five years in prison and a $250,000 fine. Each count of tax evasion carries a five-year maximum prison term, while each count of filing a false income tax return carries a three-year maximum, and a $250,000 fine. In addition, defendants convicted of tax offenses must pay the costs of prosecution and remain liable for any and all back taxes, as well as a potential civil fraud penalty of 75 percent of the underpayment plus interest. If convicted, the Court must impose a reasonable sentence under federal statutes and the advisory United States Sentencing Guidelines.

HEAT Task Force Honing In On Home Health Care Fraud

In recent months, federal health care fraud investigators have used statistical profiling and other tools to find and target fraudulent practices in the home health industry. The Chicago indictments announced March 8 follow the Justice Department’s February 28, 2012 indictment of a Dallas-area physician, the office manager of his medical practice, and five home health agency owners for involvement in a home health care fraud conspiracy that federal prosecutors allege defrauded Medicare of $375 million. Justice Department officials say the conduct charged in the Dallas indictment represents the single largest fraud amount orchestrated by one doctor in the history of the HEAT initiative. Both the Chicago and Dallas indictments resulted from the efforts of Medicare Fraud Strike Force operations conducted by the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce anti-fraud laws around the country. Federal prosecutors and investigators credit statistical profiling and other new tools in their fraud detection and enforcement efforts. See, e.g., Data Mining, Statistical Profiling Play Key Role In Arrest of Dallas Doctor, Office Manager & 5 Home Health Agency Owners.

These home health care fraud prosecutions are part of the ongoing and expanding Federal health care fraud enforcement effort that Federal officials credit with having recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011. See FY 2011 Health Care Fraud and Abuse Control Program Report. The Justice Department and HHS credit this fraud investigation and enforcement success to their vigorous use of enhanced fraud investigation and enforcement tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws. The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

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 prepare 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 » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, 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

Data Mining, Statistical Profiling Play Key Role In Arrest of Dallas Doctor, Office Manager & 5 Home Health Agency Owners

February 29, 2012

Volume, Cutting Edge Treatment or Other Statistical Variations in Care Patterns

Increasingly Raise Potential Fraud Examination Risk

Federal regulators credit sophisticated statistical profiling and other new fraud investigation tools with playing a key role in the federal health care fraud investigation that lead to the arrest on health care fraud indictments today (February 28, 2012) of a Dallas-area physician, the office manager of his medical practice, and five home health agency owners. The Dallas-area defendants charged in the indictments unsealed today face health care fraud charges related to their alleged participation in a nearly $375 million health care fraud scheme involving fraudulent claims for home health services. In a related action, the Center for Medicare & Medicaid Services (CMS) suspended an additional 78 home health agencies (HHA) associated with defendant Roy based on what CMS views as credible allegations of fraud against them.

Federal officials say today’s arrests and CMS suspensions resulted from Medicare Fraud Strike Force operations conducted by the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce anti-fraud laws around the country. Justice Department officials say the conduct charged in this indictment represents the single largest fraud amount orchestrated by one doctor in the history of the HEAT initiative.

Dallas Home Health Care Indictments

Filed in the Northern District of Texas, the indictment unsealed February 28, 2012 charges Jacques Roy, M.D., 54, of Rockwall, Texas; Cynthia Stiger, 49, of Dallas; Wilbert James Veasey Jr., 60, of Dallas; Cyprian Akamnonu, 63, of Cedar Hill, Texas; Patricia Akamnonu, RN, 48, of Cedar Hill; Teri Sivils, 44, of Midlothian, Texas; and Charity Eleda, RN, 51, of Rowlett, Texas, each with one count of conspiracy to commit health care fraud. Roy also is charged with nine counts of substantive health care fraud. Veasey, Patricia Akamnonu and Eleda each are charged with three counts of health care fraud. Eleda also is charged with three counts of making false statements related to a Medicare claim

According to the indictment, Dr. Roy owned and operated Medistat Group Associates P.A. in the Dallas area. Medistat was an association of health care providers that primarily provided home health certifications and performed patient home visits. Federal officials charge that Dr. Roy allegedly certified or directed the certification of more than 11,000 individual patients from more than 500 HHAs for home health services during the past five years. Between January 2006 and November 2011, Medistat certified more Medicare beneficiaries for home health services and had more purported patients than any other medical practice in the United States. Federal officials charge these certifications allegedly resulted in more than $350 million being fraudulently billed to Medicare and more than $24 million being fraudulently billed to Medicaid by Medistat and HHAs.

The indictment charges Dr. Roy used HHAs as recruiters so that Medistat could bill unnecessary home visits and medical services. The indictment charges three of the HHAs Dr. Roy used as part of the scheme were Apple of Your Eye Healthcare Services Inc., owned and operated by Stiger and Veasey; Ultimate Care Home Health Services Inc., owned and operated by Cyprian and Patricia Akamnonu; and Charry Home Care Services Inc., owned and operated by Eleda. According to the indictment, Veasey, Akamnonu, Eleda and others recruited beneficiaries to be placed at their HHAs so that they could bill Medicare for the unnecessary and not provided services. As part of her role in the scheme, Eleda allegedly visited The Bridge Homeless Shelter in Dallas to recruit homeless beneficiaries staying at the facility, paying recruiters $50 per beneficiary they found at The Bridge and directed to Eleda’s vehicle parked outside the shelter’s gates.

According to the indictment, Medistat maintained a “485 Department,” named for the number of the Medicare form on which the plan of care was documented. Dr. Roy allegedly instructed Medistat employees to complete the 485s by either signing his name by hand or by using his electronic signature on the document. Federal officials claim Dr. Roy and other Medistat physicians used this process to certify and recertify plans of care so that HHAs also were able to bill Medicare for home health services that were not medically necessary and not provided. In addition, Dr. Roy allegedly performed unnecessary home visits and ordered unnecessary medical services.

Apple allegedly submitted claims to Medicare from Jan. 1, 2006, through July 31, 2011, totaling $9,157,646 for home health services to Medicare beneficiaries that were medically unnecessary and not provided. Dr. Roy or another Medistat physician certified the services. From Jan. 1, 2006, to Aug. 31, 2011, Ultimate submitted claims for medically unnecessary home health services totaling $43,184,628. Charry allegedly submitted fraudulent claims from Aug. 1, 2008, to June 30, 2011, totaling $468,858 in medically unnecessary and not provided home health services.

The indictment alleges that Sivils, as Medistat’s office manager, helped facilitate the fraud scheme by, among other actions, supervising the processing of thousands of plans of care that contained Dr. Roy’s electronic signature and other Medistat physicians’ signatures, permitting HHAs to bill Medicare for unnecessary home health services and accepting cash payments from Cyprian Akamnonu in exchange for ensuring plans of care contained Dr. Roy or another Medistat physician’s signature.

As outlined in the government’s request to the court to detain Dr. Roy, in June 2011, CMS suspended provider numbers for Dr. Roy and Medistat based on credible allegations of fraud, thus ensuring Dr. Roy did not receive payment from Medicare. Immediately after the suspension, nearly all of Medistat’s employees started billing Medicare under the provider number for Medcare House Calls. The court document alleges that Dr. Roy was in fact in charge of day-to-day operations at Medcare, and that Dr. Roy continued to certify patients for home health despite the suspension.

Each charged count of conspiracy to commit health care fraud and substantive health care fraud carries a maximum penalty of 10 years in prison and a $250,000 fine. Each false statement charge carries a maximum penalty of five years in prison and a $250,000 fine. The indictment also seeks forfeiture of numerous items including funds in bank accounts, a sailboat, vehicles and multiple pieces of property.

In announcing the indictment, Federal officials said an indictment is merely an allegation and defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

New Data Mining & Other Anti-Fraud Tools Credited

In announcing the indictments, federal officials credited new data analysis mining and other fraud fighting tools with playing a key role in uncovering the alleged misconduct leading to the indictment against the Medistat defendants and as well as growing list of other federal health care fraud defendants.

Legal reforms and new resources granted under the Patient Protection & Affordable Care Act (Affordable Care Act) and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors.

Of particular note in the Medistat investigation and a growing number of other cases are new data mining tools. To target resources to highly suspect behaviors, CMS has implemented the new Fraud Prevention System, which uses advanced predictive modeling technology to fight fraud. The system has been screening all Medicare fee-for-service claims before payment is made since June 30, 2011. Much like the predictive technologies used in the credit card industry, the Fraud Prevention System uses advanced technology to identify “suspicious behavior and billing irregularities.” By streaming claims on a prepayment basis, CMS and its investigative partners are able to more efficiently identify fraudulent claims and respond quickly to emerging trends.

The Medistat indictments illustrate how the HEAT team is using these new tools. “Using sophisticated data analysis we can now target suspicious billing spikes,” said HHS Inspector General Levinson. “In this case, our analysts discovered that in 2010, while 99 percent of physicians who certified patients for home health signed off on 104 or fewer people – Dr. Roy certified more than 5,000.”

Using these data mining an a host of other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012.

In addition to the data mining tools highlighted in the Medistat indictments, other new tools helping to boost the success of federal health care fraud investigation and prosecution include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coordination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to demonstrate the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must 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.

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

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Posted by Cynthia Marcotte Stamer

DOJ & HHS Health Care Fraud Enforcement Nets $4 Billion + In 2011

February 21, 2012

Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by the Department of Health & Human Services (HHS) and the Justice Department on Valentines Day. This is the highest annual amount ever recovered from individuals and companies who attempted to defraud seniors and taxpayers or who sought payments to which they were not entitled. These latest statistics should leave little room for doubt that health care providers need to exercise care to manage fraud investigation and exposures risks.

The Justice Department and HHS credit this fraud investigation and enforcement success to their vigorous use of enhanced fraud investigation and enforcement tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, including:

Tough New Rules and Sentences for Criminals: The Affordable Care Act increases the federal sentencing guidelines for health care fraud offenses by 20-50 percent for crimes that involve more than $1 million in losses. The law establishes penalties for obstructing a fraud investigation or audit and makes it easier for the government to recapture any funds acquired through fraudulent practices. The law also makes it easier for the Department of Justice (DOJ) to investigate potential fraud or wrongdoing at facilities like nursing homes. Convictions under the Health Care Fraud and Abuse Control Program increased by over 27 percent (583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74 percent compared with 2008 (1430 vs. 821).
Enhanced Screening and Other Enrollment Requirements:Last year CMS published rules to enforce some of the Affordable Care Act’s most powerful new fraud prevention tools.
- New requirements for providers and suppliers wishing to participate in Medicare, Medicaid, and CHIP who may pose a higher risk of fraud or abuse are now required to undergo a higher level of scrutiny. This scrutiny includes licensure checks and site visits to confirm legitimacy and location.
- To support the Affordable Care Act’s new requirements for risk-based provider enrollment CMS implemented a new Automated Provider Screening (APS) system in December 2011. The APS uses existing information from public and private sources to automatically and continuously verify information submitted on a provider’s Medicare enrollment application including licensure status. The new system replaces the time- and resource-intensive process of manual review of the enrollment application.
- In addition to the enhanced enrollment and screening requirements, the Affordable Care Act also allows the Secretary to impose a temporary moratorium on newly enrolling providers or suppliers of a particular type or in certain geographic areas if necessary to prevent or combat fraud, waste, and abuse. CMS will publish a Federal Register notice to announce any enrollment moratorium and to explain the agency’s rationale for its action.
Increased Coordination of Fraud Prevention Efforts: Many of the Affordable Care Act antifraud provisions increase coordination among states, CMS, and its law enforcement partners at the Office of the Inspector General (OIG) and DOJ. For instance, the law expressly authorizes CMS, in consultation with OIG, to suspend Medicare payments to providers or suppliers during the investigation of a credible allegation of fraud. This initiative reverses a long-standing Medicare practice of paying claims then attempting to recoup funds if the claim is found to be an error or fraudulent. States must also withhold payments to Medicaid providers where there is a pending investigation of a credible allegation of fraud unless the State Medicaid agency has good cause not to do so. The Affordable Care Act also ensures that fraudulent providers and suppliers cannot move easily from state to state or between Medicare and Medicaid by requiring all states to terminate anyone whose billing privileges have been revoked by Medicare or who has been terminated by another state Medicaid program for cause.
Health Care Fraud Prevention and Enforcement Action Team (HEAT): One of the most visible examples of increased collaboration is the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint effort between HHS and DOJ to fight health care fraud. It has engaged law enforcement and professional staff at the highest levels of HHS and DOJ to increase coordination, intelligence sharing, and training among investigators, agents, prosecutors, analysts, and policymakers. A key component of HEAT is the Medicare Strike Force: interagency teams of analysts, investigators, and prosecutors who can target emerging or migrating fraud schemes, including fraud by criminals masquerading as health care providers or suppliers. In 2011, HEAT coordinated the largest-ever federal health care fraud takedown. In one action, Strike Force teams charged 115 defendants in nine cities, including doctors, nurses, health care company owners and executives, for their alleged participation in Medicare fraud schemes involving more than $240 million in false billing. In another takedown, Strike Force prosecution teams charged 91 defendants in eight cities for their alleged participation in a Medicare fraud scheme involving more than $290 million in false billings.
Use of State-of-the-Art Fraud Detection Technology: To target resources to highly suspect behaviors, CMS has implemented the new Fraud Prevention System, which uses advanced predictive modeling technology to fight fraud. The system has been screening all Medicare fee-for-service claims before payment is made since June 30, 2011. Much like the predictive technologies used in the credit card industry, the Fraud Prevention System uses advanced technology to identify suspicious behavior and billing irregularities. This targets investigative resources on areas of vulnerability that demand immediate attention and response. By streaming claims on a prepayment basis, CMS and its investigative partners are able to more efficiently identify fraudulent claims and respond quickly to emerging trends.
New Focus on Compliance and Prevention: Under the new law, some preventive measures focus on certain categories of providers and suppliers that historically have presented concerns, including Home Health agencies, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. On November 17, 2010, CMS published final regulations authorized under the Affordable Care Act requiring physician certification of a patient’s “face-to-face” visit with an appropriate health care professional to ensure Medicare only pays for necessary and covered Medicare home health and hospice services. On July 12, 2011, CMS proposed “face-to-face” encounter requirements for Medicaid home health including medical supplies, equipment and appliances. Additional face-to-face requirements to combat fraud among Medicare DME suppliers will be proposed later this year.
Expanded Overpayment Recovery Efforts: The Affordable Care Act expands the Recovery Audit Contractor (RAC) program to Medicaid, Medicare Advantage, and Medicare Part D programs. The Medicaid RAC program became effective on January 1, 2012 and is projected to save $2.1 billion over the next five years, of which $900 million will be returned to states. These efforts build on the success of the Medicare fee-for-service RAC program which in fiscal year 2011 recouped nearly $800 million in overpayments.
New Durable Medical Equipment (DME) Requirements: Under a new risk-based approach to fighting fraud, CMS has focused its efforts on combating fraud among DME suppliers by instituting enhanced enrollment standards and screening requirements. On August 27, 2010, CMS issued final rules enhancing Medicare enrollment standards for DME suppliers such as more stringent operations and facilities requirements to ensure only legitimate suppliers can participate in Medicare. Additionally, the competitive bidding program is expected to save the Medicare program and its beneficiaries $28 billion over 10 years. The second phase of the program will be expanded from 9 to 100 metropolitan areas across the country.
New Resources to Fight Fraud: The Affordable Care Act provides an additional $350 million over 10 years to ramp up anti-fraud efforts, including increasing scrutiny of claims before they’ve been paid, investments in sophisticated data analytics, and an increased number of law enforcement agents and others to fight fraud in the health care system.
Greater Oversight of Private Insurance Abuses: The new law also provides enhanced tools and authorities to address abuses of multiple employer welfare arrangements and protect employers and employees from insurance scams. It also gives new powers to the Secretary and Inspector General to investigate and audit the health insurance exchanges. This, plus the new rules to ensure accountability in the insurance industry, will protect consumers and increase the affordability of health care.
Senior Medicare Patrols: As a part of the new resources dedicated to fighting fraud, the Obama Administration has significantly expanded funding for Senior Medicare Patrols – groups of senior citizen volunteers to educate and empower their peers to identify, prevent and report health care fraud. The 75 percent increased funding from FY2008 to FY 2011 has helped thousands of Medicare beneficiaries host thousands of community meetings and educational events to increase awareness of fraud among people with Medicare and to solicit their help in preventing fraud.

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.

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 » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, 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

Update Charity and Sliding Fee Scale Policies For 2012 Federal Poverty Rate Changes

February 21, 2012

Health care and other social service agencies should review and update their charity care or sliding fee scale policies in response to the 2012 Poverty Guidelines published in late January by the U.S. Department of Health and Human Services published updated federal poverty guidelines for 2012. See here. Today, the U.S. Department of Labor followed up by releasing its updated 2012 Poverty Guidelines

Many federal programs use the federal poverty guidelines as one criterion for federal program eligibility. For example, the Medicaid and State Children’s Health Insurance (SCHIP) programs determine eligibility largely on the basis of whether the applicant’s income is below the federal poverty guidelines. Other programs determine financial eligibility based on a percentage or multiplier of the federal poverty guidelines (for example, 125 percent of federal poverty guidelines). In addition, the federal poverty guidelines are used in the immigration context, such as the required Affidavit of Support.

For 2012, the federal poverty guideline in the 48 contiguous states and Washington, D.C., for a family of 4 is 23,050. For each additional person, the poverty guideline goes up by $3,960. Alaska and Hawaii have slightly higher poverty guidelines.

Many health care and social services organizations, especially non-profit organizations, use a sliding fee scale or fee waiver based on the federal poverty guidelines. In addition, many health care organizations base their charitable care policies on the federal poverty guidelines. While use of the federal poverty guidelines is not mandated by law except by federally funded programs, keep in mind that the Joint Commission as part of its accreditation and survey process may ask whether the organization has used the most recent update to the federal poverty guidelines in its sliding scale or fee waiver policies. Therefore, if your organization will be surveyed in the near future, you should review the charity care or fee waiver policies as part of your preparation for the survey.

