Biden-Harris Administration to Expand Vaccination Requirements for Health Care and Many Other Employers

September 9, 2021

All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.

According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.

The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.

According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See .

The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.

The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.

CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.

According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.

In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.

CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.

While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.

Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).

OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.

In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.

In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation. 

Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.

In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.

Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.

While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.

Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.

In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.

More Information

This article is republished by permission of the author, Cynthia Marcotte Stamer.  To review the original work, see here.

Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

About the Author

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

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

Ms. Stamer has extensive experience advising, representing, defending, and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employers, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and other human resources, employee benefits, compensation, worker classification and other workforce and other services; insurance; health care; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other performance, risk management, compliance, public policy and regulatory affairs, and other operational concerns. 

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

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

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com,  on  Facebook, on LinkedIn or Twitter or e-mail here.

About Solutions Law Press, Inc.™

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

©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™


Beef Up Patient Education & Management Tools With Diabetes Alert Day Resources

March 26, 2019

Physicians and other health care providers concerned about helping patients and others prevent and deal with Type 2 Diabetes should use today’s annual Diabetes Awareness Day observances and resources to beef up their Diabetes screening and management efforts and toolkits.

With 1 in 3 adult Americans at risk for Type 2 diabetes, the Centers for Disease Control (“CDC”) and other public and private organizations partnering in The National Diabetes Prevention Program are urging all physicians and other health care providers to partner in their efforts to prevent, delay and manage Type 2 diabetes.

Celebrated every year on the fourth Tuesday in March, Diabetes Alert Day promotes awareness of the prevalence and risks of undiagnosed or unmanaged Type 2 Diabetes to Americans, American taxpayers, health benefit programs and their communities.

  • More than 30 million people in the United States have diabetes and an additional 84 million adults—over a third—have prediabetes, and 90% of them don’t know they have it.
  • Diabetes is the 7th leading cause of death in the United States (and may be underreported).
  • Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes; type 1 diabetes accounts for about 5%.
  • In the last 20 years, the number of adults diagnosed with diabetes has more than tripled as the American population has aged and become more overweight or obese
  • Undiagnosed or unmanaged Type 2 diabetes threatens serious and disabling medical risks for afflicted individuals that also are financially costly for patients and their families, their health plans, taxpayers and communities.

While Type 2 Diabetes and its costs often can be prevented or minimized through appropriate diagnosis and treatment, Type 2 diabetes symptoms often develop over several years and go on for a long time without being noticed.  Health care providers generally recognize the need to screen patients for Type 2 Diabetes as well as educating patients to recognize the factors for Type 2 Diabetes and to contact their physician promptly when experiencing these symptoms, but often have limited time and resources to help educate patients and their families.

To start with, the CDC and its partners are encouraging all health care providers to urge their patients to take the online Type 2 Diabetes Risk, screen and educate patients and promote use of CDC-recognized lifestyle change programs to individuals suffering or at risk for Type 2 diabetes.

To help health care providers participate more effectively in the fight to prevent, detect and manage Type 2 Diabetes, the CDC and its partners provide a number of Diabetes screening and management resources for physicians and other health care providers.  These resources include a variety of patient education and screening tools, resources on Medicare and other coverage for diabetes screening and management, a list of

Physicians and other health care providers should check out the resources available from the CDC and take advantage of some of these resources to beef up their Type 2 and other Diabetes patient education, prevention, screening and management efforts, a directory of CDC-recognized lifestyle change programs and  more

Learn more about Type 2 Diabetes cost modeling, screening, prevention and other health care resources Project Cope: Coalition for Patient Empowerment Newsletter and share your own resources and ideas on diabetes and management and other health care best practices, challenges, policies and concerns by participating in our Linkedin  SLP Health Care Risk Management & Operations Group or COPE: Coalition On Patient Empowerment Group or Project COPE: Coalition on Patient Empowerment Facebook Page

About the Author 

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

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

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

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

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

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

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

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

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

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

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, privacy and data security, 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.

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

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

About Solutions Law Press, Inc.™

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

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

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

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

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


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

May 8, 2018

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

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

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

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

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

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

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

About the Author

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

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

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

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

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

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

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

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

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

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

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, privacy and data security, 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.

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

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

About Solutions Law Press, Inc.™

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

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

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

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

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved

May 8, 2018

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HHS Picks Hargan As Acting HHS Secretary

October 11, 2017

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

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

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

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

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

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

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

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

About The Author

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

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

About Solutions Law Press, Inc.™

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

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

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

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

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


CMS Proposes Cutbacks To Medicare Bundled Payment Program

August 15, 2017

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

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

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

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

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

About The Author

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

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

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 or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

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

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

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

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

©2017 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.


CMS Releases 2017 Provider Payment Program Hardship Exception Application

August 4, 2017

The Quality Payment Program Hardship Exception Application for the 2017 transition year now is available on the Quality Payment Program website.

MIPS eligible clinicians and groups may qualify for a reweighting of their Advancing Care Information performance category score to 0% of the final score, and can submit a hardship exception application, for one of the following specified reasons:

  • Insufficient internet connectivity
  • Extreme and uncontrollable circumstances
  • Lack of control over the availability of Certified EHR Technology (CEHRT).

Some MIPS eligible clinicians who are considered Special Status, will be automatically reweighted (or, exempted in the case of MIPS eligible clinicians participating in a MIPS APM), do not need to submit a Quality Payment Program Hardship Exception Application.
In addition to submitting an application via the Quality Payment Program website, clinicians also may contact the Quality Payment Program Service Center and work with a representative to verbally submit an application.

To submit an application, a physician or other applying clinician will need:

  • The Taxpayer Identification Number (TIN) for group applications or National Provider Identifier (NPI) for individual applications;
  • Contact information for the person working on behalf of the individual clinician or group, including first and last name, e-mail address, and telephone number; and
  • Selection of hardship exception category (listed above) and supplemental information.

Applicants for a hardship exception based on the Extreme and Uncontrollable Circumstance category, also must select one of the following and provide a start and end date of when the circumstance occurred:

  • Disaster (e.g., a natural disaster in which the CEHRT was damaged or destroyed);
  • Practice or hospital closure;
  • Severe financial distress (bankruptcy or debt restructuring);
  • EHR certification/vendor issues (CEHRT issues)

Once an application is submitted, CMS will send the applicant a confirmation email acknowledging receipt of the application and when it is pending, approved, or dismissed. Applications will be processed on a rolling basis.

Physician and other clinicians or practices interested in pursuing an exemption should act promptly.

About The Author

Cynthia Marcotte Stamer is a Martindale-Hubble “AV-Preeminent (Top 1%) rated practicing attorney and management consultant, health industry public policy advocate, widely published author and lecturer, recognized for her nearly 30 years’ of work on health industry and other privacy and data security and other health care, health benefit, health policy and regulatory affairs and other health industry legal and operational as a LexisNexis® Martindale-Hubbell® “LEGAL LEADER™ and “Top Rated Lawyer,” in Health Care Law and Labor and Employment Law; a D Magazine “Best Lawyers In Dallas” in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law,” a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel.

Technical advisor to the National Physicians Council for Healthcare Policy, Vice President of the North Texas Healthcare Professionals Association, American Bar Association (ABA) International Life Sciences Committee Vice Chair, Policy; Scribe for ABA JCEB annual agency meeting with OCR, Ms. Stamer is well-known for her extensive work and leadership throughout her career on healthcare and health policy, regulatory, operations and other industry topics. Her clients include public and private healthcare systems, hospitals and other healthcare facilities, health care providers, health insurers, health plans, employers, health and other technology and other vendors, communities and others.

In addition to representing and advising these organizations, she also speaks extensively and conducts training on health care and other privacy and data security and many other matters.

Beyond these involvements, Ms. Stamer also is active in the leadership of a broad range of other health care and other professional and civic organizations. Through these and other involvements, she helps develop and build solutions, build consensus, garner funding and other resources, manage compliance and other operations, and take other actions to identify promote tangible improvements in health care and other policy and operational areas.

For additional information about Ms. Stamer, see here or contact Ms. Stamer directly by e-mail here or by telephone at (469) 767-8872. ©2017 Cynthia Marcotte Stamer.  Limited, non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


Civil Rights Settlement Highlights Health Industry Discrimination Risks As OCR Prepares To Broaden Requirements

October 27, 2015

Doctors’ Center Hospital, Inc.  (DCI) in the latest health care providers nailed in a U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) enforcement action for allegedly violating Section 504 of the Rehabilitation Act of 1973 (Section 504) by failing to provide auxiliary aids and services for deaf and hard of hearing patients under OCR’s ongoing aggressive campaigned on enforcing federal discrimination laws against health care providers and others covered by its regulations.  OCR’s announcement of the Voluntary Compliance Resolution Agreement with DCI (Agreement) announced today (October 27, 2015) comes with the November 6, 2015 deadline for health care providers and other concerned parties to comment on proposed OCR regulations on Nondiscrimination in Health Programs and Activities, implementing the federal prohibition against sex discrimination in health programs and activities enacted under Section 1557 of the Patient Protection and Affordable Care Act (ACA) and tightening other nondiscrimination requirements that generally apply to health care providers and others covered by OCR’s civil rights rules (covered entities) and various other programs and activities administered by OCR. Health care providers and others covered by these rules should provide meaningful input on the proposed rules even as they work to tighten their compliance and risk management practices to mitigate their exposures.

Section 504 of the Rehabilitation Act of 1973, Title II of the Americans with Disabilities Act (ADA) and Section 1557 of the Patient Protection and Affordable Care Act (ACA) (collectively the “Civil Rights Laws”) together require hospitals, health care providers, clinics, medical practices and other entities who receive Federal financial assistance to provide services to persons with disabilities in a non-discriminatory manner.  As construed by OCR with respect to deaf and hearing impaired individuals and their caregivers, these laws require health care providers offer services or aids need to ensure effective communication in light of the abilities of the individual who is deaf or hard of hearing, the primary method used by the individual to communicate and the complexity and nature of the information being conveyed. Failure to ensure effective communication in such health care settings may lead to misinformation, inappropriate diagnosis and/or delayed or improper medical treatments.

DCI  Discrimination Charge Settlement

The latest in a growing series of Civil Rights Law enforcement actions of these laws against health care providers by OCR, the Agreement announced October 27, 2015 resolves OCR charges stemming from a discrimination complaint made to OCR by an family that charged that one DCI facility, Doctors’ Center Hospital San Juan, Inc. violated Section 504 by failing to provide a sign language interpreter necessary to ensure effective communication during their 10 month old child’s five day hospitalization. OCR investigated the complaint under Section 504, which prohibits covered entities that receive Federal financial assistance from excluding or denying individuals with disabilities an equal opportunity to receive program benefits and services.

While the complaint that resulted in the OCR charges only specifically named its Doctors’ Center Hospital San Juan, Inc., at DCI’s request, the Agreement includes all of DCI facilities in Puerto Rico, which collectively serve an estimated 109,000 patients a year in the San Juan area as well as the northern part of the island of Puerto Rico.  Under the Agreement, DCI, Doctors’ Center Hospital San Juan, Inc. and the Doctors’ Center Hospital Bayamón, Inc. to resolve the complaint agree to take several actions to improve access to appropriate communication services for deaf and hard of hearing individuals including revising its policies and procedures, performing an assessment of the communication needs for deaf and hard of hearing patients and their companions, providing appropriate auxiliary aids and services at no cost, adopting and posting a Notice of Nondiscrimination, creating a Section 504 Grievance Procedure, appointing a Section 504 Coordinator and training all staff on the revised policies and procedures. Read the full Agreement here.

Health Industry’s Already High Civil Rights Enforcement Risks Set To Rise

The DCI Agreement highlights the already significant exposure that health care providers face under OCR’s current Civil Rights Law enforcement practices and comes as OCR is preparing to broaden and expand its existing Civil Rights regulations by adopting proposed changes to its regulations on Nondiscrimination in Health Programs and Activities. The deadline for comment on those proposed regulations is November 6, 2015.

Even before it adopts these proposed changes, health care providers already face significant Civil Rights discrimination risks.  OCR already aggressively investigates and enforces federal Civil Rights Law prohibitions against discrimination based on race, color, national origin, disability, age and sex against covered entities as part of the Obama Administration’s broader civil rights agenda. See. e.g., Health Care Employer’s Discrimination Triggers Medicare, EEOC Prosecutions; Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled; OCR Settlements Show Health Care & Disabled Housing Providers Face Growing Disability Discrimination Risks. Given the often multimillion dollar penalties and other heavy sanctions that OCR already regularly imposes against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating its Civil Rights Laws, health care providers and other providers, Medicare and Medicaid Advantage and other insurers, and other covered entities generally will want both to carefully review and comment as appropriate on the proposed rules, as well as review and tighten as advisable their existing practices to reduce the risk of being sanctioned, excluded or both for violation of these nondiscrimination and other civil rights requirements by OCR. In this respect, covered entities will want both to evaluate their risks and responsibilities under the specific rules about Section 1557’s sex discrimination prohibits, as well as changes that more broadly affect the interpretation and enforcement of the nondiscrimination rules enforced by OCR generally.

The author of this article, Cynthia Marcotte Stamer is a practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C., an attorney practicing as the co-managing member of Stamer│Chadwick │Soefje PLLC, author, pubic speaker, health policy advocate and industry thought leader, has focused on helping health industry and other organizations and their management understand and use the law and process to manage people, process, compliance, operations and risk including significant work with compliance with OCR and other regulatory requirements.

Scribe responsible for leading the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) annual agency meeting with HHS Office of Civil Rights for five years, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 28 years’ experience advising health industry clients about these and other matters.

