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random rants about news, the law, healthcare law, economics and anything I find amusing

PartnersHealthCare Announces Industry Relationship Policy

The WSJ Health Blog in its April 10, 2009 posting reported that Parterns Healthcare, which includes Harvard-affiliated Mass General, had issued a report recommending tighter restrictions on industry relationships with its physicians.

The news release by Partners listed key recommendations from its report:

Prohibition of all gifts, including meals and funding for meals, provided directly to staff by industry for their personal use, on a Partners site or off site. This ban also applies to Partners institutions accepting industry gifts for this purpose.

Development of mechanisms to have free drug samples distributed only through the hospital pharmacy or some other centralized system, and not provided directly to or distributed by physicians.

Requiring that industry representatives have written invitations defining the purpose and terms of visits before having access to Partners sites and staff.

Establishment of a process to identify and manage significant financial interests held by physicians in companies that make products they prescribe or use in their practices.

Acceptance of industry funding for educational programs and fellowships only if provided through a centrally pooled institutional President’s Fund at each hospital or approved by a newly-created, Partners-wide Educational Review Board.

Establishment of a robust, tiered approach to evaluate research-related conflicts of interest, including continued prohibition of certain high-risk circumstances.

Adoption of a stricter policy holding certain officials to a higher standard because of their influential positions within the organization.

Strengthened oversight of permitted outside activities, including a ban on faculty participation in industry speakers bureaus, an express prohibition on faculty being listed as authors on papers ghostwritten by others, and a more rigorous internal review process for certain outside activities.

Development of an enhanced infrastructure, including creation of a new Conflict of Interest Review Committee, responsible for education, oversight, and enforcement of Partners policies and practices in regard to industry interactions.

The system plans to adopt revised policies and procedures by October 1, 2009 and acknowledges that a significant training and education program will be necessary during the roll-out of these changes.  The 30 page report details the commissions charge, its process, its internal review, external factors and recommendations. The press release link is below.

CommissionPressRelease_PartnersHealthCare2009.pdf (application/pdf Object).

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Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Health Law Reporter – Economy Increases False Claims Risk, Requiring Greater Focus on Compliance

In the most recent BNA Health Law Reporter, Health Law Reporter. 18 HLR 387, there was an article opining that harder economic times increases FCA qui tam and, in general, healthcare compliance risks.  I found the following notable summary of reasons that compliance programs do not work as well as intended (taken from the BNA article, which, in turn takes from a February 11, 2009 presentation to the AHLA by Patrick S. Coffey, Chris J. Mollet, University of Illinois at Chicago, and Linda A. Wawzenski, assistant U.S. attorney for the Northern District of Illinois):

• Compliance is not a business priority;
• Programs do not operate as written and do not focus on heading off claims;
• Employee training is dull and ineffective;
• There is a lack of ongoing and meaningful risk assessment;
• Hotlines are not sufficiently promoted;
• Employees do not trust the compliance commitment so do not report concerns, while managers do not understand why this is so;
• Significant enforcement settlements are ignored or quickly forgotten;
• Organizations are not prepared to handle internal investigations and routinely mishandle internal reports;
• Disgruntled employees are dismissed and whistleblowers are not protected; and
• Difficult economic times are allowed to undercut compliance efforts.

Filed under: AKS, CMP, Compliance Programs, Fraud and Abuse, Health Law, Physician Self Referral/Stark, Risk Management,

30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com

The Cleveland Plain Dealer reports on March 27, 2009:

A federal judge on Friday sentenced the founder of a failed health-care financing company to 30 years in prison for his role as “puppet master” in what prosecutors called the biggest fraud on record at a privately held company in the United States.*** National Century offered financing to small hospitals, nursing homes and other health-care providers by purchasing their accounts receivable, usually for 80 or 90 cents on the dollar, so they wouldn’t have to wait for insurance payments. National Century then collected the full amount of the payments. The company raised the money to fund its business by selling bonds to investors. Prosecutors said National Century executives authorized millions in unsecured loans to health-care providers, then misled investors about the loans.  As the money owed to the company mounted, National Century declared bankruptcy in November 2002 after the FBI raided its offices. Since then, at least nine former executives have been convicted of corporate fraud. The government originally alleged proceeds of the fraud topped $1.9 billion, a figure Squires said Friday had been reduced to $1.7 billion. He said investors’ total losses were around $2.8 billion. At its height the company employed more than 300 people, most of them in the Columbus area. Executives made millions, with Poulsen alone earning more than $9.1 million between 1996 and 2002, according to the government.

via 30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com.