For More Information Or Assistance

If you need help reviewing or responding to health care related policy, 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 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 set up 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 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

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Posted by Cynthia Marcotte Stamer

Broad-Reaching Prosecution Of Individuals Participating In Operations Of Companies Convicted Of Fraud Shows Risks Of Participation

January 18, 2012

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

Health care owners and employees at all levels should heed the lesson shown from the continuing successful prosecution by the Justice Department against individuals ranging from owners to marketing employees for their participation in a Medicare fraud scheme allegedly orchestrated by the owners and operators of American Therapeutic Corporation (ATC); its management company, Medlink Professional Management Group Inc.; and the American Sleep Institute (ASI). The mounting guilty pleas and convictions obtained from individuals who participated in the execution of the scheme since the Justice Department secured guilty pleas from ATC, ASI and their owners shows that individuals electing to take part in aggressive Medicare referral or billing practices by their health care companies or other business partners stand a high risk of criminal prosecution if their organizations get caught engaging in health care fraud. The successful prosecutions shows 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 against the corporations and principles who were the primary actors in the scheme.

Health Care Fraud Scheme Prompts Continuing Series of Prosecutions

ATC and Medlink pleaded guilty in May 2011 to conspiracy to commit health care fraud. ATC also pleaded guilty to conspiracy to defraud the United States and to pay and receive illegal health care kickbacks. On Sept. 16, 2011, the two corporations were sentenced to five years of probation per count and ordered to pay restitution of $87 million. While both corporations have been defunct since their owners were arrested in October 2010, the Justice Department has continued its prosecution of a broad range of other individuals that it charges participated in the scheme.

Following the announcement of a January 17, 2012 guilty plea from Miami-area health care marketing representative Sandra Jimenez, Federal officials credit the investigation and prosecution activities of the Health Care Fraud Task Force with netting guilty pleas or trial convictions from ATC, Medlink and nine of the individual defendants indicted in February 2011 for their involvement in the alleged health care fraud conspiracy that the Justice Department claims resulted in the submission of $200 million in fraudulent Medicare claims. Other defendants are scheduled for trial on April 9, 2012. In addition to the prosecution of the criminal indictments, the Justice Department’s Civil Division also has filed a related civil action.

The guilty pleas, criminal convictions and other ongoing prosecutions stem from charges made against ATC, Medlink, ASI, Jimenez and several other parties in indictments unsealed on February 15, 2011 in the Southern District of Florida. Jimenez was indicted along with ATC, Medlink, and various owners, managers, doctors, therapists, patient brokers and marketers of ATC, Medlink and ASI for various health care fraud, kickback, money laundering and other offenses in the February 15, 2011 indictments.

According to court filings, ATC, Medlink and ASI were all Florida corporations headquartered in Miami. ATC operated purported partial hospitalization programs (PHPs) – a form of intensive treatment for severe mental illness – in seven different locations throughout South Florida and Orlando. ASI purported to provide diagnostic sleep disorder testing. ATC’s owners and operators paid kickbacks to owners and operators of assisted living facilities (ALFs) and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, Justice Department officials say the patients received a portion of those kickbacks. Throughout the course of the ATC and ASI conspiracy, Justice Department officials say millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries, who did not qualify for PHP services, to attend treatment programs that were not legitimate PHPs. ATC and ASI then billed Medicare for the medically unnecessary services. According to court filings, to obtain the cash required to support the kickbacks, the co-conspirators laundered millions of dollars of payments from Medicare.

Owners To Serve 91 Months To 50 Years In Prison & Ordered To Pay Millions In Restitution

Not surprisingly, the owners and principles of the convicted corporations were the first parties individually convicted for their involvement in the alleged scheme.

Co-conspirator Margarita Acevedo, pleaded guilty on April 7, 2011, for her role in the fraud scheme. Acevedo was sentenced to 91 months in prison followed by three years of supervised release and ordered to pay more than $72 million in restitution, jointly and severally with her co-defendants.

On August 23, 2011, a jury found co-conspirator Judith Negron, one of the owners of ATC, guilty of all 24 felony counts charged in the February 2011 superseding indictment.

In September, 2011, Marianella Valera, the owner of ATC, was sentenced to 35 years in prison and ordered to pay more than $87 million in restitution, jointly and severally with her co-defendants. Valera was also sentenced to three years of supervised release following her prison term. Meanwhile, another ATC owner, Lawrence Duran, was sentenced on Sept. 16, 2011, to 50 years in prison for his role in the fraud scheme. Duran’s sentence is the longest prison sentence ever imposed in a Medicare Fraud Strike Force case. The sentencing came after Valera pleaded guilty in April, 2011 to 21 felony counts and Duran to 38 felony counts, including conspiracy to commit health care fraud, health care fraud, conspiracy to pay and receive illegal health care kickbacks, conspiracy to commit money laundering, money laundering and structuring to avoid reporting requirements.

In pleading guilty, Duran and Valera admitted that they orchestrated and executed a scheme to defraud Medicare beginning in 2002 and continuing until they were arrested in October 2010. Duran and Valera submitted false and fraudulent claims to Medicare through ATC. Duran and Valera also admitted to using the related company, ASI, to submit fraudulent Medicare claims.

According to court documents, Duran, Valera and others paid bribes and kickbacks to recruit Medicare beneficiaries to attend ATC and ASI and billed Medicare for treatments purportedly provided to these recruited patients. According to court documents, the treatments were medically unnecessary or never provided at all. Duran and Valera supported the kickbacks through an extensive money laundering scheme that aimed to hide the illicit conversion of Medicare payments to cash. The defendants and their co-conspirators used advanced measures to hide their fraudulent activities from Medicare and from law enforcement.

As part of the fraud scheme, Duran, Valera and others paid kickbacks to owners and operators of assisted living facilities (ALFs) and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, the patients received a portion of those kickbacks. The defendants and their co-conspirators actively recruited ALF and halfway house owners and operators and patient brokers to take part in the scheme. Throughout the course of the ATC and ASI conspiracy, millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries, who did not qualify for PHP services, to attend treatment programs that were not legitimate PHP programs so that ATC and ASI could bill Medicare for more than $205 million in medically unnecessary services.

According to the superseding indictment to which they pleaded guilty, Duran, Valera and others caused the alteration of patient files and therapist notes for the purpose of making it falsely seem that patients being treated by ATC qualified for PHP treatments. According to court documents, Duran and Valera also instructed employees and doctors to alter diagnoses and medication types and levels to make it falsely seem that ATC patients qualified for PHP services. Duran, Valera and co-conspirators caused doctors to refer ATC patients to ASI even though the patients did not qualify for sleep studies.

According to the superseding indictment to which they pleaded guilty, the defendants also engaged in a money laundering conspiracy to enrich themselves and to provide cash for the millions of dollars in kickbacks paid to recruit Medicare beneficiaries. According to court documents, Duran and Valera used another company they owned and operated, Medlink Professional Management Inc., to hide the health care fraud and kickbacks from Medicare and law enforcement. Once Medicare paid ATC and ASI for the fraudulently billed services, Duran, Valera and others transferred millions of dollars to Medlink. They and others opened phony corporations to receive checks and wire transfers from both ATC and Medlink to convert that money into cash for their personal enrichment and for the payment of kickbacks. According to court documents, Duran, Valera and others cashed checks at different bank branches and different locations to conceal the true purpose of their activities and to evade reporting requirements.

Referring Facility Owner Pompano Faces Up To 10 Years Imprisonment & $250,000 Fine At Sentencing

Previously in November, 2011, Justice Department officials announced that the owner and operator of a Florida assisted living facility, Joseph B. Williams, pleaded guilty for his role in the Medicare fraud kickback scheme associated with the ATC fraud scheme. Williams admitted that in exchange for illegal health care kickbacks, he agreed to provide Medicare beneficiaries who resided at Avondale to ATC for mental health treatment through partial hospitalization program services. According to court documents, Williams was paid approximately $30 per beneficiary per day the beneficiary attended ATC. In his plea, Williams knew that ATC fraudulently billed Medicare for the partial hospitalization program treatment that his referrals purportedly received. Williams also admitted that he billed Medicaid for assisted living services purportedly provided at Avondale when, in fact, those services were never provided. Justice Department allegations reflect Williams paid owners and operators of halfway houses to obtain the personal identifiers of Medicaid enrollees who resided in those halfway houses and used that information to bill Medicaid fraudulently and also also billed Medicaid for assisted living services provided to residents of Avondale at times when they were not receiving any services.

According to the plea agreement, Williams’s participation in the fraud resulted in more than $2 million in fraudulent billing to the Medicare and Medicaid programs. At sentencing, scheduled on February 8, 2012, Williams faces a maximum of 10 years in prison and a $250,000 fine for each count.

Starter House Owner Nash Faces Up To 10 Years Imprisonment and $250,000 Fine When Sentenced

Barry Nash, the owner and operator of the Broward County, Florida-area halfway house, Starter House, pleaded guilty on January 5, 2012 to one count of conspiracy to commit health care fraud for his role in funneling patients through a fraudulent mental health company under the alleged fraud scheme.

In his plea, Nash admitted that, in exchange for illegal health care kickbacks, he agreed to refer Medicare beneficiaries who resided at Starter House to ACT for purported intensive mental health treatment through a partial hospitalization program and to ATC for purported sleep treatment. Nash admitted that he knew that ATC and ASI would fraudulently bill Medicare for the PHP treatment and sleep studies that his referrals would purportedly receive.

According to the plea agreement, Nash’s participation in the fraud resulted in more than $959,901 in fraudulent billing to the Medicare program. At sentencing, scheduled for March 8, 2012, Nash faces a maximum of 10 years in prison and a $250,000 fine.

Marketing Representative Jimenez Faces Up To 15 Years In Prison When Sentenced

Most recently, the Justice Department, HHS and FBI jointly announced on January 17, 2012 that marketing representative Sandra Jimenez admitted she participated in the alleged fraud scheme involving ATC, ASI and Medlink when she pleaded guilty to one count of conspiracy to commit health care fraud and one count of conspiracy to defraud the United States and to pay and receive illegal health care kickbacks.

In pleading guilty, Jimenez admitted that while serving as a marketer for ATC and ASI, she solicited beneficiaries and paid kickbacks to assisted living facility owners in exchange for the beneficiaries. The amount of the kickback was based on the number of days each patient spent at ATC. Jimenez also admitted that she participated in a separate Medicare fraud scheme through Priority Home Health, a Miami home health agency that submitted fraudulent claims to Medicare for home health services . Jimenez and her co-conspirators recruited Medicare beneficiaries to Priority Home Health who did not qualify for home health services.

According to the plea agreement, Jimenez’s participation in the ATC fraud and the Priority Home Health fraud resulted in $46 million in fraudulent billings to the Medicare program.

Sentencing for Jimenez is scheduled for June 27, 2012. She faces up to 15 years in prison and a $250,000 fine after pleading guilty to participating in a Medicare fraud scheme that Justice Department officials say resulted in the submission of more than $200 million in fraudulent Medicare claims.

Prosecutions & Convictions Show Participants In Health Care Fraud Activities Face High Risks

The zealous prosecution by the Justice Department of these and other parties who participated in the operation and furtherance of the health care fraud scheme highlights the advisability for all health care organizations and each individual working in or with health care organizations to exercise care to fully understand, and avoid participation, in aggressive activities that could be considered health care fraud.

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 and other individuals involved in their operations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws as well as other parties who participate in their operations should act to manage their exposures.

Health care organizations should take clear steps to manage compliance. Their management should make clear by policy and action their organization’s commitment to compliance. They also 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.

Meanwhile, individuals also need to assume responsibility for managing their own involvement to avoid stepping into the potential health care fraud fire.

Individuals should not assume that the prosecution of their corporations or their management leaders will insulate them from prosecution for their own participation in potential fraudulent activities will escape notice or prosecution.

Parties participating in health care marketing, billing or other activities that may give rise to potential fraud activities should take steps to develop their own strong understanding of the types of conduct that HHS or federal or state fraud investigators or prosecutors are likely to consider fraud and to avoid participating in these activities. Participants should take steps to resolve concerns about potential activities before engaging in conduct that might expose them or their companies to criminal or civil prosecution.

Individuals and corporations who participate in the conduct of activities targeted for audit or enforcement scrutiny also should consider planning in advance for the possible need to defend their actions by documenting the appropriateness of their actions as well as planning for the costs of defense that are likely to arise if their actions are called into question by making arrangements for insurance, indemnification or other sources to adequately fund these costs.

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.

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Posted by Cynthia Marcotte Stamer

Hospitals Can Expect CMS To Add Hospital Incident Reporting To Surveys In Response To OIG Report

January 6, 2012

Hospitals should prepare to face greater scrutiny from the Centers From Medicare & Medicaid Services (CMS) of the adequacy of their patient harm incident reporting.

CMS reportedly is preparing standards for its surveyors to use to assess the quality for hospital safety reporting in response to an Office of Inspector General (OIG) a report highly critical of the adequacy of hospital patient harm incident reporting systems. See Report here.

As a condition of participation in the Medicare program, Federal regulations require that hospitals develop and maintain a Quality Assessment and Performance Improvement (QAPI) program. To satisfy QAPI requirements, hospitals must “track medical errors and adverse patient events, analyze their causes, and carry out preventive actions and mechanisms that include feedback and learning throughout the hospital.” To standardize hospital event reporting, AHRQ developed a set of event definitions and incident reporting tools known as the Common Formats.

According to the OIG Report, hospital incident reporting systems captured only an estimated 14 percent of the patient harm events experienced by Medicare beneficiaries. The Report found hospitals investigated those reported events that they considered most likely to lead to quality and safety improvements and made few policy or practice changes as a result of reported events. Hospital administrators classified the remaining events (86 percent) as either events that staff did not perceive as reportable (61 percent) or as events that staff commonly report but did not report in this case (25 percent).

Because hospitals rely on incident reporting systems to track and analyze events, OIG believes that improving the usefulness of these systems is critical to hospitals’ efforts to improve patient safety.

Based upon concerns about the adequacy in hospital incident reporting in the Report, OIG is recommending various steps be taken to improve the quality of hospital incident reporting. Among other things, OIG is recommending that:

AHRQ and CMS collaborate to create and promote a list of potentially reportable events for hospitals to use;
CMS provide guidance to accreditors regarding their assessments of hospital efforts to track and analyze events;
CMS suggest that surveyors evaluate the information collected by hospitals using AHRQ’s Common Formats
CMS scrutinize survey standards for assessing hospital compliance with the requirement to track and analyze events and reinforce assessment of incident reporting systems as a key tool to improve event tracking.

According to OIG, CMS has responded that it is developing draft guidance for surveyors regarding assessment of patient safety improvement efforts within hospitals as part of its continuing quality inititives. Hospitals participating in the Medicare program can anticipate tighter oversight of the adequacy of their incident reporting will be forthcoming.

For More Information Or Assistance

If you need help reviewing or responding to health care related policy, 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 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.

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.

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Posted by Cynthia Marcotte Stamer

DFW Hospital Council Foundation Among 26 Organizations Selected To Lead Quality Effort

December 15, 2011

Affordable Care Act funding seeks to help health providers identify and spread local ideas to improve care, reduce preventable healthcare acquired conditions

The Dallas-Fort Worth Hospital Council Foundation, the Texas Center for Quality & Patient Safety Hospitals and Lifepoint Hospitals, Inc. are three of the 26 state, regional, national, or hospital system organizations selected as Hospital Engagement Networks by the U.S. Department of Health and Human Services (HHS).

As part of the Partnership for Patients initiative, a nationwide public-private collaboration to improve the quality, safety, and affordability of health care for all Americans, the selected entities will share in $218 million in funding to help find solutions already working to reduce healthcare acquired conditions, and work to spread them to other hospitals and health care providers across the country.

Learn more at http://wp.me/psDUd-3B.

For More Information Or Assistance

If you need assistance reviewing or responding to health care related policy, 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 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.

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

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Posted by Cynthia Marcotte Stamer

Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges

November 27, 2011

American pharmaceutical company Merck, Sharp & Dohme (Merck) will pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib). Merck previously withdrew Vioxx® from the market.

According to a November 23, 2011 joint announcement of the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS), Merck has agreed to plead guilty to one misdemeanor count of engaging in illegal promotional activity and to a $321,636,000 criminal fine to resolve charges that its marketing of Vioxx® violated the Food Drug and Cosmetic Act (FDCA)

Concurrent with the criminal plea agreement, Merck also is entering into a civil settlement agreement under which it will pay $628,364,000 to resolve other allegations of off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will go to the United States, and the remaining share of $201,975,000 be paid to the participating Medicaid states. The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx®, which was withdrawn from the marketplace in September 2004.

Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use. The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.

Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA).

The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck. The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug. Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.

As part of the settlement, Merck has also agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of HHS that requires it to strengthen the system of reviews and oversight procedures imposed on the company to deter and detect similar conduct in the future with respect to Merck products regulated by the FDA.

The Merck plea agreement and civil resolution agreement show the continuing commitment of DOJ and other federal regulators to investigate and prosecute off-label and other marketing of pharmaceutical products in violation of applicable federal laws. Pharmaceutical companies and members of their workforce should heed the announcement as another reminder of the need to exercise continuing diligence to comply with these requirements.

For Help With Compliance, Investigations Or Other Needs

If you need assistance providing compliance or other training, 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 24 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 medical privacy and other compliance and risk management policies, to 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/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others. Her publications and insights 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.

About Solutions Law Press

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Posted by Cynthia Marcotte Stamer

OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks

November 9, 2011

The kickoff of a new compliance audit pilot program provides another reason for health care providers, health plans, healthcare clearinghouses and their business associates to get serious about compliance with the privacy, security and data breach requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

OCR Pilot Audit Program Begins

On November 8, 2011, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) announced that it will begin auditing HIPAA compliance this month under a new pilot program.

