CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training

July 20, 2010

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) will co-host an Audio Training on the Final Rules for ONC Certification and Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs on July 22, 2010 from 2:00-3:30 pm EST. 

During the training, the Agencies plan to discuss: 

  • Benefits of HIT
  • Summary of the final rules
  • ONC temporary certification process
  • ONC initial set of standards and implementation specifications
  • Medicare and Medicaid EHR Incentives Programs including the initial definition of meaningful Use

To join the audio training, dial 1-877-251-0301 and enter the Conference ID pass code: 87841621 

Materials will be made available prior to the training at the following web address here.  

For more information about CMS EMR incentives, see here.   

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


Office of Civil Rights Proposes Changes To HIPAA Privacy, Security & Civil Sanctions Rules

July 9, 2010

Stay Tuned To Solutions Law Press For More Details

Get ready for even tighter privacy and security rules and more enforcement!  The U.S. Department of Health & Human Services Office for Civil Rights (OCR) on July 8, 2010 proposed changes to its existing Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Enforcement Rules in response to amendments enacted under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Because of the lead time required to implement needed changes in policies, technology and training, health care providers, health plans, healthcare clearinghouses and their business associates should evaluate and begin preparations to adjust their health information privacy and data security policies and practices in anticipation of the finalization and implementation of these rules. 

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

Solutions Law Press is finalizing arrangements to host a briefing on the proposed changes in August and planning more detailed updates on these developments.  Stay tuned to Solutions Law Press for additional updates and details about a future briefing on these proposed HIPAA changes and other developments affecting HIPAA and other health plan and human resources matters.   In the meanwhile, you may want to check out other existing Solutions Law Press updates and resources about HITECH Act and other HIPAA developments such as HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

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


DEA/DOJ Release Interim Final E-Prescribing Rules

March 25, 2010

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

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

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

About The Author

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

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

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More 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 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.


TSHHRAE Provides Health Industry Managers Employment Law Update & Other Timely Management Training At April Barnstorm 2010: Creating Effective Leaders Programs

March 23, 2010

Get Details & Registration Information here!

A Legal Update on Employment Law presentation by Attorney Cynthia Marcotte Stamer is among 5 hours of “Barnstorm 2010: Creating an Effective Leaders-Tools of the Trade” management training that the Texas Society for Healthcare Human Resources Administration and Education (TSHHRAE) will be hosting for health industry human resources and other managers in five Texas cities between April 26 and April 30, 2010. 

Interested health industry human resources and other managers can elect to participate in TSHHRAE’s Barnstorm 2010 management training at the following dates and locations:  

  • April 26 – Weslaco, Knapp Medical Center
  • April 28 – Sweetwater, Rolling Plains Memorial Hospital
  • April 28 – Brenham, Trinity Medical Center
  • April 29 – Lubbock, University Medical Center
  • April 30 – Odessa, Medical Center Hospital

Update on Employment Law Program Highlights

Ms. Stamer’s Legal Update on Employment Law Program will address:

  • Recent changes in FMLA, Military Leave, wage and hour, ADA & other disability, COBRA, GINA, HIPAA and other selected federal & Texas employment laws and regulations;
  • Rising government enforcement of EEOC, HIPAA, wage & hour, worker classification, and other laws and regulations;
  • Recent developments and increases in retaliation claims;
  • Recent cases related to supervision; and
  • Other selected developments impacting health industry human resources management.

Other Barnstorm 2010 Program Highlights and Details

In addition to the Legal Update on Employment Law that Ms. Stamer is scheduled to present, the Barnstorm Program also will feature presentations on:

  • Leadership in 2010
  • Dealing with Poor Performers; and
  • Cultivating a Superstar

For registration and other information about the Barnstorm Program, see here.

About Ms. Stamer

Nationally and internationally recognized for more than 22 years of work with health industry and other organizations, publications, workshops and presentations and leadership on health industry and other labor and employment, staffing and credentialing, employee benefits, performance management and discipline, regulatory compliance and internal controls, risk management, and public policy matters, Ms. Stamer is Chair of the Curran Tomko Tarski Labor & Employment & Health Care Practice Groups, Vice President of the North Texas Health Care Compliance Professionals Association, Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Committee, a Council Representative on the ABA Joint Committee on Employee Benefits and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer is.  The publisher of Solutions Law Press HR & Benefits Update, the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update and a former legal columnist for MD News, Ms. Stamer also is a popular speaker and author of these topics.  She regularly speaks and conducts training for the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, Harris County Medical Society, the Medical Group Management Association, SHRM, Southwest Benefits Association and many other organizations.  Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others.  You can review other highlights of Ms. Stamer’s health care experience here, and employment experience hereHer insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@cttlegal.com or 214.270.2402. 

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More 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 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.


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.


IRS To Allow Medical Resident FICA Refund Claims

March 2, 2010

 

By Cynthia Marcotte Stamer

The Internal Revenue Service (IRS) announced today (March 2, 2010) that it has made an administrative determination to accept the position that medical residents are excepted from FICA taxes based on the student exception for tax periods ending before April 1, 2005, when new IRS regulations went into effect.  The announcement paves the way for health care organizations that have paid and withheld covered  FICA contributions with respect to medical residents and the affected medical residents who had those amounts deducted from wages before the change in the student exemption to seek a refund.

According to the March 2, 2010 IRS Newswire, the IRS will, within 90 days, begin contacting hospitals, universities and medical residents who filed FICA (Social Security and Medicare tax) refund claims for these periods with more information and procedures. Employers and individuals with pending claims do not need to take any action although not yet posted as of the release of this update, an official copy of IR-2010-025 is expected to be posted here soon.

For Assistance With Compliance Or Other Concerns

If your organization needs advice or assistance in responding to this guidance or with 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

Ms. Stamer is nationally known for her work, training and presentations, and publications on health and managed care staffing, employment, regulatory, tax and other operations, risk management and compliance matters. 

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former 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 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.  

Other Recent Developments

If you found this information of interest, you also may be interested in information about upcoming programs to be presented by Ms. Stamer, acquiring a copy of a recording or materials from previous programs she has presented, or arranging training for your organization.  For more information about these opportunities, contact Ms. Stamer directly.

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

For More Information

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

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.


HHS Delays 2010 HHS Federal Poverty Rate Update To March 1, 2010

January 22, 2010

Rates Often Impact Federal Low Income & Other Charity Programs

By Cynthia Marcotte Stamer

Health care, educational and other charity care and other organizations participating in federal programs that determine eligibility based on the Federal Poverty Rate may continue to rely on 2009 Federal Poverty Rates until at least March 1, 2010.  However these federal program participants and other organizations and programs that otherwise rely on Federal Poverty Rates for purposes of making eligibility, sliding scale fees or other determinations will want to watch for the updated guidelines and make appropriate updates as necessary when the new guidelines are released over the next few months.

The U.S. Department of Health & Human Services (HHS) usually issues annual updates to the Federal Poverty Rates in January.  However, HHS announced January 22, 2010 that its annual update of Federal Poverty Rates for 2010 will be delayed until at least March 1, 2010.   As a result of this announcement, 2009 Federal Poverty Rates will remain in effect for the time being until at least March 1, 2010.

Health care organizations and a wide range of other organizations and programs use the Federal Poverty Guidelines to decide program eligibility or fees.  Many federal programs use the federal poverty guidelines as one criterion for federal program eligibility.  For example, the Medicaid and State Children’s Health Insurance (SCHIP) programs determine eligibility largely on the basis of whether the applicant’s income is below the federal poverty guidelines.  Other programs determine financial eligibility based on a percentage or multiplier of the federal poverty guidelines (for example, 125 percent of federal poverty guidelines).  In addition, the federal poverty guidelines are used in the immigration context, such as Form I-864 Affidavit of Support.

Under the 2009 Federal Poverty Guidelines continued in force by the HHS announcement, the applicable income amounts under the 2009 Federal Poverty Guideline in the 48 contiguous states and Washington, D.C. are as follows:

2009 Poverty Guidelines for the 48 Contiguous States and the District of Colombia* 
Number of Family Members Poverty Guideline Income
1 $10,830
2 $14,570
3 $18,310
4 $22,050
5 $25,790
6 $29,530
7 $33,270
8 $37,010
8+ Add $3,740 for each additional person.
* Alaska and Hawaii have slightly higher poverty guidelines.

 

In addition to determining eligibility for purposes of many federal programs, many health care and social services organizations, especially non-profit organizations, utilize a sliding fee scale or fee waiver based on the federal poverty guidelines.  In addition, many health care organizations base their charitable care policies on the federal poverty guidelines.  For programs where the use of federal poverty guidelines is optional, organizations may want to evaluate whether business or operational needs or other considerations merit any adjustment or use of alternative standards at this time.

While use of the federal poverty guidelines is not mandated by law except by federally funded programs, the Joint Commission as part of its accreditation and survey process may ask whether the organization has utilized the most recent update to the federal poverty guidelines in its sliding scale or fee waiver policies.  Therefore, hospitals and other organizations subject to Joint Commission or other accreditation relying on the Federal Poverty Guidelines should review their charity care or fee waiver policies and monitor for planned updates.

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 Ms. Stamer’s 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, 214.270.2402or 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:

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. 


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

October 22, 2009

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

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

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

For More Information

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.  To unsubscribe, e-mail here.


North Texas Healthcare Compliance Professional Association To Meet At Texas Health Resources On October 13

September 29, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

October 13, 2009 Meeting Reminder

2:00 – 4:00 p.m. at the Texas Health Resources Pavilion

North Texas Health Care Compliance Professional Association’s October 13, 2009 Meeting will feature a participatory Health Care Compliance Roundtable Discussion of Hot Topics moderated by the Erma E. Lee,  JPS Health Network District Compliance Officer and NTPCA President on Tuesday, October 13, 2009 from 2:00 – 4:00 p.m at the Texas Health Resources Pavilion located at 612 E. Lamar Blvd., Arlington, TX.  Topics to be discussed include:

  •  HIPAA Data Breach, Red Flag & Other Evolving Privacy & Data Security Obligations & Risks
  •   Office of Civil Rights Health Industry Disability & Other Civil Rights Enforcement
  • Tax-Exemption Issues Including Proposed Form 990 and Exemption Reforms In Health Care Reform
  • Health Care Fraud Enforcement
  • Other Hot Developments

Come catch up on these and other new developments and exchange thoughts and insights with other Health Care Compliance Professionals!                       

NTHCPA thanks Texas Health Resources for hosting this month’s meeting.

For additional information, please contact NTHCPA Vice-President Cynthia Marcotte 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 .

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.


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.


Senate Finance To Begin Markup Session on Baucus Health Care Reform Proposal On September 22

September 18, 2009

The Senate Committee on Finance plans on Tuesday, September 22, 2009 to being meetings to hash out how to convert into proposed legislation the health care reform proposal outlined in the “Chairman’s Mark America’s Healthy Future Act of 2009” introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

While the Chairman’s Markup outlining the health care reform elements that Chairman Baucus’ proposes for adoption by Congress, the specific legislation that the Chairman proposes to be used to implement these proposals has not yet been introduced.  Deciding the language and other features of such legislation -i.e., actually drafting the statutory language – is a primary purpose of the September 22, 2009 meeting.

Until actually reduced to specific legislative language, it is difficult for members of Congress and the Americans they represent to know and assess the changes proposed and their potential implications.  However, a review of the proposal outlined in the Chairman’s Markup indicates that the adoption of the proposed would impose significant burdens and costs on employers and their employees, while substantially curtailing their health coverage choices.  For instance, the Chairman’s Markup would:

  • Set up insurance “exchanges” through which some individuals and families could receive federal subsidies topurchase coverage;
  • Allow for the creation of “CO-OPs” as an alternative source of coverage
  • Mandate that most legal residents of the United States obtain health insurance and impose an income based penalty for Americans failing to secure that coverage;
  • While not explicitly requiring employers to offer health insurance, the Chairman’s markup would among other things subject businesses with more than 50 workers that did not offer coverage to a penalty for any workers who obtained subsidized coverage through the insurance exchanges also to be established under the legislation. As a rule, full-time employees who were offered coverage from their employer would not be eligible to obtain subsidies via the exchanges but an exception to that “firewall” would be allowed for workers who had to pay more than 13 percent of their income for their employer’s insurance (in which case the employer would also be penalized). Under certain circumstances, firms with relatively few employees and relatively low average wages would also be eligible for tax credits to cover up to half of their contributions toward health insurance premiums.
  • Deter employers and their employees from investing in higher grade coverage that might otherwise be available for purchase in the marketplace by subjecting insurance policies with relatively high total premiums to a 35 percent excise tax on the amount by which the premiums exceeded a specified threshold. In general, that threshold would be set initially at $8,000 for single policies and $21,000 for family policies; after 2013, those amounts would be indexed to overall inflation.
  • Significantly expand eligibility for Medicaid;
  • Significantly tighten tax-exemption requirements for hospitals and other charitable health care organizations;
  • Radically reduce the growth of Medicare’s payment rates for most services (relative to the growth rates projected under current law) and make various other changes to the Medicaid and Medicare programs and the federal tax code to reduce government program costs.  The Congressional Budget Office projects that among the proposed provisions that would result in the largest budget savings are:
    • Make permanent reductions in the annual updates to Medicare’s payment rates for most services in the fee-for-service sector (other than physicians’ services)
    • Set payment rates in the Medicare Advantage program based on the average of the bids submitted by Medicare Advantage plans in each market
    • Reduce Medicare and Medicaid payments to hospitals that serve a large number of low-income patients, known as disproportionate share (DSH) hospitals
    • Establish a Medicare Commission, which would be required, under certain circumstances, to recommend changes to the Medicare program to limit the rate of growth in that program’s spending. Those recommendations would go into effect automatically unless blocked by subsequent legislative action. Before 2019, such recommendations would be required if the Medicare Trustees project that Medicare spending per beneficiary will grow more rapidly than a measure of inflation (the average of the growth rates of the consumer price index for medical services and the overall index for all urban consumers). After 2019, recommendations would be required if projected growth exceeded the rate of increase in gross domestic product (GDP) per capita plus 1 percentage point. Because the proposal would prohibit the Commission from modifying eligibility or benefits, its recommendations probably would focus on changes to payment rates or methodologies. The Commission would develop its first set of recommendations during 2013 for implementation in 2015.

