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  This rule was rescinded because CMS became aware that coverage beyond that scope could not be easily moved to other benefit categories, resulting in great impact than previously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. 

Leave a Comment » | Doctor, Health Care, Health Care Finance, Hospital, Medicaid, Physician, Reimbursement, Rural Health Care | Permalink
Posted by Cynthia Marcotte Stamer

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. 

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Posted by Cynthia Marcotte Stamer

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. 

Leave a Comment » | Anti-KickBack, Corporate Compliance, Doctor, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Hospital, Medicaid, Medicare, Medicare Advantage, OIG, Physician, Reimbursement | Tagged: , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

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.

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Posted by Cynthia Marcotte Stamer

FDA Schedules Three Public Seminars on The Essentials of Medical Device Regulations:

June 24, 2009

The Food and Drug Administration plans to present a public seminars on FDA medical device regulations to introduce startup and small device manufacturers and their suppliers to the essentials of medical device regulations on three dates during July and August. The seminars to be hosted in three different cities will cover include:

  • Doing business in a regulated industry;
  • Organizational structure of FDA;
  • Overview of the quality system regulation;
  • Design controls;
  • Documents, records, and change control;
  • Purchasing controls and acceptance activities;
  • Production and process control;
  • Corrective and preventive actions;
  • Complaints, medical device reports, corrections, and
  • recalls;
  • Compliance issues;
  • Management responsibility;
  • Interacting with FDA–Where do you go for assistance?
  • General question and answer session;
  • Manufacturers and suppliers–The chain regulatory
  • responsibility;
  • Reimbursement of medical technology;
  • The AdvaMed code of ethics; and
  • Fraud and abuse.

The 2-day seminars to be hosted in cooperation with AdvaMed’s Medical Technology Learning Institute are scheduled on:

  • July 14-15,  2009 in Coronado, CA
  • August 4- 5, 2009 in Nashville, TN and
  • August 12-13, 2009 in San Juan

The registration fee is $650 per person per seminar.  For additional details, see the FDA Announcement in the June 24, 2009 Federal Register.

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.

 ©2009 Cynthia Marcotte Stamer.  All rights reserved.

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

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.

Leave a Comment » | ARRA Funding, Corporate Compliance, Doctor, Health Care, Health Care Finance, Health Care Provider, Health Care Reform, Health Plan, HIPAA, Hospital, Nonprofits | Tagged: , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

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. 

Leave a Comment » | Antitrust, Doctor, Health Plan | Permalink
Posted by Cynthia Marcotte Stamer

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.

Leave a Comment » | Corporate Compliance, Doctor, FACTA, Federal Sentencing Guidelines, Health Care, Health IT, HIPAA, Privacy | Tagged: , , , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

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

June 12, 2009

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

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

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

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

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

For More Information

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 Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com.

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.

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

FDA Delays Implementation of Reportable Food Registry, Announces Draft Guidance

June 11, 2009

The Food & Drug Administration (FDA) today (June 11, 2009) delayed implementation of the Reportable Food Registry requirements of section 417 of the Food and Drug Administration Amendments Act of 2007, Public  Law 110-85 (FDAAA) to September 8, 2009. It simultaneously announced the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” (the “Guidance”).

On September 27, 2007, the President Bush signed FDAAA into law. Among other things, Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act (the “Act”) to include a requirement that the Secretary of Health and Human Services to establish within FDA a Reportable Food Registry (the Registry) by September 27, 2008 under new Act § 417, 21 U.S.C. 350f.   To further the development of the Registry, the Act also requires FDA to establish a reportable food electronic portal for responsible parties and public health officials to use to submit to the FDA instances of reportable food by September 27, 2008.  The draft Guidance, when finalized, will assist the industry in complying with these Reportable Food Registry requirements.

Read the Federal Register notice here.

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 Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com.

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.

Leave a Comment » | FDA | Permalink
Posted by Cynthia Marcotte Stamer

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

June 10, 2009

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

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

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

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

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

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

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

Assistance Monitoring & Responding To Health Care Reform Proposals

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

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

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

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

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

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

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

Additional Resources & Information

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

©2009 Cynthia Marcotte Stamer. All rights reserved.