As amended by the American Recovery and Reinvestment Act of 2009 in Section 13411 of the HITECH Act, requires HHS to provide for periodic audits to make sure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards. To carry out this mandate, OCR is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance between November 2011 and December 2012.

The commencement of OCR HIPAA compliance audits is yet another sign that covered entities and their business associates should get serious about HIPAA compliance. The audit program serves as a new part of OCR’s health information privacy and security compliance program. While OCR says that it presently views the pilot audits as primarily a compliance improvement tool, this does not mean violators should expect a free walk.

Even before the impending audits, HIPAA Privacy exposures of covered entities for failing to comply with HIPAA already had risen significantly. Earlier this year, OCR imposed a $4.3 Million Civil Money Penalty (CMP) against Cignet Health of Prince George’s County (Cignet) for violating HIPAA. Meanwhile, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. Under amendments made by the HITECH Act, state attorneys general also now are empowered to bring civil lawsuits against covered entities and business associates that commit HIPAA violations that injure citizens in their state under certain circumstances. Eventually, individuals injured by HIPAA violations also will get the right to share in a portion of certain HIPAA recoveries.

These and other audit and enforcement activities send a strong message that covered entities and their business associates need to get serious about HIPAA compliance. As stated by OCR Director Georgina Verdugo when announcing the Mass General Resolution Agreement, “To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” Verdugo added, “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.” Learn more here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

Vice President of the North Texas Health Care Compliance Professionals Association, a member of the American College of Employee Benefit Counsel, Past Chair of the ABA RPTE Employee Benefits & Other Compensation Arrangements Group, 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 extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies. Ms. Stamer also regularly helps clients deal with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 publications and insights 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. Her insights on the required “culture of compliance” with HIPAA are frequently included in medical privacy related publications of the Atlantic Information Service, Modern Health Care, HealthLeaders and many others. Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here or may contact her at (469) 767-8872 or via e-mail here.

You can review other selected publications and resources and additional information about the employment, employee benefits and other experience of Ms. Stamer here.

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Posted by Cynthia Marcotte Stamer

Houston Doctor Gets 135 Month Health Care Fraud Sentence

November 6, 2011

Conviction Highlights Growing Fraud Enforcement Risks Reach Broadly

A Houston Federal Court recently sentenced Houston doctor Christina Joy Clardy to 135 months in federal prison for her conviction on charges arising from a health care fraud conspiracy that federal officials charged resulted in false billings to Medicare and Texas Medicaid programs for $45,039,230 over a 2 ½-year-period. Clardy, who was found guilty of one count of conspiracy to commit health care fraud, 14 counts of health care fraud and three counts of mail fraud on May 27, 2011, after an 18-day trial in front of U.S. District Judge Melinda Harmon, also was ordered to pay $15,626,084.01 in restitution to Medicare and Medicaid.

Federal prosecutors had charged that Clardy was a key player in a massive federal health care fraud scheme under which City Nursing Services of Texas, Inc (City Nursing Services) billed more than $25 million worth of physical therapy services under Clardy’s physician provider numbers between January 2007 and August 2008.

Clardy is the third defendant to be sentenced in this matter.

The charges against Clardy and others convicted in the City Nursing Services action are one of a growing number of health care fraud prosecutions resulting from the actions of the Medicare Fraud Strike Force that are conducted as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice-HHS Medicare Fraud Strike Force 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 their September 7, 2011 announcement, HHS and DOJ credited Strike Force Operations in nine locations with resulting in charges against more than 1,140 defendants who the government charged collectively falsely billed the Medicare program for more than $2.9 billion. Learn more here.,

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.

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.

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

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Posted by Cynthia Marcotte Stamer

UCLA Health Systems Payment of $865,500 To Settle HIPAA Charges Shows Rising HIPAA Risk

September 15, 2011

Health care providers, health plans, health care clearinghouses and their business associates got another wake up call about the growing importance of strengthening their policies, practices and safeguards of medical information and records that are “protected health information” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules with the announcement on July 7 that the University of California at Los Angeles Health System (UCLAHS) has reached an agreement with the U.S. Department of Health & Human Services Office of Civil Rights (OCR) to pay $865,500 and act to strengthen its health information privacy and security practices to settle charges of HIPAA violations.

The latest in a series of recently announced high-dollar Resolution Agreements, the UCLAHS Resolution Agreement highlights the growing risks that covered entities and their business associates run by failing to adequately adopt and administer the policies, systems and other management controls and training necessary to ensure that their organizations and their employees and other members of their workforce actually operationally comply with HIPAA.

Increased penalties, tighter rules and recent enforcement actions by OCR make it more important than ever that covered entities tighten their compliance and risk management policies and procedures.

As a result of amendments enacted as part of the HITECH Act, Congress modified and expanded the HIPAA audit and enforcement obligations of OCR, amended and expanded the potential penalties, made business associates liable for violation of the privacy rules like covered entities, added an obligation for covered entities and business associates to provide notification of breaches of unsecured PHI and tightened other HIPAA obligations. The HITECH Act also gave state attorneys general to bring civil lawsuits against covered entities and business associates that commit HIPAA violations that injure citizens in their state under certain circumstances. Eventually, individuals injured by HIPAA violations will get the right to share in a portion of certain HIPAA recoveries. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On　Website.

OCR enforcement actions and statistics make clear that OCR is serious about investigation and enforcement of HIPAA violations. This Spring, OCR assessed its first civil monetary penalty (CMP) under HIPAA – a $4.3 million against Cignet Health of Prince George’s County, Md. (Cignet) and entered into a series of Resolution Agreements under which CVS Pharmacy, Inc., General Hospital Corporation and Massachusetts General Physicians Organization Inc., Rite Aid and others paid a million or more dollars as part of the required terms of settlement. See e.g., Rite Aid Pays $1 Million HIPAA Privacy Settlement As OCR Tightens HIPAA Regulations; HIPAA Risks Soar As CVS Agrees To Pay $2.25 Million To Resolve HIPAA Charges & Stimulus Bill Amends HIPAA; Providence To Pay $100,000 & Implement Other Safeguards To Settle HIPAA Penalty Exposures Under HIPAA. Meanwhile, as of January 1, 2011, OCR reported that it had referred more than 484 Privacy Rule breach investigations to the Department of Justice for consideration for potential criminal prosecution and required changes in privacy practices and other corrective actions as part of the requirements for resolution of an additional 12,781 of cases investigated. In addition to these civil enforcement actions by OCR, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. OCR data confirms that the covered entities involved in these actions included health care providers, health plans, and others. See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health　Information

Lax HIPAA and other practices for protection of medical and other confidential personal information also increasingly exposes covered entities and other organizations to liability under state laws. State courts allow individual plaintiffs to rely on violations of HIPAA as the basis for bringing state privacy, retaliation or other actions. See, e.g. Sorensen v. Barbuto, 143 P.3d 295 (Utah Ct. App. 2006), Acosta v. Byrum, 638 S.E. 2d 246 (N.C. Ct. App. 2006). Private plaintiffs employed by covered entities also claim HIPAA related misconduct as the basis for their retaliation claims. See, e.g.,　 Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim.

HIPAA-specific exposures, wrongful use, access or disclosure of medical information also can expose covered entities, members of their workforce and others improperly using, accessing or disclosing protected health information to liability under other federal or state laws. See, Cybercrime & Identity Theft: Health Information Security Beyond HIPAA; NY AG Cuomo Announcement of 1st Settlement For Violation of NY Security Breach Notification Law; Woman Who Revealed AIDs Info Gets A Year.

These and other developments make clear that covered entities and their business associates must get serious about HIPAA compliance and risk management. These organizations should review and tighten privacy policies, breach and other monitoring, training and other practices to mitigate against exposures in light of recently tightened requirements and new enforcement risks.

For More Details Or Help With HIPAA & Other Risk Management & Compliance Needs

To learn more about the UCLAHS Resolution Agreement and other risk management tips, see UCLA Health Systems Payment of $865,000 To Settle HIPAA Charges Shows Rising HIPAA Risk.

If you need assistance　monitoring federal health reform, 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, can 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 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, 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 plans, employers, health care providers, professional associations and others. 　　

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 publications and insights 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.　 For instance, On May 3, 2011, Ms. Stamer served as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR and will moderate a teleconference featuring comments by OCR’s Susan McAndrew for the Joint Committee on Employee Benefits scheduled for May 16. Her insights on the required “culture of compliance” with HIPAA also recently were quoted in medical privacy related publications of the Atlantic Information Service. Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. To ask for legal help with these or other compliance concerns, inquire about arranging for compliance audit or training, or matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here. You can review other publications and resources and additional information about the employment, employee benefits and other experience of Ms. Stamer here and register to receive future updates about developments on these and other concerns from Ms. Stamer here. For important information concerning this communication click here.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 available at www.solutionslawpress.com.

Leave a Comment » | Academic medicine, ASC, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Electronic Medical Records, Employee Benefits, Genetic Information, GINA, Health Care, Health Care Provider, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Indian Health, Medicare Advantage, Mental Heatlh, OCR, Outpatient, Patient Empowerment, Pharmacy, Prescription Drugs, Rural Health Care | Tagged: business associate, Doctor, Health Care, Health Care Provider, Health Plans, HIPAA, Hospital, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Indictment of 91 Shows Growing Health Care Fraud Enforcement Risk

September 8, 2011

A nationwide takedown by Medicare Fraud Strike Force operations in eight cities resulted in the Department of Justice filing criminal charges against 91 defendants, including doctors, nurses, and other medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $295 million in false billing, Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius jointly announced the charges on September 7, 2011.

The charges are provide yet another powerful reminder to health care providers, leaders and organizations of the advisability of tightening compliance practices and taking other steps to guard against ever expanding health care fraud exposures. Already a lead federal enforcement priority for more than a decade, HHS recently established the Center for Program Integrity within the Centers for Medicare & Medicaid Services (CMS) to focus on identifying and stopping fraud and acting swiftly to protect beneficiaries.

Charges Announced September 7 Show Strike Force Targeting Fraud Industry Wide

In announcing the most sweeping joint action to date, HHS and Justice Department officials warned that the latest charges demonstrate the willingness and commitment of federal officials to find and prosecute health care fraud throughout the health care industry. The actions are the latest in a series of strong reminders to providers, leaders and others in the health care industry of the need to tighten compliance and risk management to minimize the risk of getting caught up in the Federal government’s ever-tightening health care fraud investigation and enforcement net.

The charges made against the 91 defendants in the indictments announced cover nearly the entire spectrum of healthcare providers for a variety alleged fraudulent schemes. The defendants charged are accused of various health care fraud-related crimes, including conspiracy to defraud the Medicare program, health care fraud, violations of the anti-kickback statutes and money laundering. The charges are based on a variety of alleged fraud schemes involving various medical treatments and services such as home health care, physical and occupational therapy, mental health services, psychotherapy and durable medical equipment (DME). HHS and Justice Department Officials warned these latest sweeping charges clearly signal the resolve of the federal government to find and prosecute health care fraud throughout the industry. Learn more details about September here.

According to the Justice Department and HHS, 70 individuals were charged by Strike Force prosecutors in indictments unsealed on September 6 and September 7, 2011 in six cities. The indictments allege a variety of Medicare fraud schemes involving approximately $263.6 million in false billings. As part of takedown operations last week, 18 additional defendants were charged in Detroit and one defendant was charged in Miami in cases unsealed on September 1, 2011, for their alleged roles in Medicare fraud schemes involving approximately $29.4 million in fraudulent claims. Additionally, two individuals are scheduled to appear in court on September 7, 2011 on charges filed on August. 24, 2011, for their roles in a separate $2 million health care fraud scheme. According to the September 7 announcement, this coordinated takedown involved the highest amount of false Medicare billings in a single takedown in Strike Force history.

According to court documents, the defendants located in Miami, Houston, Baton Rouge, Los Angeles and Detroit allegedly participated in a diverse array of schemes to submit claims to Medicare for treatments that were medically unnecessary and oftentimes never provided. In many cases, indictments and complaints allege that patient recruiters, Medicare beneficiaries and other co-conspirators were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could submit fraudulent billing to Medicare for services that were medically unnecessary or never provided. Collectively, the doctors, nurses, medical professionals, health care company owners and others charged in the indictments and complaints are accused of conspiring to submit a total of approximately $295 million in fraudulent billing. If convicted, the defendants face a broad range of criminal, civil and administrative sanctions including imprisonment, criminal penalties, civil sanctions, federal program disqualification, state licensing board disciplinary action and other consequences.

Charges Part of Ongoing National Anti-Health Care Fraud Campaign

The Medicare Fraud Strike Force operations are part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice-HHS Medicare Fraud Strike Force 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 their September 7, 2011 announcement, HHS and DOJ credited Strike Force Operations in nine locations with resulting in charges against more than 1,140 defendants who the government charged collectively falsely billed the Medicare program for more than $2.9 billion.

In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction 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.

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.

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.

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 23 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 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.

About Solutions Law Press

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Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

May 17, 2011

On January 14, 2011, a disciplinary panel of the Texas Medical Board (TMB) temporarily suspended the medical license of Julia Renee Ward, M.D. of Houston, after determining that Dr. Ward’s continuation in the practice of medicine presents a continuing threat to the public welfare. Physicians, pharmacists and others involved in pain treatment should resist the temptation to allow the allegations of extreme misconduct by Ward, others to blind them to the need for special precautions when prescribing or administering pain management or other controlled substance treatments.

Ward Pain Management Suspension

According to a January 18, 2011 TMB Press Release, TMB issued the Order of Temporary Suspension (Without Notice of Hearing) based on Dr. Ward’s operation of a pain management clinic, Tejas Urgent Care Clinic, without the certification required by law; failure to practice medicine in an acceptable, professional manner; inappropriate prescribing of controlled substances; and unprofessional or dishonorable conduct. The suspension took immediate effect. Previously, the medical board denied certification of Tejas Clinic in Houston, based on the clinic’s partial ownership by a non-physician.

According to the Press Release, TMB and Texas State Board of Pharmacy investigators staked out the clinic and observed several vehicles, some with out-of-state license plates, dropping off and picking up small groups of patients throughout the day. TMB says investigators observed four men who appeared to be patrolling the parking lot, directing patients to Tejas Clinic and H&W Pharmacy. Investigators reported the dropped-off patients would enter the clinic, exit about 20 minutes later, and then go to the pharmacy next door, H&W Pharmacy, to fill their prescriptions. Most of the prescriptions written by Dr. Ward were for hydrocodone, and a large number of prescriptions were for Xanax and Soma as well. The three drugs are a well-known combination commonly abused and diverted for sale to addicts.

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

The Temporary Suspension Hearing Without Notice took place under the Board’s authority, granted by the Medical Practice Act, to suspend or restrict a physician’s license without notice when it determines the physician’s continuation in practice would constitute a continuing threat to the public welfare. Under TMB procedures, Ward has the opportunity to have a Temporary Suspension Hearing With Notice at least 10 days after notice of the suspension.

Physician Precautions Recommended For Pain Management Activities

Physicians and other health care providers should not allow the egregiousness of allegations underlying suspensions like those alleged committed by Ward to blind them to the importance of exercising special care when engaging in pain management activities. While medical practitioners, medical boards, the Drug Enforcement Agency, accreditation agencies and others increasingly recognize the appropriateness and need for legitimate pain management, physicians, pharmacies and others prescribing and delivering pain management must conduct these activities in a defensible manner. Physicians prescribing pain management remain accountable for demonstrating and documenting the therapeutic appropriateness of prescribed management including appropriate procedures to monitor and redress potential concerns about patient medication abuse or addition. See Texas Medical Board Rules §§ 170.1-170.3. As many pain management medications both are controlled substances, physicians prescribing these medications often must comply with special prescribing, documentation and other requirements under DEA, state medical board and other rules and ethical standards. See, e.g, DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing.

Missteps by providers in the prescription, documentation, or administration of pain management or other controlled substance prescriptions and treatment are frequently the basis of medical board and other disciplinary actions and civil, criminal and administrative enforcement actions by the Justice Department, DEA, Department of Health & Human Services and others. See e.g., Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians; Texas Pain Management Physician and Psychiatrist Arrested on Federal Health Care Fraud Inditement; Pain and The Law.

To defend against these and other exposures, physicians and practices, pharmacies and pharmacists, and the hospitals and other organizations involved in the operation or management of physicians or pharmacists prescribing or dispensing pain management treatments should implement written delegation policies and other procedures to facilitate their ability to withstand DEA, medical board and other scrutiny and defend against a claim of improper conduct. As part of these efforts, prescribing practitioners should consider include:

Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
Strictly complying with DEA requirements when prescribing controlled substances;
Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

IIf 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 23 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 her highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others. 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.

About Solutions Law Press

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, Health Care, licensure, Medical Board, pain management, pharmacist, pharmacy, Physician, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

January 18, 2011

rd Pain Management Suspension

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

Physician Precautions Recommended For Pain Management Activities

Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
Strictly complying with DEA requirements when prescribing controlled substances;
Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

About Solutions Law Press

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Posted by Cynthia Marcotte Stamer

Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians

December 2, 2010

Quality, unprofessional conduct and recordkeeping issues were the most common reason for discipline among the 77 physicians disciplined by the Texas Medical Board (TMB) since August. The reported actions highlight the need for physicians and the hospitals, practices and other entities dealing with them to take appropriate steps to manage these and other related risks.

Data recently disclosed by the TMB reveals that among the 77 licensed physicians disciplined, the violations included:

11 violations based on quality of care;
10 based on inadequate medical records
9 violations based on unprofessional conduct;
4 based on other states’ action;
1 based on inadequate supervision
1 based on peer review actions;
1 based on criminal convictions; and
10 orders for minor statutory violations.