Ms. Stamer’s experience includes advising and defending hospitals, nursing home, home health, physicians and other health care professionals, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies and programs in response under CMS, OCR, HHS, FDA, IRS, DOJ, DEA, NIH, licensing, and other regulations; prevent, conduct and investigate, and respond to Board of Medicine, OIG, DOJ, DEA, DOD, DOL, Department of Health, Department of Aging & Disability, IRS, Department of Insurance, and other federal and state regulators; ERISA and private insurance, prompt pay and other reimbursement and contracting; peer review and other quality concerns; and other health care industry investigation, and enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also is widely recognized for her regulatory and public policy advocacy, publications, and public speaking on privacy and other compliance, risk management concerns. Her insights on privacy, data security, and other matters have appeared in The Wall Street Journal, Business Insurance, the Dallas Morning News, Spencer Publications, and a host of other publications. She speaks and 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, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Ms. Stamer also is active in the leadership of a broad range of other professional and civic organizations. For instance, Ms. Stamer serves on the steering committee and as a faculty member of the Southern California ISSA-HIMMS Annual Security Summit and Chaired its 2015 3rd Annual Health Care Privacy Summit.  Ms. Stamer presently serves on an American Bar Association (ABA) Joint Committee on Employee Benefits Council representative; Vice President of the North Texas Healthcare Compliance Professionals Association; Immediate Past Chair of the ABA RPTE Employee Benefits & Other Compensation Committee, its current Welfare Benefit Plans Committee Co-Chair, on its Substantive Groups & Committee and its incoming Defined Contribution Plan Committee Chair and Practice Management Vice Chair; Past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and a current member of its Healthcare Coordinating Council; current Vice Chair of the ABA TIPS Employee Benefit Committee; the former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division; on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications.  She also previously served as a founding Board Member and President of the Alliance for Healthcare Excellence, as a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association. For additional information about Ms. Stamer, see here, or the website Stamer ׀ Chadwick ׀ Soefje PLLC.  To contact Ms. Stamer, e-mail her here or telephone (469) 767-8872.

About Solutions Law Press, Inc.™

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


Health Care Org’s ERISA Health Plan Reimbursement Opportunities & Compliance Obligations Free 9/15 Study Group Topic

September 9, 2015

Solutions Law Press, Inc. is happy to share information about this upcoming free health industry study group meeting on 9/15/2015 in Irving, Texas.

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONALS ASSOCIATION

Invites Members and Guests to Our Next Group Luncheon

Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act

Featuring

Kristi Gotcher

U.S. Department of Labor Employee Benefit Security Administration Investigator

Tuesday, September 15, 2015

11:30 a.m. to 1:30 p.m.

DFW Hospital Council Offices

250 Decker Drive

Irving, Texas

RSVP here  by Noon on September 14, 2015

Space Limited!  Register Early To Reserve Your Spot To Participate!

 

Please share this invitation with others who might be interested in this topic or other NTHCPA events!

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals to join us on Tuesday, September 15, 2015 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring a program on “Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act” from U.S. Department of Labor Employee Benefit Security Administration (EBSA) Investigator Kristi Gotcher.

The health and other employee benefit plan rules of the Employee Retirement Income Security Act (ERISA) generally offer important protections and create significant compliance challenges for health care organizations and providers.  On one hand, health care providers generally rely heavily on their or their patient’s ability to obtain health benefits promised under employer or union-sponsored health plans covering their patients to help reimbursement provider charges.  Meanwhile, health care providers and their leaders also can incur significant liability for failing to comply with ERISA’s rules when establishing and maintaining health or other employee benefit programs for their own employees.  Drawing on her involvement as investigator with the Department of Labor agency primarily responsible for both interpreting and enforcing ERISA’s rules, EBSA Ms. Gotcher will share key updates and insights on both how ERISA and the EBSA can help patients and providers enforce benefit rights under ERISA-covered health plans and key health and highlight employee benefit compliance responsibilities that health care organizations and their leaders need to ensure that their own health and other employee benefit programs meet to avoid violating ERISA.

About the Speaker

Kristi A. Gotcher is an Investigator with the United States Department of Labor, Employee Benefits Security Administration (EBSA) in the Dallas Regional Office.   Kristi began working for EBSA in the Dallas Regional Office in November 2007 as a Benefits Advisor.  She earned her Bachelor of Arts in Social Political Relations from St. Edwards University and a J.D. from Texas Wesleyan University School of Law (now Texas A&M University School of Law).  Ms. Gotcher is licensed to practice law in the State of Texas.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on Tuesday, September 15, 2015 at the DFW Hospital Council Offices located at 250 Decker Drive, Irving Texas.  Participants who timely R.S.V.P. will enjoy a complimentary luncheon. Networking and lunch service will begin at 11:30. Our program will begin at Noon.

NTHCPA encourages members and other interested health care compliance professionals to register early to reserve their spot to participate and to share this invitation with others in the industry who might benefit from participation.

There is no charge to participate in the meeting.  However space is limited and available only on a first come, first serve basis.  To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on September 14, 2015.  Walk in guests will be accommodated on a space-available basis only.

Thanks To Meeting Underwriter Stamer ׀ Chadwick ׀ Soefje, PLLC

NTHCPA and its members extend our thanks to Cynthia Marcotte Stamer, P.C. and the other members of Stamer ׀ Chadwick ׀ Soefje PLLC for underwriting this month’s study group luncheon and other support of NTHCPA.

A boutique firm of exceptionally experienced and skilled “big-firm” lawyers committed to changing the way law firms serve their clients, Stamer │Chadwick │Soefje, PLLC delivers sophisticated legal advice and innovative solutions to the most challenging and complex problems. Simply put, Stamer │Chadwick │Soefje, PLLC attorneys are “Solutions Lawyers™.”

Stamer │Chadwick │Soefje, PLLC attorneys deliver sophisticated legal advice and innovative solutions to the most challenging and complex problems. Stamer │Chadwick │Soefje, PLLC attorneys possess the breadth of experience to respond to the unique legal and operational challenges health industry and other clients face and help guide them toward pragmatic resolutions that make sense for them. “Solutions Lawyers™ possess the breadth of experience to respond to the unique challenges our corporate and individual clients face and help guide them toward pragmatic resolutions that make sense for them.

Founded by nationally-known, healthcare and labor & employment attorney Cynthia Marcotte Stamer; labor & employment attorney Robert G. Chadwick; and professional liability and civil litigation attorney Timothy B. Soefje, Stamer │Chadwick │Soefje, PLLC focuses on advising and representing businesses and professionals nationally in the areas of healthcare, cyber liability, ERISA, employee benefits, labor & employment, corporate and commercial litigation, professional liability, construction litigation, and insurance defense.  All three attorneys are rated AV® Preeminent™ by Martindale-Hubbell® Peer Review Ratings™ Ms. Stamer and Mr. Chadwick are both Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, are Fellows in the American Bar Foundation, and recognized as “Top Lawyers” in Labor and Employment Law.  Ms. Stamer also has received recognition as a “Top” attorney in health care and employee benefits law and is a Fellow in the American College of Employee Benefit Council.

Ms. Stamer more than 28 years’ experience advising and representing health industry and employee benefit clients on a wide range of legal, public policy, management and operational concerns as well as extensive leadership and management experience serving in on the board of health industry nonprofit organizations. Nationally recognized for her legal work, advocacy, publications, writings and presentations on health industry concerns, Ms. Stamer provides legal and management advice, training and coaching, defense, public policy and regulatory advocacy to health industry and other clients on health and other regulatory and operational compliance, federal and state public policy and enforcement, managed care and other contracting, reimbursement, fraud, quality, employment, staffing and other workforce, benefits, licensing, credentialing and peer review, safety, disaster preparedness and response, HIPAA and other privacy and data security, corporate governance, investigations and internal controls, and a host of other health industry compliance and risk management and other legal and operational concerns. In addition to her legal experience, Ms. Stamer also contributes her experience and talents to serving in a number of health industry and other civil and professional groups.  Among other things, Ms. Stamer serves as Vice President of the NTHCPA, the RPTE representative to the American Bar Association (ABA) Joint Committee on Employee Benefits Council and scrivener for its annual agency meeting with the Office of Civil Rights, the ABA International Section Life Sciences and Health Law Committee Vice President of Policy, RPTE Liaison to the ABA Health Care Coordinating Counsel, TIPS Employee Benefit Committee Vice Chair, Founder and Executive Director of the Project COPE:  The Coalition on Patient Empowerment, and National Physicians Council for Healthcare Policy.  She also previously served as President and Founding Board Member of the Alliance for Health Care Excellence and its Health Care Heroes and Patient Empowerment Programs, as RPTE Employee Benefits & Other Compensation Group Chair and Welfare Benefit Committee Vice Chair, Exempt Organizations Coordinator of the Gulf States Area TEGE Council, Board President and Audit Committee Chair of the Richardson Development Center for Children ECI Agency, National Kidney Foundation of North Texas Board Audit Committee Chair, the United Way of North Texas Long Range Planning Committee.  She also has and continues to serve in the leadership of many other civic and professional boards, seminar faculties, editorial advisory boards and publishes and speaks extensively on health industry and employee benefit related concerns.

Mr. Chadwick has extensive experience advising and defending health industry and other clients on OSHA and other occupational health and safety, employee benefits, compensation and other labor and employment  concerns as well as defending boards and other management leaders against management liability claims.

Mr. Soefje has extensive experience advising and representing health industry clients and professionals on medical malpractice, officers and directors liability and other professional liability, errors and omissions, construction defect and other litigation and disputes.

For additional information, contact Ms. Stamer 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.

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.

Other Helpful Resources & Other Information

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

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


OCR’s Proposed Sex & Other Discrimination Rules Spell Headaches & New Risks For Health Care Providers, Insurers & Others

September 3, 2015

November 6, 2015 is the deadline for health care providers, health insurance exchanges, Medicare Advantage plans, Medicaid Advantage plans, health insurers providing coverage in the health insurance marketplaces, their contractors and other concerned parties to comment on a proposed rule on Nondiscrimination in Health Programs and Activities published today by the Department of Health and Human Services (HHS) to implement the federal prohibition against sex discrimination in health programs and activities enacted under Section 1557 of the Patient Protection and Affordable Care Act (ACA) and tightening other nondiscrimination requirements that generally apply to Health Insurance Marketplaces, any health program that HHS itself administers, and any health program or activity, any part of which receives funding from HHS, such as hospitals that accept Medicare patients or doctors who treat Medicaid patients, and health insurance issurers participating in the Health Insurance Marketplaces, Medicare or Medicaid Advantage Plans and other entities covered by the HHS Office of Civil Rights (OCR) civil rights rules (covered entities) and various other programs and activities administered by HHS’ Office of Civil Rights (OCR).

Since OCR already aggressively investigates and enforces federal prohibitions against discrimination based on race, color, national origin, disability, age and sex against covered entities as part of the Obama Administration’s broader civil rights agenda, covered entities can look forward to OCR’s adoption of the proposed rules to add even more teeth and fire to the already aggressive enforcement by OCR of health care providers, insurers and other parties subject to the civil rights laws enforced by OCR. See. e.g., Health Care Employer’s Discrimination Triggers Medicare, EEOC Prosecutions; Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled; OCR Settlements Show Health Care & Disabled Housing Providers Face Growing Disability Discrimination Risks Given the often multimillion dollar penalties and other heavy sanctions that OCR already has imposed against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating the discrimination or other civil rights rules administered by OCR, health care and other providers, Medicare and Medicaid Advantage and other insurers, and other covered entities generally will want both to carefully review and comment as appropriate on the proposed rules, as well as review and tighten as advisable their existing practices to reduce the risk of being sanctioned, excluded or both for violation of these nondiscrimination and other civil rights requirements by OCR. In this respect, covered entities will want both to evaluate their risks and responsibilities under the specific rules about Section 1557’s sex discrimination prohibits, as well as changes that more broadly affect the interpretation and enforcement of the nondiscrimination rules enforced by OCR generally.

Sex and Gender Identity Discrimination

Concerning the new prohibition against sex discrimination added by Section 1557 of the ACA, the proposed rule expressly provides that covered entities must treat woman equally with men in the health care they receive generally as well as specifically comments on the obligations of covered insurers with respect to sex discrimination including gender identity. While other provisions of the ACA bar certain types of sex discrimination in insurance, for example by prohibiting women from being charged more than men for coverage, the proposed regulation makes clear that the protections of Section 1557 reach even more broadly to prohibit sex discrimination both in the health coverage patients obtain as well as in the health services they seek from providers.

Not unexpectedly in light of the Supreme Court’s ruling in Obergefell and the Obama Administration’s proactive agenda on the advance of rights for lesbian, bisexual, gay and transsexual (LBGT) individuals, the proposed rule makes clear that OCR construes prohibited sex discrimination under Section 1557 to include discrimination based on gender identity as well as to address various coverage and care practices that OCR views as prohibited sex discrimination of LBGT individuals. In this respect, the proposed rule makes clear HHS’s commitment, as a matter of policy, to preventing discrimination based on sexual orientation by providing, among other things that Individuals may not be subject to discrimination based on gender identity by any covered entities including insurance policies and their issuers. OCR also highlights various policy provisions and other practices by insurers that it views as prohibited sex discrimination against transsexual individuals such as categorical exclusions on coverage of all care related to gender transition.  Similarly, the proposed rule also states that health care providers, insurers and other covered person must treat all individuals consistent with their gender identity, including in access to facilities. Beyond the already proposed safeguards against sex discrimination based on gender identity, OCR also requests comment on how a final rule can incorporate the most robust set of protections  against discrimination that are supported by the courts on an ongoing basis.

