OCR Dental Practices Settlements Warn Providers To Honor HIPAA Access Rights

September 20, 2022

Today’s U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announcement of resolution agreements with three separate dental practices warns all health care providers, health plans and health care clearinghouses of the importance of complying with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s patient right of access and other federal and state mandates about providing patients and health plan members access to their records.

The following three resolution agreements OCR announced September 20, 2022 underscore the importance and necessity of compliance with the right of access and other HIPAA requirements:

Chicago-based Family Dental Care, P.C. (“FDC”), paid $30,000.00 to resolve potential OCR charges aiding from OCR’s investigation located in Chicago, Illinois. OCR received a complaint on August 8, 2020, alleging that FDC failed to provide a former patient with timely access to her complete medical records. The former patient requested her entire medical records in May 2020, but received only portions. The former patient filed a complaint with OCR, and during OCR’s investigation, FDC provided her with the remainder of her records in October 2020. Thus, FDC did not provide a complete copy of the records until more than five months after the request was made. OCR’s investigation determined that FDC’s failure to provide timely access to the requested medical records was a potential violation of the HIPAA right of access provision. FDC agreed to pay $30,000 and implement a corrective action plan.

Georgia based dental and orthodontics provider Great Expressions Dental Center of Georgia, P.C. (“GEDC-GA”) paid $80,000 to resolve concerns arising from OCR’s investigation of a November 2020 complaint alleging that GEDC-GA would not provide an individual with copies of her medical records because she would not pay GEDC-GA’s $170 copying fee. The individual first requested her records in November 2019, but did not receive them until February 2021, over a year later. OCR’s investigation determined that GEDC-GA’s failure to provide timely access to the requested medical records, and its practice of assessing copying fees that were not reasonable and cost-based, were potential violations of the HIPAA right of access provision. GEDC-GA agreed to pay $80,000 and implement a corrective action plan.

Las Vegas, Nevada dental practice B. Steven L. Hardy, D.D.S., LTD, doing business as Paradise Family Dental (“Paradise”) paid $25,000 to resolve potential violations uncovered after OCR investigated an October 26, 2020 complaint alleging that Paradise had failed to provide a mother with copies of her and her minor child’s protected health information. The mother submitted multiple record requests between April 11, 2020, and December 4, 2020, but Paradise did not send the records until December 31, 2020, more than eight months after her initial request. OCR’s investigation determined that Paradise’s failure to provide timely access to the requested medical records was a potential violation of the HIPAA right of access provision. Paradise agreed to pay $25,000 and implement a corrective action plan.

The three newly announced resolution agreements bring to 41 the number of resolution agreements OCR has announced since announcing its program targeting access right violations. OCR call Rosov call Riedel access violations are the most common of all reported HIPAA violations.

OCR made clear its announcements of these resolution agreements to “send an important message to dental practices of all sizes that are covered by the HIPAA Rules to ensure they are following the law,” said OCR Director Melanie Fontes Rainer. “Patients have a fundamental right under HIPAA to receive their requested medical records, in most cases, within 30 days. I hope that these actions send the message of compliance so that patients do not have to file a complaint with OCR to have their medical records requests fulfilled.”

Health care providers as well as health plans should heed thus strong warning by ensuring their compliance with the HIPAA right of access as well as other applicable rules about providing patient and plan members copies of records or other data. for healthcare providers, you can please but are not limited to State medical records, ethics, and other rules and regulations. Or health plan, the HIPAA Records access rules are in addition to the Employee Retirement Invome Security Act mandates to provide plan records when requested.

If circumstances come to light that indicate a breach of the access or any other HIPAA standards, Covered Entities also promptly should work with legal counsel timely to investigate, determine and provide any required notifications or other corrective action and document their actions to meet applicable HIPAA and other legal obligations and mitigate liability.