The disciplinary actions imposed varied based on the nature and circumstances of the offense. It included 8 voluntary surrenders; 1 suspension; 3 revocations; 18 corrective orders and one cease and desist order.

A review of the TMB statistics and reports about these actions demonstrates the continuing need for physicians and the practices, hospitals, insurers, and others with liability or responsibility for monitoring, reporting or insuring their conduct to provide and administer effective training, quality and performance management and oversight to monitor and promote appropriate physician performance in these and other performance areas that may give rise to discipline or disciplinary reporting obligations. Additionally, a review of the circumstances of the reported circumstances also highlights the advisability of strengthening stress and substance abuse monitoring, education and intervention processes and procedures to head off or minimize potential licensing board and other risks.

For More Information or Assistance

If you need help evaluating or responding to this development of other health care reimbursement, technology and process, compliance, risk management, transactional, operational, enforcement or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, or via e-mail to cstamer@solutionslawyer.net.

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 physicians, hospitals and other health industry clients about quality assurance, peer review, licensing and discipline, and other medical staff performance matters. She continuously advises health industry clients about the use of technology, process and other mechanisms to promote compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational needs. As part of this experience, she has worked extensively with health care providers, payers, health care technology and consulting and other health industry clients to investigate, address and defend physician and other health care workforce conduct, quality, communication and other concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer also publishes and speaks extensively on health care staffing and human resources, compensation and benefits, technology, medical staff, public policy, reimbursement, privacy, technology, and other health and managed care industry regulatory, and other operations and risk management concerns for medical societies and staffs, hospitals, the HCCA, American Bar Association, American Health Lawyers Association and many other health industry groups and symposia. Her highly popular and information packed programs include specific training for physicians and other health industry leaders on “Sex, Drugs & Rock ‘N Role: Personal Misconduct In Health Care,” “Managing Physician Performance,” “Physician Gainsharing,” improving health care communication and collaboration and many other related matters. 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. To review some of her many publications and presentations, or for more information about Ms. Stamer, her experience, involvements, programs or publications, see here.

For More Information

We hope that this information is useful to you. You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here.

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Posted by Cynthia Marcotte Stamer

DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing Functions, Urges Adoption of Written Policies & Agreements

November 2, 2010

Physicians, dentists, veterinarians, hospitals, and other persons prescribing or managing practitioners that prescribe controlled substances should require written agreements with staff and others communicating controlled substance prescriptions on their behalf and implement other suitable controls to ensure compliance with Drug Enforcement Administration requirements for prescribing controlled substances according to a new DEA Statement of Policy On Role of Authorized Agents in Communicating Controlled Substance Prescriptions To Pharmacies (Statement) published by the Department of Justice Drug Enforcement Administration (DEA) on October 6, 2010.

The Statement reflects that the DEA is concerned that about practitioners improperly delegating medical need determinations and other responsibilities for prescribing controlled substances. The Statement indicates that practitioners using agents to communicate controlled substance prescriptions should ensure that their delegations are appropriately documented by written agreements with the agents detailing the scope of their authority and implement background checks, monitoring, written and operational policies and procedures governing delegations and other controlled substance prescribing and other controls to appropriately comply with DEA controlled substance prescription mandates.

Under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA) and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), a valid prescription issued by a DEA-registered practitioner is required for dispensing a controlled substance. Existing rules prohibit DEA-registered practitioners from delegating their authority to prescribe controlled substances. To be effective (i.e., valid), a DEA-registered practitioner must issue the required prescription for a controlled substance for a legitimate medical purpose as determined by the practitioner acting in the usual course of professional practice. The registered practitioner actually must make the required determination of legitimate medical purpose underlying a controlled substance prescription. He cannot delegate responsibility for determining the legitimacy of the medical purpose for a controlled substance prescription or other core responsibilities.

While DEA rules prohibit a registered practitioner from delegating his core responsibilities pertaining to prescribing controlled substances to anyone else, DEA rules allow an individual practitioner to authorize an agent to perform a limited role in communicating controlled substance prescriptions to a pharmacy in order to make the prescription process more efficient. The ability to delegate these communication responsibilities is very restricted and requires that the practitioners apply appropriate controls to prevent delegation of core prescribing responsibilities.

In the Statement, the DEA cautions that DEA requires that DEA registered practitioners must be prepared to demonstrate that the registered practitioner alone makes all required medical determinations to prescribe the communicated controlled substances when delegating responsibility to communicate controlled substance prescriptions to pharmacies on their behalf to nurse or other person acting as the practitioner’s agent. The Statement warns that delegation must be limited to participation in the communication of the prescription in accordance with DEA requirements. The Statement urges practitioners allowing agents to participate in the communication of controlled substance prescriptions to make those delegations pursuant to written agreements with t he agent and to adopt other safeguards to maintain compliance with DEA rules. To learn more, see here

For More Information Or Assistance

If you need assistance reviewing or responding to the DEA prescribing guidance contained in the Statement or addressing other health care related risk management or compliance 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 23 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. 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here. To unsubscribe, e-mail here.

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Posted by Cynthia Marcotte Stamer

OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct

October 21, 2010

The Department of Health & Human Services Office of Inspector General (OIG) this morning (October 21, 2010) posted to its website key guidance about when OIG will exercise its authority under the permissive exclusion rules of Social Security Act (Act) § 1128(b)(15)(A)(ii) to exclude from Federal health program participation owners, officers or managing employees of health care organizations based on their role, involvement or ownership interest in a health industry company convicted of certain offenses or excluded from Federal health program participation.

The Guidance For Implementing Permissive Exclusion of Authority under Section 1128(b)(15) of the Social Security Act (Guidance) provides valuable insights for health care organizations, their owners, officers and managers about how OIG expects them to act and the evidence that OIG likely will require should OIG bring an OIG exclusion action against them personally following the conviction or OIG exclusion of their health care organization for misconduct. To position themselves to survive OIG or related exclusion or prosecution, health care organizations and their owners, officers and management use the Guidance as a guide to help strengthen the defensibility of their daily actions against potential OIG scrutiny and consider the advisability of updating their personal and organizational practices, policies and leadership training in response to this Guidance.

The Guidance discusses the guiding principles and core factors and presumptions that OIG generally will apply to decide if the OIG will should exclude an individual from Federal health program participation based on the involvement of the individual as an owner, officer or manager of company that has been excluded from Federal program participation or convicted of certain health care crimes.. Because these OIG has identified these factors as core considerations in its exclusion analysis, the Guidance provides invaluable guidance for health care entities, their owners, officers and management employees about opportunities position their conduct for defensibility against OIG enforcement exposures. Consequently, owners, officers and managers alike concerned about their exposure to Federal program exclusion or other personal liability under Federal health care fraud laws should use the Guidance to help strengthen their ability to avoid personal exclusion or other prosecution by the OIG as a result of their involvement with a health care organization excluded from Federal program participation or convicted of other crimes. For a more detailed discussion of the Guidance, see here

For More Information or Assistance

If you need assistance evaluating or responding to this development of other health care compliance, risk management, transactional, operational, reimbursement, enforcement or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Other Resources

We hope that this information is useful to you. If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

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Posted by Cynthia Marcotte Stamer

CMS Publishes Corrections To Proposed 2011 Physician Fee Schedule Rules

August 26, 2010

Physicians and others likely to be affected by the proposed payment and other Medicare policy changes set forth in the “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011” (“2011 Physician Fee Schedule”) proposed by the Centers for Medicare & Medicaid Services (CMS) on July 13, 2010 Federal Register should review and consider the potential implications, if any, of a series of corrections to the proposed 2011 Physician Fee Schedule (“Corrections”) published by CMS today (August 26, 2010) when evaluating the implications of the 2011 Physician Fee Schedule on their reimbursement and other operations.

The 2011 Physician Fee Schedule previously published in the Federal Register here on July 13, 2010 outlines a detailed series of proposed changes to the physician fee schedule and other Medicare Part B payment policies that CMS is proposing to implement in 2011. Among other things, the proposed 2011 Physician Fee Schedule would:

Change Medicare reimbursement rules and amounts to reflect changes in medical practice and the relative value of services;
Interprets and implements certain provisions of both the Affordable Care Act and the Medicare Improvements for Patients and Providers Act of 2008;;
Discusses payments under the Ambulance Fee Schedule, Clinical Laboratory Fee Schedule, payments to ESRD facilities, and payments for Part B drugs; and
Discusses rules regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for Durable Medical Equipment and Provider and Supplier Enrollment Issues associated with Air Ambulances.

The Corrections published in the August 26, 2010 Federal Register here list a series of corrections to specific provisions of the 2011 Physician Fee Schedule that CMS has identified as necessary to address technical or typographical errors in the 2011 Physician Fee Schedule as originally published in July. Physicians and others evaluating the potential implications of the previously proposed 2011 Physician Fee Schedule should review and take into account these proposed edits as part of their analysis and response.

For More Information or Assistance

If you need assistance with these or other health industry regulatory, reimbursement or other operational or compliance concerns, please contact the author of this update, attorney Cynthia Marcotte Stamer. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients with licensure, contracting, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also regularly publishes and conducts training on these and other compliance, management and operations matters. You can contact Ms. Stamer to inquire about engaging her services or for information about training or other resources that she provides at (469) 767-8872 or via e-mail here. To get more information about Ms. Stamer and her health industry experience, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

About Solutions Law Press

Solutions Law Press™ provides health industry and other 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 available for review here. If you or someone else you know would like to receive future updates and notices about other upcoming Solutions Law Press events, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. For important information concerning this communication click here.

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Posted by Cynthia Marcotte Stamer

Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules

August 3, 2010

One of the nation’s largest drug store chains, Rite Aid Corporation and its 40 affiliated entities (Rite Aid) will pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The U.S. Department of Health and Human Services (HHS) Office of Civil Rights announcement of the HIPAA resolution agreement with Rite Aid and the concurrent negotiation of a separate consent order of potential FTC Act violations between Rite Aid and the Federal Trade Commission (FTC) follows HHS’ announcement of proposed changes to its HIPAA Privacy Rules and associated penalties in response to changes enacted under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The Rite Aid settlement and the proposed Privacy Rule changes illustrate the growing penalty risks that health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) face for violating the Privacy Rules.

Rite Aid Resolution Agreement

The Rite Aid resolution agreements settle charges that Rite Aid failed to appropriately safeguard the privacy of its customers when disposing of identifying information on pill bottle labels and other health information. The settlements apply to all of Rite Aid’s nearly 4,800 retail pharmacies and follow an extensive joint investigation by the HHS Office for Civil Rights (OCR) and the FTC.

OCR opened its investigation of Rite Aid after television media videotaped incidents in which pharmacies were shown to have disposed of prescriptions and labeled pill bottles containing individuals’ identifiable information in industrial trash containers that were accessible to the public in a variety of Rite Aid locations in cities across the United States. OCR and FTC previously settled a similar case involving the national drug store chain CVS in February 2009.

The HIPAA Privacy Rule requires covered entities to safeguard the privacy of patient information and other “protected health information” including during its disposal. In addition to the detailed requirements for protection and safeguarding of protected health information and electronic protected health information under the Privacy Rules, breach notification rules added to HIPAA under the HITECH Act also generally require that Covered Entities investigate and provide timely notification of breach to patients, OCR and in some cases the media when “unsecured protected heath information” is breached. Meanwhile, the FTC Act and associated regulations require those retailers and certain other parties receiving personal financial information to comply with certain requirements for the protection and use of that information and to provide certain notifications of their privacy polices for protecting personal financial information.

The joint OCR and the FTC investigations raised concerns that:

Rite Aid failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
Rite Aid failed to adequately train employees on how to dispose of such information properly; and
Rite Aid did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Under the HHS resolution agreement, Rite Aid agreed to pay a $1 million resolution amount to HHS and must implement a strong corrective action program under which Rite Aid agreed to:

Revise and distribute its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
Train workforce members on these new requirements;
Conduct internal monitoring; and
Engage a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

In addition, under its FTC consent order, Rite Aid separately agreed to external, independent assessments of its pharmacy stores’ compliance with the FTC consent order.

The HHS corrective action plan will be in place for three years; the FTC order will be in place for 20 years.

Proposed Privacy Rule Changes

The Rite Aid resolution agreement and consent order follows the July 8, 2010 publication by OCR of proposed changes to its existing HIPAA Privacy, Security, and Enforcement Rules in response to amendments enacted under the HITECH Act. Because of the lead time required to implement needed changes in policies, technology and training, Covered Entities need to begin preparations to adjust their health information privacy and data security policies and practices in anticipation of the finalization and implementation of these rules as well as to act quickly to submit their comments about the proposed changes. .

The more than 220 page Notice of Proposed Rulemaking (NPRM) proposes to revise the existing Standards for Privacy of Individually Identifiable Health Information (Privacy Rule); the Security Standards for the Protection of Electronic Protected Health Information (Security Rule); and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with HIPAA and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also is regularly conducts training on HIPAA and other health industry compliance, management and operations matters. 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

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Posted by Cynthia Marcotte Stamer

NCPDP SCRIPT 10.6 Approved As Medicare Part D/Advantage E-Prescribing Option

July 1, 2010

The Centers for Medicare & Medicaid Services (CMS) today (July 1, 2010) issued an interim final rule (Rule) that permits the voluntary use of the National Council for the Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 10, Release 6 (Version 10.6) (NCPDP SCRIPT 10.6) for conducting certain e-prescribing transactions for the Medicare Part D electronic prescription drug program. Review the Rule here.

Prior to the adoption the Rule, only NCPDP SCRIPT 8.1 was authorized for use in communicating Medicare Part D medication history among sponsors, prescribers and dispensers. The Rule revises Regulation §423.160(b)(4) to specify that entities now may use either NCPDP SCRIPT 10.6 or 8.1 for the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

Along with the rule, CMS issued a request for comments on the Rule. The deadline for interested parties to comment is 5 p.m. Eastern Daylight Time on August 30, 2010.

Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires that Prescription Drug Plan (PDP) sponsors, Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans and other Medicare Part D sponsors (Plans) provide for electronic transmittal the prescribing provider, dispensing pharmacy and the dispenser of information about:

Eligibility,
Benefits (including drugs included in the applicable formulary, any tiered formulary structure and any requirements for prior authorization),
The drug being prescribed or dispensed and other drugs listed in the medication history,
The availability of lower cost, therapeutically appropriate alternatives (if any) for the drug prescribed, and
Certain other information.

Before the Rule, CMS had approved NCPDP SCRIPT 8.1 for conducting these electronic transmittals.

As a consequence of the Rule, Plans, prescribers and dispensers now may use either NCPDP SCRIPT 10.6 or 8.1 when conducting e-Prescribing to conduct:

Get message transaction.
Status response transaction.
Error response transaction.
New prescription transaction.
Prescription change request transaction.
Prescription change response transaction.
Refill prescription request transaction.
Refill prescription response transaction.
Verification transaction.
Password change transaction.
Cancel prescription request transaction.
Cancel prescription response transaction.
Fill status notification transaction.
For the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

The MMD does not require that prescribers or dispensers implement e-Prescribing, prescribers and dispensers who electronically transmit prescription and certain other prescription-related information for Medicare Part D covered drugs prescribed for Medicare Part D eligible individuals, directly or through an intermediary, must comply with any applicable final standards that are in effect. The Rule provides new choices on how to accomplish this.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. You can get more information about her health industry experience here. If you need help 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

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Posted by Cynthia Marcotte Stamer

OIG Touts Expanding Health Care Fraud Enforcement Success & Launches New Health Care Fraud Hotline

May 20, 2010

Continuing expansion of health care fraud enforcement initiatives, the Office of Inspector General (OIG) recently released its Health Care Fraud and Abuse Control Program Report and launched a new online Fraud Hotline Website to allow individuals the option of reporting federal health care fraud suspicions to OIG online.

The May 12 launch of the Fraud Hotline Website means whistleblowers now can report suspected federal health care fraud to OIG over the Internet, by telephone or by mail. CMS hopes the addition of online fraud reporting capability will lead to more investigations, audits and/or monetary recoveries.

OIG followed up May 13, by releasing its latest Health Care Fraud and Abuse Control Program Report, In addition to detailing 2009 healthcare fraud enforcement activities and accomplishments, the Report also highlights the continuing success of its HEAT initiative as well as new enforcement tools created by the recent health care reform legislation, the “Fraud Enforcement and Recovery Act of 2009”(FERA) and other recent developments that facilitate the ability of OIG and the Justice Department to prosecute and secure larger fines and penalties from healthcare providers engaging in health care fraud. For more information, read the OIG Press Release here.

The heightened emphasis by federal officials on enforcement of federal health care fraud laws and the implementation of tools like the new Fraud Hotline Website increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct. These and other activities are part of a significant ramp up in federal emphasis on the detection and prosecution of violations of federal health care fraud laws by both the Administration and Congress. Many state agencies also are stepping up their health care fraud investigations and enforcement. In light of this new emphasis upon health care fraud detection and enforcement, health care providers now more than ever need to prepare to demonstrate the appropriateness and defensibility of their health care billing and other compliance efforts.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

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Posted by Cynthia Marcotte Stamer

DEA/DOJ Release Interim Final E-Prescribing Rules

March 25, 2010

Health care providers wishing to electronically prescribe controlled substance should begin reviewing and updating their practices and technology to comply with requirements of the Interim Final Regulations scheduled for publication in the Federal Register on March 31, 2010. Read details at http://wp.me/ptOGJ-94

An advance copy of the new Interim Final Regulation with Request for Comments released March 24, 2010 by the Drug Enforcement Administration (DEA) and Department of Justice on Electronic Prescribing of Controlled Substance on is posted for review here.

Concurrent with publication of the Interim Final Rule, the DEA is inviting comment on DEA is seeking additional comments on the following issues: identity proofing, access control, authentication, biometric subsystems and testing of those subsystems, internal audit trails for electronic prescription applications, and third-party auditors and certification organizations.