Other Nondiscrimination Rule Expansions

Beyond its requirements relating to sex discrimination, the proposed rule also addresses a host of other concerns relating to the civil rights rules more generally. As an initial matter, the proposed rule invites individuals in protected classes to file complaints and pursue other enforcement by confirming that OCR interprets Section 1557 as allowing individuals to seek legal remedies for discrimination under Section 1557. While OCR already has been allowing this in practice, this blessing of the right of individuals to seek legal remedies unquestionably will encourage the filing of more complaints and other private actions.

The proposed rule also would add more teeth to the already aggressive enforcement by OCR of its position that covered entities must accommodate community deficiencies of persons with cognitive, speech, hearing or other disabilities and English proficiency limitations on their ability to communicate on health care matters by establishing more detailed minimum standards for the provision of language services, such as oral interpreters and written translations to persons with limited English proficiency and to provide individuals with hearing or other disabilities affecting their ability to communicate to provide auxiliary aids and services, including alternative formats and sign language interpreters, and the accessibility of programs offered through electronic and information technology.  These proposed requirements are designed to provide more teeth and compliance with OCR’s expectation that covered entities will affirmatively act to offer accommodations needed to ensure the ability of individuals to communicate when the individual’s ability to understand or respond is impaired by disabilities or limited English proficiency.

Also, the proposed regulations specifically addresses various practices by Medicare and Medicaid Advantage plans and other insurers offering coverage in the marketplace that OCR views as discriminatory. For instance, the proposed rule states that insurers participating or offering coverage through any Health Insurance Marketplace cannot engage in any marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age, or disability.  This prohibition would extend to all the plans of insurers participating in the Marketplace are covered by the proposed rule.

Beyond the already proposed expansion in the current regulatory expectations, OCR also invites input about additional requirements to broaden the safeguards in the proposed regulations by requesting comment on whether Section 1557 should include an exemption for religious organizations and what the scope of any such exemption should be as well as comment on how a final rule can incorporate the most robust set of protections  against discrimination that are supported by the courts on an ongoing basis.

Unquestionably these and other changes proposed in the proposed regulation likely will impact the practices and risks of virtually all covered entities. The proposed rule is open for public comment through November 6, 2015. Covered entities and other interested persons will want to promptly review the specifics of the proposed regulation in light of OCR’s already existing investigation and enforcement activities and their current or contemplated practices. To the extent appropriate, covered entities will want to ensure that they carefully prepare and submit all revelevant comment or other feedback promptly submitted on or before the November 6, 2015 comment deadline. Whether or not a covered entity elects to comment of the proposed regulations, however, all covered entities also should begin tightening and adapting their existing policies and practices to respond to the positions revealed by the proposed regulations, as OCR’s enforcement activities reflect that OCR will act to enforce many of these expectations even as it pursues adoption of the proposed regulations in final form.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 28 years experience advising health industry clients about these and other matters. Her experience includes more than 23 years experience advising and defending hospitals, nursing home, home health, rehabilitation and other health care, housing, insurance and other  clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to discrimination and other charges from OCR, HUD, EEOC, DOJ, private claimants and others.  She also advises and assists a broad range of health industry and other clients to respond to and defend Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR, CMS & other HHS agencies, Department of Labor, IRS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.  The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting for several years with OCR.  Ms. Stamer also works extensively with health care providers, health plans and insurers, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance, investigations, defense, and other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns.  Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.  In addition to representing and advising these organizations, she also has conducted training on discrimination and other civil rights, pandemic and other contagious disease, HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance, quality, reimbursement, and a broad range of other industry internal controls, compliance, risk management, employment, patient safety, staffing, credentialing, board governance, antitrust, contracting and other legal and operational concerns for a multitude of clients and associations ranging from the Association of State & Territorial Health Plans, Los Angeles County Health Department, ISSA, HIMMS, the ABA, the American Health Lawyers Association, the Medical Group Management Association, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

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

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

About Solutions Law Press

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.

Other Helpful Resources & Other Information

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

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

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

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


CMS Issues Last Call For Comments, Questions On Proposed Medicare Home Health Billing Templates

April 21, 2015

Physicians and other practitioners and others with concerns or other input on a plan by the Centers for Medicare & Medicaid Services (CMS) to implement a voluntary electronic clinical template and a voluntary home health paper clinical template available for review here will have one final chance share their concerns by submitting feedback and questions on the templates via email here, participating in the final Open Forum telephone conference call about the proposed templates that CMS has scheduled for Tuesday, April 28, 2015 from 1:30-2:30 pm Eastern Time, or both.

Physicians and others who prescribe or bill for home health services should use these or other opportunities to learn about the proposed templates and the CMS plans to implement them for “voluntary” use by home health care subscribers.  At minimum, physicians and other health care providers prescribing or billing for these services will want to take the voluntary guidelines, if implemented, into account when ordering, providing or billing for this care to minimize potential problems in billing of Medicare for these services.  Even if never implemented in final form, however, reviewing the proposed template provides valuable insights into CMS’ perspectives on the requirements that home health care must meet to qualify for Medicare benefit coverage and CMS’ expectations about how physicians and others should order and bill services intended to qualify for reimbursement by Medicare..

CMS developed the proposed templates over the past year in response to reported findings of extraordinarily high error rates in Medicare home health care claims submissions and payments. According to CMS, analysis performed under the Comprehensive Error Rate Testing (CERT) program raised concerns about the accuracy and appropriateness of Medicare home health claims submissions and payment. CMS reports that in fiscal year 2014, the CERT program analysis revealed that more than half (51.4 percent) of the home health claims were paid improperly and that approximately 90 percent of the 1308 CERT-reviewed claim lines in error were found to have insufficient documentation errors.

According to an Apri1 21, 2015 announcement, CMS now plans to deploy the proposed voluntary home health electronic and paper clinical templates developed by CMS over the past year to help physicians and other practitioners better meet CMS’ requirements for accurately documenting patient eligibility for the Medicare home health benefit. CMS believes the use of clinical templates may reduce burden on the physicians and practitioners who order home health services to code and bill care in accordance with CMS expectations.

As part of the developmental process, CMS has hosted a series of Special Open Door Forum calls inviting physicians and other practitioners, home health agencies and other interested parties to provide feedback on the draft templates. The next and final Open Door Forum to discuss the draft templates is scheduled to take place on Tuesday, April 28, 2015 at 1:30p.m. Eastern Standard Time.

Interested persons can use the following information to join the April 28, 2015 Open Door Forum conference call: Participant Dial-In Number: 1-800-603-1774, Conference ID#: 78964234. Questions or feedback on the templates can be emailed here.

We value all of the comments submitted and consider each one, but we cannot guarantee all questions will be addressed during the Open Door Forum Call. We will try to address the most common issues/concerns received. CMS will continue to accept comments sent to the email address even after the call. Stakeholders are encouraged to submit questions or comments as quickly as possible.

Physicians and other practitioners with questions, concerns or other input about the proposed templates or their use should consider participating in the telephone conference, submitting questions or other input to the designated email, or both.

For More Information Or Assistance

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

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

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

About Solutions Law Press

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.

Other Helpful Resources & Other Information

We hope that this information is useful to you.   If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available hereYou also can t access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

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

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

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


CMS To Host Provider Webinar To Celebrate National Health IT Week

September 13, 2013

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

Details of Webinar

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

  • Administrative Simplification
  • eRx Incentive Program
  • ICD-10
  • Quality Measurement

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

Registration Information

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

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

For More Information Or Assistance

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

About Solutions Law Press

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:

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

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Stamer Speaks On Managing Physician Conduct At 9/17 NTHCPA Meeting

August 21, 2013

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals faced with these and other challenges to join us on Tuesday, September 17, 2013 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring attorney Cynthia Marcotte Stamer speaking on “Sex Drugs & Rock ‘N Role: Managing Physician Conduct in Health Care.”Interested persons can RSVP here by Noon on September 16, 2013 to attend this meeting free of charge.

About the Program

Whether false claims and other aggressive billing, referral or treatment practices, chemical dependency or other impairment, medical staff or other rule breaking, harassing or other disruptive conduct or a host of other personal behavioral or performance concerns, preventing and addressing personal misconduct and other risky behaviors by physicians on the staff or team of a hospital, medical practice personal misconduct often present major legal, quality, financial, political and operational challenges and risks for health care compliance, medical staff, risk management and other leaders.  Alternatively, properly directed physicians can significantly help the operation and performance of health care organizations in many critical ways.

While physician involvement remains an operational necessity for most hospitals, group practices and other health care organizations, these and other health care organizations and other members of their team often face significant legal, financial, reputational and operational risks when a physician becomes impaired by chemical dependency, mental illness, stress, personal tragedy or other personal impairment; is disruptive; or engages in sexual or other harassment of staff or patients, billing, treatment, referral, anticompetitive or other illegal conduct, medical board or facility rule violations, or other acts of personal or professional misconduct. While these behaviors often create major risks for health care organizations and others, successful redress of these or other physician performance or misconduct concerns often depends upon the ability to successfully negotiate a complex minefield of due process and other procedural, legal, political, operational and other challenges.

Ms. Stamer will use lead participants in a workshop examining these challenges and discussion of strategies to help health care organizations and their compliance officers can use to help their organization prevent, investigate and redress these and other physician performance and misconduct concerns while managing HCQIA and other peer review, licensing board, contractual, defamation and other legal, professional and operational traps that often arise out of physician discipline or other corrective actions. On the other hand, well-motivated and properly focused physicians play a key role in leading quality, financial, compliance and other improvements in health care organizations and practices.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on September 17, 2013 at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706 will feature a complimentary luncheon for those who timely R.S.V.P. Networking and lunch service will begin at 11:30 a.m.. Our program will begin at Noon.  There is no charge to participate in the meeting. However space is limited and available only on a first come, first serve basis. To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on September 16, 2013. Walk in guests will be accommodated on a space-available basis only.

About The Speaker, Cynthia Marcotte Stamer, J.D.

Attorney, author and health care change leader Cynthia Marcotte Stamer, J.D. is nationally and internationally recognized for her more than 25 years of health policy and legal work, process improvement and reengineering, publications and programs, and advocacy. Ms. Stamer works extensively with public and private health care organizations, managed care and health insurance organizations, governments and community leaders and others health industry compliance, risk management, quality, staffing, workforce, patient, quality and performance management, operations, governance, compensation, reimbursement and financing, regulatory and public policy, process improvement and reengineering and other health industry legal and operational concerns.

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Vice-President of the North Texas Health Care Compliance Professionals Association, past Board Compliance Chair of the National Kidney Foundation of North Texas, Past President of Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, combines her health industry operations compliance, and risk management experience with an in-depth knowledge of federal and state healthcare, workforce, governance, internal controls, enforcement and other operational issues to help health industry clients to support legal and operational risk and performance management. Her experience includes advising public and private health care systems, hospitals, managed care organizations and physician management organizations, physicians and physician practice groups, skilled nursing, home health, rehabilitation, pharmacy, and other health industry clients domestically and internationally on a wide range of matters including physician and other staffing, credentialing and peer review, gainsharing and other performance management, compliance, enforcement, and a wide range of other matters. Her experience includes extensive work with health care systems, hospitals, physicians and physician organizations, medical staffs, peer review, credentialing and quality committees, ACOs, managed care organizations, and others on physician credentialing, peer review and discipline, quality improvement, performance management, compensation, leadership development, and other matters.

A widely recognized health industry thought leader, advocate, author and speaker, Ms. Stamer’s insights are sought out by health care and other business, government and community leaders, and quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications. She also conducts continuing board, medical education, workforce and other health industry compliance and risk management training for many organizations on a wide range of topics.  She also regularly represents health care organizations and other health industry clients before peer review and other disciplinary bodies, federal and state regulators, investigators, Congress and state legislatures, licensing and credentialing and other governmental and regulatory authorities.  To learn more or contact Ms. Stamer, see www.CynthiaStamer.com.

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.

Would you or someone you know like to join the NTHCPA, get notice of upcoming meetings or events and network on relevant professional developments with other health care professionals? Stay on top of information about upcoming meetings and share and dialogue with other NTHCPA members about health care compliance challenges and developments by participating in our meetings and events, joining our North Texas Health Care Compliance Professionals Association LinkedIn Group  and checking out the NTHCPA News here. To be added to our invitation list, we also encourage interested persons to make sure we have your current contact information by registering to receive health care updates here or sending your current contact information including name, title, company, preferred mailing address, e-mail, and telephone number to Vice-President Cynthia Marcotte Stamer here.

Thanks To Solutions Law Press, Inc.

The NTHCPA thanks Solutions Law Press, Inc.™ and its Coalition for Responsible Health Policy and Project COPE: the Coalition on Patient Empowerment, for its generous underwriting support of the September 17, 2013 luncheon.  Solutions Law Press, Inc.™ publishes the Solutions Law Press Health Care Update and other resources, as well as provides health care risk management, compliance and risk management and other operational consulting, briefings, training, policy, event management, recruiting and other resources and services on health care, human resources, employee benefits, compensation, data security and privacy, insurance, and other key compliance, risk management, internal controls and other key operational concerns.

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

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these  needs is the purpose of Project COPE, The Coalition on Patient Empowerment & It’s Affiliate, the Coalition on Responsible Health Policy.