Other Recent Developments

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

For More Information

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

Ms. Stamer has extensive experience in these and other health industry related representation.  You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group

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.


CMS Proposes New Prospective Payment System For Renal Dialysis Facilities

September 15, 2009

November 16, 2009 is the deadline to comment on a new prospective payment system (PPS) for facilities that provide dialysis services to Medicare beneficiaries who have end-stage renal disease (ESRD) proposed by the Centers for Medicare & Medicaid Services (CMS) today (9/15/09).  Interested persons can review the proposed rule here.

Currently, ESRD is the only category for Medicare eligibility that is based on a specific diagnosis, without regard to the age of the patient. Patients diagnosed with ESRD must rely on dialysis or receive a kidney transplant for survival.  ESRD services are furnished on an outpatient basis in independent or hospital-based dialysis facilities. Currently, Medicare pays for certain dialysis services under a partial bundled rate, referred to as the composite rate. Payments for these composite rate services represent about 60 percent of total Medicare payments to ESRD facilities. The remainder of Medicare spending for dialysis services is for separately billed items such as drugs, but may also include laboratory services, supplies and blood products.

Today’s notice proposes three quality measures that CMS plans to use for its quality incentive program (QIP) and lays out a conceptual model for public comment.  

Quality Improvement Measures

The ESRD PPS proposed rule proposes the following specific measures that will apply to the initial performance period of the Quality Incentive Program:

  • Hemodialysis Adequacy: Achieved urea reduction ratio (URR) of 65 percent or more;
  • Anemia Management: Controlled anemia, as shown in two measures:
    • The percentage of patients at a facility whose hemoglobin levels were less than 10 grams per deciliter (g/dL), and
    • The percentage of patients at a facility whose hemoglobin levels were greater than 12 g/dL.

CMS reports the proposed measures were chosen because dialysis facilities have used them since 2001. These measures are currently collected from Medicare dialysis facility claims so there is no need for separate reporting. Finally, CMS already has data on these measures which it can use to develop and test models for the operation of the QIP.

As required by law, CMS plans to establish performance standards for each of the measures and facilities would be scored based on their adherence to the measures. Providers and facilities that do not meet or exceed the total performance score during a performance period would see up to a two percent reduction from their payment rates in the succeeding year.

CMS will accept comments on this conceptual QIP model in the ESRD PPS proposed rule through November and will is 

The ESRD PPS proposed rule proposes the following specific measures that will apply to the initial performance period of the Quality Incentive Program:

  • Hemodialysis Adequacy: Achieved urea reduction ratio (URR) of 65 percent or more;
  • Anemia Management: Controlled anemia, as shown in two measures:
    • The percentage of patients at a facility whose hemoglobin levels were less than 10 grams per deciliter (g/dL), and
    • The percentage of patients at a facility whose hemoglobin levels were greater than 12 g/dL.

CMS reports the proposed measures were chosen because dialysis facilities have used them since 2001. These measures are currently collected from Medicare dialysis facility claims so there is no need for separate reporting. Finally, CMS already has data on these measures which it can use to develop and test models for the operation of the QIP.

As required by law, CMS plans to establish performance standards for each of the measures and facilities would be scored based on their adherence to the measures. Providers and facilities that do not meet or exceed the total performance score during a performance period would see up to a two percent reduction from their payment rates in the succeeding year.

Proposed PPS Model

The proposed PPS would provide a single bundled payment to dialysis facilities that would cover the items and services used in providing outpatient such services, including the dialysis treatment, prescription drugs, and clinical laboratory tests.  

Under the proposed rule, CMS would establish a base bundled payment rate of $198.64 for all of the services related to a dialysis session, including the services in the current composite rate as well as items, including oral drugs that are billed separately. CMS reports the proposed base rate was derived from 2007 claims data for both composite rate and separately billable services and updated to reflect projected 2011 prices. CMS would adjust this base rate for case mix factors such as the patient’s age, gender, body size, and time on dialysis. A special case-mix adjustment would apply to pediatric patients. Additional adjustments to the payment rate would be made for specific conditions, or co-morbidities that have a significant impact on a course of treatment. By accounting for more characteristics of patients, the new PPS would target payments more appropriately, paying higher rates to those facilities with the most costly patients. The base rate would also be adjusted to reflect geographic differences in labor costs. In addition, CMS is proposing to provide an adjustment for low-volume facilities, as well as an outlier policy that would make an adjustment for particularly expensive cases.

The following are highlights of the proposed mechanics of the proposed new PPS:

ESRD Base Rate and Bundle of Services: CMS is proposing to pay a base rate of $198.64 per dialysis treatment, representing the average Medicare allowable payment per treatment for composite rate and separately billable services, including training and home dialysis costs, laboratory services and all ESRD-related Part B and former Part D drugs. The proposed base rate would be adjusted to reflect patient- and facility-specific differences in case-mix and other adjustments as required by MIPPA.

To arrive at a base rate, CMS is proposing to adjust the average payment per treatment using 2007 claims data adjusted to reflect 2011 projected prices. The rate will not include positive adjustments for case-mix and the wage index as those will be introduced into the payment formula at a later time. This standardized amount must then be reduced by 1.0 percent to fund the proposed outlier policy, and reduced by the percentage required by MIPPA to reflect 98 percent of the estimated payments that would have been made absent the statutory changes.  

Proposed Standardized Amount: Based on 2007 claims data, total per treatment payments in CY 2011 are projected to be $261.58. To eliminate the overall positive effects of the proposed case-mix and geographic adjustments, CMS is proposing a 21.73 percent reduction, yielding a standardized amount of $204.74.  

Proposed Outlier Adjustment: CMS is proposing to reduce the standardized amount by 1.0 percent for outlier payments for cases requiring unusually high amounts of drugs or other services that are separately payable under the current payment system. This 1.0 percent reduction lowers the standardized amount of $204.74 to $202.69.

MIPPA Required 98 Percent Adjustment: As required by MIPPA, CMS is also proposing to adjust the reduce the standardized amount by 2.0 percent to ensure that estimated total Medicare payments to ESRD facilities in CY 2011 are 98 percent of what they would have been under the existing system. This additional reduction yields a proposed base rate of $198.64.

Transition Budget Neutrality Adjustment: Also required by MIPPA, CMS is proposing that a transition budget neutrality adjustment factor (a 3.0 percent reduction) be applied to all payments during the four-year phase-in and would make payments under the transition the same as they would have been had there not been a transition. As part of this transition budget neutrality adjustment, during the transition, CMS is proposing to apply a $14 per treatment adjustment to the composite rate portion of the blended payment amount to reflect ESRD-related Part D drugs.

Patient-Level Adjustments: As authorized by MIPPA, CMS is proposing to adjust the base rate for case mix using a variety of factors which have been found to affect costs. Under the existing payment system, the composite rate is adjusted for age, body surface area (BSA), body mass index (BMI), and pediatric status. The proposed rule would add adjustments for patient sex (female patients) and certain co-morbidities, as well as a “new patient adjustment” that recognizes that patients have higher costs in their first four months of maintenance dialysis. In addition, special payment adjusters would apply for providers of pediatric services. CMS is specifically seeking comment about these and other patient characteristics that may affect costs of treatment and for which a payment adjustment may be appropriate.

Facility-Level Adjustments: MIPPA specifically requires CMS to adopt an adjustment for low-volume facilities and gives the HHS secretary discretion to adopt additional facility-level adjustments. Based on an analysis of ESRD data, CMS is proposing to define low-volume facilities as those facilities that: (1) furnished fewer than 3,000 treatments in each of the three years preceding the payment year; and (2) have not opened, closed, nor received a new provider number due to a change in ownership during the three years preceding the payment year. Other definitions may be added to include geographic restrictions. CMS is also proposing to continue to apply a wage index adjustment using the core-based statistical area (CBSA) definitions. The index would be based on the most current hospital wage data, prior to application of the rural floor and occupational mix adjustments, and geographic reclassifications.

Outlier Policy: MIPPA requires CMS to make adjustments for high cost patients, called outlier payments, to ESRD facilities that treat patients who use more than the predicted amount of services, including the amount of erythropoietin stimulating agents (ESAs) used to manage dialysis-related anemia. As noted previously, CMS is proposing to reduce the standardized amount for all dialysis treatments by 1.0 percent, to fund the proposed 1.0 percent policy under the new ESRD PPS. CMS is proposing a fixed loss dollar amount of $134.96 for adult and $174.31 for pediatric dialysis patients. Once the fixed dollar amount is met, CMS would pay 80 percent of the ESRD facility’s outlier service costs. CMS projects that approximately 5.3 percent of adult and 2.6 percent of pediatric patient months would qualify for outlier payments.

Annual Payment Rate Updates: As required by MIPPA, beginning in CY 2012 the ESRD PPS base rate will be updated annually by an ESRD market basket index minus one percentage point. The proposed rule includes a discussion of how the ESRD market basket would be calculated.

Beneficiary Coinsurance: CMS is proposing that the beneficiary coinsurance amount be 20 percent of the ESRD bundled payment amount, including applicable case-mix adjustments and outlier payments. CMS will accept comments on the proposed rule through November 2009, and will respond to them in a final rule to be issued in 2010. The new payment system would apply to renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2011.

Required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS reports the new payment system set forth in the proposed rule is designed to improve the efficiency of care, while promoting high quality services.

CMS will accept comments on the proposed rule through November 16, 2009, and will respond to them in a final rule to be issued in 2010. The new payment system would apply to dialysis services furnished to Medicare beneficiaries on or after January 1, 2011.

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Leader Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.  The former Compliance Committee Chair of the National Kidney Foundation of North Texas, Ms. Stamer has extensive experience advising nephrology, dialysis and other health care providers about gainsharing and other reimbursement, quality, regulatory and compliance, risk management, workforce and staffing and other operational matters.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solutions Law Press 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.   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.


DEA Seeks Comments on Standardization of Code Number For Institutionally Based Practitioners Dispensing Controlled Substances

September 9, 2009

Midnight on November 9, 2009 is the deadline to respond to request for comments of the Drug Enforcement Administration (DEA) on how best to standardize the specific internal code number associated with each individual practitioner permitted by the hospital  or other institutional practitioner to administer, dispense, or  prescribe controlled substances using that institution’s DEA registration.

DEA is soliciting public input in response to comments received to its Notice of Proposed Rulemaking  “Electronic Prescriptions for Controlled Substances” regarding electronic prescriptions for controlled substances published on June 27, 2008, 73 FR 36722.  In that Notice, DEA proposed:

  • That  pharmacy applications receiving electronic prescriptions for controlled  substances be capable of reading and retaining the full DEA  registration number, including any extensions, or other identification  numbers used under 21 CFR 1306.05(c).
  • That the full number including extensions must be retained in the prescription record.
  • That the pharmacy application must verify that the practitioner’s DEA registration was valid at the time the prescription was signed by checking the DEA CSA database or by having another entity check the DEA CSA database during transmission and indicate on the record that the check has occurred and the registration is valid.
  • That the pharmacy application must reject prescriptions signed by practitioners without valid DEA registrations.    
  • Every person who dispenses controlled substances is required to obtain a DEA registration under the Comprehensive Drug Abuse Prevention  and Control Act of 1970, often referred to as the Controlled Substances  Act (CSA) and the Controlled Substances Import and Export Act (21  U.S.C. 801-971), (CSA).
  • An individual practitioner who is an agent or employee of a  hospital or other institution registered with DEA may use the DEA  registration of that hospital or other institution to administer,  dispense, or prescribe controlled substances in accordance with the  regulations (21 CFR 1301.22(c)). Specifically,  an individual practitioner who is an agent or employee of a  hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe  controlled substances under the registration of the hospital or  other institution which is registered in lieu of being registered  himself if:
  • The dispensing, administering or prescribing is done in the  usual course of his professional practice;  
  • The individual practitioner is authorized or permitted to  do so by the jurisdiction in which he is practicing;    
  • The hospital or other institution by whom he is employed  has verified that the individual practitioner is so permitted to  dispense, administer, or prescribe drugs within the jurisdiction;    
  • The individual practitioner is acting only within the scope  of his employment in the hospital or institution;  
  • The hospital or other institution authorizes the individual  practitioner to administer, dispense or prescribe under the hospital  registration and designates a specific internal code number for each  individual practitioner so authorized consisting  of numbers, letters, or a combination thereof and shall be a suffix  to the institution’s DEA registration number, preceded by a hyphen; and
  • A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. See 21 CFR  1301.22(c).