Of course, all HIPAA-covered entities and their leaders always must keep in mind that their responsibilities and potential liability for mishandling protected health information could extend well beyond HIPAA. In addition to the civil monetary penalties HIPAA authorizes, mishandling the collection, protection or disposal of PHI or other sensitive data also can trigger other legal exposures. For instance, as HIPAA compliance is part of the Conditions of Participation that Medicare participating Covered Entities and Medicare Advantage Plans must meet to qualify for program participation, noncompliance could trigger program exclusion, False Claims Act or related exposures. Deficiencies in security or destruction of credit card, banking or other PHI that also qualifies as personal financial information could trigger exposure under Federal Trade Commission, state identity theft and privacy or other laws. Public companies and their leaders also may need to evaluate if deficiencies in their security or destruction protocols trigger investor disclosure obligations under Securities and Exchange Commission rules or other federal or state laws. Considering these and other exposures, documented, compliance and defensibility of PHI and other sensitive information use, protection, disclosure and destruction should rank high among the priorities of all Covered Entities and their leaders.

More Information

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

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

About the Author

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.

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

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

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

About Solutions Law Press, Inc.™

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

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 advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication. 

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

©2022 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

Learn About DOJ Federal Antitrust Health Industry Market Competition Enforcement & Latest On $2.67 Billion BCBS Class Action Antitrust Settlement In 9/8 JCEB Webex

September 2, 2022

As qualifying individuals and companies that purchased or received health insurance await instructions on how to claim their share of the $2.67 billion In re: Blue Cross Blue Shield Antitrust Litigation private federal class action civil antitrust lawsuit settlement (“Settlement”) finally approved August 9, 2022 against the Blue Cross Blue Shield Association (“BCBSA”) and other settling individual Blue Cross Plans, employers and other plan sponsors, health care systems and providers, health insurers, pharmacy benefit managers, brokerages, and other health and health insurance market participants need to keep in mind that the private antitrust judgements are not their only exposure under federal antitrust laws. Health insurance and health industry market participants that engage in anticompetitive conduct or business transactions also risk investigation and prosecution under federal antitrust laws by the U.S. Department of Justice, the Federal Trade Commission and state regulators or attorneys general.

Market participants and others with health or health insurance industry market competitiveness concerns or interests should register and attend the September 8, 2022 Justice Department Health Industry Antitrust Enforcement Update to learn about key federal antitrust statutes regulating or prohibiting anticompetitive conduct and business transactions and hear how the Department of Justice uses these laws to promote market competition in the health care and health insurance marketplaces.

Hosted by the American Bar Association Joint Committee on Employee Benefits, the webinar will feature a discussion by U.S. Department of Justice Civil Division Healthcare and Consumer Products Section Antitrust Attorney Natalie Melada of basic federal antitrust rules and principles the Justice Department relies upon to safeguard market competitiveness and discusses selected Justice Department antitrust litigation and other compliance and enforcement initiatives the Department of Justice has undertaken to protect competition in the healthcare industry. Attorney and Solutions Law Press, Inc. editor and author Cynthia Marcotte Stamer also will provide an update on the In re: Blue Cross Blue Shield Antitrust Litigation and resulting $2.67 billion settlement approved August 9.

For more details and to register for the program, see here.

More Information

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

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

About the Author

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.

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

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

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

About Solutions Law Press, Inc.™

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

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 advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication. 

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

©2022 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

HIT Committee To Meet October 14 In Washington, D.C.

September 29, 2009

The next meeting of the HIT Standards Committee of the Office of the National Coordinator for Health Information Technology (ONC) will be held on October 14, 2009, from 9 a.m. to 3 p.m./Eastern Time at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Interested members of the public are invited to attend. 

Created under the American Recovery and Reinvestment Act of 2009 (ARRA), the HIT Standards Committee is charged with making recommendations to the Office of National Coordinator for Health Information Technology (ONC) on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee.   Even as Congress debates further reforms, the activities of the HIT Committee and other components of the ONC are key actors in the continuing efforts of the Obama Administration to promote health care efficiency by reengineering health care technology.