The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans.  The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch.  Americans can best improve health care by not waiting for someone else to step up:  Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can.  Building health care neighborhoods filled with good neighbors throughout the community is the key. Project COPE: The Coalition On Patient Empowerment brings together people, organizations, and resources to promote awareness and collaboration, share ideas, tools and other solutions and other resources to help promote patient empowerment, heath care access, health care quality and health and health coverage operations in meaningful, tangible ways.  Its focus is little and big actions that help patients, providers, communities and others deal with or work within the health care system in the real world.  The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

To review or receive the Health Care Update, learn or get involved with the Coalition on Responsible Health Policy or its PROJECT COPE: The Coalition on Patient Empowerment, or participate in discussions in a Solutions Law Press, Inc.™ LinkedIn Group or for other information about Solutions Law Press, Inc™  resources and services, see www.SolutionsLawPress.com.


Doc Caught Submitting Conflicting Patient Records to Private Payer Versus Medicare Criminally Sentence, Pays Civil Settlement

July 23, 2013

The  recent criminal sentencing and civil settlement of Illinois physician Dr. Mahmoud Yassin highlights the growing- but too often appreciated exposure of physicians and other health care providers and their billing or other management who submit conflicting claims data to private and government claims or otherwise permit in false  falsely bill or participate in the cover-up of fraudulent or other improper billings to payers.  The Yassin sentencing is notable both because Yassin incurred criminal liability for obstruction based on his presentation of altered patient records to a private payer and and civil liability for  making false claims to Medicare and others.

Yassin was sentenced July 22, 2013 to serve 30 days in prison and 3 years of probation and to pay  a fine of $10,000, a special assessment of $100, and restitution to Blue Cross Blue Shield of Illinois in the amount of $19,615.17 in federal district court in Benton, Illinois for Obstructing a Criminal Health Care Fraud Investigator.  The felony obstruction conviction stemmed from charges that on March 2, 2012, when a FBI agent, having served a subpoena for patient records on Dr. Yassin, gave an altered patient progress note  that showed an in-office examination previously claimed to an insurance carrier, but which had not taken place.

In a separate civil settlement with the United States Attorney’s Office regarding false claims to Medicare, Dr. Yassin also previously has paid double damages for $87,348.64. The restitution and civil false claims settlement were based on claims for in person office visits in which the patient either failed to show up for an appointment or only was spoken to by telephone.

The Yassin prosecution demonstrates the importance of providers getting their records and billings straight when billing both private payers and government payers.  While most  health care providers recognize  the significant exposure they incur from overbilling Medicare or other federal programs as a result of the highly publicized, heavy-handed audit and enforcement activities of the Centers for Medicare & Medicaid Services (CMS), the Department of Health & Human Services Office of Inspector General (OIG) and Department of Justice (DOJ), many  don’t recognize their exposure from private payer billings or the potential interaction between private and government claims investigations  Amendments enacted as part of the anti-fraud provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added private health plans to the list of plans protected by federal prohibitions against fraudulent billing by providers.  Furthermore, federal fraud investigators and private payers increasingly are working together on the investigation and redress of false billing and other aggressive practices.  These and other risks mean that providers cannot afford to be unprepared when asked to respond to investigations like one that lead to the Yassin conviction, recoupment or other audit and enforcement actions  See,  Secondary Payers Hit Physician Group With Recoupment After Medicare Audit Findings.   Rather, physicians and other health care clinics must be ready to prove and defend their billings to public and private payers.  In both cases, these preparations should ensure that records accurately and completely document the care provided, that the coding and billing applied is reflective of actual care and consistent with existing reimbursement, and otherwise defensible.  As demonstrated by Yassin, inconsistencies between records presented to different payers should be avoided.

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 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.

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 presentations and programs include a wide range of compliance, risk management and other workshops, programs and publications.

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:

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

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

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Improper Billing Of Private Payers Increasing Source Of Liability & Risk For Providers

July 8, 2013

Physicians or other health care providers now have even more to worry about when a Medicare or other federal program audit reveals overpayments – repayment demands from commercial insurers and self-insured health plans, who are secondary payers.  Federal officials and private payers alike increasingly are coming after providers to recover overpayments or other inappropriate billings identified through audits or other investigations.  In the face of these actions, providers should use care to ensure that their billing and compliance programs appropriately manage and monitor the defensibility of claims billed to private payers as well as those to Medicare or other government programs.

Most  health care providers recognize  the significant exposure they incur from overbilling Medicare or other federal programs as a result of the highly publicized, heavy-handed audit and enforcement activities of the Centers for Medicare & Medicaid Services (CMS), the Department of Health & Human Services Office of Inspector General (OIG) and Department of Justice (DOJ).

Unfortunately, many health care providers don’t recognize that overbilling private payers can carry similar risks and liabilities.  Amendments enacted as part of the anti-fraud provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added private health plans to the list of plans protected by federal prohibitions against fraudulent billing by providers.

While CMS, OIG and DOJ tend to emphasize Medicare and other federal program recoveries in media releases about their overbilling and health care fraud enforcement efforts, careful review of these actions increasingly shows that these enforcement actions often also cover overbilling of private health plans uncovered in connection with the underlying  Medicare or other federal program overpayment audit or investigation.   For instance, upcoding and other false billing of claims was the basis of the federal criminal health care fraud prosecution of the Chief Executive Officer of a small, rural Texas health care clinic.  Texas Clinic CEO Sentence Highlights Risks Of Upcoding. See, also Pharmas Face New Pressure To Put Patients Before Profits After GlaxoSmithKline Record $3 Billion Health Care Fraud & FDCA Settlement.

Unfortunately, many providers have failed to recognize and adequately respond to these and other clear indicators of their exposure to fraud, recoupment and other enforcement actions from sloppy or otherwise improper billings to private insurers and self insured plans.  With health care reform increasingly focusing on reducing health care expenditures in the private as well as public arena, already existing federal and state enforcement against providers for improper billing of private payers will inevitably grown.

Taking into account these and other trends toward stepped up enforcement against aggressive billing by providers of private insurance or self-insured plans, physicians and other providers should not be surprised or unprepared to respond to recoupment or other audit and enforcement actions like that recently reported by Nina Youngstrom in AIS Health about the recoupment demands by commercial insurers against a Kansas health care clinic based on the Medicare audit findings of overpayments. See,  Secondary Payers Hit Physician Group With Recoupment After Medicare Audit Findings.   Rather, physicians and other health care clinics must be ready to prove and defend their billings to private payers as well as Medicare and other government payers.

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 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.

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 presentations and programs include a wide range of compliance, risk management and other workshops, programs and publications.

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:

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

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

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Ambulatory Care Orgs Face New Joint Commission Standards Beginning January 1, 2014

July 8, 2013

Ambulatory care organizations should review their current policies and procedures for compliance with revised ambulatory care organization accreditation standards published by the Joint Commission (TJC) on June 25, 2013.   The new changes are effective January 1, 2014. The revisions include changes to standards on:

  • Renewal of clinical privileges
  • Requirements on providing care without regard to a patient’s ability to pay
  • Requirements for patient education about follow-up care to apply at the end of any episode of care;
  • Human resources
  • Leadership
  • Medication management
  • National patient safety goals
  • Provision of care, treatment, and services.

Ambulatory care organizations should begin assessing the implications of the new standards and identifying and implementing any changes they determine necessary or advisable to meet the new standards as soon as possible to ensure adequate time to operationalize compliance necessary to maintain desired accreditation.

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 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.

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 presentations and programs include a wide range of compliance, risk management and other workshops, programs and publications.

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:

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

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

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


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

July 6, 2013

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

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

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

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

 55 Settlements Impact Systems & Providers Across The Nation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Whistleblower Involvement Played Big Role

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

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

 Mitigate Risks With Effective Oversight of Both Documentation & Operations

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

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

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

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

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

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters.

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

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

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:

 

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

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press, Inc..  All other rights reserved.


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

July 6, 2013

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

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

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

Former SIP Employee’s Qui Tam Claim Prompted Suit

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

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

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

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

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

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

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

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

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

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

Mitigate Risks With Effective Oversight of Both Documentation & Operations

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

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

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

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

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

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters.

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

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

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:

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

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press, Inc..  All other rights reserved.


Updated 2013 ACA Prescription Drug Fee Calculation & Payment Rules Released; 12/18 Deadline To File Form 8947

December 4, 2012

December 17, 2012 is the deadline for covered entities to file a Form 8947 as part if its reporting and payment of the Form 8947The Internal Revenue Service (IRS) Notice 2012-74 sets forth the instructions for calculation and reporting branded prescription drug fee for the 2013 fee year under Section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act).

The Act imposes an annual fee on covered entities engaged in the business of manufacturing or importing branded prescription drugs.  The Branded Prescription Drug Fee Regulations in 26 C.F.R. Part 51 published on August 18, 2011 provide the method for calculating each covered entity’s annual fee and the fee year for purposes of these rules and how the fee must be reported and paid.  See  76 Fed. Reg. 51245.  These regulations also define terms for the administration of the fee.

Notice 2012-74/s instructions on the 2013 prescription drug fee discusses:

  • The submission of Form 8947, “Report of Branded Prescription Drug Information,”
  • The time and manner for notifying covered entities of their preliminary fee calculation;
  • the time and manner for covered entities to submit error reports for the dispute resolution; process; and
  • The time for the IRS to notify covered entities of their final fee calculation.

12/18/12 Deadline to File Form 8947

One of the deadlines for this process is rapidly approaching.  Section 51.3T provides that annually, each covered entity may submit a completed Form 8947, “Report of Branded Prescription Drug Information,” in accordance with the instructions for the form. Generally, the form solicits information from covered entities on National Drug Codes, orphan drugs, designated entities, rebates, and other information specified by the form or its instructions. The form is to be filed by the date prescribed in guidance published in the Internal Revenue Bulletin.

Notice 2012-74 sets the deadline for a covered entity that chooses to submit Form 8947 for 2013 at December 17, 2012.

Preliminary Fee Calculation

For the 2013 fee year, the IRS will mail each covered entity a paper notice of its preliminary fee calculation by April 1, 2013. This mailing will include a National Drug Code (NDC) attachment (NDC attachment) that lists the covered entity’s NDCs and the sales data reported to the IRS by each government program pursuant to § 51.4T.

A covered entity may request that the IRS send a CD-ROM with the NDC attachment in Microsoft Excel format. The covered entity must make this request by March 15, 2013. This request must be made either by telephone to Ingrid Taylor at (908) 301-2118 or Mi Lim at (312) 292-3775 (not toll-free calls) or by email to it.bpd.fee@irs.gov. If a covered entity makes this request timely, the IRS will mail the covered entity its notice of preliminary fee calculation on paper and the NDC attachment on paper and CD-ROM by April 1, 2013.

Submitting Error Reports For The Dispute Resolution Process

For the 2013 fee year, a covered entity that chooses to submit an error report regarding its preliminary fee calculation must mail the error report by May 16, 2013.   When the IRS mails each covered entity a notice of its preliminary fee calculation by April 1, 2013, the IRS will also send each covered entity a template on a CD-ROM that the covered entity must use to prepare its error report. All completed templates and the supporting documentation must be submitted on a CD-ROM to the IRS in a timely fashion.

Final Fee Calculation & Payment

The IRS will notify each covered entity of its final fee calculation for 2013 by August 31, 2013. In accordance with § 51.8T(c), each covered entity must pay this fee by September 30, 2013.

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

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, 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, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology 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, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy and other technology, risk management and compliance-related publications of a broad range of health care, health plan and other industry publications 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, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

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

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Hospitals Urged To Tighten Inpatient & Outpatient Admission Records As OIG Audits Hospitals for New vs. Established Patients,

November 29, 2012

Hospitals should act quickly to adopt appropriate compliance policies and tighten outpatient and inpatient admissions recordkeeping and associated billing activities to minimize exposures signaled by audits announced by the Department of Health & Human Services (HHS) Office of Inspector General (OIG).

OIG reportedly is auditing inpatient and outpatient hospital claims for new and established patients to identify potential overcharges by some hospital-based outpatient clinics that may have resulted from treating established patients as if they were new patients. OIG’s Office of Audit Services reportedly sent letters to some hospitals in October, asking about a handful of claims for new patient visits that OIG suspects the hospital should have billed as established patient visits. In addition to requesting specific information about line items on the claims and their internal controls for billing new versus established patients and provide descriptions of written policies and procedures governing the facilities classification of new versus established patients and internal controls for detecting errors.

Medicare typically pays more for new versus established patients since CMS  implemented the outpatient prospective payment system in 2000. Since 2008, CMS rules have specified that patients who visit the hospital outpatient clinic within three years are established patients, and after that they are new, with Medicare paying more for the latter. See(73 Fed. Reg. 68502, 68679 (November 18, 2009).  Data mining technology increasingly used by CMS and other federal fraud investigators facilities the ability of Medicare and others to identify errors in coding and billing resulting from misclassication of existing patients as new.  

Many hospitals may be exposed under this requirement for a variety of reasons including failure to appropriately track and coordinate inpatient and outpatient admission data, defaults built into recordkeeping systems and omissions to timely update practices or training.  In contrast to the risk of overbilling from incorrectly treating patients as new, hospitals that bill all patients as established to overcome inadequacies in their ability to track new versus established patients often leave money on the table unnecessarily by foregoing added reimbursement that the facility otherwise would qualify for it could reliably identify new patients.

While strengthening coding and billing to ward of risks, may debate the appropriateness of CMS’ new versus existing patient distinction outside the physician office context.  Critics contend that unlike in the physician office context, the level of care or resources delivered for a new patient compared to a patient who previously visited the hospital doesn’t generally differ. Parties with these concerns should continue to ensure appropriate compliance with existing rules while providing input and feedback to CMS and other regulators about their concerns with the policy’s suitability.