Leave a Comment » | Childrens Health Insurance Program, Corporate Compliance, Disease Management, Doctor, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Reform, Health IT, Health Plan, Health Policy, HIPAA, Hospital, Indian Health, Medicaid, Medicare Advantage, Physician, Prescription Drugs, Public Policy, Reimbursement, Tax | Tagged: , , , , , , , , , , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

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

Leave a Comment » | Doctor, Public Policy | Permalink
Posted by Cynthia Marcotte Stamer

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.

Leave a Comment » | ARRA, Doctor, Grants, Health Care Reform, Health Policy, Hospital, Public Policy, Technology | Tagged: , , , , , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

HHS, Sesame Workshop, & Ad Council National Ad Campaign Reminds Americans Of Need to Continue To Protect Against H1N1 (Swine Flu) Virus

June 3, 2009

Declining press attention on the H1N1 flu virus (swine flu) pandemic does not mean the need for precautions is over for Americans, their employers, schools and other community organizations.

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 federal and state regulatory, reimbursement, grant, enforcement and other 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.    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.

1 Comment | Disease Management, Employer, Wellness | Tagged: , , , , , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

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.

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Posted by Cynthia Marcotte Stamer

Cindy Mann Appointed Director of the Center for Medicaid and State Operations

June 3, 2009

U. S. Health and Human Services Secretary Kathleen Sebelius recently announced the appointment of Cindy Mann to serve as Director of the Center for Medicaid and State Operations (CMSO), part of the Centers for Medicare & Medicaid Services (CMS).  Secretary Sebelius announced the appointment May 29, 2009.

Prior to her appointment, Mann most recently served as a research professor and executive director of the Center for Children and Families at Georgetown University’s Health Policy Institute. From 1999-2001, Ms. Mann was the director of the Family and Children’s Health Program Group at the Health Care Financing Administration (HCFA), now the Centers for Medicare & Medicaid Services. In that capacity, she directed, at the federal level, the implementation and oversight of the Medicaid program with respect to families, children, and pregnant women, and oversaw the implementation of CHIP. Prior to her work at HCFA, Ms. Mann led the Center on Budget and Policy Priorities’ federal and state health policy work. She also has extensive state-level experience, having worked on health care, welfare, and public finance issues in Massachusetts, Rhode Island, and New York. She holds a law degree from New York University School of Law.

Cynthia Marcotte Stamer and other attorneys practicing with Curran Tomko Tarski LLP are experienced advising and representing health industry clients about federal and state regulatory, reimbursement, grant, enforcement and other 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.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

Leave a Comment » | Anti-KickBack, Childrens Health Insurance Program, Health Care, Health Care Fraud, Health Care Provider, Hospital, Medicaid, Medicare, Medicare Advantage, OIG, Physician, Public Policy, Reimbursement, Stark, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

HHS Releases $30 Million to Help Medicare Beneficiaries Access Their Benefits In Vulnerable Communities

June 2, 2009

Health & Human Services (HHS) Secretary Kathleen Sebelius today (June 2, 2009) released $25 million in grants to help older people, individuals with disabilities and their caregivers apply for special assistance through Medicare, and an additional $5 million for a national resource center to support these important efforts.

Made possible by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), these grants provide funding to state and local organizations involved in reaching and providing assistance to people likely to be eligible for the Low-Income Subsidy program (LIS), Medicare Savings Program (MSP), the Medicare Part D Prescription Drug Program and in helping beneficiaries to apply for benefits. This initiative also includes special targeting efforts to rural areas of the country and to Native American elders.

This MIPPA funding, which is jointly administered by HHS’ Administration on Aging (AoA) and the Centers for Medicare & Medicaid Services (CMS), is being awarded to State Health Insurance Assistance Programs (SHIPs), State Agencies on Aging, Area Agencies on Aging (AAAs), Aging and Disability Resource Centers (ADRCs), Native Americans Tribal Organizations and local communities to help seniors, caregivers and those with disabilities on Medicare. These organizations part of HHS’ national network of state, tribal and community-based organizations that assist seniors, caregivers and those with disabilities with health benefits information and information on other services, and enable them to remain independent and living in their communities as long as possible.

Look here for more information about these grants.

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 federal and state regulatory, reimbursement, grant, enforcement and other 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.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

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Posted by Cynthia Marcotte Stamer

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