During a previous meeting on August 20, 2009, the HIT Committee finalized certain recommendations concerning meaningful use of electronic medical records, clinical quality, and privacy and security of protected health information, which are available for review here.

According to the ONC announcement regarding the upcoming meeting in today’s (September 29, 2009) Federal Register available here, the Committee plans during the meeting to:

  • Discuss reports from its Clinical Operations, Clinical Quality, and Privacy and Security Workgroups
  • Take testimony from invited experts in the field of security as it relates to health information technology

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 6, 2009. Oral comments from the public will be scheduled between approximately 2:30 p.m. to 3 p.m. Time allotted for each presentation may be limited. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business.

ONC hopes to make background material available to the public at least two (2) business days prior to the meeting. However, if ONC is unable to post the background material on its Web site before the meeting, it will make that material publicly available at the location of the advisory committee meeting, and post the background material on ONC’s web site after the meeting here.

The designated person to contact for additional information is Jonathan Ishee, Office of the National Coordinator, HHS, 200 Independence Ave, SW., Room 729-G, Washington, DC 20201, 202-205-8493, Fax: 202-690-6079, e-mail: jonathan.ishee@hhs.gov.

If you need assistance preparing or presenting comments to the HIT Standards Committee or with monitoring or responding to other health care IT, privacy and data security, regulatory, operational, public policy or other health care concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Chair and Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

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 Updates available online by clicking on the applicable article title below:

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, 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 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, registering to receive updates in blog form here or e-mailing this information to support@solutionslawyer.net.

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.

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Posted by Cynthia Marcotte Stamer

Where To Read & Share Your Feedback About The Health Care Reform Legislation

August 1, 2009

As the health care reform policy debate continues, Americans increasingly are asking where to read the text of the health care reform legislation that members of Congress are debating and how to share their input. 

 While numerous alternatives presently are pending before Congress, much of recent discussion and debate has focused around one of the following bills:

  • H.R. 3200: America’s Affordable Health Choices Act of 2009,  introduced in the House by Rep Dingell, John D. on July 14, 2009  the text of which as originally introduced may be reviewed  here.  It has been the focus of significant mark up negotiation through out July before the following House Energy and Commerce, House Ways & Means, and House Education & Labor Committees; and
  • S. __, the Affordable Health Choices Act approved by the Senate Committee on Health, Education, Labor and Pensions, the text of which as approved may be reviewed here.

When reviewing these bills, Americans should keep in mind that members of Congress are engaged in ongoing negotiations about the specific provisions and language of these bills, as well as other legislation.  Official developments generally may be monitored here.

Many American businesses and individuals also are asking about how and where to share their views, how to organize others to do the same and other questions about getting the word out. Here a some quick ideas. We encourage others to share. 

  • The Coalition For Patient Empowerment and the Coalition for Responsible Health Care Reform linkedin group are two one of many resources where individuals are sharing information about these matters. 
  • Concerned individuals should share their views both by faxing, e-mailing or telephoning key decisionmakers in Congress, as well as joining and participating in activities of other individuals and groups that share their concerns.  Contact and get involved with this and other groups that share your concerns.
  • Contact the offices of your Congressional representatives in the House and Senate as well as other members of Congress that support your views and ask them about other groups and ways that you can share your views. They will welcome your input and involvement.
  •  If you are aware of or involved in a group that shares your views, we encourage you to share it on the Coalition for Responsible Health Care Reform linkedin group.  If you or others are planning a town hall or other health care reform meeting, use this or other linked in groups to spread the word.
  • If you are interested in volunteering to plan events in your region, let us know.   

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, and registering to receive these updates here.

When communicating, consider targeting your messages to members of Congress whose votes are likely to be impacted by your communications. 