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

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, 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, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology 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, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy and other technology, risk management and compliance-related publications of a broad range of health care, health plan and other industry publications 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, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

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

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

November 29, 2012

The Department of Health & Human Services Office of Inspector General is recommending the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) act to improve the effectiveness of its oversight and management of the Medicare electronic health record (EHR) incentive program.  The recommendations are likely to impact on the requirements that hospitals and other professionals will be required to meet to get and keep EHR program incentive payments.  Consequently, hospitals, physicians and other providers and their technology and other systems advisors and vendors should carefully watch and respond to changes that these two agencies implement in response to the OIG feedback.

According to an OIG study reported here, the CMS estimates that it will pay $6.6 billion in EHR incentive payments to providers under the program between 2011 and 2016.  Many hospitals, physician organizations and other providers are making substantial investments in EHR and related technologies in reliance of expectation of receiving program incentive payments.  Accordingly, parties hoping to qualify for incentive programs need to watch closely the actions that the agencies take in response to this OIG input or otherwise that impacts on qualification and audits.

OIG Study & Findings

OIG’s early assessment of CMS’s oversight of the Program found that because professionals and hospitals self-report data to prove fulfillment of program requirements, CMS’s efforts to verify these data will help make sure the integrity of Medicare EHR incentive payments.

The recommendation comes from an OIG study reviewing CMS’s oversight of professionals’ and hospitals’ self-reported meaningful use of certified EHR technology in 2011, the first year of the program.  OIG evaluated self-reported information against program requirements.  It also looked at CMS’s audit planning documents, regulations and guidance for the program and conducted structured interviews with CMS staff on CMS’s oversight.

Based on this evaluation, OIG foundCMS faces obstacles to overseeing the Medicare EHR incentive program that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements.  OIG says CMS has not yet implemented strong prepayment safeguards, and has limited ability to safeguard incentive payments postpayment. OIG also reports that the ONC requirements for EHR reports may contribute to CMS’s oversight obstacles.

OIG Recommended Corrective Action

Based on its study, OIG is recommending that CMS take the following actions.

  • Obtain and review supporting documentation from selected professionals and hospitals prior to payment to verify the accuracy of their self‑reported information and
  • Issue guidance with specific examples of documentation that professionals and hospitals should maintain to support their compliance. 

CMS did not agree with our first recommendation, stating that prepayment reviews would increase the burden on practitioners and hospitals and could delay incentive payments.  Despite this CMS feedback, OIG nevertheless is continuing to recommend that CMS conduct prepayment reviews to improve program oversight. CMS concurred with our second recommendation.

OIG also recommended that ONC take the following actions: 

  • Require that certified EHR technology be capable of producing reports for yes/no meaningful use measures where possible and
  • Improve the certification process for EHR technology to make sure applicants provide accurate EHR reports. 

ONC concurred with both recommendations.

Recommended Provider Action

Hospitals and providers looking to take advantage of the HER incentive payments should carefully monitor the developments resulting from these recommendations and take proper actions to stay compliant with evolving requirements as they move forward.

Along with monitoring these responses, providers participating in the incentive program also need to stay abreast of other developments.  For instance, last month, ONC announced the release of the Wave 7 2014 Edition Draft Test Methods (test procedures, tools, and applicable test data and files).  See 2014 Edition Draft Test Procedures webpage. Additional waves of test methods are impending.  ONC says it expects the final set of Test Methods to be available for use in early 2013. 

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

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, 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, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology 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, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications 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, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

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

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

ONC Releases Proposed Rules For Meaningful Use Stage 2

February 23, 2012

The Office of the National Coordinator for Health Information Technology (ONC) published its Notice of Proposed Rulemaking  for Stage 2 Meaningful Use (Proposed Rule) in the Federal Register today (February 23).

The Proposed Rule available here outlines the next stage of meaningful use for the Electronic Health Record (EHR) Incentive Programs administered by CMS.

CMS has developed a fact sheet to give providers an overview of the rule and how Stage 2 expands upon Stage 1 of meaningful use. The fact sheet can be found here.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related technology, 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, health care technology and other health industry clients to set up and administer privacy and technology; workforce and staffing; operations; 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, technology, privacy, quality assurance 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 presentations and programs including a wide range of works on health care privacy and technology and other health industry matters.

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:

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

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

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Bill Extending Funding For Certain Veteran Medical and Other Projects Heads To President

September 25, 2011

H.R.2646

Extended funding for various veterans health facilities and programs and audits of private payers providing certain services to veterans provided for under the Veterans Health Care Facilities Capital Improvement Act of 2011, H.R. 2646 are about to become law.  Congress has passed and sent H.R. 2646 to President Obama for signature.

Among other things, H.R. 2646:

  • Designates the VA telehealth clinic in Craig, Colorado, as the “Major William Edward Adams Department of Veterans Affairs Clinic.”
  • Extends to December 31, 2018, specified authority for: (1) treatment, rehabilitation, and added services for seriously mentally ill and homeless veterans; (2) housing assistance for homeless veterans; and (3) the Advisory Committee on Homeless Veterans and (4) transfers of real property under the Secretary’s jurisdiction or control.
  • Extends to September 30, 2020, the recovery audit program for certain fee basis and other medical services contracts concerning non-VA care and services for veterans and beneficiaries
  • Eextends funding for construction at Department of Veterans Affairs (VA) medical centers in Seattle, Washington and West Lost Angeles, California; and leases at various outpatient and community-based outpatient clinics.  
  • Changes authorizations for certain previously authorized construction projects in Fayetteville, Arkansas, the Orlando, Florida area, Palo Alto, California, San Juan, Puerto Rico, and St. Louis, Missouri.
  • Along with these funding extensions, H.R. 2646 also requires that requests for funding of  veteran medical facilities projects and leases sent to Congress include: (1) a detailed estimate of the total costs of the medical facility including the number of personnel and itemized costs for construction, activation, special purpose alteration, ancillary services, and equipment; and (2) data concerning demographics, workload, utilization, and operating costs over a 5-, 10-, and 20-year period.  For  a proposed new or replacement facility, funding requests also must include a detailed: (1) report of the consideration given to acquiring an existing facility by lease or purchase and to the sharing of health-care resources with the Department of Defense (DOD); and (2) total cost estimate and a cost-benefit comparison for each considered alternative to construction of the facility and an explanation of why the preferred alternative is the most effective means to achieve the stated project goals.

For Assistance or Additional Information

Nationally and internationally known for her knowledge and work on health and other employee benefit matters and engaging and informative presentations, attorney, author and policy advocate Cynthia Marcotte Stamer will help you prepare your plan and organization to cope with these and other challenges of understanding and coping with health care reform. 

Chair of the American Bar Association (ABA) RPPT Employee Benefits & Other Compensation Arrangements, an ABA Joint Committee on Employee Benefits Council Representative, incoming ABA TIPS Employee Benefit Plan Committee Vice Chair, former ABA Health Law Section Managed Care & Insurance Interest Group Chair, past Southwest Benefits Association Board Member, Employee Benefit News Editorial Advisory Board Member, Board Certified in Labor and Employment Law and a widely published speaker and author,  Ms. Stamer has more than 24 years experience advising businesses, plans, fiduciaries, insurers and governments on health care, retirement, employment, insurance, :and tax program design, administration, defense and policy and related employment, insurance and health care matters.    Her experience includes extensive experience  advising insured and self-insured ERISA group medical and other plans,  Medicare and Medicaid Advantage plans, mini-med, high-deductible and other consumer driven medical, long-term care, occupational injury, ex-pat, association, fraternal benefit and other managed care and medical benefit plans and insurers, their service providers,  insurers,  sponsors, fiduciaries, technology providers and others.   A primary drafter of the Bolivian pension law, Ms. Stamer also has more than 30 years experience working on legislative and regulatory health care, pension, workforce, education and immigration reform matters including extensive work on the Pension Protection & Affordable Care Act, HIPAA, COBRA, state managed care and other  insurance and other laws.  In addition to her experience advising governments and others internationally about these matters, she  regularly advises and represents employers, employee benefit plans, insurers, health care and managed care providers and others about evolving laws and regulations and assists them in dealing with Congress, the Internal Revenue Service, the Department of Labor, Immigration and Customs, OCR, OIG, CMS and other HHS agenices, the FTC, the Justice  Department, state insruance and health departments, and others.

 A widely published author and popular speaker, Ms. also regularly publishes and speaks for a broad range of organizations  including American Bar Association, Aspen Publishers, World At Work, Benefits Magazine, Employee Benefit News, Spencer Publications, SHRM, the International Foundation, Solutions Law Press and many others.  She  currently or previously has served on the editorial advisory board of Employee Benefits News,  BNA Employee Benefits CDRolm and a wide range of other highly regarded publications.  Her insights on these and other matters have appeared in Managed Care Executive, Health Leaders, Private Payers News, the Wall Street Journal, various publications of  the Bureau of National Affairs, Aspen, Atlantic Information Serices, the Wall Street Journal, and many other industry and news publications.   In recognition of this extensive record of employee benefit experience and involvement, Ms. Stamer recently was selected to be inducted as a Fellow in the American  College of Employee Benefits Counsel.

You can learn more about Ms. Stamer and her experience, review some of her other training, speaking, publications and other resources, 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.

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 available at www.solutionslawpress.com

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

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


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.

©2010 Solutions Law Press. All rights reserved.


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.

©2010 Solutions Law Press. All rights reserved.


Last Call: Today Deadline To Comment on Proposed Edits To CMS Nursing Home Civil Monetary Penalty Regs

August 11, 2010

Today (August 11, 2010) is the deadline to submit comments on proposed changes to Medicare and Medicaid regulations governing the imposition and collection of civil monetary penalties against nursing homes for failing to comply with Medicare & Medicaid regulations. 

The Centers for Medicare & Medicaid Services proposed regulations that would expand and revise current Medicare and Medicaid regulations regarding the imposition and collection of  civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with the Patient Protection and Affordable Care Act of 2010 on July 12.  A copy of the proposed regulations is available for review here.  Comments must be submitted today by 5 P.M. Eastern Time.

If you need assistance evaluating, preparing comments, or responding to the proposed regulations or with other health industry matters, please consider contacting 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. Ms. Stamer also regularly publishes and conducts training on 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

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.

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. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related concerns. 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. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

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.

©2010 Solutions Law Press. All rights reserved.


CMS Proposes Changes To Civil Monetary Penalty Rules For Nursing Homes

July 12, 2010

August 11, 2010 is the deadline to submit comments on proposed changes to Medicare and Medicaid regulations governing the imposition and collection of civil monetary penalties against nursing homes for failing to comply with Medicare & Medicaid regulations.  

The Centers for Medicare & Medicaid Services today (July 12, 2010) proposed regulations that would expand and revise current Medicare and Medicaid regulations regarding the imposition and collection of  civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with the Patient Protection and Affordable Care Act of 2010.  A copy of the proposed regulations is available for review here.

If you need assistance evaluating, preparing comments, or responding to the proposed regulations or with other health industry matters, please consider contacting 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. Ms. Stamer also regularly publishes and conducts training on 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

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.

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. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related concerns. 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. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

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.

©2010 Solutions Law Press. All rights reserved.


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

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.

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.  A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about these and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, 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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

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.

©2010 Solutions Law Press.  All rights reserved.


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.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


Southern States Collect Largest Share of $162 Million AARA Fund Meaningful Use Development Grants

March 16, 2010

By Cynthia Marcotte Stamer

Southern states are the big winners among the 16 states and qualified state designated entities (SDEs) to share in the approximately $162 Million in American Recovery and Reinvestment Act of 2009 (ARRA) fund grants to facilitate the development of health information exchange and advance health information technology (health IT) announced by the U.S. Department of Health and Human Services HHS today (March 15, 2010).

Drawn from the $2 billion in funding set aside in ARRA to promote widespread meaningful use of health IT and use of an electronic health record, the following  health information exchange awards seek to facilitate to facilitate non-proprietary health information exchange that adheres to national standards widely perceived as critical to enabling care coordination and improving the quality and efficiency of health care.

The recipients and award amounts of the grants announced today are:

  • Texas Health and Human Services Commission, $28,810,208
  • Florida Agency of Health Care Administration, $20,738,582
  • New Jersey Health Care Facilities Financing Authority, $11,408,594
  • Louisiana Health Care Quality Forum, $10,583,000
  • State of Mississippi, $10,387,000
  • Indiana Health Information Technology, Inc., $10,300,000
  • The Maryland Department of Health and Mental Hygiene, $9,313,924
  • South Carolina Department of Health & Human Services, $9,576,408
  • Iowa Department of Public Health, $8,375,000
  • State of Connecticut Department of Public Health, $7,297,930
  • Nebraska Department of Administrative Services, $6,837,180
  • South Dakota Department of Health, $6,081,750
  • Idaho Health Data Exchange, $5,940,500
  • State of North Dakota, Information Technology Department,  $5,343,733
  • State of Alaska, $4,963,063

Additional information about the state HIE program may be found here.  Other information about other health IT programs funded through ARRA generally can be found at here.

For Assistance With This Opportunity Or Other Health Industry Concerns

If your organization needs advice or assistance with commenting on the AHRO proposal or to respond to other health care quality or other 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

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 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:

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. 

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 to cstamer@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 here or e-mailing this information here.  To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


Stamer Speaks To Chiefs of Staff About JCAHO Physician Performance Evaluation Requirements

March 2, 2010

Curran Tomko Tarski LLP Partner and Health Care Practice Chair Cynthia Marcotte Stamer will speak about “Physician Performance Evaluation Requirements of Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)” at the Harris County Medical Society Council of Hospital Chiefs of Staff meeting on March 9, 2010.