In response to the comments on these proposed provisions, DEA has determined standardization of the internal code numbers assigned by institutional  practitioners to the individual practitioners they permit to use their  registration to administer, dispense, and prescribe controlled  substances is essential for DEA to require pharmacy systems to retain this  information.

Since this number has never been standardized, however, DEA anticipates that institutional practitioner registrants have established a variety of internal code number systems. Accordingly, DEA is soliciting information from the regulated  industry and other interested members of the public regarding current methods used and how best to implement industry standardization  in this area. Specifically, DEA seeks the following information:

  • Information regarding formats used by institutional  practitioners when establishing internal code numbers for individual  practitioners permitted to use the institution’s registration number;     
  • Estimates of the number of individual practitioners using  internal code numbers for identification purposes;    
  • Estimates of the number of individual practitioners using  internal code numbers for identification purposes in a particular  institutional practitioner;    
  • Estimates of costs to institutional practitioners if code  numbers for individual practitioners were to be standardized and what  changes would be associated with those costs;  
  • Formats pharmacy applications could accommodate or would  prefer, recognizing that pharmacy applications may need to be  reprogrammed to accept this information;
  • Estimates of the costs to pharmacies and/or pharmacy  application providers for such reprogramming;
  • Comments regarding whether pharmacies have had difficulty obtaining information from institutional practitioners regarding individual practitioners’ internal code numbers and, if so, any proposed solutions.

Persons wishing to address the above topics or provide other information relative to these proposed rules should submit their comments by Midnight on November 9, 2009 in accordance with the instructions contained in the Notice available for review here.

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:

  • 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 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 health care fraud concerns 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.


Pfizer To Pay $2.3 Billion For Fraudulent Marketing In Largest DOJ Health Care Fraud Settlement

September 2, 2009

Announcement Highlights Growing Fraud Prosecution Risks of Health Industry Businesses

Today’s announcement that Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (collectively “Pfizer”) will pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability for alleged illegal promotion of certain pharmaceutical products and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

The pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the alleged illegal promotion of certain pharmaceutical products, the Justice Department (DOJ) announced today (September 2, 2009).

According to DOJ, Pharmacia & Upjohn Company agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead.  Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. 

The Food, Drug and Cosmetic Act requires that a company specify the intended uses of a product in its new drug application to FDA.  Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA.  DOJ charged Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.  Under the announced settlement, Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter.  Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs.  The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs.  The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170.  This is the largest civil fraud settlement in history against a pharmaceutical company.

As part of the settlement, Pfizer also has agreed to enter into an expansive 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.

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation.  As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.

Today’s announcement of this historic settlement emphasizes the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by pharmaceutical industry and other health care providers.  The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

The enhanced coordination among agencies central to this strategy is reflected in the collaboration among the many agencies involved in the investigation leading to these charges. The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases.  The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra.  The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.

These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

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 health care fraud concerns 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.


Health Care Providers & Other HIPAA Covered Entities Must Comply With New Data Breach Rules By September 23

August 26, 2009

Health care providers, health clearinghouses, health plans and their business associates generally must start complying with new federal data breach notification rules on September 23, 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).

HITECH Act Data Breach and Unsecured PHI Rules

Published 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 23, 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.

OCR officials are continuing to work on other guidance concerning the amendments to HIPAA’s privacy and security rules enacted under the HITECH Act and the Genetic Information and Nondiscrimination Act (GINA).  Differences in the effective dates of certain requirements generally will necessitate that Covered Entitites and their business associates move forward to comply with the Breach Regulations and other aspects of these changes before some of these other rules or guidance relating to them takes effect.

About The Author

The author of this update, Curran Tomko Tarski LLP Health Practice Leader Cynthia Marcotte 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 this 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. 

 


CDC Healthcare Infection Control Practices Advisory Committee Schedules Teleconference on Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008

August 25, 2009

The Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC) plans to hold a public meeting by teleconference on September 9, 2009 from 2 p.m.-3 p.m. Eastern Time on the Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008, available at here. Members of the public can participate in the teleconference meeting subject to the availability of telephone ports. To participate in the teleconference, dial 1-888-324-8568 and enter conference code 7126207.  HICPAC announced the planned meeting in the August 25, 2009 Federal Register.  Agenda items are subject to change as priorities dictate. 

HICPAC is charged with providing advice and guidance to Health & Human Services, the Centers for Disease Control and the National Center for Preparedness, Detection, and Control of Infectious Diseases  (NCPDCID), regarding: (1) The practice of hospital infection control; (2) strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and (3) periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions.

For more information, contact: Wendy Vance, HICPAC, Division of Healthcare Quality Promotion, NCPDCID, CDC, 1600 Clifton Road, NE., Mailstop A-07, Atlanta, Georgia 30333.

Other Helpful Resources & Other Information

We hope that this information is useful to you.  If you need assistance monitoring, evaluating or responding to these or other health industry, public policy, staffing and workforce, regulatory and compliance, risk management, transactional or operational 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.

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@solutionslawyer.net.

©2009 Cynthia Marcotte Stamer.   All rights reserved. 


Border Health Care Study Sheds Some Light of Health Care Utilization, Needs & Costs

August 24, 2009

 

Health care costs, care concerns and other health care utilization and risk patterns are a common issue of discussion in the continuing health care reform discussion by health care providers and policymakers in Border States or elsewhere. Meanwhile, employers, who employ a significant number of migrant workers frequently express interest in more information about the health care and disability care and benefit needs, understanding and utilization patterns of migrant families for purposes of planning benefit and human resources practices. A new report published by the Texas Department of State Health Services may shed some light on these issues. 

 

The Texas Department of State Health Services 2007 Health Risk Factors in the Texas-Mexico Border report presents a summary of health-related risk factors and trends among residents of fifteen Texas counties along the US-Mexico border. Its findings are based on data collected through the 2007 Behavioral Risk Factor Surveillance System (BRFSS), a nation-wide telephone-based survey of randomly-selected adults that gathers information on many conditions and behaviors known to influence personal health. Data from the fifteen counties were clustered into five areas: the Lower Rio Grande Valley – commonly known as ‘The Valley’ – (Hidalgo, Starr, and Cameron Counties), Webb and Zapata Counties, Val Verde and Maverick Counties, the Big Bend area (Brewster, Culberson, Hudspeth, Jeff Davis, Pecos, Presidio, and Terrell Counties), and El Paso County. For the purposes of this analysis, “the border” refers to these five areas.

 

Interested persons can review this report here

 

 

 

About The Author

 

Past Chair of the ABA Health Law Section Managed Care & Insurance Section and currently the Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Section and a Council Representative of the ABA Joint Committee On Employee Benefits, Ms. Stamer has more than 20 years experience advising health industry and other clients about labor and employment, health and other employee benefits, public policy and other health care and workforce matters. A primary drafter of the Bolivian Social Security Privatization law, Ms. Stamer also frequently provides input domestically and internationally on workforce, health care, migration and other policies. A popular lecturer and widely published author on these and other matters, she frequently writes and speaks about health and workforce issues of special populations including migrant workers, ex pats, and others.  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 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. 


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. 


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 or e-mailing this information to cstamer@cttlegal.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.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


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

July 20, 2009

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

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

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

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

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

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

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

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

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

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

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

The Blue Dog Members and their telephone numbers are :

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cooper, Jim  (TN 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.


August 31 Deadline To Comment On CMS Proposed Changes To Hospital, ASC Payment Rules

July 20, 2009

August 31, 2009 at 5:00 p.m. E.S.T is the deadline to comment on the “Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment” rules published by the Centers for Medicare & Medicaid Services (CMS) in the Federal Register today (July 20, 2009). 

The Proposed Rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements that CMS proposes to apply to services furnished on or after January 1, 2010.  It also would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. If also sets for the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other pertinent rate setting information for the CY 2010 ASC payment system.

To review the proposed rule and for instructions about how to submit comments, see 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 care providers to evaluate and comment on health care industry reimbursement and other health industry legislation and regulations, as well as a diverse range of other health care reimbursement, and other legal and operational risk concerns. She also writes and speaks extensively on these issues.  You can get more information about her health industry experience here.  

If you need assistance investigating the adequacy of your current compliance efforts, 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 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 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.


CMS Expands, Revises Hospital Compare Website Mortality, Readmission Data On 4000+ U.S. Hospitals As Part of Continuing Emphasis on Health Care Quality Improvement

July 14, 2009

Effort Seeks To Use Consumer Market Pressure To Pressure Hospital Quality Improvement, Cost Savings

The Centers for Medicare & Medicaid Services last week (July 9, 2009) expanded the information included on the Hospital Compare Website, a CMS resource that reports how frequently patients return to a hospital after being discharged and other selected quality data.  

By sharing data through Hospital Compare, CMS seeks to pressure hospitals to improve quality by creating market pressure from consumers empowered with hospital quality data.  The initiative is one of many government and private efforts to promote quality and reduce costs by tapping the power of health care consumers.

According to CMS, Hospital Compare now provides “better” data on the previously posted mortality rates for individual hospitals, as well as new data on 30-day readmissions for heart attack, heart failure, and pneumonia.  Previously, Hospital Compare had provided only mortality rates for these three conditions.

The Hospital Compare Web site will show a hospital’s mortality or readmissions rate is “Better than,” “No different from,” or “Worse than” the U.S. national rate. This data information includes each hospital’s risk-standardized mortality rate (RSMR), an estimate of the rate’s certainty (also known as the interval estimate), and the number of eligible cases for each hospital.  By posting hospital RSMRs, interval estimates, and the number of eligible cases, CMS is giving consumers and communities additional insight into the performance of their local hospitals in hopes that this will prompt all hospitals to work toward achieving the level of the top-performing hospitals in the country.

Reducing the rate of hospital readmissions to improve quality and achieve savings are key components of President Obama’s health care reform agenda.  Administration officials indicate that hospital readmissions are reducing the quality of health care while increasing hospital costs.  CMS officials hope posting of this expanded health care outcome data will help consumers make more informed health care choices.

According to CMS data, on average 1 in 5 Medicare beneficiaries who are discharged from a hospital today will re-enter the hospital within a month. Hospital Compare data show that for patients admitted to a hospital for heart attack treatment, 19.9 percent of them will return to the hospital within 30 days, 24.5 percent of patients admitted for heart failure will return to the hospital within 30 days, and 18.2 percent of patients admitted for pneumonia will return to the hospital within 30 days.  Both the mortality and the readmissions measures have been endorsed by the National Quality Forum (NQF) and are supported by the Hospital Quality Alliance (HQA).  CMS says both sets of measures are risk-adjusted and take into account previous health problems to “level the playing field” among hospitals and to help ensure accuracy in performance reporting.

“Providing readmission rates by hospital will give consumers even better information with which to compare local providers,” said Charlene Frizzera, CMS Acting Administrator.  “Readmission rates will help consumers identify those providers in the community who are furnishing high-value healthcare with the best results.”

CMS has been tracking selected hospital outcomes data since 2007, when Hospital Compare debuted 30-day mortality rates for heart attack and heart failure. Thirty-day mortality rates for pneumonia were added to the Website in 2008.  Hospital Compare also includes 10 measures that capture patient satisfaction with hospital care, 25 process of care measures, and two children’s asthma care measures.  The site also features information about the number of selected elective hospital procedures provided to patients and what Medicare pays for those services.

According to CMS, public reporting of these and other measures is intended to empower patients and their families with information they need to engage their local hospitals and physicians in active discussions about quality of care.  CMS officials assert that all hospitals, regardless of their readmission and mortality rates, should use the data available in these free, detailed reports to find ways to continually improve the care they deliver.”

This year, CMS has changed the way it calculates the mortality data to provide even better information to consumers.  In 2007 and 2008, Medicare used only one year of claims data to compute mortality, while  the rates added to the Web site today encompass three full years of claims data (from July 1, 2005 – June 30, 2008).  Although this means that consumers cannot compare data from last year’s rate with this year’s rate, CMS officials believe the expanded data set should provide a clearer picture of how well hospitals are performing.

Using the three-year data method, CMS estimates that the national 30-day mortality rate for patients originally admitted for heart attack care is 16.6 percent.  For heart failure patients, the national 30-day mortality rate is 11.1 percent, and for pneumonia patients the national rate is 11.5 percent.