About The Author

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or (469) 767-8872.

Nationally and internationally recognized for more than 22 years of work with health industry technology, privacy and data security, regulatory compliance, reimbursement, workforce and staffing, licensure and accreditation, and other quality, risk management, operations and public policy matters organizations, publications, workshops and presentations and leadership Cynthia Marcotte Stamer has worked extensively with physicians, health systems, specialty and other pharmacy, telemedicine and other health technology, and other health industry clients on a diverse range of operational, product and process development, regulatory, licensure, public policy and risk management protections relating to e-prescribing, telemedicine, interoperable and other electronic health and medicine arrangements and other health care internal controls, process and privacy and technology matters. The publisher of the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update, Ms. Stamer also is a popular speaker and author of these and other health industry topics. She regularly publishes, speaks and conducts training for health industry and other organizations, the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, various medical society and other professional organizations, the Medical Group Management Association, and many other organizations. Her many publications and programs include“Changing Regulations Will Ease Way for E-Prescribing, But Physicians Shouldn’t Jump the Gun,” “Telemedicine, E-Prescribing & Electronic Health Records: Opportunities & Exposures,” “Telemedicine & E-Prescribing: Evolving Ethical, Licensing & Reimbursement Rules & Realities,” the “Tort & Other Liability” Chapter of the ABA Health Law Section/BNA E-Health & Technology Treatise, “Protecting & Using Patient Data in Disease Management Opportunities, Liabilities and Prescriptions,” Chapter 1: Privacy.” The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks (AHLA 2005) (Contributing Author), “Cybercrime and Identity Theft: Health Information Security beyond HIPAA,” “Privacy & Securities Standards-A Brief Nutshell” and numerous other programs and publications on telemedicine and e-prescribing, HIPAA and other privacy and data security, and other related internal controls and operational matters. Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others. You can review other highlights of Ms. Stamer’s health care experience here, and employment experience here. Her insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

Other Resources

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Posted by Cynthia Marcotte Stamer

House Could Vote On Health Care Reform As Early As Sunday

March 19, 2010

By Cynthia Marcotte Stamer

The stage now appears to be set for the House of Representatives to vote as early as Sunday on the latest version of health care reform backed by President Obama, Speaker Nancy Pelosi and other key Congressional Democrats, the Reconciliation Act of 2010 (H.R. 4872). The impending deadline means that health industry providers and other Americans concerned about the potential outcome of the impending vote need to act quickly if they wish to attempt to influence the decision. For tips about sharing your input with Congress effectively, see Getting Your Health Care Reform Message Heard By Key Congressional Leaders.

Developments Today Start Clock Running For Vote

On Thursday, March 18, 2010, two key developments set the stage for a vote on H.R. 4871 as early as Sunday:

The House Rules Committee posted the text of H.R. 4872 on its website; and
The Congressional Budget Office (CBO) delivered its scoring of H.R 4872 to House Speaker Nancy Pelosi.

The delivery of CBO scoring started the clock running on the 72 hour mandatory period between the release of the CBO scoring and any final vote on the bill. This means the House could vote on H.R. 4872 as early as Sunday, March 21.

If passed by the House, H.R. 4872 would make sweeping changes to the U.S. health care system impacting virtually every American patient, health care provider, employer and taxpayer. To learn the facts about these proposed changes, read the full text of H.R. 4872 here.

According to the CBO, H.R. 4872 will cost $940 billion over 10 years to extend coverage to 32 million uninsured people. To learn more specifics about these cost and other determinations, review the CBO scoring here.

This Is Only The Beginning: Stay Involved

The outcome of this latest health care reform push is only a small part of a continuing process. Whether or not the President’s proposal or some other version of health care reform passes this week, Congress already has and will continue to consider other legislation impacting health care reform. This reality is demonstrated by Congressional actions recently taken on the COBRA premium subsidy extension, Medical reimbursement for physicians, continuing federal efforts to develop and implement federal health care quality and technology standards, and other legislative, regulatory and enforcement actions taken while public attention has been focused largely only on the broader health care reform debate.

Upcoming mid-term elections will significantly impact the nature and scope of these upcoming efforts. Perhaps even more significantly, the enactment of legislation is only a beginning point. The real meaning of these or other health care reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye. Monitoring and staying active in these ongoing processes provides a critical opportunity to continue to monitor your issues and provide input to shape how they are addressed.

Individuals concerned about these and other health care reform proposals and concerns are invited to stay involved in the discussion by sharing their input with Congress, regulators. Concerned individuals also are invited to stay involved in the discussion by joining the Coalition for Responsible Health Care Reform Group on Linkedin and registering to receive these updates here. The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

Help Monitoring & Responding To Developments

If you need assistance evaluating or formulating comments on the proposed reforms contained in the House Bill or on other health industry matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com or 214.270.2402.

From her extensive involvement with federal and state legislative and regulatory licensing, telemedicine, managed care, privacy and other health, pension and other reforms in the U.S. to her involvement as a lead advisor to the Government of Bolivia on its pension privatization legislation, Ms. Stamer’s experience includes significant experience working with clients domestically on key health care and other public policy matters. 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 Chairman of the Board of Richardson Development Center for Children and past Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer couples her policy experience with her extensive experience working with health industry clients on regulatory, staffing, reimbursement, risk management and compliance and other operational matters. She has more than 22 years experience advising health industry clients about these and other matters. A popular lecturer and widely published author on health industry matters, Ms. Stamer advises hospitals and other health industry clients about responding to and using these and other quality measures and other related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns. 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. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

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Posted by Cynthia Marcotte Stamer

Medicare Ends Fox Insurance Company Drug Plan Contract As CMS Turns Up Heat on Medicare Advantage & Part D Plan Enforcement & Oversight

March 16, 2010

By Cynthia Marcotte Stamer

The Centers for Medicare & Medicaid Services (CMS) terminated its Medicare Part D prescription drug coverage contract with Fox Insurance Company (Fox) on March 9, 2010. The action highlights CMS’s growing scrutiny and enforcement of Medicare requirements against Medicare Part D, Medicare Advantage Plans and other federal health care program contractors.

CMS terminated the Fox contract after CMS found the failure by Fox’s plan and services to meet Medicare’s requirements to provide enrollees with prescription drugs according to recognized standards of care jeopardized the health and safety of Fox enrollees. When announcing the contract termination, CMS reported that an on-sight review by CMS showed that Fox committed a series of violations, including improperly denying its enrollees coverage of critical HIV, cancer, and seizure medications. CMS issued an enrollment and marketing sanction to Fox on Feb. 26, 2010, because the organization was not following Medicare’s rules for providing prescription drug coverage to its enrollees. According to CMS, an onsite audit conducted between March 2 and March 4 showed that Fox’s problems persisted and that Fox continued to subject its enrollees to obstacles in getting sustaining medicines or other needed medications. Among other things, CMS found Fox:

Failed to provide access to Medicare prescription drugs benefits by imposing unapproved prior authorization and step therapy criteria that made it more difficult for beneficiaries to get drugs that are protected by law;
Failed to meet the plan’s appeals deadlines; and
Did not comply with Medicare regulations requiring enrollees to be transitioned to new drugs at the beginning of the new plan year.
Failed to notify enrollees about prior authorization and step therapy determinations as required by Medicare.

CMS also found that many of the obstacles were in place to limit access to high-cost drugs, which could have led to enrollees’ clinical needs not being met.

In many cases, CMS reported that Fox required enrollees to have unnecessary and invasive medical procedures before they were able to obtain drugs. Finding that Fox was unable to satisfactorily address these compliance concerns and furnish medicines to its Medicare enrollees, CMS immediately terminated the Fox contract.

At the time of the termination, more than 123,000 Medicare beneficiaries were enrolled in Fox plans. Beginning March 10, 2010, CMS indicated that LI-NET, a Medicare run program administered by Humana, would replace the Medicare Part D coverage of enrollees affected by the Fox contract termination on an interim basis. Fox enrollees will be able to choose a new Medicare prescription drug plan through May 1, 2010. Current enrollees who do not choose a plan will be enrolled into a new plan by Medicare. CMS is sending letters explaining the actions taken by CMS to enrollees and has established a 1-800 number to receive questions.

The action against Fox is part of an ongoing series of oversight, disciplinary and enforcement actions by CMS against Medicare Advantage and other federal health care program participants. These programs and CMS’ oversight and enforcement of federal programs are drawing increasing Congressional scrutiny in connection with Congressional health care reform efforts. Amid this heightened scrutiny, Medicare Part D and Medicare Advantage Plans; health care providers, administrative services providers and others contracting with these plans and others involved with this programs should take appropriate action to maintain compliance, tighten their contracts with and oversight of actions of partners and vendors performing critical functions; review complaint reporting, investigation and response processes and procedures; and strengthen other practices to minimize exposures to audit or other enforcement actions.

For Assistance With Medicare Managed Care or Other Matters

If your organization needs advice or assistance about Medicare Part D or other Medicare Advantage contracting or other requirements or about other health plan or health care matters, consider contacting the author of this article, Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail here.

Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Chair of the American Bar Association RPTE Employee Benefits & Compensation Committee and an ABA Joint Committee on Employee Benefits Council member, Ms. Stamer has more than 22 years experience advising health plans, health care providers, and other health industry and insurance clients. Her experience includes specific experience assisting Medicare, Medicaid and other health plan sponsors, administrators, or administrative services providers about contracting, compliance, coverage and other matters. A popular lecturer and widely published author on health industry matters, Ms. Stamer also conducts compliance and other training on Medicare Advantage and other contract and compliance matters, as well as a broad range of other health industry related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns. Her insights on health industry 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. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent updates available online by clicking on the article title:

You can review other recent health plan, health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here; e-mailing this information to cstamer@cttlegal.com; or registering to participate in the distribution of these and other Solutions Law Press updates here. For important information concerning this communication click here.

To unsubscribe, e-mail here.

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Posted by Cynthia Marcotte Stamer

HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website

February 25, 2010

By Cynthia Marcotte Stamer

The Department of Health and Human Services Office of Civil Rights (OCR) has begun posting on its website the names and certain information about health care providers, health insurers, employer and other health plans, health care clearinghouses and their business associates (Covered Entities) reporting to OCR “breaches” of “unsecured protected health information” (UPHI) under new breach notice rules added by the Health Information Technology for Economic and Clinical Health Act (HITECH Act).

Covered Entities should anticipate the posting of the breach information and other HITECH Act breach notices coupled with amendments to the medical privacy and security requirements of the Health Insurance Portability & Accountability Act (HIPAA) effective since February 17, 2010, will heighten enforcement risks and public sensitivities about medical information privacy safeguards. As failing to comply with the amended rules effective February 17, 2010 can trigger obligations under the Breach Regulations and other significant liability exposures, Covered Entities should act quickly to manage these emerging risks.

Covered Entity Breach Notification Requirements

The initial list of Covered Entities reporting breaches of UPHI affecting 500 or more individuals posted by OCR on February 22, 2010 discloses the Covered Entity’s name and State, the approximate number of individuals affected, the date and type of breach and the location of the breached information. OCR’s posting of this information is required under the HITECH Act breach notification requirements as part of its implementation and enforcement of new breach notification requirements added to HIPAA by Section 13402(e)(3) of the HITECH Act.

The HITECH Act amended HIPAA to require Covered Entities to require Covered Entities provide notification to individuals, OCR and others when certain breaches of UPHI happen. The implementing interim “Breach Notification For Unsecured Protected Health Information” regulations (Breach Regulation) published by OCR here require Covered Entities subject to HIPAA to notify affected individuals, OCR and in some cases the media within specified periods following a “breach” of UPHI occurring on or after September 23, 2009 unless the Covered Entity can demonstrate that the breach qualified as exempt from the breach notification obligation under the Breach Regulations.

Covered Entities generally should consider the need to provide breach notification under the Breach Regulation whenever electronic or non-electronic protected health information which is not adequately encrypted or destroyed to qualify as “secured” under the breach rules is used, accessed or disclosed in violation of HIPAA.

Since the potential need to provide breach notification is triggered by an impermissible use, access or disclosure of UPHI, up-to-date maintenance, monitoring and enforcement is at the heart of compliance with the Breach Regulation as well as HIPAA generally.

You can review the currently posted list of Covered Entities that have reported breaches on the OCR website here. Learn more about the Breach Regulation requirements here.

Broader & Stricter Medical Privacy Mandates Effective 2/17/210

The new breach notification requirements are part of a series of changes made to HIPAA under the HITECH Act that are increasing the responsibilities and liability exposures of Covered Entities. On February 17, 2010, Covered Entities and their business associates also became subject to tighter federal requirements for the use, access, protection and disclosure of protected health information under amendments to HIPAA’s Privacy & Security Standards enacted in the HITECH Act. When the HITECH Act was signed into law on February 17, 2009, Covered Entities also became subject to expanded sanctions and remedies for HIPAA violations.

To comply with the HITECH Act changes to HIPAA effective on February 17, 2010, most Covered Entities and their business associates generally will need to update their written policies, operational procedures, technical safeguards, privacy notices, vendor and other agreements, training, and other management procedures in several respects. For more details, see here.

While the HITECH Act gave Covered Entities and business associates a year to complete the necessary arrangements to comply with these HITECH Act changes, many Covered Entities and business associates have not adequately implemented the necessary arrangements. To mitigate these exposures, Covered Entities and their business associates should act quickly to review and update their policies, procedures, training, business associate and other services agreements, and other practices and procedures, as well as to implement the training, oversight, and other management necessary to comply with the HITECH Act changes and to mitigate other HIPAA risks.

Exposures Significant & Growing

HIPAA-associated exposures for Covered Entities are significant and growing. Timely action to comply with the amended HIPAA requirements and Breach Regulations is important to avoid triggering the breach notification requirements; to prevent loss of public trust and reputation; and to minimize exposures to legal actions, administrative complaints and sanctions and the investigation, defense and correction costs likely to result when a Covered Entity violates or is accused of violating HIPAA or otherwise mishandling medical or other personal information.

Even before the HITECH Act changes became effective, federal regulators were stepping up HIPAA enforcement. The HITECH Act amendments further increase the risk that Covered Entities violating HIPAA face investigation and sanction. The HITECH Act amendments increase the likelihood that Covered Entities violating HIPAA will get caught and will face some form of damage or penalty assessment. Heightened awareness of UPHI breaches resulting from HITECH Act mandated breach notifications are likely to fuel new HIPAA-related complaints, charges and demands. Covered Entities, workforce members who wrongfully access protected health information now face potential civil penalties, criminal prosecution, civil lawsuits and other actions. Allowing state attorneys general to bring suit adds more manpower to the enforcement team. Furthermore, the wrongful use, access or disclosure of protected health information or other confidential information also increasingly is the basis of civil or criminal actions brought under a variety of other federal and state laws.

New Risks Created By HITECH Act Amendments

Heightened HIPAA exposures stem in part from the HITECH Act’s amendments to HIPAA’s remedy provisions. Among other things, the HITECH Act amended HIPAA to:

Allow a State Attorney General to sue Covered Entities that commit HIPAA violations after February 16, 2009 for damages caused to state citizens;
Expand the mandate by OCR to investigate violations and audit compliance with HIPAA;
Require OCR to impose civil sanctions against Covered Entities and business associates involved in violations of HIPAA in accordance with tightened standards added to HIPAA by the HITECH Act;
Revise the criminal sanctions that the Department of Justice can seek against Covered Entities and others for violations of HIPAA; and
Amend HIPAA to make clear that workforce members and others improperly using, accessing or disclosing protected health information in violation of HIPAA can face criminal prosecution.

State Attorney General Lawsuit Exposures

Covered Entities must be concerned about the potential that a state Attorney General may bring civil suit to remedy damages caused to state citizens by a breach of HIPAA. In certain situations, the HITECH Act empowers a state attorney general to sue Covered Entities for damages if their HIPAA violations harm state citizens. Statutory damages equal to the sum of the number of violations multiplied by 100 up to a maximum of $25,000 per calendar year plus attorneys fees and costs are authorized.

A HIPAA civil lawsuit demonstrates the willingness of at least some states to exercise the new authority to sue Covered Entities. On January 13, 2010 Connecticut Attorney General Richard Blumenthal sued Health Net of Connecticut, Inc. (Health Net) for failing to secure private patient medical records and financial information involving 446,000 Connecticut enrollees and promptly notify consumers endangered by the security breach. The first attorney general enforcement action brought based on amendments made to HIPAA under the HITECH Act, Connecticut charges that Health Net violated HIPAA by failing to safeguard protected medical records and financial information on almost a half million Health Net enrollees in Connecticut then allowing this information to remain exposed for at least six months before notifying authorities and consumers. The suit also names UnitedHealth Group Inc. and Oxford Health Plans LLC, who have acquired Health Net.

Stepped Up Federal Enforcement

Even before the HITECH Act amendments, OCR and Department of Justice increased HIPAA investigation and enforcement. The Department of Justice has obtained a variety of criminal convictions against violators of HIPAA. See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health Information. Meanwhile, OCR also is emphasizing HIPAA enforcement. In February, 2009, OCR announced that CVS Pharmacies, Inc. would pay $2.25 million to resolve HIPAA charges. This announcement followed OCR’s announcement in July, 2008 that Providence Health Care would pay $100,000 to resolve HIPAA violation charges. OCR also has taken HIPAA enforcement actions against a broad range of other Covered Entities. See more details here. While not resulting in the significant payments involved in CVS or Providence, all Covered Entities involved in these and other enforcement actions or investigations have incurred significant legal and other defense costs, loss of community trust, or both.