Former Chair of the American Bar Association Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer has more than 22 years experience acting as outside operations and special counsel to a broad range of health care providers, payers and other health industry clients. Health care inherently is a people business.  Board Certified in Labor and Employment Law by the Texas Board of Specialization, Ms. Stamer has extensive experience advising, assisting and defending public and private health industry clients staffing, performance and internal controls matters.  Ms. Stamer also provides other real-time, strategic risk management, staffing and services, transactional, and operational advice to physicians; hospitals, health care systems and other health care providers; managed care and insurance organizations; health plans; health and managed care consultants and outsourcers, health information technology providers; and other health industry clients.  She assists them to respond to regulatory and enforcement changes.  She also represents these and other health industry clients before federal and state regulators and lawmakers.  She also regularly conducts training for health and managed care industry clients on a wide range of topics. You can get more information about the CTT Health Care Practice and more specifics about Ms. Stamer’s health industry experience

If you need assistance with these or other health care concerns, please contact Ms. Stamer directly at (214) 270‑2402, cstamer@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 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.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


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 InformationMeanwhile, 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 hereWhile 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

If you found these updates of interest, you also be interested in one or more of the following other recent articles:

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.

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 here.

©2010 Cynthia Marcotte Stamer.  All rights reserved. 


Federal HEAT & Other Federal Health Care Fraud Efforts Score More Than 15 Successes As OIG Claims $20.97 Billion Saved From Enforcement Activities In December

December 30, 2009

As the interagency Medicare Fraud Strike Force targeting Medicare Fraud scored another series of more than 15 successful criminal enforcement actions across the national during December, 2009, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) credited the Medicare Fraud Strike Force and other stepped up oversight and enforcement activities as helping it achieve $20.97 Billion in Medicare and other federal health care program savings during Fiscal Year 2009 in its Semiannual Report to Congress

The Detroit convictions were among three of more than 15 other criminal enforcement successes reported by the Department of Justice during December.  These and other reports document the rising prosecution and enforcement risks that health care providers face for failing to tailor their billing and other practices to comply with federal health care fraud laws.  In light of the growing enforcement and emphasis of federal prosecutors and regulations on the detection and prosecution of organizations and individuals participating in billing or other activities that violate federal health care fraud laws, health care organizations, their officers, directors, employees, consultants and other business partners should tighten practices and step up oversight to minimize the likelihood that they or their organizations will engage in activities that federal regulators view as federal health care fraud.

December 13 Detroit Criminal Convictions

The U.S. Department of Justice Criminal Division (Justice Department), Federal Bureau of Investigation (FBI) and Inspector General for the U.S. Department of Health and Human Services (HHS) jointly announced Friday (December 11, 2009) that Baskaran Thangarasan, Sandeep Aggarwal and Wayne Smith had plead guilty for their roles in connection with several Detroit-area health care fraud scheme.

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud and Aggarwal plead guilty to one count of conspiracy to launder money. On December 11, 2009, Smith plead guilty to one count of conspiracy to commit health care fraud.

  • Thangarasan Guilty Plea To Conspiracy To Commit Health Care Fraud

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud. And Aggarwal plead guilty to one count of conspiracy to launder money. He faces a maximum sentence of 10 years in prison and a $250,000 fine at sentencing.

According to information contained in plea documents, Thangarasan, a licensed physical therapist, admitted that he began working in approximately September 2003 as a contract therapist for a co-conspirator. This co-conspirator owned and controlled several companies operating in the Detroit area that purported to provide physical and occupational therapy services to Medicare beneficiaries. Thangarasan admitted that he, the co-conspirator and others created fictitious therapy files appearing to document physical therapy services provided to Medicare beneficiaries, when in fact no such services had been provided. According to court documents, the fictitious services reflected in the files were billed to Medicare through sham Medicare providers controlled by Thangarasan’s co-conspirators.

Thangarasan admitted that his role in creating the fictitious therapy files was to sign documents and progress notes indicating he had provided physical therapy services to particular Medicare beneficiaries, when in fact he had not. Thangarasan was paid approximately $50 by co-conspirators per file that he falsified in this manner. Thangarasan also admitted that in the course of the scheme charged in the indictment, he signed approximately 1,011 fictitious physical therapy files, falsely indicating he had provided physical therapy services to Medicare beneficiaries. Thangarasan admitted he knew that the files he helped falsify were used to justify fraudulent billings to Medicare.

In addition, Thangarasan admitted that between approximately September 2003 and May 2006, his co-conspirators submitted claims to the Medicare program totaling approximately $5,055,000 for files that were falsified by Thangarasan. Medicare actually paid approximately $2,325,000 on those claims. Thangarasan admitted that throughout the conspiracy, he was fully aware that Medicare was being billed for occupational therapy services he had falsely indicated he had performed.

  • Aggarwal Guilty Plea to Money Laundering

Aggarwal faces a maximum sentence of 20 years in prison and a $500,000 fine after admitting in the same case to assisting co-conspirator Suresh Chand in laundering the proceeds of Chand’s Medicare fraud scheme. Chand, who pleaded guilty in September 2009 to conspiracy to commit health care fraud and conspiracy to launder money, admitted to conspiring to submit approximately $18 million in fraudulent physical and occupational therapy claims to the Medicare program. Aggarwal, who admitted working at Chand’s office, acknowledged that his role in the scheme was to set up sham entities at Chand’s direction, with the purpose of using those entities to distribute the proceeds of the fraud to the various co-conspirators. According to plea documents, one such entity was called Global Health Care Management Services. Aggarwal admitted that Global Health Care Management Services, which he helped create, provided no health or management services of any type, but existed solely as a mechanism to conceal the location of fraudulently obtained Medicare proceeds. Aggarwal admitted in his plea that he and Chand laundered approximately $393,000 through this sham entity.

  • Smith Guilty Plea To Conspiracy To Commit Health Care Fraud

At sentencing, Smith face a maximum sentence of 10 years in prison and a $250,000 fine for his participation in a scheme to falsely bill Medicare.  His indictment charged that he transported and paid Medicare beneficiaries to attend Sacred Hope Center, a Southfield, Mich.-infusion clinic. According to the indictment, the Medicare beneficiaries he paid and transported were paid to sign paperwork indicating that they had received infusions and injections of specialty medications that they did not in fact receive.

According to the indictment, Sacred Hope Center routinely billed the Medicare program for services that were medically unnecessary and/or never provided. The primary owners and operators of Sacred Hope Center have pleaded guilty and admitted purchasing only a small fraction of the medications that the clinic billed the Medicare program for providing. These co-conspirators have also stated that patients were prescribed medications at the clinic based not on medical need, but instead based on which medications were likely to generate Medicare reimbursements.

Other Criminal Enforcement Actions During December

The Detroit convictions are three of nearly 20 successful criminal enforcement activities that DOJ announced during December, 2009.  During the same month, DOJ also announced:

  • On December 20, 2009, sentencing of an Audiologist to six months in prison for Medicare Fraud in California  here
  • On December 17, 2009 , the guilty plea and sentencing of a Houston physician for operating an illegal pill mill here
  • On December 16, 2009, the sentencing in Michigan of the owner of health care agency to 18 months prison in Medicare kickback scheme here
  • On December 15, 2009, the sentencing of a Lexington. South Carolina doctor to perform community service in a health care fraud case  here
  • On December 15, 2009, the guilty plea of a Plymouth, Minnesota man to defrauding Medicaid out of $74,000  here
  • On December 14, 2009, the sentencing of a Miami, Georgia man to more than a decade in Federal prison for million dollar Medicaid fraud here
  • On December 11, 2009, the charging of a durable medical equipment company and six other defendants in Pennsylvania in a Medicare Fraud And Kickback Scheme here
  • On December 11, 2009, the guilty plea of an Aulander, North Carolina woman to $650,000 Health Care Fraud  here
  • On December 7, 2009, the guilty plea of a corporation various health care fraud schemes here
  • On December 6, 2009, the guilty plea of a Dallas, Texas durable medical equipment business owner to aggravated id theft in a Medicare Fraud scheme  here
  • On December 3, 2009, the arrest of the owner of a Florida home health care provider and his alleged accomplice for a scheme to bribe a government contractor  here
  • On December 3, 2009, the conviction of two defendants for Health Care Fraud in Idaho here
  • On December 2, 2009, the entry of an order requiring a Sioux City, Iowa hospital to pay $400,000 to resolve false claims allegations  here
  • On December 1, 2009, the admission by a Maryland man to health care fraud on a hospital in the District of Columbia  here
  • On December 1, 2009, the arrest of a Miami, Florida man for obstructing a Health Care Fraud Investigation here
  • On December 1, 2009, the $125,000  fine of a Michigan chiropractor for Falsifying Records here

HEAT Operations Continued & Expanded

The Detroit and many of these other criminal successes resulted from joint investigations by the FBI and the OIG as part of the Medicare Fraud Strike Force as part of various interagency Medicare Fraud “Strike Forces” operating in several regions of the U.S. as part of the continuing Health Care Fraud Prevention and Enforcement Action Team (HEAT) operations of the FBI, HHS and the Justice Department which DOJ credits with producing more than 250 criminal convictions since their inception,  Based on initial successes of Strike Force operations in Miami (Phase One) and  Los Angeles (Phase Two), the Justice Department and HHS on May 20, 2009 expanded the scope of these operations to include Detroit and Houston Strike Force teams. Recently, DOJ and HHS announced the expansion of its HEAT operations to include Strike Force teams also targeting health care fraud in Brooklyn, New York; Tampa, Florida and Baton Rouge, Louisiana.

The heightened emphasis on enforcement of federal health care fraud laws reflected in the HEAT program the enactment of recent amendments to the False Claims Act, 31 U.S.C. § 3729 (FCA)  under the “Fraud Enforcement and Recovery Act of 2009”(FERA).  The FERA 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.

The FERA amendments and the HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws by both the Administration and Congress.  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.  Many state agencies also are stepping up their health care fraud investigations and enforcement.

Health Care Providers Must Step Up Compliance & Risk Management

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.

Solutions Law Press author and Curran Tomko and Tarski LLP Health Care Practice Chair 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 the CTT Health Care Practice  and more specifics about Ms. Stamer’s health industry experience here on the CTT Website.

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 Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402, CTT White Collar Defense Litigation Practice Chair Edwin J. Tomko at etomko@cttlegal.com, or  214.270.1405 or another Curran Tomko Tarski LLP attorney of your choice.. 

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 other updates on HEAT activities such as the following:

Other recent updates that also may be of interested published on our electronic Solutions Law Press Health Care Update publication include:

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.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


HEAT Initiative Snares Health Fraud Related Guilty Pleas of Physical Therapist, Money Launderer and Patient Recruiter In Detroit

December 14, 2009

By Cynthia Marcotte Stamer

The interagency Medicare Fraud Strike Force targeting Medicare Fraud in the Detroit area scored another series of criminal convictions last week. 

The U.S. Department of Justice Criminal Division (Justice Department), Federal Bureau of Investigation (FBI) and Inspector General for the U.S. Department of Health and Human Services (HHS) jointly announced Friday (December 11, 2009) that Baskaran Thangarasan, Sandeep Aggarwal and Wayne Smith had plead guilty for their roles in connection with several Detroit-area health care fraud scheme.

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud and Aggarwal plead guilty to one count of conspiracy to launder money. On December 11, 2009, Smith plead guilty to one count of conspiracy to commit health care fraud.

Thangarasan Guilty Plea To Conspiracy To Commit Health Care Fraud

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud. And Aggarwal plead guilty to one count of conspiracy to launder money. He faces a maximum sentence of 10 years in prison and a $250,000 fine at sentencing.

According to information contained in plea documents, Thangarasan, a licensed physical therapist, admitted that he began working in approximately September 2003 as a contract therapist for a co-conspirator. This co-conspirator owned and controlled several companies operating in the Detroit area that purported to provide physical and occupational therapy services to Medicare beneficiaries. Thangarasan admitted that he, the co-conspirator and others created fictitious therapy files appearing to document physical therapy services provided to Medicare beneficiaries, when in fact no such services had been provided. According to court documents, the fictitious services reflected in the files were billed to Medicare through sham Medicare providers controlled by Thangarasan’s co-conspirators.

Thangarasan admitted that his role in creating the fictitious therapy files was to sign documents and progress notes indicating he had provided physical therapy services to particular Medicare beneficiaries, when in fact he had not. Thangarasan was paid approximately $50 by co-conspirators per file that he falsified in this manner. Thangarasan also admitted that in the course of the scheme charged in the indictment, he signed approximately 1,011 fictitious physical therapy files, falsely indicating he had provided physical therapy services to Medicare beneficiaries. Thangarasan admitted he knew that the files he helped falsify were used to justify fraudulent billings to Medicare.

In addition, Thangarasan admitted that between approximately September 2003 and May 2006, his co-conspirators submitted claims to the Medicare program totaling approximately $5,055,000 for files that were falsified by Thangarasan. Medicare actually paid approximately $2,325,000 on those claims. Thangarasan admitted that throughout the conspiracy, he was fully aware that Medicare was being billed for occupational therapy services he had falsely indicated he had performed.

Aggarwal Guilty Plea to Money Laundering

Aggarwal faces a maximum sentence of 20 years in prison and a $500,000 fine after admitting in the same case to assisting co-conspirator Suresh Chand in laundering the proceeds of Chand’s Medicare fraud scheme. Chand, who pleaded guilty in September 2009 to conspiracy to commit health care fraud and conspiracy to launder money, admitted to conspiring to submit approximately $18 million in fraudulent physical and occupational therapy claims to the Medicare program. Aggarwal, who admitted working at Chand’s office, acknowledged that his role in the scheme was to set up sham entities at Chand’s direction, with the purpose of using those entities to distribute the proceeds of the fraud to the various co-conspirators. According to plea documents, one such entity was called Global Health Care Management Services. Aggarwal admitted that Global Health Care Management Services, which he helped create, provided no health or management services of any type, but existed solely as a mechanism to conceal the location of fraudulently obtained Medicare proceeds. Aggarwal admitted in his plea that he and Chand laundered approximately $393,000 through this sham entity.