For instance, with both the House and Senate in the majority in Congress, Democrats generally have greater control over what legislation moves forward.  The Democratic Leadership of the House and Sentate generally can get legislation passed by their members as long as they can maintain consensus among the members of their parties.  In connection with the health care reform proposals, however, cost and other considerations have made maintaining a consensus more difficult than on other legislation.  Certain fiscally moderate members of the Democratic Party have expressed concern about the expense and other aspects of their Leadership proposed health care reform proposals.  These Democrats in Congress generally the members of Congress whose votes are most likely to be impacted by public input and feedback generally and from voters in their districts and contributors specifically. 

In the House of Representatives, these members likely are the “Blue Dog Democrats.”  Read about Blue Dog Democrats here.    

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

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

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

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

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

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

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

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

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

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

The Blue Dog Members and their telephone numbers are :

  • Altmire, Jason (PA-04),(202)225-2565
  • Arcuri, Mike (NY-24), (202)225-3665
  • Baca, Joe (CA-43),(202)225-6161
  • Barrow, John (GA-12), (202) 225-2823
  • Berry, Marion (AR-01), (202) 225-4076
  • Bishop, Sanford (GA-02), (202) 225-3631
  • Boren, Dan (OK-02), (202) 225-2701
  • Boswell, Leonard (IA-03), (202) 225-3806
  • Boyd, Allen (FL-02), (202) 225-5235
  • Bright, Bobby (AL-02), (202) 225-2901
  • Cardoza, Dennis (CA-18), (202) 225-6131
  • Carney, Christopher (PA-10), (202) 225-3731
  • Chandler, Ben (KY-06), (202) 225-4706
  • Childers, Travis (MS-01), (202) 225-4306
  • Cooper, Jim  (TN 5th), (202) 225-4311
  • Costa, Jim  (CA 20th), (202) 225-3341
  • Cuellar, Henry  (TX 28th), (202)  225-1640
  • Dahlkemper, Kathleen A. (PA 3rd), (202) 225-5406
  • Davis, Lincoln (TN 4th),(202) 225-6831
  • Donnelly, Joe  (IN 2nd), (202) 225-3915
  • Ellsworth, Brad  (IN 8th), (202) 225-4636
  • Giffords, Gabrielle  (AZ 8th), (202) 225-2542
  • Gordon, Bart  (TN 6th), (202) 225-4231
  • Griffith, Parker  (AL 5th), (202) 225-4801
  • Harman, Jane  (CA 36th), (202) 225-8220
  • Herseth Sandlin, Stephanie  (SD At Large), (202) 225-2801
  • Hill, Baron P.  (IN 9th), (202) 225-5315
  • Holden, Tim  (PA 17th), (202) 225-5546
  • Kratovil, Frank Jr. (MD 1st), (202) 225-5311
  • McIntyre, Mike  (NC 7th), (202) 225-2731
  • Marshall, Jim  (GA 8th), (202) 225-6531
  • Matheson, Jim  (UT 2nd), (202) 225-3011
  • Melancon, Charlie  (LA 3rd), (202) 225-4031
  • Michaud, Michael H. (ME 2nd), (202) 225-6306
  • Minnick, Walt  (ID 1st), (202) 225-6611
  • Mitchell, Harry E.  (AZ 5th), (202) 225-2190
  • Moore, Dennis  (KS 3rd), (202) 225-2865
  • Murphy, Patrick J.  (PA 8th), (202) 225-4276
  • Nye, Glenn C.  (VA 2nd), (202) 225-4215
  • Peterson, Collin C.  (MN 7th), (202) 225-2165
  • Pomeroy, Earl  (ND At Large), (202) 225-2611
  • Ross, Mike  (AR 4th), (202)  225-3772
  • Salazar, John T.  (CO 3rd), (202) 225-4761
  • Sanchez, Loretta  (CA 47th), (202) 225-2965
  • Schiff, Adam B.  (CA 29th), (202) 225-4176
  • Scott, David  (GA 13th), (202) 225-2939
  • Shuler, Heath  (NC 11th), (202) 225-6401
  • Space, Zachary T. (OH 18th), (202) 225-6265
  • Tanner, John S.  (TN 8th), (202) 225-4714
  • Taylor, Gene  (MS 4th), (202) 225-5772
  • Thompson, Mike  (CA 1st), (202) 225-3311
  • Wilson, Charles (OH-06), (202) 225-5705

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

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

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Posted by Cynthia Marcotte Stamer

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

July 15, 2009

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.  