In addition to these HIPAA-specific exposures, wrongful use, access or disclosure of medical information also can expose Covered Entities, members of their workforce and others improperly using, accessing or disclosing protected health information to liability under other federal or state laws. Federal and state prosecutors may and increasingly do bring criminal or civil actions against organizations or individuals for improperly accessing or using medical or other personal information under a variety of other federal or state laws . See e.g., Cybercrime & Identity Theft: Health Information Security Beyond HIPAA; NY AG Cuomo Announcement of 1st Settlement For Violation of NY Security Breach Notification Law; Woman Who Revealed AIDs Info Gets A Year.

State Civil Lawsuits

Covered Entities also need to prepare to defend HIPAA-related conduct in state civil actions. Individual plaintiffs increasingly used alleged HIPAA violations in state privacy, negligence, retaliation, wrongful discharge or other lawsuits. State courts have allowed private plaintiffs to use the obligations imposed by HIPAA as the basis of a Covered Entity’s duty for purposes of certain state law lawsuits. In Sorensen v. Barbuto, 143 P.3d 295 (Utah Ct. App. 2006), for example, a Utah appeals court ruled a private plaintiff could use HIPAA standards to establish that a physician owed a duty of confidentiality to his patients for purposes of maintaining a state law damages claim. Similarly, the Court in Acosta v. Byrum, 638 S.E. 2d 246 (N.C. Ct. App. 2006) ruled that a plaintiff could use HIPAA to establish the “standard of care” in a negligence lawsuit. Meanwhile, disgruntled employees or other business partners performing services for Covered Entities also increasingly are pointing to HIPAA as the basis for their retaliation or wrongful discharge claims. See, e.g., Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim. Read more here.

Coupled with the HITECH Act changes, these and other enforcement actions signal growing potential hazards for Covered Entities that fail to properly manage their HIPAA compliance obligations and risks. To help guard against these exposures, Covered Entities should act quickly to strengthen their HIPAA defenses by updating policies, contracts, practices, security, training, oversight, documentation and management.

Covered Entities & Business Associates Urged To Act Promptly To Manage Mitigating Expanded HIPAA Risks & Obligations

Faced with these expanding obligations and exposures, Covered Entities should prepare for the need to defend the adequacy of their HIPAA compliance efforts on paper and in operation. As part of these efforts, Covered Entities should consider:

Reviewing the adequacy of the practices, policies and procedures of the Covered Entities, business associates, and others that may come into contact with protected health information within the scope of attorney-client privilege taking into consideration the Corrective Action Plan, published OCR noncompliance and enforcement statistics, their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable;
Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility;
Renegotiating and enhancing service provider agreements to detail the specific compliance obligations of each party; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; to clarify rights of indemnification; and other related relevant matters;
Improving technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information;
Conducting well-documented training as necessary to ensure that members of the Covered Entity’s workforce understand and are prepared to comply with the expanded requirements of HIPAA, can detect potential breaches or other compliance concerns, and understand and are prepared to follow appropriate procedures for reporting and responding to suspected violations;
Tracking actual and near miss violations and making adjustments to policies, practices, training, safeguards and other compliance components as necessary to deter future concern
Establishing and providing well-documented monitoring of compliance;
Establishing and providing well-documented timely investigation and redress of reported violations or other compliance concerns;
Establishing contingency plans for responding in the event of a breach;
Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and requirements;
Preparing and maintaining a well-documented record of compliance activities; and
Pursuing other appropriate strategies to enhance the Covered Entity’s ability to demonstrate its compliance commitment both on paper and in operation.

For Assistance With Compliance Or Other Concerns

The author of this article, Ms. Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. 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 the author of this article, Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or another Curran Tomko Tarski LLP attorney of your choice. You can get more information about the CTT Health Care Practice and more specifics about Ms. Stamer’s health industry experience here.

Ms. Stamer is nationally known for her work, training and presentations, and publications on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts.

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 22 years experience advising clients, conducting workshops and other training, and providing policy advice about health care, privacy, data security, and other matters. She advises health care providers, health insurers and administrators, employer and other health plan sponsors, employee benefit plan fiduciaries, schools, financial services providers, governments and others about privacy and data security, health care, insurance, human resources, ERISA, technology, and other legal and operational concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. A widely published author on privacy, data security, health care and other related matters, Ms. Stamer is the author of “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of other highly regarded publications. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

Other Helpful Resources & Other Information

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Posted by Cynthia Marcotte Stamer

Senate Finance Committee Releases Statutory Language of America’s Healthy Future Act To Present To Full Senate

October 22, 2009

Americans finally have a chance to read the actual statutory language of the painfully negotiated package of proposed health care reforms that the Senate Finance Committee proposes for adoption. The Senate Finance Committee leadership finally finished drafting has posted the 1506 page long text of the proposed statutory language of the health care reform provisions of the “America’s Healthy Future Act” on its website here.

When the Senate Finance Committee vote passing the America’s Health Future Act, members of the Senate Finance Committee had not yet had the opportunity to review the actual statutory language to be proposed to implement the package of heatlh care reforms painfully hashed out in their committee. As the actual statutory language had not been completed at the time a majority of the Democrats and one Republican Senator serving on the Senate Finance Committee voted to send the legislation to the the full Senate, the vote actually was taken based on a narative description of the intended reforms set forth in a revised draft of the “Chairman’s Mark” of the legislation. Since that time Senate Finance Committee Chairman Max Baucus and other key Democrat Senators on the Senate Finance Committee have worked behind closed doors to prepare the actual statutory language to be presented to the full Senate.

As proposed, the America’s Healthy Future Act would require sweeping changes to the U.S. health care systems that if adopted will radically impact the roles and responsibilities of every patient, health care provider, health care payor, employer and other American. Because of the potential implications on the way health care is financed, delivered and administered and the projections that the legislation will cost approximately $1 Trillion, all parties are urged to carefully review the complex and lengthy legislation to gain an understanding of the legislation and to act quickly to make any concerns known to elected leaders in Congress.

For More Information

We hope that this information is useful to you. If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters. You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn. To unsubscribe, e-mail here.

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Posted by Cynthia Marcotte Stamer

Medicare Cautions Medicare-Contracted Insurance Companies & Drug Plans About Health Care Reform Advocacy Mailings As Investigation Opened Into Humana, Inc. Reform Related Communications To Beneficiaries

September 21, 2009

The Centers for Medicare & Medicaid Services (CMS) is considering taking action against Humana, Inc. based on communications about health care reform it sent to enrollees in its Medicare Advantage Plans and calling on other Medicare-contracted health insurance and prescription drug plans to suspend potentially misleading mailings to beneficiaries about health care and insurance reform.

According to a CMS announcement distributed today, CMS is investigating whether Humana, Inc. acted improperly in connection with its communications with enrollees in its plans about health care reform. The CMS investigation reportedly initiated at the request of Senate Finance Chair Max Baucus (D-Mont.) questions the propriety of letters sent by Humana, Inc. to Medicare enrollees alleging that they could lose their benefits under healthcare reform bills moving through Congress.

According to CMS, CMS learned that Humana had been contacting enrollees in one or more of its plans and, in mailings that CMS obtained, made claims that current health care reform legislation affecting Medicare could hurt Medicare beneficiaries. The message from Humana urges enrollees to contact their congressional representatives to protest the actions referenced in the letter.

The Humana Letter allegedly letter told beneficiaries that “millions of seniors and disabled individuals could lose many of the important benefits and services that make Medicare Advantage health plans so valuable” and urged enrollees to contact their congressional representatives and protest the possible changes. Humana, Inc. sent the letter in an envelope stating that the envelop contained ‘important information about beneficiaries’ plans.’

CMS has commenced an investigation into whether the Humana, Inc. mailings violate Federal laws. Specifically, CMS is investigating whether Humana inappropriately used the lists of Medicare enrollees for unauthorized purposes or violated regulations requiring CMS prior approval of advertisements to beneficiaries.

Late last week, CMS requested that Humana, Inc. end similar mailings and remove related communications from its website pending the completion of its investigation. CMS reports that Humana has agreed to do so.

In an announcement e-mailed to members of its list-serve today, CMS notified other Medicare contracted health insurance and prescription drug plans of the investigation and urged them to abstain from engaging in similar communications. “We are concerned that the materials Humana sent to our beneficiaries may violate Medicare rules by appearing to contain Medicare Advantage and prescription drug benefit information, which must be submitted to CMS for review” said Jonathan Blum, acting director of CMS’ Center for Drug and Health Plan Choices. “We also are asking that no other plan sponsors are mailing similar materials while we investigate whether a potential violation has occurred.”

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Health Care Updates available online by clicking on the article title below:

For More Information

We hope that this information is useful to you. If you need assistance with these or other Medicare Advantage or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

Ms. Stamer has extensive experience in these and other health industry related representation including specific experience assisting Medicare/Medicaid Advantage and other health plans, their outsourcers and others about regulatory compliance, contracting and other risk management and public policy matters. You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer 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 at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

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Posted by Cynthia Marcotte Stamer

Health Care Providers & Other HIPAA-Covered Entities & Their Business Associates Must Comply With New HHS Health Information Data Breach Rules By September 24

August 24, 2009

Register Now To Participate in September 9 “HITECH Act Health Data Security & Breach Update”

Health care providers, health clearinghouses, health plans and their business associates generally must start complying with new federal data breach notification rules on September 24, 2009.

The new “Breach Notification For Unsecured Protected Health Information” regulation (Breach Regulation) published here in today’s Federal Register requires health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) covered under the personal health information privacy and security rules of the Health Insurance Portability & Accountability Act (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. The Breach Regulation is part of a series of guidance that HHS is issuing to implement new and stricter personal health information privacy and data security requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA).

You are invited to catch up on what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time.

HITECH Act Data Breach and Unsecured PHI Rules

Scheduled for publication in the Federal Register on August 24, 2009, the new Breach Regulation implements the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, when a breach of “unsecured protected health information” happens and the form, manner, and timing of that notification. Covered Entities must begin complying with the new Breach Regulation on September 24, 2009.

Part of a series of new HHS rules implementing recent changes to HIPAA enacted under the HITECH Act to strengthen existing federally mandates requiring Covered Entities to safeguard protected health information, the Breach Regulation will obligate Covered Entities and business associates to provide certain notifications following a breach of “protected health information” that not secured at the time of the breach through the use of a technology or methodology meeting minimum standards issued by HHS pursuant to other provisions of the HITECH Act.

Under the HITECH Act, the breach notification obligations contained in the Breach Notification only apply to a breach of “unsecured protected health information.” The Breach Regulation exempts breaches of protected health information that qualify as “secured” under separately issued HHS and Federal Trade Commission (FTC) standards for encryption and destruction of protected health information from its breach notification requirements.

For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the Covered Entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act. Earlier this year, HHS and the FTC issued interim rules defining the minimum encryption and destruction technologies and methodologies that Covered Entities must use to render protected health information unusable, unreadable, or indecipherable to unauthorized individuals for purposes of determining when protected health information is “unsecured” for purposes of the HITECH Act. Concurrent with its publication of the Breach Regulation, HHS also released guidance updating and clarifying this previously issued guidance.

Read the Breach Regulation here. To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

September 9 “HITECH Act Health Data Security & Breach Update” Briefing

Interested persons are invited to register here now to learn what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201. For information about registering for this program or other questions here.

Conducted by Curran Tomko and Tarski LLP Partner Cynthia Marcotte Stamer, the briefing will cover:

Who must comply
What your organization must do
How to qualify protected health information as exempt from the breach regulations as “secure” protected health information
What is considered a breach of unsecured protected health information
What steps must a covered entity take if a breach of unsecured protected information happens
What liabilities do covered entities face for non-compliance
What new contractual requirements, policies and procedures Covered Entities and Business Associates will need
How the Breach Regulation, the Privacy Regulation, impending FTC red flag rules and state data breach and privacy rules interrelate
Other recent developments
Practical tips for assessing, planning, moving to and defending compliance
Participant questions
More

About The Presenter

The program will be presented by Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer. Ms. Stamer is nationally known for her work, publications and presentations on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts.

Vice President of the North Texas Health Care Compliance Professionals Association and Past Chair of the ABA Health Law Section Managed Care & Insurance Section, and Former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 20 years experience advising clients about health and other privacy and security matters. A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer is the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010, as well as the author of “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of other highly regarded publications. She has continuously advises employers, health care providers, health insurers and administrators, health plan sponsors, employee benefit plan fiduciaries, schools, financial services providers, governments and others about privacy and data security, health care, insurance, human resources, technology, and other legal and operational concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other compliance, risk management, transaction or operation concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or another Curran Tomko Tarski LLP Partner of your choice.

Other Helpful Resources & Other Information

If you found these updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Curran Tomko Tarski LLP publications available for review 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 at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

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Posted by Cynthia Marcotte Stamer

House Democratic Leaders Work To Resolve Differences In Committee Versions of Health Care Reform Legislation and Build Public Support During August Recess

August 5, 2009

Democratic Leaders in the House of Representatives plan to hammer out differences three versions of the America’s Affordable Health Choices Act (H.R. 3200) as separately passed by three key House Committees in July before House members return from their August recess in hopes of bringing the agreed to version of H.R. 3200 to the full house in September. Regardless of which version ultimately emerges, the enactment of H.R. 3200 would result in sweeping new regulation and federal control over health care providers, health care payers, employers, and individuals.

After negotiating a last minute pre-August recess deal with certain Blue Dog Democrat Committee members, the House Energy and Commerce Committee on July 31, 2009 passed its version of H.R. 3200, the America’s Affordable Health Choices Act (H.R. 3200). The version of H.R. 3200 passed by the House Energy and Commerce Committee incorporates a series of amendments to the language of H.R. 3200 as originally introduced. For instance, this version of H.R. 3200 provides incentives for states to adopt certain tort reforms, provides for a public plan option that would reimburse physicians based on negotiated rates rather Medicare rates, and would allow states to offer both state-based heath insurance exchanges and health insurance co-ops. To review H.R. 3200 as amended by the House Energy and Commerce Committee, see here.

The approval by the Energy and Commerce Committee of its version of H.R. 3200 follows the July 17, 2009 approval by the House Ways and Means Committee and Education and Labor Committee of their own versions of H.R. 3200. For details on the version of H.R. 3200 approved by the House Ways and Means Committee, see here. For details on the version of H.R. 3200 approved by the House Education and Labor Committee, see here.

Leading House Democrats have announced their intention to work to resolve differences between these three versions of H.R. 3200 as passed by these Committees during August recess in hopes of bringing the agreed to version of H.R. 3200 to a vote of the full House of Representatives in September.

Meanwhile, House members from both parties also generally are using the August recess as an opportunity to reconnect with local constituents on health care reform and other core issues.

For More Information

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other proposed health care or other regulatory reforms or with other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

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 our electronic Solutions Law Press Health Care Update publication available here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

Leave a Comment » | Disease Management, Electronic Health Records, Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Plans, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, Outcomes Data, Physician, Prescription Drugs, Reimbursement, Rural Health Care, Tax, Wellness | Tagged: Affordable Health Choices Act, America's Affordable Health Choices Act, Doctor, Employer, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HHS, Hospital, Medicare, Medicare Part B, Nonprofits, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Blue Dog Democrats Hold Key Voice On House Democrats Proposed Health Care Reform Plan; Contact Numbers Here

July 20, 2009

Health care providers and others concerned about the “American’s Affordable Health Care Choices Act of 2009” health care reform proposal introduced by the House Democratic Leadership should target their input on the Democrats in Congress most likely to listen to those concerns. In the House of Representatives, these members likely are the “Blue Dog Democrats” in the House. Read about Blue Dog Democrats here.

The fiscal conservatism of Blue Dog Democrats makes them more likely to listen to concerns about the cost and other concerns relating to the health care reform bills touted by the Democrat Leadership in the House and Senate. In fact, many Blue Dog Democrats already are speaking out about their concerns about the cost and other aspects of the Bill.

Contact from voters and contributors in their districts and others could make a major difference in the ability that the House Democrat Leadership needs to pass their Bill. Immediately contacting these members and getting others – particularly voters and contributors in the districts that elect these members – is one of the most important steps that concerned Americans can do to position their concerns to be heard.

For most concerned voters, telephone or fax contact is the best means to convey these messages. To minimize spam, most members only accept e-mail submitted through their website links. Security concerns can delay receipt of written correspondence for weeks.

For persons interested in making their voices heard and sharing information with others who wish to do the same, the following contact information may be of interest:

The number of the Capital Switchboard is 202-224-3121.