Smith Guilty Plea To Conspiracy To Commit Health Care Fraud

At sentencing, Smith face a maximum sentence of 10 years in prison and a $250,000 fine for his participation in a scheme to falsely bill Medicare.  . 

Smith pleaded guilty to an indictment that charged he transported and paid Medicare beneficiaries to attend Sacred Hope Center, a Southfield, Mich.-infusion clinic. According to the indictment, the Medicare beneficiaries he paid and transported were paid to sign paperwork indicating that they had received infusions and injections of specialty medications that they did not in fact receive.

According to the indictment, Sacred Hope Center routinely billed the Medicare program for services that were medically unnecessary and/or never provided. The primary owners and operators of Sacred Hope Center have pleaded guilty and admitted purchasing only a small fraction of the medications that the clinic billed the Medicare program for providing. These co-conspirators have also stated that patients were prescribed medications at the clinic based not on medical need, but instead based on which medications were likely to generate Medicare reimbursements.

HEAT Operations Continuing

The cases are being investigated by the FBI and the HHS Office of the Inspector General. Theses cases were brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and U.S. Attorney’s Office for the Eastern District of Michigan.

The investigation resulting in these guilty pleas were conducted as part of a series of interagency Medicare Fraud “Strike Forces” operating in several regions of the U.S. as part of the continuing Health Care Fraud Prevention and Enforcement Action Team (HEAT) operations of HHS and the Justice Department.  Based on initial successes of Strike Force operations in Miami (Phase One) and  Los Angeles (Phase Two), the Justice Department and HHS on May 20, 2009 expanded the scope of these operations to include Detroit and Houston Strike Force teams.

The heightened emphasis on enforcement of federal health care fraud laws reflected in the HEAT program the enactment of recent amendments to the False Claims Act, 31 U.S.C. § 3729 (FCA)  under the “Fraud Enforcement and Recovery Act of 2009”(FERA).  The FERA 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.

The FERA amendments and the HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws by both the Administration and Congress.  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.  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.

Solutions Law Press author and Curran Tomko and Tarski LLP Health Care Practice Chair 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 Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or your other favorite Curran Tomko Tarski LLP attorney. 

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 other updates on HEAT activities such as the following:

Other recent updates that also may be of interested published on our electronic Solutions Law Press Health Care Update publication include:

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.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


2010 Medicare Part B Monthly Premium Rate, Annual Part B Deductible & Actuarial RatesAnnounced

October 27, 2009

The Centers for Medicare & Medicaid Services recently announced that the monthly premiums, actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program that will apply for calendar year 2010. 

The rates announced here in the Federal Register on October 22, 2009 are as follows:

  • The monthly actuarial rates for 2010 are $221.00 for aged enrollees and $270.40 for disabled enrollees. The standard monthly Part B premium rate for 2010 is $110.50, which is up from the 2009
  • standard premium rate of $96.40.)
  • The Part B deductible for 2010 is set at $155.00 for all Part B beneficiaries.

A beneficiary who has to pay an income-related monthly adjustment may have to pay a total monthly premium of roughly 35, 50, 65 or 80 percent of the total cost of Part B coverage.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


Baucus Health Care Reform Proposal Calls For Significant Tightening In Tax-Exemption Rules

September 22, 2009

Senate Finance Set To Begin Markup Sessions Today – Repeal of Rebuttable Presumption Rule In Reasonable Compensation Rules, Other Tightening of Requirements Threatened

With Senate Finance Committee meetings to mark up Chairman Max Baucus’ health care reform proposal as outlined in his 220-page “Chairman’s Mark of America’s Healthy Future Act of 2009” (the “Baucus Proposal”) scheduled to begin today (September 22, 2009), tax-exempt health care and other non-profit organizations should evaluate carefully proposed amendments that could impact their tax-exempt status or related obligations.  The proposed amendments have serious implications for non-profits within and beyond the health care industry.

Markup Scheduled To Begin Tuesday

The Senate Committee on Finance began meeting today (September 22, 2009) to negotiate how to convert into proposed legislation the Baucus Proposal introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

Since no text of the proposed legislation itself has been released yet, it is impossible to fully evaluate the specific nature and implications of the Baucus Proposal.  While this week’s planned Senate Finance Committee mark up will further clarify these matters, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals nevertheless provides significant insight of what health care organizations can expect to be discussed and, in all likelihood incorporated into the draft legislation ultimately proposed in some form.  Accordingly, tax-exempt health care organizations should carefully evaluate and act promptly to share their input with members of the Senate Finance Committee and other members of Congress about a series of proposed amendments that would impact their tax-treatment and other responsibilities.

All Tax-Exempts Should Monitor Proposals To Shift Burden Of Proof On Compensation Reasonability & Expanded IRS Powers

Among a multitude of proposed tax amendments, tax-exempt organizations inside and outside the health care industry will want to keep a a close eye on discussions and proposals to amend the Baucus Proposal to further modify the tax-exemption requirements for tax-exempt hospitals and other tax-exempt organizations.  Late last week, Ranking Member Senator Chuck Grassley submitted a proposal to amend the Baucus Proposal to further tighten tax-exemption requirements in two material respects likely to generally concern tax-exempt organizations:

  • For the stated purpose of avoiding wasteful legal challenges to the management and governance questions on the revised Form 990, to specifically grant statutory authority to the Internal Revenue Service to ask management and governance questions on the Form 990; and
  • To make it easier for the Internal Revenue Service to challenge as unreasonable compensation payments made by tax-exempt entities by shifting the burden to the taxpayer of proving the reasonability of compensation and removing the burden currently borne by the Internal Revenue Service of going forward with the evidence on comparability.  This would be accomplished by overruling the rebuttable presumption of reasonableness currently set forth in Treasury Regulation § 53.4958-6 of the intermediate sanctions rules and replacing it with a requirement that public charities due diligence demonstrate that their compensation payments meet the 3 current elements of the presumption:
    • Review by an authorized body made of members without a conflict of interest
    • Use of appropriate data as to comparability and
    • Adequate and contemporaneous documentation. This amendment is expected to raise revenue, according to the summary.

Given the potential implications of these proposed amendments, tax-exempt health care and other organizations should keep a close eye on proposed tax provisions of the Baucus Proposal and other related proposals.

Proposal To Tighten Other Tax-Exemption & Reporting Requirements For Tax-Exempt Hospitals

While the Senate Finance Committee as of yet has not released text of the proposed legislation itself, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals and other subsequently proposed amendments to the Baucus Proposal reveal other plans to materially change the tax-exemption qualification, governance and reporting requirements for tax-exempt hospitals beyond the proposal to create CO-OPs.  Among other things, the Baucus Proposal calls for the Internal Revenue Code § 501(c)(3) and its related provisions to be amended to require tax-exempt hospitals:

  • To conduct or participate in and share with the public a community-needs analysis with input from a broad cross section of the community at least once every 3 years and thereafter to report on its implementation, including explaining where applicable why identified needs were unaddressed.  These additional requirements would supplement rather than replace existing community benefit standards already generally applicable to charitable entities
  • To provide non-discriminatory emergency care
  • To have, implement and widely disseminate a written financial assistance policy  defining among other things:
    • The rules for determining who qualifies for financial assistance
    • How the hospital determines amounts to be billed to patients in manner that provides for patient discounts to be based on Medicare rates, “best” commercial rates or other approved statutory measures rather than “chargemaster rates”
    • Require hospital to notify patients of the financial assistance policy on admission, on bills and in telephone calls of its financial assistance policy before initiating various collection actions or reporting the account to a credit rating agency
  • To make its audited financial statements (and where applicable, the consolidated financial report of any entity of which it is a part) available widely
  • The Internal Revenue Service (IRS) to conduct a SEC-type review of each 501(c)(3) hospital’s community benefit activities at least once every three years based on data reported on Schedule H of the Form 990
  • The IRS and the Department of Health and Human Services (HHS)  to report annually to Congress on community benefit activities of non-governmental tax-exempt hospitals, charity care, bad debt, and unreimbursed costs of government programs (means-tested and non-means-tested) incurred by tax-exempt, taxable, and governmental hospitals.

CO-Ops As Health Coverage Alternative

Much more widely discussed is the Chairman’s CO-OP proposal.  The Baucus Proposal calls for the creation of a new vehicle to provide an alternative source of health care coverage called “CO-Ops.”  As contemplated by the Baucus Proposal, CO-Ops would be associations controlled by a beneficiary board unrelated to existing organizations providing health insurance as of July 16, 2009.  Subject to their meeting non-inurement and other common existing requirements for charitable status as well as other conditions, CO-Ops would be able to apply for tax-exempt status as well as federal funding.

New Taxes and Fees On Insurers & Others

The Baucus Proposal proposes to finance its health care reforms through a variety of mechanisms including, excise taxes and penalties on employers and individuals that fail to purchase the government specified health care package, taxes on premiums paid for health insurance coverage in excess of certain specified annual limits, the imposition of certain premium taxes and “sector fees” on healthcare insurers (with some exceptions possible under certain circumstances for certain 501(c)(3) and (c)(4) HMOs not providing commercial-type insurance within the meaning of Section 501(m)).

Other Baucus Proposal Highlights

In its current summary form, the 220-page Baucus Proposal includes a host of other sweeping reforms, which are certain to be further expanded and refined during this week’s scheduled Senate Finance Committee markup session.  Many of these other proposed reforms were highlighted in an overview of the Baucus Proposal published hereYou can join the discussion of these and other proposed health care forms and exchange updates and other resources about health care reform and related concerns by registering to participate in the Coalition For Responsible Health Care Policy Group on Linkedin.

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 health care compliance, risk management, reimbursement, staffing, credentialing, transactional, operational or public policy 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.  Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and related matters. 

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, by e-mailing this information to support@cttlegal.com or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

©2009 Curran Tomko Tarski LLP.  All rights reserved.


Two Recent Criminal Prosecutions For HIPAA Privacy Rule Violations Signal Rising Criminal Enforcement Risks

September 8, 2009

Register here  To Participate In September 9 or September 17 Briefings on New HIPAA Data Breach Rules

September 8, 2009

Two recent separate criminal actions against hospital workers for wrongfully accessed medical records in violation of the medical privacy provisions of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA) are the latest reminders to health care providers, health plans, health care clearinghouses, their business associates and members of their workforce that the criminal provisions of the HIPAA Privacy Rules have teeth. 

Palmetto General Hospital Employee And Accomplice Indicted For Stealing Patient Records As Part Of Fraud

 In Miami-Dade County, federal felony charges are pending against Jacquettia L. Brown, 29, and Tear Renee Barbary, 25, prosecution on for offenses relating to the theft of patient profile records from Palmetto General Hospital to further a fraud scheme.

A seven-count Indictment announced by the Department of Justice on May 26, 2009 charges Brown and Barbary with conspiracy to commit access device fraud in violation of Title 18, United States Code, Section 1029(b)(2), and criminal violations of HIPAA. In addition, Brown is charged with aggravated identity theft, in violation of Title 18, United States Code, Section 1028A(a)(1).  If convicted, the defendants face a statutory maximum of five (5) years’ imprisonment on Count 1, and a statutory maximum of ten (10) years’ imprisonment as to each of Counts 2, 3, and 7. As to Counts 4-6, Brown faces a two (2) year mandatory prison sentence per count. 

According to the Indictment, Brown, a medical records employee of Palmetto General Hospital, took records containing personal profile information of Palmetto General Hospital patients. Defendant Brown and Barbary then used the stolen personal information to further a credit card fraud conspiracy. The patient profile records that Brown stole included personal identifying information, such as patients’ names, birthdates, Social Security numbers, addresses, driver’s license numbers, and next of kin contacts. Brown used the stolen identifying information to obtain patients’ credit card account numbers. She gave patient profile records and credit card account numbers to Barbary, who used the information to make unauthorized credit card purchases. When law enforcement officials disrupted the scheme, Brown was in possession of 41 patient profile records and Barbary was in possession of six patient profile records.

Curiosity Check of Medical Records Results In Arkansas Doctor, 2 Former Hospital Employees Guilty Plea To HIPAA Violation

Three Arkansas health care workers could be sentenced to up to 1 year in prison, a fine of not more than $50,000, or both after pleading guilty in July, 2009 to misdemeanor violations of the health information privacy provisions of HIPAA for accessing a patient’s record without any legitimate purpose.

United States Magistrate Judge Henry L. Jones, Jr. accepted the guilty pleas of Dr. Jay Holland, age 56, of Little Rock, Arkansas; Sarah Elizabeth Miller, age 28, of England Arkansas; and Candida Griffin, age 34 of Little Rock, Arkansas after each admitted to accessing patient records to satisfy their own curiosity.

Dr. Holland, Medical Director of Select Specialty Hospital, located on the 6 floor of the St. Vincent Infirmary Medical Center (SVIMC), admitted that after watching news reports on television, he logged on to the SVIMC patient records from his computer at home and accessed a patient’s files to determine if the news reports were accurate. He admitted he accessed the file because he was curious even though he had had HIPAA training and understood he was violating HIPAA when he accessed the file. SVIMC suspended Dr. Holland’s privileges for two weeks and required him to complete on-line HIPAA training.