Filed under: Fraud and Abuse, Health Law, Risk Management, ,

Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ

In its Health Blog, the WSJ reports on March 25, 2009:

GlaxoSmithKline last year promised to publish payments to U.S. docs for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is expanding on its promise.For clinical trials starting in 2010 and after, Glaxo said yesterday it will publicly report the money it pays U.S. doctors and their institutions to carry out the studies*** Disclosing more and more about payments to health-care professionals is a trend du jour in the industry. The list of drug companies and device makers that have said they’ll start reporting payments to docs includes Pfizer, Eli Lilly, Merck and Medtronic. Exactly what payments get reported varies from company to company.  All those self-imposed reporting plans could soon be moot. The Physician Payment Sunshine Act, which has been kicking around for a while, would create national rules for what payments drug and device makers have to publicly disclose.

via Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ.

Filed under: AKS, Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, , ,

An Overseer of Medical Trials Comes Under Fire – NYTimes.com

The NYT reports:

“The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist. *** The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast. ***Over a five-year period, Coast reviewed 356 study proposals and rejected only one[.] *** In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation.***In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O. ***In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

via An Overseer of Medical Trials Comes Under Fire – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

HHS OIG Open Letter March 24, 2009 – SDP Guidance

OpenLetter3-24-09.pdf (application/pdf Object).

Today, March 24, 2009, the HHS OIG published and Open Letter informing us that providers can no longer used the Self-Disclosure Protocol (SPD) for the physician self-referal (“Stark”) law and will limit SPD submissions to those with a minimum $50,000 settlement.

OIG will no longer accept disclosure of a matter that involves only liability under the physician self-referral law in the absence of a colorable anti-kickback statute violation. We will continue to accept providers into the SDP when the disclosed conduct involves colorable violations of the anti-kickback statute, whether or not it also involves colorable violations of the physician self-referral law… To better allocate provider and OIG resources in addressing kickback issues through the SDP, we are also establishing a minimum settlement amount. For kickback-related submissions accepted into the SDP following the date of this letter, we will require a minimum $50,000 settlement amount to resolve the matter.

The Open Letter casts this as necessary to ensure resources are focused on antikickback violations.  These  “remain[] a high priority for OIG.”  OIG does caution that providers should not read this decision to “draw any inferences about the Government’s approach to enforcement of the physician self-referral law.”

This is a rather remarkable position given the challenges that health systems face with technical (and sometimes  potentially costly) Stark violations without any antikickback component.   And, notwithstanding the OIG’s caution, it is clear that the OIG, recognizing resource limitations, wants to focus on anti-kickback violations rather than purely Stark law violations.   And what about civil monetary penalties SDPs associated with inducement of patients?  One must conclude that if there is not a significant antikickback component, it is not now appropriate for the SDP due to limitations with OIG resources.   Probably more to come.

Filed under: AKS, CMP, Fraud and Abuse, Health Law, Physician Self Referral/Stark

New York Medicaid Provider Self-Disclosure Process

As reported in the March 13, 2009 BNA Health Law Reporter, The New York State Office of the Medicaid Inspector General (OMIG) on March 12 announced the release of the Provider Self-Disclosure Guidance.  According to the the OMIG, this will “enabling health care providers to identify, reveal, and return to the OMIG overpayments they have received from the Medicaid program.”  BNA reports that the guidance is significantly more expansive in scope than the Department of Health and Human Services Office of the Inspector General’s Self-Disclosure Protocol.   OMIG reports that it hopes to save up to $820 million in Medicaid costs in the 2009-2010 fiscal year.  The OMIG also “highly discourages” providers from attempting to avoid the self-disclosure process when circumstances warrant its use and it will not accept full and final payments for self-disclosed violations before the investigatory process is finalized. See  http://www.omig.state.ny.us/data/images/stories/self_disclosure/omig_provider_self_disclosure_guidance.pdf for the new guidelines and http://www.omig.state.ny.us/data/images/stories/self_disclosure/voluntary_disclosure_form.pdf for the disclosure form.

Filed under: AKS, Fraud and Abuse, Health Law, Medicaid, , , , ,

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