According to CMS, Hospital Compare readmissions and mortality measures are risk-adjusted measures and were developed by a team of clinical and statistical experts from Yale and Harvard Universities under the direction of CMS and are endorsed by the NQF. The model CMS uses to assess hospital readmissions and mortality rates is based on claims data and has been validated by models based on clinical data. It takes into account medical care received during the year prior to each patient’s hospital admission, as well as the number of admissions at each hospital. The model uses this information to adjust for differences in each hospital’s patient mix, so that hospitals that care for older, sicker patients are on a “level playing field” with those whose patients would be expected to be at less risk of dying within 30 days of admission.

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 and payers establish, administer health care quality assurance and other programs.  Former Chair of the American Bar Association Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer advises and represents health care payers and providers with a diverse array of quality assurance and other legal and operational risk management initiatives and writes and speaks extensively on these issues.  Her many publications and presentations on health care quality include “Making Gainsharing Work:  Contracting & Managing Physician Performance To Promote Quality, Manage Costs,“ “Payment (or Not) For Never Events,” “Practical Solutions for Achieving Clinical Quality & Financial Efficiency in an Evolving Health Care Arena,” “Building Your Patient Empowerment Toolkit,” “Selected Thoughts About Medical Judgment-Based Coverage Decisions Under ERISA-Covered Health Plans After Davila” and numerous other quality improvement workshops for medical societies, health care systems, and others. You can get more information about her health industry experience here.  

If you need assistance investigating the adequacy of your current compliance efforts, 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 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.

 


OCR Requires Health Care Providers To Improve Services for Limited English Speakers, Hearing Impaired As HHS Steps Up Enforcement of Federal Discrimination Laws

July 14, 2009

Health care providers should review the adequacy of translation and other mechanisms required to allow limited English speakers, hearing impaired, and other language limited populations effective access to services in light of recent enforcement actions taken by Department of Health and Human Services (HHS) Office of Civil Rights (OCR) against health care providers for discrimination under Title VI of the Civil Rights Act of 1964 (Title VII), the Americans With Disabilities Act (ADA) and other federal discrimination laws. 

As part of a broader Obama Administration initiative to make prevention and redress prohibited national origin, disabilities and other discrimination in employment, public services, public accommodations and telecommunications a priority, HHS has announced that OCR will hold health care providers accountable for ensuring effective and adequate access by individuals seeking services having limited English language proficiency, hearing loss or other language or communication restrictions impacting on their ability to access care and services.

Medco Health Solutions, Inc. National Origination Settlement

On June 22, 2009, OCR announced that national pharmacy benefit management company Medco Health Solutions, Inc. had agreed to implement a multi-faceted plan to improve services to limited and non-English speaking members in 2009. 

The commitment to take corrective action by the nation’s largest mail-order pharmacy operation arose from OCR’s investigation of a complaint filed with OCR on behalf of a Spanish-speaking member. The complaint alleged that Medco violated Title VI of the Civil Rights Act of 1964 (Title VII) by failing to provide limited English proficiency members (LEP members) with meaningful access to mail-order pharmacy services and other pharmacy benefit management services. 

Under Title VI, health care providers and other recipients of federal financial assistance are required to take reasonable steps to provide meaningful access to their programs by limited English proficient individuals who are eligible to receive their services.

Under the commitment letter, Medco agreed to implement a number of measures to strengthen its provision of language assistance services to LEP members starting with those for Spanish-speaking members in 2009.  The corrective actions agreed to by Medco include:

  • Expanding its pool of bilingual customer service representatives who speak Spanish
  • Revising its systems to enhance its ability to route Spanish-speaking members who need help with prescription drug questions or problems directly to bilingual staff, including pharmacists where possible and appropriate
  • Continuing to use a telephonic interpreter service available for more than 150 other languages to communicate with other non-English speakers. 
  • Implementing a critical improvement in Medco’s internal computer systems that will flag language preference on an ongoing basis to aid effective communication with limited English proficient persons during member-Medco contact. 
  • Continuing to improve its ability to identify and track individuals’ language preferences so that important written communications and outbound telephone calls are placed to members in their primary language. 
  • Reviewing how best to notify limited English proficient members that language assistance services are available.
  • Developing an evaluation process with respect to interpreter competency.  Staff at call centers and pharmacies expected to communicate directly with members in languages other than English will be assessed as to language proficiency, and those serving as interpreters will be assessed for interpreting competency. 
  • Training all relevant staff on system changes intended to improve access to limited English proficient members, and will monitor the results of these efforts through periodic assessments.

Read the Medco Commitment Letter here.

Scottsdale Healthcare – Osborn (SHO) Voluntary Resolution Agreement

 The Medico Commitment Letter follows OCR’s April, 2008 announcement that d a signed Resolution Agreement that requiring Scottsdale Healthcare – Osborn (“SHO”) a 337–bed full–service Arizona hospital to improve access to sign language interpreters and other services required for hearing impaired patients to effectively access services.  The SHO VRA resolves a disability discrimination complaint against SHO brought by a patient with severe hearing loss, who reported that she was denied a sign language interpreter when treated in the SHO emergency room and intensive care unit.

Following OCR’s investigation of the complaint, SHO among other things agreed to: (1) affirm its compliance with Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794; (2) issue and post revised policies to ensure that appropriate auxiliary aids, including sign language interpreters or video interpretation services, are provided to deaf or hard-of-hearing patients or companions within a two hour time period; (3) develop procedures to assess the sign language interpreter needs of patients or companions; (4) train hospital personnel and physicians on its revised policies and procedures to ensure effective communication; (5) place TTY lines throughout its facility; (6) maintain a centralized telecommunication number 24-hours per day, 7-days per week for sign language interpreter requests; and (7) provide regular compliance reports to OCR. Read SHO VRA here

Health Care Providers Should Act To Manage Risks As Obama Administration Makes Enhanced Investigation and Enforcement of Federal Discrimination Laws A Priority

Health care providers and other businesses covered by Title VII, the Americans with Disabilities Act and other federal discrimination laws should heed the Medco and SHO actions of the advisability of taking prompt action to review and if necessary, strengthen the adequacy of reasonable accommodations necessary to enable individuals with limited English proficiency, hearing or other language impairments to access services.

Beyond the adequacy of services to address language impairments, health care providers and others also generally should anticipate that the willingness by the OCR under the Obama Administration to act on the Medco and SHO complaints reflects a heightened willingness by federal agencies to investigate and enforce disabilities, national origin and charges of federal discrimination violations by health care providers and others by OCR and other federal agencies under the Obama Administration.  Review Obama Administration Civil Rights Enforcement Agenda here. While OCR took a series of enforcement actions under the predecessor Bush Administration, this announced renewed emphasis on federal discrimination law enforcement coupled by the series of actions taken by OCR and other federal agencies since January, 2009 reflects that OCR and other agencies are acting on the direction of President Obama to make prevention and redress of disabilities and other discrimination in employment, public services, public accommodations and telecommunications a priority. Read about other recent OCR federal discrimination enforcement activates here. See also, e.g., recent discrimination policies and enforcement activities by Department of Justice, the Equal Employment Opportunity Commission, the Department of Housing and Urban Development.

The Medco and SHO actions, as well as a series of other recently announced enforcement actions reflect that OCR and other federal agencies are likely to continue to expand investigation and enforcement of disability and other violations by health care providers of federal disability and other discrimination laws in recent months.  Health care providers and others regulated by these federal discrimination laws should consider auditing the adequacy of existing practices, reaffirming their commitment to compliance to workforce members and constituents, retraining workforce and taking other appropriate steps to help prevent illegal discrimination within their organization and to position their organization to respond and defend against potential discrimination investigations or charges.

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 practitioners and other businesses and business leaders to establish, administer, investigate and federal and state discrimination and other compliance and internal control policies and practices to reduce risk under federal and state health care, discrimination and other laws. Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s practice emphasizes assisting health industry clients to monitor compliance and other legal and operational risks and to design, administer and defend internal controls and other risk management practices to mitigate these exposures.  You can get more information about her health industry experience here.  

If you need assistance investigating the adequacy of your current compliance efforts, 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 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. 


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

July 13, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

July 14, 2009 Meeting Reminder

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

Date:  Tuesday, July 14, 2009

Time:  2:00 p.m.

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

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

About the NTHCPA

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

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

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

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


HHS Rescinds Key Medicaid Regulations

June 29, 2009

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius today (June 29, 2009) announced that the administration will rescind all or part of three Medicaid regulations that were previously issued and delay the enforcement of a fourth regulation.  Each of these rules, in whole or in part, had been subject to Congressional moratoria set to expire on July 1, 2009.

 Specifically, the Centers for Medicare & Medicaid Services (CMS) and HHS are:

  • Rescinding a final rule, published December 28, 2007, that would have eliminated reimbursement for school-based administrative costs and costs of transportation to and from schools.  The rescission reflects concern that the rule could limit the Medicaid administrative outreach activities of schools, and that the overall budgetary impact on schools could potentially impact their ability to offer Medicaid services to students. 
  • Rescinding a rule, published November 7, 2008, that would have limited the outpatient hospital and clinic service benefit for Medicaid beneficiaries to the scope of services recognized as an outpatient hospital service under Medicare.  This rule was rescinded because CMS became aware that coverage beyond that scope could not be easily moved to other benefit categories, resulting in great impact than previously anticipated.
  • Rescinding provisions of an interim final rule published December 4, 2007, which would have restricted beneficiary access to case management services. These provisions appeared to, in practice, restrict beneficiary access to needed covered case management services, and limit state flexibility in determining efficient and effective delivery systems for case management services. 
  • Delaying until June 30, 2010, the enforcement of portions of a regulation that clarified limitations on health care related tax programs so that CMS could determine whether states need additional clarification or guidance.  CMS may also further review the potential impact of the regulation, and give additional consideration to alternative approaches.

Announcing the rescission, Secretary Sebelius said “By rescinding these rules, we can expect that children will continue receiving services through their schools, beneficiaries will be able to access all available case management resources to help them better manage their health care, and outpatient hospital and clinic services can continue to be covered in the most efficient manner.”

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 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. 


8 Miami-Area Residents Charged, Assets Frozen in $22 Million Home Health Medicare Fraud Scheme

June 29, 2009

Eight Miami-Dade County, Florida residents have been indicted in connection with an alleged $22 million Medicare fraud scheme operated out of Miami businesses purporting to specialize in home health care services and the assets of those charged and their companies frozen as part of a joint Department of Justice (DOJ) and Department of Health & Human Services (HHS) Medicare Fraud Strike Force operation.

DOJ and HHS officials jointly announced the Florida indictments and injunction action on June 26, 2009, just two days after their June 24, 2009 joint announcement of that a Detroit Medicare Fraud Strike Force had secured indictments against 53 people for schemes to submit more than $50 million in false Medicare claims.

Both the Florida and Detroit actions arose from health care fraud conducted by Medicare Fraud Strike Force teams acting as part of a recently formalized and expanded Health Care Fraud Prevention & Enforcement Action Team (HEAT) jointly announced by the DOJ and HHS on May 20, 2009.  The Florida and Detroit actions announced last week reflect the growing commitment of federal officials to investigate and prosecute Medicare and other alleged heath care fraud.

8 Florida Indictments

The Florida indictments announced June 26, 2009 charge Gladys Zambrana, Javier Zambrana, Enrique Perez, Alejandro Hernandez Quiros aka Alex Hernandez, Vanessa Estrada, Vicenta Tellechea, Modesto Hidalgo and Carlos Castaneda conspiracy to commit health care fraud.  Gladys Zambrana was also charged with four counts of health care fraud.  Gladys Zambrana and Hernandez Quiros were charged with three counts each of paying health care kickbacks, while Perez, Hidalgo and Tellechea were charged with one count each of paying health care kickbacks.  Gladys Zambrana, Perez, Alejandro Quiros, Tellechea and Castaneda were also charged with conspiracy to launder health care fraud proceeds.

According to the indictment, Gladys Zambrana, Perez and Hernandez Quiros operated ABC Home Health Care Inc. (ABC), listing Javier Zambrana as the owner; and Gladys Zambrana and Castaneda operated Florida Home Health Care Providers Inc. (Florida Home Health), listing Tellechea as the owner.  Both ABC and Florida Home Health purported to be home health agencies that catered to Medicare beneficiaries.  The indictment alleges that at both agencies, beneficiaries were recruited and paid kickbacks and bribes to arrange for their Medicare beneficiary numbers to be used by their co-conspirators to file claims with Medicare for purported home health care services.  The indictment alleges that the services were not provided and were not medically necessary.