The Blue Dog Leadership Team and there telephone and fax numbers are:

Rep. Stephanie Herseth Sandlin (SD), Blue Dog Co-Chair for Administration, Telephone: 202.225.2801 , Fax: 202.225.5823

Rep. Baron Hill (IN-09), Blue Dog Co-Chair for Policy,Telephone: 202-225-4031, Fax: (202) 226-6866

Rep. Charlie Melancon (LA-03), Blue Dog Co-Chair for Communications, Telephone: 202-225-4031, Fax: (202) 226-3944

Rep. Heath Shuler (NC-11), Blue Dog Whip, Telephone: 202-225-6401, Fax: (202) 226-6422

The Blue Dog Members and their telephone numbers are :

Altmire, Jason (PA-04),(202)225-2565

Arcuri, Mike (NY-24), (202)225-3665

Baca, Joe (CA-43),(202)225-6161

Barrow, John (GA-12), (202) 225-2823

Berry, Marion (AR-01), (202) 225-4076

Bishop, Sanford (GA-02), (202) 225-3631

Boren, Dan (OK-02), (202) 225-2701

Boswell, Leonard (IA-03), (202) 225-3806

Boyd, Allen (FL-02), (202) 225-5235

Bright, Bobby (AL-02), (202) 225-2901

Cardoza, Dennis (CA-18), (202) 225-6131

Carney, Christopher (PA-10), (202) 225-3731

Chandler, Ben (KY-06), (202) 225-4706

Childers, Travis (MS-01), (202) 225-4306

Cooper, Jim (TN 5^th), (202) 225-4311

Costa, Jim (CA 20^th), (202) 225-3341

Cuellar, Henry (TX 28^th), (202) 225-1640

Dahlkemper, Kathleen A. (PA 3^rd), (202) 225-5406

Davis, Lincoln (TN 4^th),(202) 225-6831

Donnelly, Joe (IN 2^nd), (202) 225-3915

Ellsworth, Brad (IN 8^th), (202) 225-4636

Giffords, Gabrielle (AZ 8^th), (202) 225-2542

Gordon, Bart (TN 6^th), (202) 225-4231

Griffith, Parker (AL 5^th), (202) 225-4801

Harman, Jane (CA 36^th), (202) 225-8220

Herseth Sandlin, Stephanie (SD At Large), (202) 225-2801

Hill, Baron P. (IN 9^th), (202) 225-5315

Holden, Tim (PA 17^th), (202) 225-5546

Kratovil, Frank Jr. (MD 1^st), (202) 225-5311

McIntyre, Mike (NC 7^th), (202) 225-2731

Marshall, Jim (GA 8^th), (202) 225-6531

Matheson, Jim (UT 2^nd), (202) 225-3011

Melancon, Charlie (LA 3^rd), (202) 225-4031

Michaud, Michael H. (ME 2^nd), (202) 225-6306

Minnick, Walt (ID 1^st), (202) 225-6611

Mitchell, Harry E. (AZ 5^th), (202) 225-2190

Moore, Dennis (KS 3^rd), (202) 225-2865

Murphy, Patrick J. (PA 8^th), (202) 225-4276

Nye, Glenn C. (VA 2^nd), (202) 225-4215

Peterson, Collin C. (MN 7^th), (202) 225-2165

Pomeroy, Earl (ND At Large), (202) 225-2611

Ross, Mike (AR 4^th), (202) 225-3772

Salazar, John T. (CO 3^rd), (202) 225-4761
Sanchez, Loretta (CA 47^th), (202) 225-2965

Schiff, Adam B. (CA 29^th), (202) 225-4176
Scott, David (GA 13^th), (202) 225-2939

Shuler, Heath (NC 11^th), (202) 225-6401

Space, Zachary T. (OH 18^th), (202) 225-6265

Tanner, John S. (TN 8^th), (202) 225-4714

Taylor, Gene (MS 4^th), (202) 225-5772

Thompson, Mike (CA 1^st), (202) 225-3311

Wilson, Charles (OH-06), (202) 225-5705

We also encourage you and others to join the discussion about these and other health care reform proposals and concerns by joining the Coalition for Responsible Health Care Reform Group on Linkedin, registering to receive these updates here The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

Other Helpful Resources & Other Information

Leave a Comment » | American's Affordable Health Choices Act, Childrens Health Insurance Program, Consumer Driven Health Care, Doctor, Electronic Medical Records, Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, Outcomes Data, Outpatient, Physician, Prescription Drugs, Reimbursement, Rural Health Care, Stark, Uncategorized, Veterans Health, Veterans Health Care | Tagged: American's Affordable Health Care Choices act of 2009, Health Care, Health Care Policy, Health Care Provider, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HHS, Hospital, House Democrat Majority, Long Term Care Hospital, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Contact House Blue Dog Democrats About Health Care Reform Bill Concerns

July 17, 2009

Individuals concerned about the “American’s Affordable Health Care Choices Act of 2009” health care reform proposal introduced by the House Democratic Leadership earlier this week should target their input on the Democrats in Congress most likely to listen to those concerns. In the House of Representatives, these members likely are the “Blue Dog Democrats” in the House. Read about Blue Dog Democrats here.

For persons interested in making their voices heard and sharing information with others who wish to do the same, the following contact information may be of interest:

The number of the Capital Switchboard is 202-224-3121.

The Blue Dog Leadership Team and there telephone and fax numbers are:

Rep. Stephanie Herseth Sandlin (SD), Blue Dog Co-Chair for Administration

Telephone: 202.225.2801 , Fax: 202.225.5823

Rep. Baron Hill (IN-09), Blue Dog Co-Chair for Policy

Telephone: 202-225-4031, Fax: (202) 226-6866

Rep. Charlie Melancon (LA-03), Blue Dog Co-Chair for Communications

Telephone: 202-225-4031, Fax: (202) 226-3944

Rep. Heath Shuler (NC-11), Blue Dog Whip

Telephone: 202-225-6401, Fax: (202) 226-6422

The Blue Dog Members and their telephone numbers are :

Altmire, Jason (PA-04),(202)225-2565

Arcuri, Mike (NY-24), (202)225-3665

Baca, Joe (CA-43),(202)225-6161

Barrow, John (GA-12), (202) 225-2823

Berry, Marion (AR-01), (202) 225-4076

Bishop, Sanford (GA-02), (202) 225-3631

Boren, Dan (OK-02), (202) 225-2701

Boswell, Leonard (IA-03), (202) 225-3806

Boyd, Allen (FL-02), (202) 225-5235

Bright, Bobby (AL-02), (202) 225-2901

Cardoza, Dennis (CA-18), (202) 225-6131

Carney, Christopher (PA-10), (202) 225-3731

Chandler, Ben (KY-06), (202) 225-4706

Childers, Travis (MS-01), (202) 225-4306

Cooper, Jim (TN 5^th), (202) 225-4311

Costa, Jim (CA 20^th), (202) 225-3341

Cuellar, Henry (TX 28^th), (202) 225-1640

Dahlkemper, Kathleen A. (PA 3^rd), (202) 225-5406

Davis, Lincoln (TN 4^th),(202) 225-6831

Donnelly, Joe (IN 2^nd), (202) 225-3915

Ellsworth, Brad (IN 8^th), (202) 225-4636

Giffords, Gabrielle (AZ 8^th), (202) 225-2542

Gordon, Bart (TN 6^th), (202) 225-4231

Griffith, Parker (AL 5^th), (202) 225-4801

Harman, Jane (CA 36^th), (202) 225-8220

Herseth Sandlin, Stephanie (SD At Large), (202) 225-2801

Hill, Baron P. (IN 9^th), (202) 225-5315

Holden, Tim (PA 17^th), (202) 225-5546

Kratovil, Frank Jr. (MD 1^st), (202) 225-5311

McIntyre, Mike (NC 7^th), (202) 225-2731

Marshall, Jim (GA 8^th), (202) 225-6531

Matheson, Jim (UT 2^nd), (202) 225-3011

Melancon, Charlie (LA 3^rd), (202) 225-4031

Michaud, Michael H. (ME 2^nd), (202) 225-6306

Minnick, Walt (ID 1^st), (202) 225-6611

Mitchell, Harry E. (AZ 5^th), (202) 225-2190

Moore, Dennis (KS 3^rd), (202) 225-2865

Murphy, Patrick J. (PA 8^th), (202) 225-4276

Nye, Glenn C. (VA 2^nd), (202) 225-4215

Peterson, Collin C. (MN 7^th), (202) 225-2165

Pomeroy, Earl (ND At Large), (202) 225-2611

Ross, Mike (AR 4^th), (202) 225-3772

Salazar, John T. (CO 3^rd), (202) 225-4761
Sanchez, Loretta (CA 47^th), (202) 225-2965

Schiff, Adam B. (CA 29^th), (202) 225-4176
Scott, David (GA 13^th), (202) 225-2939

Shuler, Heath (NC 11^th), (202) 225-6401

Space, Zachary T. (OH 18^th), (202) 225-6265

Tanner, John S. (TN 8^th), (202) 225-4714

Taylor, Gene (MS 4^th), (202) 225-5772

Thompson, Mike (CA 1^st), (202) 225-3311

Wilson, Charles (OH-06), (202) 225-5705

Other Helpful Resources & Other Information

Leave a Comment » | Health Care, Health Care Finance, Health Care Provider, Health Care Reform, Health Plan, Health Plans, Health Policy, Hospital, Medicaid, Medicare, Medicare Advantage, Outcomes Data, Physician, Prescription Drugs, Reimbursement, Rural Health Care, Tax | Permalink
Posted by Cynthia Marcotte Stamer

House Democrats Introduce the “American’s Affordable Health Care Choices Act of 2009”

July 15, 2009

House Democrats introduced their proposal for health care reform this afternoon (July 14, 2009), the “America’s Affordable Health Choices Act of 2009 (the “House Bill”). Introduced under the sponsorship of three key House committees — Energy and Commerce, Ways and Means, and Education and Labor — the 1018 page House Bill details the sweeping and comprehensive health care reforms touted by House Democrat Leaders.. A copy of the House Bill as introduced may be reviewed here.

The House Bill proposes sweeping reforms built around the establishment of a public plan option while technically continuing to permit private plans to operate but in a federally regulated form allowing for little meaningful plan design control to private payers, health care providers or the individuals choosing among the plan options. The Congressional Budget Office estimates that the coverage side of the bill will cost $1 trillion and cover 97 percent of the legal population within 10 years.

The following is a brief overview of certain key provisions of the House Bill drawn mostly from a series of high level summaries released by House Democrats along with the House Bill. Long on politically comforting phrasing and short on details, you can read these summaries here.

Public Plan Option. The House Bill proposes the establishment of a public health insurance option that would compete with allowable private plans, both of which would be subject to sweeping federal controls. Democrat House co-sponsors represent the House Bill:

Provides a public health insurance option that would compete with private insurers within the Health Insurance Exchange.
The public health insurance option would be made available in the new Health Insurance Exchange (Exchange) along with private health insurance plans that comply with the design dictates established in the House Bill.
The public health insurance option and private plan options meet the same benefit requirements and comply with the same insurance market reforms
The public option’s premiums would be established for the local market areas designated by the Exchange.
Individuals with affordability credits could choose among the private carriers and the public option.
Require that the public health plan and private health plan options and private options each must be financially self-sustaining
Promote primary care, encourage coordinated care and shared accountability, and improve quality.
Institute new payment structures and incentives to promote these critical reforms.
Specify health care provider participation in the plans will be voluntary; Medicare providers are presumed to be participating unless they opt out.
Provides for provider reimbursements for services from the plans initially will be established using “rates similar to those used in Medicare with greater flexibility to vary payments.
Speaker of the House Nancy Pelosi has announced plans to proceed immediately on mark up on the House Bill with the intention to of scheduling a vote on the House Bill by the end of July. Assuming that House leaders adhere to this schedule, the planned timetable leaves little opportunity for critical evaluation and input by members of Congress or the public who may have questions or concerns about the proposed legislation. Prompt and coordinated action is required for individuals with concerns about any of the proposed reforms.

Federal Mandates Health Plan Benefits. In order to achieve affordable, quality health care for all, the House Bill would impose federal standards regulating the benefits that the public health plan and private health plans would be required and permitted to offer. Under these provisions, the House Bill would:

Establish a standardized benefit package that covers essential health services.
Vest the power in the Secretary of Health & Human Services to decide the coverage that would be included in this mandated standardize benefit package.
Eliminate cost-sharing for preventive care (including well baby and well child care)
Impose caps annual out-of-pocket spending for individuals and families.
Create a new independent Benefits Advisory to recommend to the Secretary and update the core package of benefits.
Provide for the public health plan option to offer four tiers of benefit packages from which consumers can choose to best meet their health care needs. Each allowable plan would be required to provide the dictated core benefits.
- The Basic Plan would include the federally mandated core set of covered benefits and cost sharing protections;
- The Enhanced Plan would include the federally mandated core set of covered benefits with more generous cost sharing protections than the Basic plan;
- The Premium Plan would include the federally mandated core set of covered benefits with more generous cost sharing protections than the Enhanced plan; and
- The Premium Plus Plan would include the federally mandated core set of covered benefits, the more generous cost sharing protections of the Premium plan, and additional covered benefits (e.g., oral health coverage for adults, gym membership, etc.) that will vary per plan. In this category, insurers must disclose the separate cost of the additional benefits so consumers know what they’re paying for and can choose among plans accordingly.

The House Bill empowers the Secretary of Health & Human Services to decide the federally dictated, required core set of benefits provides coverage with input from a newly created Benefits Advisory Commission. These core benefits are intended to include inpatient hospital services, outpatient hospital services, physician services, equipment and supplies incident to physician services, preventive services, maternity services, prescription drugs, rehabilitative and habilitative services, well baby and well child visits and oral health, vision, and hearing services for children and mental health and substance abuse services. However, the particular, terms and scope of these benefits is left to HHS to define.

Health Insurance Exchange. The House Bill also calls for the establishment of a “Health Insurance Exchange” meeting federal mandates through which low income individuals initially, and certain small businesses would be offered the option to purchase health care coverage through federally mandated purchasing groups. In the first year, the House Bill provides for the Health Insurance Exchange to accept those without health insurance, those who are buying health insurance on their own, and small businesses with fewer than 10 people. In the second year, the Health Insurance Exchange could accept small businesses with fewer than 20 people. After that, “larger employers as permitted by the Commissioner.” In other words, expansion is discretionary, not mandated.

Affordability & Subsidies. The House Bill provides sliding-scale affordability credits for individuals and families with incomes above the Medicaid thresholds but below 400% of poverty and imposes a cap on total out-of-pocket spending for individuals and families covered under the plans regardless of income. In addition, the House Bill would broaden Medicaid coverage to include individuals and families with incomes below 133% of poverty.

Effective 2013, sliding scale affordability credits would be provided provided to individuals and families between 133% to 400% of poverty. That means the credits phase out completely for an individual with $43,320 in income and a family of four with $88,200 in income (2009).

The sliding scale credits limit individual family spending on premiums for the essential benefit package to no more than 1.5% of income for those with the lowest income and phasing up to no more than 11% of income for those at 400% of poverty.

The affordability credits also subsidize cost sharing on a sliding scale basis, phasing out at 400% of poverty, ensuring that covered benefits are accessible.

The Health Insurance Exchange would administer the affordability credits in relationship with other federal and state entities, such as local Social Security offices and Medicaid agencies.

The essential benefit package, and all other benefit options, limit exposure to catastrophic costs with a cap on total out of pocket spending for covered benefits. Special provisions would apply to Medicaid.

Effective 2013, individuals with family income at or below 133% of poverty ($14,400 for an individual in 2009) are eligible for Medicaid. State Medicaid programs would continue to cover those individuals with incomes above 133% of poverty, using the eligibility rules states now have in place.

Paying The Tab. House Democrats propose to finance approximately half of the estimated $1 trillion bill for their proposed reforms through projected $500 billion or so in savings from Medicare and Medicaid achieved by a variety of reimbursement and benefit cutbacks and other reforms. The rest of the financing would come from a combination of revenue expections from employer and individual mandates (an estimated $200 billion over 10 years) and a surtax on the richest 1.5 percent of Americans. The surtax is 1 percent on income between $350,000 and $500,000; 1.5 percent on income between $500,000 and $1,000,000; and 5.4 percent in income above $1,000,000. The House Bill permits the amount of this surtax to vary if the bill is less or more expensive than initially anticipated.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update in real time here, joining the LinkedIn SLP Health Care Risk Management & Operations Group, and/or subscribing to receive e-mail distributions of some of these updates by sharing your current contact information – including your preferred e-mail- by creating or updating your profile here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject here.

Leave a Comment » | Anti-KickBack, Centers For Disease Control, Childrens Health Insurance Program, Consumer Driven Health Care, Corporate Compliance, Disease Management, Doctor, Electronic Health Records, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, FDA, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Outcomes Data, Patient Empowerment, Peer Review, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Tax, Veterans Health, Veterans Health Care, Wellness | Tagged: Corporate Compliance, Doctor, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, HIPAA, Hospital, Medicare, Medicare Part B, PBMs, Physician, Physicians, Prescription Drugs, Privacy, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

“Health Care Government Relations and Legislative Update” Focus On July 14 North Texas Healthcare Compliance Professional Association Meeting

July 13, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

July 14, 2009 Meeting Reminder

Congress and federal regulators are making health care regulation and reform their latest priority. The NTHCPA invites interested health care compliance and ethics professionals to join us on July 14, 2009 for a lively discussion about “Health Care Government Relations and Legislative Update” lead by as Sandy Pappas, from Congressman Pete Session’s Office and Cynthia Marcotte Stamer from Curran Tomko Tarski LLP.

Date: Tuesday, July 14, 2009

Time: 2:00 p.m.

Location: Texas Health Resources, 612 E. Lamar Blvd., Arlington, TX 76011

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles.

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration to receive notice of other upcoming events, e-mail your contact information to lfigueroa@cttlegal.com.

This communication may be considered a marketing communication for certain purposes. If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading to lfigueroa@cttlegal.com

Leave a Comment » | Anti-KickBack, Centers For Disease Control, Childrens Health Insurance Program, Corporate Compliance, Disability Discrimination, Discrimination, Doctor, Electronic Health Records, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Reform, Health IT, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OIG, Peer Review, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Rural Health Care, Veterans Health, Veterans Health Care | Tagged: Antitrust, Doctor, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Policy, HHS, HIPAA, Hospital, Long Term Care Hospital, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs, public health, Red Flag Rules, Reimbursement, retaliation, Retalitory Discharge | Permalink
Posted by Cynthia Marcotte Stamer

FTC Releases Report, Testifies To Congress On Biologic Drug Pricing & Competition

June 12, 2009

Federal Trade Commission (FTC) Commissioner Pamela Jones Harbour yesterday (June 11, 2009) shared the FTC’s findings and recommendations about when and how competition from follow on biologic drugs (FOBs) would reduce the price of existing biologic drugs during her testimony to the Subcommittee on Health of the U.S. House of Representatives Energy and Commerce Committee.

The findings and recommendations about biologic drug pricing and competition are detailed in a new FTC report, “Follow-on Biologic Drug Competition” (Report), The Report examines whether and how the price of biologic drugs – products manufactured using living tissues and microorganisms – could be reduced by competition from so-called follow-on biologics (FOBs). Biologics are increasingly used to treat arthritis, cancer, diabetes, and other diseases. Lower-priced FOBs are like generic drugs, but with significant differences.