Sarah Elizabeth Miller, formerly an account representative at SVIMC, Sherwood Campus, was responsible for checking patients in and out of the clinic and for processing patient billing. In order to perform her duties, she had access to the SVIMC patient records program which includes all locations, not just that of the Sherwood clinic. Miller admitted that on October 20 and 21, 2008, she accessed a patient’s files approximately 12 times out of curiosity. She admitted that she accessed the records without any legitimate purpose. Records show that Miller was trained on HIPAA privacy laws by SVIMC. SVIMC fired Miller from her position.

Candida Griffin was the emergency room unit coordinator at SVIMC. Her responsibilities were to order patient tests, perform data entry into electronic patient files for patients and perform other secretarial functions in the emergency room. Griffin admitted that on October 20, 2008, she was told by the charge nurse to set-up an alias for a particular patient admitted to the emergency room. On October 21, 2008, after the patient had been moved to ICU, Griffin admitted that she became curious about the patient’s status and accessed the medical chart to find out if the patient was still living. Although Griffin did not inform anyone about accessing the chart, hospital records show that the patient’s records were accessed three times that day by Ms. Griffin. SVIMC records show that Griffin was trained on HIPAA privacy laws. SVIMC fired Griffin from her position.

Pursuant to plea agreements with the United States, Holland, Miller and Griffin pleaded guilty to a misdemeanor a violation of the health information privacy provisions of HIPAA based on their accessing a patient’s record without any legitimate purpose. Each faces a maximum penalty of 1 year imprisonment, a fine of not more than $50,000, or both. A sentencing date has not yet been set, but is expected within the next few weeks.

Criminal Referral and Enforcement Continues

Together with the HIPAA-related criminal convictions of in 2008 of David Gibson, Ferando Ferrer, Jr. and Andrea Smith discussed here, these new Arkansas and Florida criminal actions document the willingness of Justice Department attorneys to investigate and prosecute certain criminal violations.  Because they involved the theft of health information for use in furtherance of other health care fraud schemes, many have viewed as predictable and understandable the prosecution of Gibson, Ferrer, Brown and Barbary.  In contrast, the willingness of Jane W. Duke, United States Attorney for the Eastern District of Arkansas, to prosecute criminally the wrongful access by the SVIMC health care workers and Andrea Smith in the absence of other health care fraud motives challenges the perception widely held among certain segments of the health care and health plan industry that the criminal provisions of HIPAA have little teeth.  Since U.S. Attorney Duke pursued both the SVIMC and Smith prosecutions, it remains to be seen whether other U.S. Attorneys will be equally willing to pursue prosecution of HIPAA violations in the absence of evidence of other federal health care crimes.  

Less speculative is the growing readiness of the Department of Health & Human Services Office of Civil Rights to pursue civil remedies for HIPAA violations.  On February 18, 2009, for instance, OCR and the Federal Trade Commission (“FTC”) issued a joint announcement (the “Announcement”) ordering CVS Pharmacy, Inc., the nation’s largest retail pharmacy chain, to pay the U.S. government a $2.25 million settlement and to take other corrective action to ensure that it does not violate the privacy rights patients under HIPAA when disposing of patient information such as identifying information on pill bottle labels.  In a coordinated action, CVS Caremark Corp., the parent company of the pharmacy chain, also signed a consent order and agreed to a settlement with the FTC to settle potential violations of the FTC Act.  The investigation resulting in the settlement marks the first instance where the OCR formally coordinated on investigation and resolution of a case with the FTC. 

Coming as new data breach notification requirements for HIPAA-covered entities are set to take effect on September 23, 2009, these and other stepped up oversight and enforcement activities make it critical that all health care providers, health plans, health care clearinghouses and their business associates need to update their policies and practices, tighten their compliance and data breach monitoring processes, and strengthen their internal controls, compliance in preparation for defending their actions under the newly strengthened Privacy Rules.  Covered entities and their business associates more than ever must ensure their ability to demonstrate to federal regulators the effectiveness of their HIPAA compliance efforts by both adopting the written policies and procedures required by HIPAA and continuously monitoring and administering these safeguards.  Covered entities should consider reviewing the adequacy of their current HIPAA Privacy and Security compliance practices 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.

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, please contact Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

  • HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP 
  • How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
  • Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Curran Tomko Tarski LLP Latest in Health Care 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. 

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 to cstamer@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 here or e-mailing this information here.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


North Texas Healthcare Compliance Professional Association September 8 Meeting Covers Provider Outreach Activities, New Data Breach Rules.

September 4, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

September 8, 2009 Meeting Reminder

North Texas Health Care Compliance Professional Association’s September, 2009 Meeting will feature a discussion by Adele Culpepper, Health Integrity, on Provider Outreach Activities, followed by a discussion of the new HIPAA Data Breach Regulations scheduled to take effect this month.

Date:  Tuesday, September 8, 2009,  2:00 – 4:00 p.m.

Location:          Offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas TX  76011.  Click here for a map and driving directions.

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.  We look forward to seeing you there!

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 or to receive notice of future meetings, e-mail here .  There is no charge to participate.

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 here.


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.

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@cttlegal.net.

©2009 Cynthia Marcotte Stamer.   All rights reserved. 

 


HHS Issues Interim Final Requiring Health Care Provider, Health Plans & Other Covered Entities To Give Breach Notifications When Certain Personal Health Information Breached Beginning In September; Register to Participate In September 10th Briefing on New Rules In Person or Via Telephone

August 20, 2009

The U.S. Department of Health and Human Services (HHS) yesterday (August 19, 2009) issued “breach notification” regulations requiring health care providers, health plans and other covered entities (Covered Entities) under the personal health information privacy and security rules of the Health Insurance Portability & Accountability  (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. Scheduled for publication in the Federal Register on August 24, 2009, the new breach notification regulations are part of a series of new rules that implement new electronic personal health information data security and data breach notification 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).  Covered entities must begin complying with the new rules no later than September 24, 2009.

Curran Tomko Tarski, LLP Health Practice leader Cynthia Marcotte Stamer will conduct a briefing on these new protected health information data security and data breach rules on Thursday, September 10, 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 more information, e-mail here.

 HITECH Act Data Breach and Unsecured PHI Rules

The new data breach notification rules are part of a series of recent HIPAA enacted under the HITECH Act to strengthen the federal rules requiring HIPAA covered entities to safeguard electronic and certain other protected health information. Enhanced data security and data breach rules added as part of these HITECH Act amendments obligate  covered entities and business associates to provide certain notifications following a breach of “unsecured”  “protected health information” within the meaning of HIPAA, as amended.  “Unsecured protected health information” is defined as protected health information that is not secured through the use of a technology or methodology specified by the HHS Secretary.

The new data breach regulations implement the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach and the form, manner, and timing of that notification.  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.  HHS and the Federal Trade Commission previously issued certain initial guidance concerning the HITECH Act standards for determining when electronic personal health information qualifies as secure.  To help further define when electronic health information is treated as “unsecured” and therefore subject to the breach notification requirements, the data breach rules also update and clarify the previously issued existing HHS guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals published earlier this year by HHS to for purposes of determining when protected health information will be considered “unsecured” for purposes of the HITECH Act data breach rules.  Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information.  

The HHS interim final regulations are effective September 24, 2009, which is the date 30 days after the date they will be published on the Federal Register and include a 60-day public comment period. To review the interim final data breach regulations, see here.  To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

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 care providers, payors and their business associates about HIPAA and other privacy and data security matters, as well as a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. 

Past chair of the American Bar Association Health Law Section Managed Care & Insurance Section, Martindale Hubble AV-rated and recognized in International Who’s Who of Professionals, Ms. Stamer continuously advises health care providers, health care payers and administrators, employers, governments and others about health care, insurance, human resources, privacy and data security, technology, and other legal and operational concerns.  A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer also writes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters.  She currently serves as 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.  Examples of her other works include “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 others.  Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service Privacy Report, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a various 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 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.

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.

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.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


CMS Publishes Updated FY 2010 Inpatient Rehabilitation Facility Prospective Payment System Final Rule

August 7, 2009

On August 6, 2009, the Center for Medicare & Medicaid Services (CMS) published its updated final rule governing the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010.  The provisions of the final rule generally are effective October 1, 2009 and will apply to IRF discharges occurring on or after October 1, 2009 and on or before September 30, 2010 (FY 2010).  However, amendments to Sections 412.23, 412.29, and 412.622 don’t take effect until January 1, 2010.

Among other things, the final rule:

  • Updates the FY 2010 IRF PPS relative weights and average length of stay values using the most current and complete Medicare claims and cost report data in a budget neutral manner;
  • Updates the FY 2010 IRF facility level adjustments (rural, LIP, and teaching status adjustments) using the most current and complete Medicare claims and cost report data in a budget neutral manner;
  • Updates the FY 2010 IRF PPS payment rates by the proposed market basket;
  • Updates the FY 2010 IRF PPS payment rates by the wage index and labor-related share in a budget neutral manner;
  • Updates the outlier threshold amount for FY 2010;
  • Updates the cost-to-charge ratio ceiling and the national average urban and rural cost-to-charge ratios for purposes of determining the outlier payments under the IRF PPS for FY 2010;
  • Removes the words “or assessment” from Sections 412.23(b)(3) and 412.29(b) to indicate that CMS is no longer providing for a 3 to 10 day inpatient assessment period after admission to an IRF to assess the appropriateness of the IRF admission;
  • Amends paragraphs Section  412.23(b)(4) and Section 412.29(c) to require that IRFs “furnish, through the use of qualified personnel, rehabilitation nursing, physical therapy, and occupational therapy, plus, as needed, speech-language pathology, social services, psychological services (including neuropsychological services), and orthotic and prosthetic services;”
  • Replaces the word “multidisciplinary” with the word “interdisciplinary” in Section 412.23(b)(7) and Section  412.29(e) to make the terminology consistent with the new IRF coverage criteria in Section 412.622(a);
  • Requires in both Section  412.23(b)(7) and Section 412.29(e) that the interdisciplinary team meetings occur at least once per week (rather than once every two weeks) to be consistent with the new IRF coverage criteria in Section  412.622(a);
  • Adds new paragraphs (3), (4), and (5) to Section 412.622(a) to implement new IRF coverage requirements;
  • With respect to Sections  412.604, 412.606, 412.610, 412.614 and 412.618, removes from Section  412.614(a) current subparagraph (3); and
  • In Section  412.614(d), makes a technical correction to the paragraph formerly designated as paragraph and assigns the revised language to a new paragraph (1)(a), redesignates paragraph (2) as (1)(b), and adds a new paragraph (2).

You can review the actual text of the final rule here.

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.

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.

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.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 

 


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.

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.

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.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


Reassignment of HIPAA Security Rule Enforcement Signals Growing Seriousness About Enforcing HIPAA

August 4, 2009

The Department of Health & Human Services (HHS) today (August 3, 2009) transferred authority for the administration and enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to the Office for Civil Rights (OCR).  Prior to this announcement, responsibility for interpretation and enforcement of the Security Rule rested with the Centers for Medicare & Medicaid Services (CMS).  The change reflects the growing seriousness of HHS and others about enforcing federal privacy and data security mandates for health information.  HHS anticipates the transfer of authority will eliminate duplication and increase efficiencies in how the department ensures that Americans’ health information privacy is protected.

HHS has the authority for administration and enforcement of the federal standards for health information privacy called for in HIPAA. The Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. OCR has been responsible for enforcement of the Privacy Rule since 2003. The Security Rule specifies a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information. The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA), mandated improved enforcement of the Privacy Rule and the Security Rule.

Through a separate delegation, CMS continues to have authority for administration and enforcement of the HIPAA Administrative Simplification regulations, other than privacy and security of health information.

The transfer of Security Rule enforcement authority comes as guidance about new data breach rules for electronic protected health information is impending.  This impending guidance relates to  the implementation of new breach notification rules for covered entities and their business associates concerning their obligation to use of technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, as required by amendments to HIPAA enacted under the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of the American Recovery and Reinvestment Act of 2009 (ARRA) last February.  OCR officials have stated that they are working to publish the next set of regulations regarding these new breach notifications before the end of August, 2009. 

In addition to adding the breach notification requirements, the HITECH Act also tightened the HIPAA mandates in several other respects.  Among other things, it amended HIPAA to:

  • Broaden the applicability of the HIPAA’s Privacy Rules and penalties to include business associates;
  • Clarify that HIPAA’s criminal sanctions apply to employees or other individuals that wrongfully use or access PHI held by a covered entity;
  • Increase criminal and civil penalties for HIPAA Privacy Rules violators;
  • Allow State Attorneys General to bring civil damages actions on behalf of certain state citizens who are victims of HIPAA Privacy and Security Rule violations;
  • Modify certain HIPAA use and disclosure and accounting requirements and risks;
  • Prohibits sales of PHI without prior consent;
  • Tighten certain other HIPAA restrictions on uses or disclosures;
  • Tighten certain HIPAA accounting for disclosure requirements;
  • Clarify the definition of health care operations to excludes certain promotional communications; and
  • Expand the Business Associates Agreement Requirements.

These and other developments make it imperative HIPAA covered entities and their business associates take prompt action to immediately review and update their data security and privacy practices to guard against growing liability exposures under HIPAA and other federal and state laws. Covered entities must update policies and practices to avoid these growing liabilities. Business associates that have not already done so also must appoint privacy officers and adopt and implement privacy and data security policies and procedures fully compliant with HIPAA and other applicable federal and state rules, including amendments enacted as part of the American Recovery and Reinvestment Act of 2009 signed into law on February 17, 2009.

 

For more information about today’s announcement, see here.  See here for the initial guidance and request for comments issued by HHS regarding these new security standards.

For More Information

We hope that this information is useful to you.  If you need assistance with health care privacy and data security, technology, 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 or your other favorite Curran Tomko Tarski LLP Partner.  Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health care privacy and data security and related matters. 

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