The indictment alleges that in addition to exerting ownership and control of the home health agencies, Hernandez Quiros and Castaneda acted as Medicare beneficiary recruiters for ABC and Florida Home Health, respectively; and Hidalgo, a medical assistant, falsified medical tests and records to make it appear that the services were needed.  The indictment alleges that ABC billed more than $17 million to the Medicare program for services provided from January 2006 through December 2008 that were medically unnecessary and were not actually provided.  During that time frame, Medicare paid more than $11 million on those fraudulent claims submitted by ABC.  The indictment also alleges that from October 2007 through March 2009, Florida Home Health billed more than $5 million to the Medicare program for services that were medically unnecessary and not actually provided.  During that time frame, Medicare paid more than $4 million on those fraudulent claims submitted by Florida Home Health.

The charge of conspiracy to commit health care fraud carries a maximum prison sentence of 10 years.  Each charged count of health care fraud carries a maximum prison sentence of 10 years and each count of paying health care kickbacks carries a maximum prison sentence of five years.  Conspiracy to launder health care fraud proceeds carries a maximum prison sentence of 10 years per count.

In conjunction with the criminal case, on June 24, 2009, the U.S. Attorney’s Office filed a civil complaint for injunctive relief under the fraud injunction statute and obtained a temporary restraining order freezing the assets of ABC, Florida Home Health, Gladys Zambrana, Javier Zambrana, Perez, Hernandez Quiros, Castaneda and Tellechea.  In addition, that temporary restraining order also freezes certain financial assets of four other companies the defendants owned or controlled and allegedly used to launder money fraudulently obtained from Medicare.  The temporary restraining order is intended to preserve the remaining proceeds of the fraud for recovery by the United States as part of the criminal case and any related civil proceedings.

53 Indicted In Detroit June 24

The announcement of the Florida indictment comes just 2 days after DOJ, HHS and FBI officials announced that a Detroit Medicare Fraud Strike Force had secured indictments against 53 people for their involvement in alleged schemes to submit false Medicare claims.  The indictments unsealed June 24, 2009 returned by a grand jury in Detroit resulted in arrests in Miami, New York City and Detroit resulted from a concentrated effort by the Detroit Medicare Fraud Strike Force targeting infusion therapy and physical/occupational therapy providers involved in schemes orchestrated to defraud the Medicare program.

Collectively, the Detroit indictment accuses the physicians, medical assistants, patients, company owners and executives charged in the indictments of conspiring to submit more than $50 million in false claims to the Medicare program.  According to the indictments, the defendants participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided.  In many cases, indictments also allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments. 

Federal Officials Turning On The HEAT on Health Care Fraud

 

The Florida and Detroit indictments reflect the growing commitment and cooperation among federal and state officials to investigation and prosecution of health care fraud using Medicare Fraud Task Forces operating as part of HEAT.  Drawing upon successful experiences gained from Medicare Fraud Task Forces operating in Miami and Los Angeles since 2007, HEAT is an expanded multi-agency effort jointly announced by HHS and DOJ in May, 2009 that uses a multi-agency team of federal, state and local investigators to investigate and combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since strike force operations began in March 2007, DOJ officials report that the Medicare Fraud Task Forces already have resulted in the indictment of 257 defendants in 115 cases for their allegedly fraudulently billing Medicare for more than $600 million.

Before the May 20, 2009 HEAT announcement, Medicare Fraud Strike Forces operating demonstration projects in South Florida and Los Angeles already had produced a number of indictments. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries.  After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses.  To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program.  DOJ and HHS officials have indicated that the success of these demonstration projects lies behind the founding of the HEAT initiative.

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.

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 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@SolutionsLawyer.net.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


53 Doctors, Health Care Executives & Beneficiaries Indicted For Involvement In A $50 Million Alleged False Billing Ring

June 24, 2009

Fifty-three people have been indicted for schemes to submit more than $50 million in false Medicare claims in the continuing operation of the Medicare Fraud Strike Force in Detroit, Attorney General Eric Holder, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and FBI Director Robert Mueller announced today (June 24, 2009).

The charges were unsealed today against the 53 individuals who are accused of various Medicare fraud offenses, including conspiracy to defraud the Medicare program, criminal false claims and violations of the anti-kickback statutes.  The indictments returned by a grand jury in Detroit resulted in arrests in Miami, New York City and Detroit. 

According to the DOJ, federal agents from the FBI and the HHS Office of Inspector General (HHS-OIG) began executing arrest warrants and made arrests in Detroit, Miami and New York City earlier today as part of a concentrated effort targeting infusion therapy and physical/occupational therapy providers involved in schemes orchestrated to defraud the Medicare program.

Collectively, the indictment accuses the physicians, medical assistants, patients, company owners and executives charged in the indictments of conspiring to submit more than $50 million in false claims to the Medicare program.  According to the indictments, the defendants participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided.  In many cases, indictments also allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments.  An indictment is merely an allegation, and defendants are presumed innocent until and unless proven guilty.

The investigation and enforcement action that lead to today’s indictment was conducted as part of the continuing activities of the new interagency Health Care Fraud Prevention and Enforcement Action Team (HEAT) that DOJ and HHS jointly announced last month.  On May 20, 2009, DOJ and HHS jointly announced they were combining forces to find and prosecute health care fraud through the HEAT and identified Detroit and Houston as cities targeted for Medicare Fraud Strike Force attention.

Before the May 20, 2009 HEAT announcement, Medicare Fraud Strike Forces operating demonstration projects in South Florida and Los Angeles already had produced a number of indictments. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries.  After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses.  To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program.  The success of these demonstration projects lies behind the founding of the HEAT initiative.

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.

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 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@SolutionsLawyer.net.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


Veterans’ Rural Health Advisory Committee July 16, 2009 Telephone Meeting Open To Public

June 24, 2009

Health care providers and other interested members of the public can participate in a telephone meeting of the Department of Veterans Affairs (VA) Veterans’ Rural Health Advisory Committee from 2 p.m. to 3:30 p.m. Eastern on Thursday, July 16, 2009. 

The Committee is scheduled to meet to discuss the current status of the Office of Rural Health operations, progress towards completion of the Committee’s first report to the Secretary and upcoming meeting dates.   

The Committee advises the Secretary of Veterans Affairs on health care issues affecting enrolled Veterans residing in rural areas. It examines programs and policies that impact the provision of VA health care to enrolled Veterans residing in rural areas.

The July 16, 2009 meeting is open to the public.  The toll free number for the meeting is 1-866-802-4355, and the access code is 1372672. The Committee has indicated that a 15 minute period will be reserved at 3:15 p.m. Eastern for public comments. Members of the public may also submit a one page summary of their comments for inclusion in the official meeting record. For additional information, see the Committee Meeting Notice or contact Kara Hawthorne, Designated Federal Officer, at rural.health.inquiry@va.gov or (202) 461-7100.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

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 here or e-mailing this information to CStamer@CTTLegal.com.


Comments On Definition of Meaningful Use of EMR For Purposes of HITECH Act Provider Incentives Due June 26

June 16, 2009

Friday, June 26, 2009 at 5:00 p.m. Eastern Time is the deadline to submit comments to the Office of the National Coordinator for Health Information Technology (ONC) on the recommendations about what should be considered the term “meaningful use” of electronic health records (EHRs) presented to the Health Information Technology Policy Committee today (June 16, 2009) available for review here. Comments will be received by the Committee for consideration and further recommendations to the National Coordinator of Health Information Technology on the elements and measures of Meaningful Use of a certified EHR.

The HIT Policy Committee is a Federal Advisory Committee (FACA) to the U.S. Department of Health and Human Services (HHS).  The American Recovery and Reinvestment Act of 2009 (ARRA”) provides for Medicare and Medicaid incentive payments for eligible providers, such as physicians and hospitals, in order to promote the adoption of EHRs.  To receive the incentive payments, providers must demonstrate “meaningful use” of a certified EHR.  Building upon the work of the HIT Policy Committee, HHS anticipates developing a proposed rule that provides greater detail on the incentive programs and “meaningful use.”  HHS expects to issue the proposed rule in late 2009, which will be followed by a comment period.

How OCR decides to define meaningful use of EMR is likely to play a central role in determining how effective provider incentives to use EMR included in ARRA’s HITECH Act provisions work and ultimately influence how effectively those provisions and other OCR efforts to accelerate EMR and other health information technology use to promote health care efficiency and quality work.

For instructions on how to comment or additional information, see here.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

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.


FTC ABMG Antitrust Settlement Shows Risks For Health Care Providers Using “Messenger Model” To Negotiate Payor Contracts

June 15, 2009

July 6, 2009 is the deadline for interested persons to submit comments to the Federal Trade Commission (FTC) on its proposed consent order proposed a part of a settlement agreement announced June 9 with the multi-practice specialty group, Alta Bates Medical Group (ABMG).  The settlement agreement resolves price-fixing charges brought by the FTC against ABMG and certain Northern California health care providers for refusing to deal with payors except on a collectively determined basis with respect to fee-for-service (non-capitated).  The invitation to comment on the proposed settlement order appears here in today’s Federal Register.

The Consent Agreement would be implement as part of the June 9 settlement agreement between the FTC and ABMG to resolve FTC charges that ABMG violated Section 5 of the Federal Trade Commission Act, 15 U.S.C. Sec.  45, by fixing prices charged to those offering coverage for health care services (“payors”) in the Berkeley and Oakland, California area and refusing to deal with payors except on a collectively determined basis.

Interested parties may submit written comments electronically or in paper form. Comments should reference “Alta Bates, File No. 051 0260.” Comments along with the name and state of the party making the submission will appear in the public record of this proceeding including on the publicly accessible FTC website.   

FTC Price Fixing Charges Against Alta Bates Medical Group, Inc.

ABMG is a multi-specialty independent practice association (“IPA”) comprised of multiple, independent medical practices serving the Berkeley and Oakland, California area. It has approximately 600 physician members, including approximately 200 primary care physicians. The price-fixing charges challenge negotiation practices by ABMG with respect to fee-for-service contracts on behalf of physician members of the IPA. Under the fee-for service arrangements, the payor compensates physicians or group practices for services actually rendered pursuant to agreed-upon fee schedules.

The complaint challenges the conduct of ABMG while ABMG participated in negotiations relating to fee-for-service contracts as a “messenger” where ABMG claimed to act as a conduit facilitating negotiations between individual physician members and health plans.  The FTC complaint does not challenge ABMG’s activities concerning capitated contracts as it viewed the capitated agreements as providing sufficient financial integration among members to qualify the IPA and its member physicians as a single entity for antitrust purposes when engaging in negotiations relating to capitated contracts.

Since its formation, ABMG has negotiated group contracts with payors on behalf of IPA member physicians. The negotiations cover both contracts for fee-for-service and contracts for capitated (per member, per month) payment arrangements.  The charges related to the negotiation practices relating to fee-for-service contracts.

In the absence of financial risk-sharing or clinical integration on the part of providers, the FTC takes the position that IPA members are competitors for purposes of its price-fixing antitrust analysis. Federal antitrust laws generally prohibit collaboration or other joint action among competitors to fix or conspire to fix price. 

The FTC complaint charges that since at least 2001, ABMG, acting as a combination of its physician members and in conspiracy with its members, illegally acted to restrain competition in violation of federal antitrust laws with respect to fee-for-service contracts in Northern California.  The FTC complaint charges that ABMG and its members engaged in prohibited price-fixing by:

  • Facilitating, entering into, and implementing agreements,  express or implied, to fix the prices and other terms at which they would contract with payors;
  • To engage in collective negotiations over  terms and conditions of dealing with payors; and
  • To have ABMG members refrain from negotiating individually with payors or contracting on terms other than those approved by ABMG.

The FTC charged that although claiming to employ a lawful messenger arrangement, ABMG on behalf of its physician members instead orchestrated collective negotiations for fee-for-service contracts. The FTC alleges specifically prohibited acts by ABMG including the following in the absence of the required clinical or financial practice integration required to exempt the collective action from price-fixing prohibitions:

  • Making proposals and counter- proposals, as well as accepting or rejecting offers, without consulting  with its individual physician members regarding the prices they  unilaterally would accept, and without transmitting the payors’ offers  to its individual physician members until ABMG had approved the  negotiated prices;
  • Participation in a concerted refusal to deal intended to impede competition by one of ABMG’s major competitors, the Permanente Medical Group, which provides physician services to Kaiser Foundation Health Plan, Inc.

 According to the FTC, under a lawful messenger model, ABMG could only act as a messenger and was prohibited from collectively negotiating the terms of the contracts on the prices its members would accept for their services on behalf of providers that have not sufficiently clinically or financially integrated their practices to create efficiencies sufficient to justify their acts and practices.