If you need assistance evaluating or formulating comments on the proposed reforms contained in the House Bill or on other health industry matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 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 or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update in real time here, joining the LinkedIn SLP Health Care Risk Management & Operations Group, and/or subscribing to receive e-mail distributions of some of these updates by sharing your current contact information – including your preferred e-mail- by creating or updating your profile here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

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

©2009 Cynthia Marcotte Stamer.  All rights reserved.

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Posted by Cynthia Marcotte Stamer

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

June 10, 2009

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

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

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

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

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

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

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

Assistance Monitoring & Responding To Health Care Reform Proposals

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

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

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

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

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

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

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

Additional Resources & Information

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

©2009 Cynthia Marcotte Stamer. All rights reserved.

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Posted by Cynthia Marcotte Stamer

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

May 26, 2009

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

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

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

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

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

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

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

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

For More Information

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

You can review other recent health care and internal controls resources and additional information about the health industry and white collar experience of the Curran Tomko Tarski LLP attorneys at http://www.CTTLegal.com. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at CTTLegal.com or e-mailing this information to CStamer@CTTLegal.com.

Leave a Comment » | Anti-KickBack, ARRA, Construction, Corporate Compliance, Doctor, Federal Sentencing Guidelines, Grants, Health Care, Health Care Fraud, Health Care Provider, Health Care Reform, Health Plan, Health Policy, Hospital, OCR, OIG, Physician, Prescription Drugs, Reimbursement, Stark | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

Stamer To Discuss “Making Gainsharing Work: Managing Physician Performance” At June 17, 2009 Dallas Bar Association Health Law Section Meeting

May 26, 2009

Health care organizations, health plans and regulars increasingly point to gainsharing and pay-for-performance strategies as key to securing needed key physician buy-in and performances to achieve desired health care quality and cost objectives.  Using physician gainsharing to promote desired performances within the bounds of the law without undesirable side effects involves more than staying within the STARK exceptions and anti-kickback safe harbors. 

Curran, Tomko Tarski, LLP attorney Cynthia Marcotte Stamer will discuss key strategies and processes for designing and administering legally defensible pay-for-performance and other gainsharing arrangements that promote desired outcomes in operation at the Dallas Bar Association Health Law Section meeting on June 17, 2009. 

Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, attorney and author Cynthia Marcotte Stamer is nationally and internationally recognized for her legal work, publications and programs, and advocacy on health industry performance management and other health industry matters.  Ms. Stamer works extensively with health care organizations, managed care and health insurance organizations, governments and others to manage performance and legal risks.  Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer combines her more than 22 years of health industry regulatory and risk management experience with an in-depth knowledge of workforce management and regulation to help clients manage performance and legal and operational risks.  Her experience includes advising public and private health industry clients domestically and internationally on a wide range of matters.  A widely published author and popular speaker, Ms. Stamer’s insights on health industry matters also are quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications.

 Ms. Stamer is scheduled to begin her remarks at Noon on June 17, 2009 at the offices of the Dallas Bar Association located at 2101 Ross Avenue, Dallas, Texas 75201.  For additional information, call the Dallas Bar Association at 214-220-7400 or see http://www.dallasbar.org.

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Posted by Cynthia Marcotte Stamer

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

April 20, 2009

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

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

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

If you have questions about the Report, Medicare reimbursement or compliance or any other health care compliance and risk management policies, practices or programs, assessing the strength of your controls in addressing these laws or other healthcare laws and regulations, or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer at cstamer@CTTLegal.com or (214) 270- 2402. For More Information We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com. You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at slphealthcareupdate.wordpress.com. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

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Posted by Cynthia Marcotte Stamer