The Commission’s Report draws a number of conclusions about the likely impact of possible incentives to promote FOB competition:

Legislation creating an abbreviated FDA approval process of fobs is likely to be an efficient way to bring them to market, because of the time and cost savings it would provide;
Patent protection and market-based pricing will promote competition by fobs, as well as spur biologic innovation;
A 12- to 14-year regulatory exclusivity period for pioneer biologics is too long to promote innovation by these firms, particularly since they likely will retain substantial market share after FOB entry;
Special procedures to resolve patent issues between pioneer and FOB manufacturers before FDA approval are not needed and could undermine patent incentives and harm consumers; and
FOB manufacturers are unlikely to need additional incentives – such as a 180-day marketing exclusivity period – to develop interchangeable FOB products.

Copies of the Report can be found on the Commission’s Web site here.

For More Information

Leave a Comment » | FDA, Health Care, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

Democrats Unveil Comprehensive Health Care Reform Proposal, Move To Fast Track Enactment

June 10, 2009

Coalition For Responsible Health Care Reform Founded To Help Concerned Americans Respond

Americans concerned about plans of President Obama and Congressional Democrats to enact comprehensive health care reform this year must speak up now.

Senator Edward M. Kennedy yesterday (June 9, 2009) circulated a 625 page proposal to radically reform the U.S. health care system. The latest draft of the “Affordable Health Choices Act” (the “Act”) details the comprehensive health care reforms that President Obama and Democrats in Congress propose to enact before year end. President Obama and key Congressional Democrats are moving quickly to enact their vision for “comprehensive health reform” this year.

The Act circulated yesterday by Senator Kennedy would radically change the U.S. health care system in enacted as currently proposed. Consistent with announced plans by President Obama and key Congressional Democrats to enact “comprehensive health care reform” this year, Democratic leaders in Congress are rushing to enact this legislation well before year end. In furtherance of plans to fast track enactment of the Act, the Senate Committee on Health, Education, Labor and Pensions (HELP) chaired by Senator Kennedy will hold a hearing on the Act this week in anticipation of meetings to mark up of the Act on Tuesday, June 16 at 2:30 p.m. in Russell 325.

The Act, as proposed, would make sweeping changes to the U.S. health care system and radically expand the involvement of government in the delivery and financing of health care. Among other things, the Act as proposed would:

Establish government provided “Gateway” health care coverage programs to provide coverage for Americans not insured under qualifying employer or other privately run “qualified health plan” to be financed in part through surcharges on private health plans and health insurers and other taxes and assessments and in part through premiums on enrolled individuals
Require that Americans participating in the Gateway health care coverage programs be offered the opportunity to enroll in at least one “public health insurance option”
Require Americans to chose either to enroll in a government run Gateway health program or enroll in qualifying coverage under a privately run qualified health plan
Impose sweeping new mandates on employer and union-sponsored group health plans and insurers
Impose newly created taxes on individuals that fail to maintain enrollment in health coverage under either a Gateway health program or a private qualified health plan
Tax and/or eliminate the deductibility of health coverage premiums and certain other amounts paid by certain employers and employees
Impose new federal mandates for health care providers, health plans and health insurers relating to the quality standards, the use of health care technology and other matters
Grant federal regulators sweeping authority to define what qualifies as appropriate health care and health care coverage, the health care services that qualify for health care coverage and the payment and delivery of health care services.

You can review a copy of currently proposed provisions of the 615 page Act here. Individuals concerned about these and other proposed health care reforms must act immediately to become familiar and share their input on the proposals.

Assistance Monitoring & Responding To Health Care Reform Proposals

If you or someone else you know would like to receive updates about health care reform proposals and other related legislative, regulatory, and enforcement developments, please:

Register for this resource at the link above;
Join the Coalition for Responsible Health Policy group at linkedin.com to share information and input;
Share your input by communicating with key members of Congress on committees responsible for this legislation and your elected officials directly and by actively participating in and contributing to other like-minded groups; and
Be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile here.

You can register to receive future updates on legislative and regulatory health care reform proposals and other related information by registering for this resource or access other publications by Ms. Stamer and access other helpful resources here.

Long-time health policy advocate and advisor Cynthia Marcotte Stamer has more than 22 years of experience advising and assisting clients to evaluate and respond to health care reform proposals and other proposed or adopted changes in federal or state health care, employee benefit, employment, tax and other federal and state laws. Former Chair of the American Bar Association’s Managed Care & Insurance Section, Ms. Stamer is highly regarded legal advisor, policy advocate, author and speaker recognized both nationally and internationally for her more than 20 years of work assisting U.S. public and private employers, health care providers, health insurers, and a broad range of other clients to respond to these and other health care, employee benefit and workforce public policy, regulatory and compliance and risk management concerns within the U.S. as well as internationally. Her work includes extensive involvement providing input and assistance about health care, workforce, pensions and social security and other reforms domestically and internationally. In addition to her continuous involvement in U.S. health care, pensions and savings, and workforce policy matters, Ms. Stamer has served as an advisor on these matters internationally. As part of this work, she served as a lead advisor to the Government of Bolivia on its social security reform as well as has provided input on ethics, medical tourism, workforce and other reforms internationally.

Ms. Stamer is a widely published author and popular speaker on health plan and other human resources, employee benefits and internal controls issues. Her work has been featured and published by the American Bar Association, BNA, SHRM, World At Work, Employee Benefit News and the American Health Lawyers Association. Her insights on human resources risk management matters have been quoted in The Wall Street Journal, the Dallas Business Journal, Managed Care Executive, HealthLeaders, Business Insurance, Employee Benefit News and the Dallas Morning News.

Ms. Stamer also serves in a number of professional leadership roles including the leadership council of the ABA Joint Committee on Employee Benefits, Vice Chair of the ABA Real Property, Probate & Trust Section and Employee Benefits & Compensation Group.

If your organization needs assistance with monitoring, assessing, or responding to these or other health care, employee benefit or human resources reforms, please contact Ms. Stamer via e-mail here, or by calling (214) 270-2402. For additional information about the experience, services, publications and involvements of Ms. Stamer specifically or to access some of her many publications, see here.

Additional Resources & Information

We hope that this information is useful to you. For additional information about the experience, services, publications and involvements of Ms. Stamer specifically or to access some of her many publications, see here.

Leave a Comment » | Childrens Health Insurance Program, Corporate Compliance, Disease Management, Doctor, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Reform, Health IT, Health Plan, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medicare Advantage, Physician, Prescription Drugs, Public Policy, Reimbursement, Tax | Tagged: Affordable Health Choices Act, employer mandates, Health Care, health care access, Health Care Finance, Health Care Provider, health care quality, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, HIPAA, Hospital, Medicare, Medicare Part B, PBMs, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement, Uninsured | Permalink
Posted by Cynthia Marcotte Stamer

Newly Enacted FERA Amendments To False Claims Act Signal New Risks For Health Industry Organizations & Others

May 26, 2009

Health care providers and other parties covered by the False Claims Act, 31 U.S.C. § 3729 (FCA), now face expanded whistleblower and other liability under amendments to the FCA enacted under the “Fraud Enforcement and Recovery Act of 2009”(FERA). The amendments increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.

Signed into law by President Obama last Wednesday (May 20, 2009), FERA immediately upon enactment:

Amends the whistleblower protections afforded to employees, contractors and agents who suffer retaliation for taking lawful efforts to stop violations of the FCA and to make it easier for those individuals to pursue retaliation claims;
Expands liability under for making false or fraudulent claims to the federal government under the FCA;
Applies liability under the FCA for presenting a false or fraudulent claim for payment or approval (currently limited to such a claim presented to an officer or employee of the federal government); and
Requires persons who violate such Act to reimburse the federal government for the costs of a civil action to recover penalties or damages

Concurrent with President Obama’s signature of FERA into law, the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS) jointly announced the expansion of federal health care fraud enforcement efforts. On May 20, 2009, HHS and DOJ announced their activation of a new interagency team to combat health care fraud highlights the increasing need for health care providers and health plans to review and tighten their practices for dealing with Medicare and other federal programs to survive scrutiny under federal health care fraud initiatives. Coupled with FERA and the already significant increase in federal health care fraud detection and enforcement activities in recent years and a proposed 50 percent increase in funding for these activities included in President Obama’s Fiscal Year 2010 budget, health care providers and payers must be prepared to defend their dealing with Medicare, Medicaid and other federal health care programs.

The expanded protections afforded under FERA to whistleblowers and others suffering retaliation for opposing or reporting illegal actions can be expected to serve as a key tool in these efforts. These new retaliation safeguards are designed further increase the likelihood that employees and other insiders will help government officials ferret out false claims and other fraud. Specifically with regard to retaliatory action claims Section 4(d) of FERA amends 31 U.S.C.§ 3730(h) to provide for the recovery of “all relief necessary to make that employee, contractor, or agent whole” where that individual is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts he does or takes on behalf of an individual in furtherance of other efforts to stop a violation of the FCA.

FERA expressly provides that relief to victims of retaliation will include “reinstatement with the same seniority status that employee, contractor, or agent would have had but for the discrimination, 2 times the amount of back pay, interest on the back pay, and compensation for any special damages sustained as a result of the discrimination, including litigation costs and reasonable attorneys’ fees.”

The FERA amendments to the FCA, the new TEAMS enforcement effort announced simultaneously with its signature into law mean that health care industry organizations and others covered by the FCA must implement appropriate fraud prevention, detection, redress and other procedures to help defend against possible FCA or other health care fraud claims and investigations.

The attorneys at Curran Tomko Tarski, LLC have extensive experience representing and advising health industry and other clients against FCA and other federal health care and fraud laws.

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transactions or operations concerns, please contact Curran Tomko Tarski LLP Partners Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com; Michael T. Tarski at (214) 270-1420 or MTarski@CTTLegal.com; Edwin J. Tomko at (214) 270-1405 or ETomko@CTTLegal.com.

You can review other recent health care and internal controls resources and additional information about the health industry and white collar experience of the Curran Tomko Tarski LLP attorneys at http://www.CTTLegal.com. 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 at CTTLegal.com or e-mailing this information to CStamer@CTTLegal.com.

Leave a Comment » | Anti-KickBack, ARRA, Construction, Corporate Compliance, Doctor, Federal Sentencing Guidelines, Grants, Health Care, Health Care Fraud, Health Care Provider, Health Care Reform, Health Plan, Health Policy, Hospital, OCR, OIG, Physician, Prescription Drugs, Reimbursement, Stark | Tagged: Antitrust, ARRA, Bid Rigging, Construction, Corporate Compliance, Data Security, Doctor, Economic Aid, Employer, false claims act, Federal Sentencing Guidelines, Fraud, Health Care, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Plans, Health Policy, Hospital, Identity Theft, Medicare, Medicare Part B, Nonprofits, PBMs, Physician, Physicians, Prescription Drugs, public health, Reimbursement, retaliation, Retalitory Discharge, Whistleblower | Permalink
Posted by Cynthia Marcotte Stamer

DOJ/HHS Step Up Health Care Fraud Enforcement By Announcing New Interagency Health Care Fraud Prevention and Enforcement Action Team

May 20, 2009

Lead DOJ Health Care Fraud Enforcer Speaks In Dallas Tomorrow

The joint announcement today (May 20, 2009) by the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS) of a new interagency team to combat health care fraud highlights the increasing need for health care providers and health plans to review and tighten their practices for dealing with Medicare and other federal programs to survive scrutiny under federal health care fraud initiatives. Houston and Detroit are targeted for the attention of a new Strike Force.

Participants attending tomorrow’s Dallas Health Industry Council Southwest Healthcare Transaction Conference will get to hear the latest about these and other federal health care fraud prevention and enforcement activities from one of its key players. The Justice Department’s lead federal health care fraud prosecutor, John “Jay” S. Darden, the U.S. Department of Justice Assistant Chief for Healthcare Fraud is scheduled to provide an update on these and other federal regulatory and enforcement activities affecting health care transactions when he speaks at the Conference tomorrow afternoon at the Omni Mandalay Hotel Dallas at Las Colinas at 1:30 p.m.

Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius announced the creation of the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat Medicare fraud and the expansion of Strike Force team operations to Detroit and Houston. Medicare Fraud Strike Forces, currently in operation in South Florida and Los Angeles, fight Medicare fraud on a targeted local level. Statements made by Secretary Sebelius and Attorney General Holder in connection with the announcement of HEAT and the Strike Force Expansion make clear that the Obama Administration views health care fraud enforcement and prevention as a key element of its efforts to control health care costs.

The HEAT team will include senior officials from DOJ and HHS who will build upon and strengthen existing programs to combat fraud while also investing new resources and technology to prevent fraud, waste and abuse before it happens. Efforts will include the expansion of joint DOJ-HHS Medicare Fraud Strike Force teams that have been successfully fighting fraud in South Florida and Los Angeles.

Established in 2007, these Strike Force teams have a proven record of success using a “data-driven” approach to identify unexplainable billing patterns and investigating these providers for possible fraudulent activity. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries. After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses. To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program.

In addition to health care fraud enforcement and prosecution, HHS and DOJ also view prevention as critical to reforming the system. Therefore, in addition to investigating and prosecuting fraud, the HEAT team will also focus critical resources on preventing fraud from occurring in the first place. These efforts are expected to include:

Drawing from demonstration projects by the HHS Inspector General and the Centers for Medicare & Medicaid Services (CMS) that have focused on suppliers of durable medical equipment (DME) including increasing site visits to potential suppliers to prevent imposters from posing as legitimate DME providers.
Increasing training for providers on Medicare compliance, offering providers the resources and the knowledge they need to help identify and prevent fraud.
Improving data sharing between CMS and law enforcement to help identify patterns that lead to fraud.
Strengthening program integrity activities to monitor and ensure Medicare Parts C (Medicare Advantage plans) and D (prescription drug programs) compliance and enforcement.

The Attorney General and the HHS Secretary also called on the American people to visit a new Web site http://www.hhs.gov/stopmedicarefraud or call 1-800-HHS-TIPS (1-800-447-8477) to report suspected Medicare fraud.

The HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws. President Obama’s proposed Fiscal Year 2010 budget seeks to further increase funding for fraud prevention and enforcement by investing $311 million — a 50 percent increase from 2009 funding — to strengthen program integrity activities within the Medicare and Medicaid programs. The Obama Administration anticipates that all combined, the anti-fraud efforts in the President’s budget could save $2.7 billion over five years by improving oversight and stopping fraud in the Medicare and Medicaid programs, including the Medicare Advantage and Medicare prescription drug programs.

For More Information

We hope that this information is useful to you. 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) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. 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 at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

Leave a Comment » | Anti-KickBack, ARRA, ARRA Funding, Corporate Compliance, Doctor, Federal Sentencing Guidelines, Health Care, Health Care Fraud, Health Care Provider, Health Care Reform, Health Policy, Hospital, Medicare Advantage, OCR, OIG, Physician, Prescription Drugs, Privacy, Reimbursement, Stark | Tagged: Corporate Compliance, Federal Sentencing Guidelines, Fraud, Health Care Reform, Health Care Reimbursement, Health Insurance, Health Policy, HHS, Hospital, Medicare, Medicare Part B, Physician, Physicians, Prescription Drugs, public health, Public Policy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

HHS Releases Report Comparing Average Sales Price to Average Manufacturer Prices of Prescription Drugs

April 20, 2009

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its latest “Comparison of Third-Quarter 2008 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2009″ (the “Report”) on April 17, 2009. The findings are used to help determined Medicare Part B reimbursement rates for prescription drugs. You can review the entire Report at http://www.oig.hhs.gov/oei/reports/oei-03-09-00150.pdf.

Mandated by Congress under Section 1847A(d)(2)(B) of the Social Security Act (the Act), the Report reviews the average sales prices (ASP) and average manufacturer prices (AMP) for Medicare Part B prescription drugs to identify the ASPs that exceed AMPs by at least 5 percent. The review also determines the impact of lowering reimbursement amounts for drugs that meet the 5-percent threshold. Pursuant to sections 1847A(d)(3)(A) and (B) of the Act, if OIG finds that the ASP for a drug exceeds the AMP by a certain percentage (currently 5 percent), HHS may disregard the ASP for the drug when setting reimbursement amounts. According to the Report, of the 325 drugs with complete AMP data, OIG found 15 met the 5-percent threshold under the revised ASP payment methodology recently mandated. Twelve of these 15 drugs were previously eligible for price adjustment under the revised methodology, with 2 drugs meeting the 5-percent threshold in each of the past 7 quarters. OIG estimates that, if reimbursement amounts for all 15 drugs had been based on 103 percent of the AMPs, Medicare expenditures would have been reduced by almost three-quarters of a million dollars in the first quarter of 2009. The Report also states that of the 129 drugs with only partial AMP data in the third quarter of 008, 21 had ASPs that exceeded the AMPs by at least 5 percent in the third quarter of 2008.

Under the revised methodology, 12 of the 21 drugs would have met the 5 percent threshold in at least 2 of the past 7 quarters, dating back to the first quarter of 2007. OIG estimates that Medicare expenditures would have been reduced by $9 million during the first quarter of 2009 if reimbursement amounts for all 21 drugs had been based on 103 percent of the AMPs.

If you have questions about the Report, Medicare reimbursement or compliance or any other health care compliance and risk management policies, practices or programs, assessing the strength of your controls in addressing these laws or other healthcare laws and regulations, or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer at cstamer@CTTLegal.com or (214) 270- 2402. For More Information We hope that this information is useful to you. 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) 270-2402 or via e-mail to cstamer@CTTLegal.com. You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. 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 at here or by registering to participate in the Solutions Law Press Health Care Update blog at slphealthcareupdate.wordpress.com. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

Leave a Comment » | Doctor, Health Care, Health Plan, Hospital, OIG, Prescription Drugs, Reimbursement | Tagged: Health Care, Medicare, Medicare Part B, PBMs, Prescription Drugs, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

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