Proposed Consent Order

Among other things, the proposed Consent Order, if adopted as proposed would:

  • Require ABMG to terminate, without penalty, pre-existing payer contracts that it had entered into since 2001, within the time periods covered by the Consent Order;
  • Prohibit ABMG from entering into or facilitating any agreement between or among any health care providers, negotiating with any physician on behalf of any physician and/or refusing to deal, or threatening to refuse to deal with any payor regarding any term, condition, or requirement upon which any physician deals, or is willing to deal, including, but not  limited to price terms;
  • Prohibit AMBG (or encouraging any individual physician ) from refusing or threatening to refuse to deal individually with any payor, or not to deal with any payor other than through ABMG;
  • Require AMBG provide certain notifications about the settlement agreement and complaint order to its member physicians and others

As a means for monitoring and enforcing compliance with these commitments, the Consent Order also would:

  • Require that ABMG notify the FTC and file contracts and other documentation when it deals on behalf of providers with respect to pay-for-performance contracts
  • Prohibit ABMG from facilitating exchanges of information between health care providers concerning whether, or on what terms, to contract with a payor.
  • Bar attempts to engage in any action prohibited by the Consent Order
  • Proscribe ABMG from encouraging, suggesting, advising, pressuring, inducing, or attempting to induce any person to engage in any action that would be prohibited by the Consent Order
  • Require ABMG to notify the FTC before it acts as a messenger on fee-for-service contracts with payors on behalf of its member physicians

As in other FTC orders addressing health care providers’ collective bargaining with health care payors, the proposed Consent Order excludes from coverage by its bar against joint negotiations agreements involving sufficiently integrated groups, such as: 

  • Conduct “reasonably necessary” to form or participate in legitimate “qualified  risk-sharing” or “qualified clinically-integrated” joint  arrangements
  • Agreements that only involve physicians who are part of the same medical group practice

 Health Care Providers Must Manage Antitrust Risks

These and other recent FTC and Department of Justice actions reflect the willingness of the FTC and DOJ to investigate and prosecute non-integrated health care providers that try to band together to gain leverage when negotiating fee-for-service or other contracts with health plans or other payors for price-fixing, boycott and other antitrust violations. Antitrust violations can result in substantial civil and in some instances criminal liability risks for organizations and their representatives that participate in the prohibited conduct. Since the felony penalties associated with federal antitrust violations bring antitrust sanctions within the purview of the Federal Sentencing Guidelines, most health care organizations and their leadership will wish to consider including appropriate antitrust compliance policies and compliance strategies in their organizations corporate ethics and compliance programs. 

The action also makes clear that health care providers should not assume that representation by an entity claiming to act as a “messenger” and negotiating under the “messenger model” will escape scrutiny.  Rather, the action makes clear that federal regulators will look beyond the surface for anticompetitive collaboration hidden behind the activities of the claimed messenger.  Accordingly, to prevent and position themselves and their organizations to defend against potential antitrust complaints, health care providers and practice managers and others involved in negotiation of fee-for-service contracts for independent practitioners must exercise caution.

To effectively manage these exposures, health care providers and others involved in negotiations relating to fee-for-service contracts where other independent practitioners are involved or are represented by the same organization as the practice should take affirmative steps that their organization has in place appropriate procedures for preventing, investigating and redressing potential violations.  For example, most practices would want to be certain their practice and its consultants:

  • Can demonstrate it prohibits, and abstains from participation in prohibited collective action directly or through a messenger;
  • Includes written provisions in contracts with practice consultants and others prohibit involvement in prohibited anti-competitive activity
  • Has up to date policies in place and a process to monitor regulatory and enforcement developments for necessary updates;
  • Can demonstrate that it is appropriately administering well-documented audit, training and enforcement practices to prevent and redress potential violations as part of its corporate ethics and human resources practices;
  • Uses appropriate vendor selection, contracting, audit and oversight processes to promote compliance by business partners, agents and others with which it does business;
  • Has identified experienced counsel and developed a process for engaging counsel to assist in the audit of ongoing compliance efforts as well as the timely conduct of internal investigations of possible infractions within the scope of attorney-client privilege;
  • Designated an ethics or compliance officer, or other appropriate party to receive and investigate suspected compliance concerns and reports;
  • Has effective privacy, investigations, employment and other policies and procedures to enable the business to investigate, discipline and defend employment actions against employees or other workers for improper conduct;
  • Has appropriate processes and procedures for responding to government investigations and private compliance complaints;
  • Promptly investigates and responds to reports of infractions or other compliance concerns in an appropriate and well documented manner.

Curran Tomko Tarski LLP Attorneys Can Help

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, enforce and defend antitrust and other compliance and internal control policies and practices to reduce risk under federal and state antitrust and other laws covered by the Federal Sentencing Guidelines. 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.  Curran Tomko Tarski offers a variety of updates, publications, training and other resources to assist its business clients and their leaders meet their legal and operational challenges.  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, get information about their briefings and speeches, and review highlights of their experience and 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. 


FTC Issues FAQ Guidance On Red Flag Rules Applicable To Health Care Providers & Others

June 12, 2009

The Federal Trade Commission (FTC) and five other federal agencies yesterday (June 11, 2009) jointly issued a set of frequently asked questions (FAQs) about  federal regulations on the “Red Flags and Address Discrepancy Rules” (Red Flag Rules) implementing sections of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act) now scheduled to take effect on August 1, 2009.  

Health care providers and a broad range of other entities are among the organizations generally required to comply with the broadly reaching Red Flag Rules, which require “financial institutions” and “creditors” to develop and implement written Identity Theft Prevention Programs and require issuers of credit cards and debit cards to assess the validity of notifications of changes of address.  The rules also provide guidance for users of consumer reports regarding reasonable policies and procedures to employ when consumer reporting agencies send them notices of address discrepancy.  

The sweeping reach of the definition of “creditor: and “financial institutions” in the Red Flag Rules and other confusion about the Red Flag Rules have prompted the agencies to delay the deadline for compliance several times.  The most recent delay, which extended the compliance deadline from May 1 to August 1, 2009, was announced by the FTC on April 30, 2009.  The FTC promised to issue additional guidance to help promote better understanding of the rules when it announced this latest delay in the compliance deadline on April 30, 2009.

Fulfilling this promise, the FAQs discuss numerous aspects of the Red Flag Rules, including:

  • Types of entities and accounts covered;
    Establishment and administration of an Identity Theft Prevention Program;
  • Address validation requirements applicable to card issuers; and
  • Obligations of users of consumer reports upon receiving a notice of address discrepancy.

FACTA directed financial regulatory agencies, including the FTC, to promulgate rules requiring “creditors” and “financial institutions” with covered accounts to implement programs to identify, detect, and respond to patterns, practices, or specific activities that could indicate identity theft. FACTA’s definition of “creditor” applies to any entity that regularly extends or renews credit – or arranges for others to do so – and includes all entities that regularly permit deferred payments for goods or services. Accepting credit cards as a form of payment does not, by itself, make an entity a creditor. Some examples of creditors are finance companies; automobile dealers that provide or arrange financing; mortgage brokers; utility companies; telecommunications companies; non-profit and government entities that defer payment for goods or services; and businesses that provide services and bill later, including many  doctors and other health care providers and other professionals. “Financial institutions” include entities that offer accounts that enable consumers to write checks or make payments to third parties through other means, such as other negotiable instruments or telephone transfers.  The FTC has made clear it perceives most health care providers as falling within the scope of these rules.

FACTA is only one of a growing list of the evolving privacy and data security mandates applicable to businesses under federal and state laws that organizations must address under applicable federal laws.   In addition to FACTA, most businesses also face other specific data security and data breach requirements under a tapestry of other federal and state laws which are constantly evolving.  In addition to these FACTA and other generally applicable data security and breach rules, many organizations face evolving industry specific mandates. For example, health care providers, health plans, health care and their business associates also are required to update their privacy and data security practices to comply with recent amendments to the Health Insurance Portability & Accountability Act Privacy & Security Standards signed into law February 17, 2009.

Many of these federal laws provide for both civil penalties as well as criminal penalties that bring violations of these regulations under the Federal Sentencing Guidelines.  As a consequence, most organizations need to implement and administer compliance programs to manage these Federal Sentencing Guideline risks.  Even where criminal sanctions are not triggered, noncompliance with these and other data security mandates can trigger substantial judgment awards, administrative penalties or both.

If you need assistance with auditing, updating, administering or defending your privacy, data security or other privacy and data security practices or addressing other health care compliance, risk management, transactions or operations concerns, please contact Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com.

For More Information

We hope that this information is useful to you. You can find more information about the Red Flag Rules and other privacy and identity theft matters at here. You also 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.


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.


Thomas R. Frieden, MD, MPH, Is New CDC Director & ATSDR Administrator

June 10, 2009

Thomas R. Frieden, M.D., M.P.H. took over as  the new director of the Centers for Disease Control and Prevention (CDC) and administrator for the Agency for Toxic Substances and Disease Registry (ATSDR) on Monday, June 8, 2009. 

An infectious disease expert  who has lead initiatives supporting wellness and prevention, Dr. Frieden replaces Dr. Richard Besser who has been the acting CDC director and acting ATSDR administrator since mid January.  Dr. Besser returns to his role as director of CDC’s Coordinating Office for Terrorism Preparedness and Emergency Response. 

Prior to assuming his new role, Dr. Frieden served as the director of the New York City (NYC) Health Department since 2002.   He was a CDC Epidemic Intelligence Service Officer (EIS) from 1990 until 1992.  He worked in NYC and investigated and fostered pubic awareness around tuberculosis, including strains of the bacteria with drug resistance.  Along with then NYC Health Commissioner and current US Food and Drug Administration Commissioner Dr. Margaret Hamburg, Dr. Frieden led the effort that stopped the spread of drug-resistant tuberculosis in NYC in the mid 1990s.  Following that, Dr. Frieden helped the Indian government establish a tuberculosis control program which has now saved more than one million lives.  As NYC Health Commissioner, Dr. Frieden led efforts that reduced the number of smokers by 350,000 and cut teen smoking in half.  NYC has also increased cancer screening, reduced AIDS deaths by 40%, improved collection and availability of information on community health, and implemented the nation’s largest community electronic health records project.  Dr. Frieden and this team have responded effectively to several urgent health problems, including cases of anthrax, plague, and, most recently novel H1N1 influenza. 

Dr. Frieden earned his B.A. degree at Oberlin College in Ohio and his M.D. degree at Columbia University College of Physicians and Surgeons in New York.  He earned his Masters of Public Health (MPH) at Columbia University’s School of Public Health. He completed his internship and residency in internal medicine at Columbia-Presbyterian Medical Center and sub-specialty training in infectious diseases at Yale University.  

More Information

We hope you found this information helpful.  For assistance with health care regulatory or other legal matters or to inquire about services and experience of Cynthia Marcotte Stamer, please Ms. Stamer at  Cstamer@CTTLegal.com or telephone her at 214.270.2402.  

If you or some that you know would like to register to receive these updates and other helpful information on health care regulatory, public policy, compliance and risk management matters, please be sure that we have your current contact information including your preferred e-mail by registering at and/or sign up to receive the Solutions Law Press Health Care Updates here.  To learn more about Cynthia Marcotte Stamer and/or access some of her many publications and presentations, see here. For important information concerning this resource, see here.

©Cynthia Marcotte Stamer.  All rights reserved


June 11 Deadline To Comment On Proposal For Establishing HITECH Act Regional Extension Centers

June 3, 2009

On May 28, 2009, the new Office of the National Coordinator for Health Information Technology Program (“ONC”) published a Federal Register Notice and Request for Comments (the “Notice”) that describes the program ONC proposes to use to establish “Regional Extension Centers” to assist health care providers seeking to adopt and become meaningful users of health information technology under Title XIII of Division A and Title IV of Division B (the “HITECH Act”) of the American Recovery and Reinvestment Act of 2009 (“ARRA”).  The deadline for commenting on the Notice is 5 p.m. on June 11, 2009.

The HITECH Act directs the ONC to establish Health Information Technology Regional Extension Centers to provide technical assistance and disseminate best practices and other information to providers to support and accelerate efforts to adopt, implement and effectively utilize electronic health records and other health information technology to improve the quality and value of American health care.  ARRA appropriates a total of $2 billion in discretionary funding, in addition to incentive payments under the Medicare and Medicaid programs for providers’ adoption and meaningful use of certified electronic health record technology. 

The Notice describes how ONC plans to establish the Regional Health Program and their goals.  It also includes information and addresses needed to submit comments on this draft program description for the regional centers program. To review the Notice online, click on the following link:  Federal Register Notice.

More Information

We hope you found this information helpful.  If you are interested in commenting on the Notice or assistance with other aspects of the HITECH Act or other health care privacy or technology related laws, or wishes to inquire about services and experience of Cynthia Marcotte Stamer, please Ms. Stamer at  Cstamer@CTTLegal.com or telephone her at 214.270.2402.  

If you or some that you know would like to register to receive these updates and other helpful information on HIPAA and other health care and human resources risk management matters, please be sure that we have your current contact information including your preferred e-mail by registering at and/or sign up to receive the Solutions Law Press Health Care & IT Updates at https://slphealthcareupdate.wordpress.com.   To learn more about Cynthia Marcotte Stamer and/or access some of her many HIPAA and other publications, see here. For important information concerning this resource, see here.

©Cynthia Marcotte Stamer.  All rights reserved.


HHS, Sesame Workshop, and the Ad Council Launch National Campaign to Protect Families from H1N1 (Swine Flu) Virus and Stay Healthy

June 3, 2009

The Department of Health and Human Services (HHS),the Ad Council and Sesame Workshop, the nonprofit educational organization behind Sesame Street, recently launched a national public service advertising campaign designed to encourage American families and children to take steps to protect themselves from the 2009 H1N1 flu virus (swine flu) and continue to practice healthy habits.  The announcement of the campaign signals continuing concerns by government and other health experts that the swine flu pandemic may continue to circulate or even worsen unless proper precautions are taken.

The 2009 H1N1 flu virus is a new flu virus of swine origin that was first detected in April 2009. While press attention has died down in recent weeks, the virus is spreading from person-to-person, sparking a growing outbreak of illness in the U.S. and internationally. To date, over 5,700 cases have been reported in the United States and there are nine deaths associated with the novel H1N1 infection. Experts believe that the 2009 H1N1 flu spreads in the same way that seasonal influenza viruses spread — primarily through the coughs and sneezes of people who are sick with the virus.

HHS Secretary Kathleen Sebelius unveiled the campaign at the HHS/Department of Education Childcare Center in Washington, D.C. The PSAs will be distributed nationwide and will be supported in airtime donated by television stations. 

The new PSA campaign focuses on the importance of providing parents, teachers and children with accurate information about how to practice healthy habits, highlighting proper hand-washing and simple everyday actions that lead to staying healthy and keeping germs away. Created by Sesame Workshop, the television PSAs encourage audiences to visit http://www.cdc.gov to get more information on how to stay healthy. The PSAs are an extension of Sesame’s Healthy Habits for Life initiative, which helps young children and their caregivers establish an early foundation of healthy habits.  As part of HHS/Ad Council campaign, Sesame Workshop produced a television PSA featuring Sesame Street’s Elmo and Gordon explaining the importance of healthy habits such as washing your hands, avoid touching your eyes, nose and mouth and sneezing into the bend of your arm.

The PSAs are part of an initiative to provide practical steps recommended by HHS’ Centers for Disease Control and Prevention (CDC) to help prevent the spread of the flu virus and other infectious disease, including:

  • Avoid close contact with people who are sick.
  • Keep your distance from others if you are sick.
  • When possible, stay home from work, school, and errands when you are sick, and don’t send your children to childcare or school if they are sick.
  • Cover your mouth and nose when coughing or sneezing.
  • Wash your hands often with soap and water, especially after coughing and sneezing.
  • Avoid touching your eyes, nose and mouth.

Cynthia Marcotte Stamer and other attorneys practicing with Curran Tomko Tarski LLP are experienced advising and representing health industry clients, community organizations and others about pandemic planning and other disease management and health industry risk management and compliance concerns.   If you have questions about these matters, please contact Ms. Stamer at 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 Health Care Update Blog. For important information concerning this communication click here.


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.


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.


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

May 20, 2009

Lead DOJ Health Care Fraud Enforcer Speaks In Dallas Tomorrow

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

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

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

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

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

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

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

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

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

For More Information

We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.


OCR Disability Charges Settlement Requires Equal Access to Transportation Services at Anchorage Pioneer Home

May 15, 2009

A State of Alaska owned licensed assisted living facility for seniors, the Anchorage Pioneer Home (APH), has modified its transportation policies and practices to better accommodate qualified individuals with disabilities as part of its recently announced settlement agreement with the U.S. Department of Health and Human Services (HHS) and the Alaska Department of Health and Social Services (DHSS).   The settlement agreement resolves an administrative complaint filed with the HHS Office of Civil Rights (OCR) that charged DHSS and APH  with violating Section 504 of the Rehabilitation Act of 1973 (Section 504) and Title II of the Americans with Disabilities Act of 1990 (ADA). DHSS owns and operates APH, a licensed assisted living facility for seniors, 65 years of age or older. Serving more than 160 Alaska residents, APH provides care at three different levels: Level I (independent); Level II (basic assistance); and Level III (24-hour care for Alzheimer’s disease and related disorders).  The Obama administration’s promise to emphasize disability and other federal discrimination law enforcement means public and private plans and providers should audit and strengthen practices to withstand scrutiny.

Section 504 requires state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance. Title II of the ADA extends the prohibition against disability discrimination to state and local governments who do not receive federal financial assistance.  After conducting an investigation prompted by an administrative complaint filed with OCR, OCR issued a Jan. 16, 2009, letter detailing its findings that among other things, DHSS had violated Section 504 and Title II of the ADA, by declining to consider a legitimate request for a reasonable modification to its policies to enable an APH resident with Alzheimer’s disease to use APH’s transportation services for medical appointments.

Under the settlement, APH will consider individual requests for reasonable modifications to its transportation policies and practices to ensure that APH residents with disabilities are afforded an equal opportunity to access transportation services. If, after an individualized assessment, an APH resident, who is a qualified individual with a disability, is determined to need an escort to access and benefit from APH transportation services, APH will provide an escort at no cost.

 Under the settlement agreement:

  • DHSS reaffirmed its legal responsibility to ensure that no qualified individual with a disability is discriminated against in any DHSS service, program, or activity.
  • DHSS reaffirmed its legal responsibility to not retaliate against any person for opposing discrimination under Section 504 or Title II of the ADA, or participating in an investigation under those laws.
  • APH agreed to appoint a senior staff person to coordinate its compliance efforts under Section 504 and Title II of the ADA; provide additional staff training on preventing disability discrimination; publish a notice informing its residents and their guardians of their rights and responsibilities under these laws; and publish grievance procedures for handling disability discrimination complaints.
  • APH agreed to implement a revised transportation policy to ensure that its residents with disabilities, who are eligible to receive transportation services, are afforded an equal opportunity to participate in APH’s transportation program.

A copy of the OCR letter of finding and the settlement agreement, along with more information about OCR’s civil rights enforcement activities, can be found at http://www.hhs.gov/ocr/civilrights/activities/agreements/akpioneeragreement.pdf

For More Information

We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.


CMS Proposes Policy And Payment Rate Changes For Inpatient Stays In Acute Care And Long-Term Care Hospitals In Fy 2010

May 2, 2009

The Centers for Medicare & Medicaid Services (CMS) today (May 1, 2009) proposed the fiscal year (FY) 2010 policies and payment rates for inpatient services furnished to people with Medicare by both acute care hospitals and long-term care hospitals.  Interested persons have until June 30 to submit comments to CMS.  CMS plans to finalize the rule by August 1, 2009.

The proposed rule placed on display at the Federal Register today and available for review at www.archives.gov/federal-register/public-inspection/index.html would apply to approximately 3,500 acute care hospitals paid under the Inpatient Prospective Payment System (IPPS), and 400 long-term care hospitals paid under the Long-Term Care Hospital Prospective Payment System (LTCH PPS), beginning with discharges occurring on or after October 1, 2009.  The proposed payment rates are based on the most recently available data and are subject to revision in the final rule to reflect more current data.

In today’s announcement, CMS proposes:

  • To update acute care hospital rates by 2.1 percent for inflation less an adjustment of 1.9 percentage points to remove the effect of increases in aggregate payments due to changes in hospital coding practices that do not reflect increases in patient’s severity of illness.
  • To update long-term care hospital rates by 2.4 percent for inflation less an adjustment of 1.8 percentage points to account for changes in documentation and coding practices that do not reflect increases in patient’s severity of illness. 

Beginning October 1, 2008, Medicare adopted a new classification system for general acute and long term care hospitals to better recognize severity of illness and the cost of treating Medicare patients.  According to the announcement, hospitals changed their documentation and coding of patient diagnoses under the new system in a manner that CMS states leads to an increase in aggregate payments without corresponding growth in actual patient severity. CMS says the proposed documentation and coding adjustments help ensure that estimated aggregate payments to these hospitals under the new classification systems would not increase solely as a result of the changes to the classification system and hospital coding practices.

The Medicare Actuary found based on analysis of 2008 data that additional coding that did not reflect actual changes in the severity of patients’ illnesses increased total payments under IPPS by 2.5 percent in FY 2008 and will further increase total payments in FY 2009.  Based on current estimates, the Medicare Actuary estimates that total adjustments of approximately 8.5 percent would have to be made to the acute care hospital rates to address changes in hospitals’ coding practices, including the increase in FY 2008 payments and the estimated increase in FY 2009 payments.  CMS is proposing a prospective adjustment of 1.9 percentage points for FY 2010, which means additional adjustments of approximately 6.6 percentage points, will be needed in FY 2011 and FY 2012.  CMS is requesting public comment on whether to apply a different documentation and coding adjustment than the one being proposed for FY 2010.

Under current Medicare law, hospitals that successfully report the 2010 quality measures included in the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program will get the full update.  Hospitals that do not participate in the quality reporting program will get the update less two percentage points. Ninety-seven percent of participating hospitals received the full update last year. The proposed rule adds four new measures for which hospitals must submit data under the RHQDAPU program to receive the full market basket update.  Two of these measures are additions to the existing Surgical Care Improvement Project (SCIP) measure set, and CMS believes that the other two measures will promote hospital participation in nursing-sensitive care and stroke care registries.

CMS is also proposing changes to regulations affecting payment adjustments to teaching hospitals (hospitals that offer graduate medical education programs), and disproportionate share hospitals (hospitals that provide care to a disproportionate share of low income patients), and to clarify the regulations implementing the Emergency Medical Treatment and Labor Act (EMTALA).  In addition, the proposed rule describes five applications for new technology add-on payments and CMS’ preliminary findings about those technologies.

For More Information

We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.


Texas Senate Committee Schedules May 5 Hearing On Proposed Texas Medical Board Reforms

May 2, 2009

Physicians and others concerned about physician oversight and discipline by the Texas Medical Board (“Board”) may want to share their input with key Texas legislators before or during a hearing scheduled on May 5, 2009. 

This Tuesday, May 5th, the Texas Senate Health & Human Services Committee will hold a hearing on proposed medical licensing reforms in SB 2336.  Advocates of SB 2336 and its companion, HB 3816, are urging supporters to attend the hearing and/or communicate their perspectives on the legislation.  The hearing is scheduled to begin on Tuesday, May 5th, 2009 at 9:00am in the Senate Chambers.

Supported by a broad range of physician and other health care organizations, SB 2336 and the companion HB 3816 seek to address a series of concerns expressed by physicians and others about certain practices by the Texas Medical Board. Interested persons should review the proposed changes and express their input quickly to ensure their views have an opportunity for consideration.

 Persons unable to attend the hearing in person who wish to make their views known also can consider contacting one or more members of the 2009 Senate Committee on Health and Human Services:

Chair:  Senator Jane Nelson (R-12)

1E.5

(512) 463-0112

jane.nelson@senate.state.tx.us

Steve Roddy – Chief of Staff

steve.roddy@senate.state.tx.us

Nnenna Ezekoye Policy Analyst

Nnenna.ezekoye@senate.state.tx.us

Dave Nelson – Legislative Aide

Dave.nelson@senate.state.tx.us

 

Vice-Chair: Senator Bob Deuell (R-2)

E1.706

(512) 463-0102

bob.deuell@senate.state.tx.us

Don T. Forse, Jr. – Chief Staff

Don.forse@senate.state.tx.us

Scot Kibde – Legislative/Health Policy

Scot.kibde@senate.state.tx.us

 

Members:

 

 

Senator Joan Huffman (R-17)

GE.5

joan.huffman@senate.state.tx.us

(512) 463-0117

Jonathon Stinson – Legislative Director

Jonathon.stinson@senate.state.tx.us

Kyle Kamrath – Policy Director

Kyle.kamrath@senate.state.tx.us

Ryan Hutchison – Legislative Aide

 ryan.hutchison@senate.state.tx.us

 

Senator Robert Nichols (R-3)

E1.708

Robert.nichols@senate.state.tx.us

(512) 463-0103

Steven Albright – Chief of Staff

Steven.albright@senate.state.tx.us

Adrianne Emr

Adrianne.emr@senate.state.tx.us

Angus Lupton – Policy Director

Angus.lupton@senate.state.tx.us

 

Senator Dan Patrick (R-7)***introduced and supports SB 2336

3S.3

(512) 463-0107

Dan.patrick@senate.state.tx.us

Logan Spence JD – Legislative Director

logan.spence@senate.state.tx.us

Kate Pigg – Legal Counsel

kate.pigg@senate.state.tx.us

John Gibbs – Legislative Aide

john.gibbs@senate.state.tx.us

 

Senator Eliot Shapleigh (D-29)

E1.610

eliot.shapleigh@senate.state.tx.us

(512) 463-0129

Eduardo Hagert – Chief of Staff

Eduardo.hagert@senate.state.tx.us

Sushma Jasti – Policy Director

Sushma.jasti@senate.state.tx.us

 Senator Carlos Uresti (D-19)

E1.810

carlos.uresti@senate.state.tx.us

(512) 463-0119

Tomas Larralde – Chief of Staff

Tomas.larralde@senate.state.tx.us.

Rachel Johnston – Legislative/Policy Director

Rachel.johnston@senate.state.tx.us

 Senator Royce West (D-23)

1E.12

royce.west@senate.state.tx.us

(512) 463-0123

LaJuana Barton – Chief of Staff

Lajuana.barton@senate.state.tx.us

Graham Keever – Policy Analyst

Graham.keever@senate.state.tx.us

Senator Judith Zaffirini (D-21)

1E.14

judith.zaffirini@senate.state.tx.us

(512) 463-0121

Warren von Eschenbach – Chief of Staff

Warren.voneschenbach@senate.state.tx.us

Jessica Ramos – Legislative Aide/Policy

Jessica.ramos@senate.state.tx.us

For More Information

We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here.


FTC Extends Red Flag Rule Compliance Deadline From May 1 to August 1, 2009

May 1, 2009

Today is no longer the deadline for health care providers and other businesses regulated by the Fair and Accurate Credit Transactions Act of 2003 (“FACTA”) to begin complying with the identity theft detection and prevention (“Red Flag Rules”) adopted by the Federal Trade Commission (“FTC”).   

While health care providers have more time to comply, they can’t breathe easy.  Finalizing arrangements to comply with these new mandates and other recent amendments to the health care privacy and data security requirements applicable to health care providers under recently enacted amendments to the Health Insurance Portability & Accountability Act (“HIPAA”) and FACTA and other recent regulatory and enforcement changes to these rules requires that health care providers move quickly.  Learn more about these recent changes at http://solutionslaw.wordpress.com/2009/04/18/hhs-ftc-release-guidance-on-hitech-act-data-breach-rules-for-hipaa-covered-entities-entities-dealing-with-personal-health-records.

The FTC announced yesterday (April 30, 2009) its extension of the Red Flag Rule enforcement date to until August 1, 2009.  Before yesterday’s announcement, health care providers and certain other FACTA-regulated businesses were required to comply with the Red Flag Rules today.  The announcment means these organizations now have an additional three months to adopt the necessary policies and processes to monitor and respond to possible identity theft required under the Red Flag Rules. 

According to the FTC announcement, organizations regulated by FACTA also will need to review their practices in light of additional guidance that the FTC expects to issue soon.  For entities that have a low risk of identity theft, such as businesses that know their customers personally, the FTC plans to  soon release a template to help them comply with the law.  Yesterday’s announcement does not affect other federal agencies’ enforcement of the original November 1, 2008 compliance deadline for institutions subject to their oversight.

The FACTA directed financial regulatory agencies, including the FTC, to promulgate rules requiring “creditors” and “financial institutions” with covered accounts to implement programs to identify, detect, and respond to patterns, practices, or specific activities that could indicate identity theft. FACTA’s definition of “creditor” applies to any entity that regularly extends or renews credit – or arranges for others to do so – and includes all entities that regularly permit deferred payments for goods or services. Accepting credit cards as a form of payment does not, by itself, make an entity a creditor. Some examples of creditors are finance companies; automobile dealers that provide or arrange financing; mortgage brokers; utility companies; telecommunications companies; non-profit and government entities that defer payment for goods or services; and businesses that provide services and bill later, including many  doctors and other health care providers and other professionals. “Financial institutions” include entities that offer accounts that enable consumers to write checks or make payments to third parties through other means, such as other negotiable instruments or telephone transfers.

During outreach efforts last year, the FTC staff learned that some industries and  entities within the agency’s jurisdiction were uncertain about their coverage under the Red Flags Rule. During this time, FTC staff developed and published materials to help explain what types of entities are covered, and how they might develop their identity theft prevention programs. Among these materials was an alert on the Rule’s requirements, www.ftc.gov/bcp/edu/pubs/business/alerts/alt050.shtm.  The resources also included a Web site with more resources to help covered entities design and implement identity theft prevention programs, www.ftc.gov/redflagsrule.

You can find more information about the Red Flag Rules and other privacy and identity theft matters at CynthiaStamer.com.  If you need assistance with questions or compliance with these or other privacy and data security rules or other health law matters, contact Cynthia Marcotte Stamer at (214) 270.2402, or cstamer@cttlegal.com.  To receive future Solutions Law Press Health Care Updates, register to participate in this Solution Law Press Health Care Update blog, register at CynthiaStamer.com or join the SLP Health Care Risk Management & Operations Group on linkedin.com.


Swine Flu Treatment & Pandemic Response Information Updated

April 30, 2009

With U.S. officials confirming the first swine flu attributed death in the U.S. yesterday and the number of U.S. reported cases expected to top 100 today, health care providers and organizations are initiating their pandemic response plans to help their organizations, people, patients and communities respond to the rapidly spreading epidemic.

 

Whether or not the swine flu outbreak reaches the level of an official pandemic, official reports reflect a legitimate need for concern.  According to officials from the Centers for Disease Control and Prevention (CDC), victims of the swine influenza A (H1N1) virus infection already have been reported in 10 states, and the number of people known to be infected with the 2009 H1N1 influenza strain grew to 91 in the U.S. as of Wednesday. That number includes the first U.S. swine flu fatality: a 22-month-old child from Mexico who died of the illness Monday at a Houston, Texas hospital while visiting the United States. While swine flu victims have been reported in more than 11 countries, the majority of the incidents of the disease and deaths as of Wednesday morning had occurred in Mexico.  Alarm that the outbreak will reach pandemic proportions continues to grow.

 

In response to the expanding crisis, the CDC yesterday released updated interim guidance on the use of antiviral agents for treatment and chemoprophylaxis of patients with confirmed, probable or suspected swine influenza virus infection and their close contacts. This guidance is only part of a host of growing resources for health care providers and other parties posted at http://www.pandemicflu.gov, the website founded by the U.S government to provide one-stop access to U.S. Government swine, avian and pandemic flu information.  The website links to a growing list of special guidance provided by the CDC and other organizations for health care organizations and providers, public officials, schools, businesses, the public and others.  Health care providers and other concerned parties should check this site regularly for updates about the latest guidance for responding to and treating swine flu.

 

Health care providers, schools, government agencies and others concerned about preparing to cope with pandemic or other infectious disease challenges also may want to review the guidance for health care providers and public health officials as health care providers, employers, and public entities contained in the pandemic and privacy planning workshop materials “Planning for the Pandemic” authored by Curran Tomko Tarski LLP partner Cynthia Marcotte Stamer available at http://www.cynthiastamer.com/documents/speeches/20070530%20Pan%20Flu%20Workplace%20Privacy%20Issues%20Final%20Merged.pdf.

 

Health care providers also should educate employees, patients and the public about the steps they should take to help minimize their risk of contracting the disease.  While the CDC says getting employees and their families to get a flu shot remains the best defense against a flu outbreak, it also says getting individuals to consistently practice good health habits like covering a cough and washing hands also is another important key to prevent the spread of germs and prevent the spread of respiratory illnesses like the flu.  Health care providers, employers, public officials and others should encourage patients, employees and their families and others to take the following steps and to coach others they know to do so as well:

  • Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick too.
  • Stay home when you are sick to help prevent others from catching your illness.  Cover your mouth and nose.
  • Cover your mouth and nose with a tissue when coughing or sneezing. It may prevent those around you from getting sick.
  • Clean your hands to protect yourself from germs.
  • Avoid touching your eyes, nose or mouth.
  • Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.
  • Practice other good health habits.  Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.

To help promote this message, health care providers, public officials and businesses may want to download and circulate some of the many free resources published by the CDC at http://www.cdc.gov/flu/protect/habits.htm

 

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting health care providers, public agencies, schools, businesses and others employers with these and other health care, workforce, crisis preparedness and response and related matters. If your organization needs assistance with assessing, , please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402.  For additional information about the experience and services of Ms. Stamer and to access some of her publications, see www.cynthiastamer.com or www.cttlegal.com.


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.


Hearing On Texas Medical Board Reforms Scheduled April 14, 2009

April 7, 2009

The 11 member Texas House Committee on Public Health has scheduled a hearing Tuesday, April 14th to consider Texas Medical Board reforms proposed in HB 3816.  Advocates of the legislation are urging supporters to attend the hearing and/or communicate their support for the legislation now.

 

Supported by a broad range of physician and other health care organizations, HB 3816 and a companion bill pending in the Texas Senate, SB 2336, seek to regulate certain practices by the Board which many physicians and others perceive as overly heavy handed.  As currently proposed, HB 3816 would implement the following reforms effective September 1, 2009:

·         Require that the Executive Director of the Board be a physician licensed in good standing

·         Require that individuals filing complaints swear under oath to the truth of the statements in the complaint

·         Require that the Board have “good cause” to file a complaint on its own initiative

·         Require the Board to encourage each person with a complaint to attempt to resolve the complaint with the license holder directly before filing a formal complaint with the Board, in situations where that would be appropriate.  Preprinted complaint forms provided by the Board would be required to include a prominent statement encouraging persons with complaints to attempt to resolve their complaints directly with the physician, when appropriate, before filing a formal complaint with the Board.

·         Require that the Board notify physicians charged in a complaint be personal delivery or certified mail

·         Prohibit the Board from considering or acting on a complaint involving care provided more than 4 years after the date the complaint is filed

·         Deny civil, criminal, or regulatory immunity to persons filing complaints when the complaint is filed with malice or with an anticompetitive purpose.

·         Require that the Board provide the physician charged in the complaint with an unredacted copy of the complaint unless there is a risk of harm to the public or unless it would jeopardize a criminal investigation. 

·         Ensure that physicians subject to a complaint receive at least 30 days after receiving a copy of the complaint to prepare and submit a response

·         Establish a schedule for conducting each phase of a complaint that is under the control of the Board not later than the 30th day after the date the physician’s time for preparing and submitting a response expires.

·         Restrict the physicians qualified to serve on the expert physician panel for a complaint to physicians actively practicing medicine in the State of Texas

·         Require that the Board review a report concerning a physician’s medical competency prepared by an expert at the request of the physician who is the subject of the complaint

·         Require that any review by a second expert be independent of the first review, without knowledge by the second reviewer of the identity of the first reviewer, and without any communication between the two reviewers.

·         When the first and second reviewer disagree, require that the physician subject of the complaint be notified of the conflict and provided with copies of the conflicting reports and require that the final written report include a copy of the dissenting report.

·         Requires that before using a report under this section, the Board provide the identity and qualifications of each expert physician who reviewed the complaint to the physician subject to the complaint

·         Require considerations of the medical competency of the physician charged be conducted only by a physician engaged in an active practice in the same or similar specialty as the physician in the year preceding the review.

·         Requires that the identity of the members of the expert panel considering medical competency be promptly disclosed to the physician who is the subject of the complaint

·         Would require that a report concerning the medical competency of a charged physician be in the form of an affidavit sworn under oath to qualify for consideration by the Board

·         Would excuse a charged physician from the obligation to provide evidence concerning patient records in the absence of a court order where the patient objects to this disclosure of the records for reasons of patient privacy

·         Require “clear and convincing evidence” that, through the practice of medicine, the physician poses a continuing threat to the public welfare before the Board could deny or restrict a physician’s license or otherwise discipline a physician.

·         Prohibit the Board from ordering or requiring a physician to practice medicine in a particular manner, to practice medicine, or to direct anyone in the practice of medicine, except by ordering that a physician not engage in a practice that causes actual harm or an imminent risk of harm to a patient

·         Prohibit the Board from imposing a penalty, sanction, or other disciplinary action that is different from the action recommended by the panel in an informal proceeding and agreed upon by the license holder

·         Prohibit the Board from involving itself in fee disputes or taking disciplinary action against a license holder for using the “fee for service” method of billing

·         Prohibit the Board from taking disciplinary action against a license holder based upon the manner in which the license holder maintains the license holder’s office or records, unless the conduct has a likelihood of causing an actual harm or an imminent risk of harm to a patient

·         Requires that a physician receive notice at least 48 hours prior to a an Informal Settlement Conference proceeding of the identity of the panel members presiding over the Informal Settlement Conference proceedings; and the opportunity to have an  audio or video record or arrange for transcription of the Informal Settlement Conference proceedings

·         Provide that decisions of the administrative law judge be binding on the Board

·         Protect the right of a license holder may access and obtain a copy of any information relating to the license holder

·         Provide that the district court reviewing a Board disciplinary action may only sustain the discipline on a finding by clear and convincing evidence that the action was supported by facts and law.

·         Guarantee a jury trial right for physicians seeking to challenge the revocation of their license in the courts

·         Require greater proof that a drug or treatment is nontherapeutic and that the prescribed treatment be have a “likelihood of harm to a patient” to constitute grounds for discipline. 

You can review the current language of the bill at http://www.legis.state.tx.us/tlodocs/81R/billtext/doc/HB03816I.doc.  For a list of the current members of the Texas House Committee on Public Health, see http://www.house.state.tx.us/committees/list81/410.htm.

If you need assistance evaluating or responding to these or other proposed legislative or regulative changes, responding to a licensing board complaint, peer review, or other disciplinary investigation or matter, or other health care matters, contact Cynthia Marcotte Stamer or other members of Curren Tomko and Tarski LLP. please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402 or see CTTLegal.com or CynthiaStamer.com.