Massachusetts Gift Ban Intact

August 2nd, 2010

As we noted on June 27, the Massachusetts House version of an economic development package would have repealed the Massachusetts gift ban. Today, the Boston Globe reports that reconciliation of the House and Senate economic packages has left the gift ban intact.

We also reached out to Vermont State Representative Dr. George Till (D), who is a member of the Vermont House Healthcare Committee. Dr. Till quashed rumors that Vermont was considering a similar repeal of its gift ban and disclosure requirements. Dr. Till noted that he had not heard anything about a repeal effort in Vermont, and would be surprised to see one. “That bill had strong bipartisan support.”

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Massachusetts House bill would overturn Gift Ban

June 27th, 2010

The Massachusetts House last week proferred a bill that would repeal Chapter 111N, the Pharmaceutical and Medical Device Manufacturer Conduct, colloquially known as the Gift Ban. Section 105 of the House Economic Development, states simply, “Chapter 111N of the General Laws is hereby repealed.”

Whether the House will succeed in repealing the Gift Ban is unclear. The House bill must first pass the Committee on Economic Development and Emerging Technologies, before facing a full vote before the House. The Massachusetts Senate has already passed a similar economic development bill that does not call for the repeal of Chapter 111N. If the House version passes, it will have to be reconciled with the Senate version before being enacted.

As always, stay tuned.

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The Plot Sickens

June 9th, 2010

More on our previous post…. There’s news today on the Nemeroff front, as the Washington Post reports Dr. Charles Insel’s response to the latest flurry of inquiries from Senator Charles Grassley about Dr. Insel’s purported ties to Dr. Nemeroff.

“Dr. who?” responded Dr. Insel.

Dr. Insel expressed surprise that his relationship with Dr. Nemeroff had come under scrutiny by Sen. Grassley, describing the story to the Post as a “little surreal.”

According to Dr. Insel, he did not recommend Dr. Nemeroff to the University of Miami, nor did he have “any great relationship with him.” In fact, said Dr. Insel, “what Nemeroff had done was so outrageous, he became the poster boy for conflict of interest.”

Emails tracking the saga may be found here, courtesy of The Chronicle of Higher Education.

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From the desk of Senator Grassley

June 9th, 2010

Senator Grassley has his quill out again. On June 7, 2010, Senator Grassley sent a letter to Donna E. Shalala, the president of the University of Miami. The letter asked Ms. Shalala to produce documents and other information related to conflicts of interest by recently hired Dr. Charles Nemeroff. Dr. Nemeroff, you will remember, left Emory University precipitously after a Senate probe revealed that he was accepting consulting fees from GlaxoSmithKline, while at the same time acting as the primary investigator on a National Institutes of Health-funded grant for research into a GlaxoSmithKline drug.

In his letter to Ms. Shalala, Sen. Grassley expressed dissatisfaction with comments made by Dr. Pascal Goldschmidt, the head of the University of Miami medical school:

I was also troubled by Dr. Goldschmidt’s comments that a ban against Dr. Nemeroff from receiving NIH grants was “an immediate reaction to the political pressure that the university was under.” President Shalala, I hope that you would agree–contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue–that enforcing federal conflict of interest policy involves ethical and legal issues that ensure taxpayer trust.

Sen. Grassley also wrote a letter to the Health and Human Services Office of Inspector General Dan Levinson, asking him to look into ties between Dr. Nemeroff and National Institute of Mental Health director Tom Insel:

I was extremely disturbed to read a story today in The Chronicle of Higher Education. For almost a year, Dr. Charles Nemeroff has been under investigation by your office for failing to fully disclose his conflicts of interest regarding his grants from the National Institute of Mental Health (NIMH). During this same time, The Chronicle of Higher Education reports that the Director of the NIMH was assisting Dr. Nemeroff in obtaining a new job and made assurances that Dr. Nemeroff would be able to apply for new NIMH grants.

Stay tuned. Ms. Shalala’s response is due June 21, 2010.

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Medtronic Discloses Aggregate Spend

June 1st, 2010

Today, Medtronic, Inc. publicly disclosed aggregate compensation to entities and healthcare professionals for the first quarter of 2010 ending in March. Payments for Training and Education, Research Development, and Advisory Services are reported in $5,000 increments up to $25,000, and then $25,000–$49,999, and $50,000–$99,000. Royalties are reported as exact amounts. The data is sortable by the name of the payee or physician, or the payee’s state. According to Medtronic, payment categories cover:

  1. Engagement in clinical practice (diagnose, advise or treat patients).
  2. Performance of academic or sponsored (private, charity, government) medical (basic medical science, clinical, medical economic or social) research.
  3. Lecture (didactic or panel participant for academic or sponsored venues) on medical (basic medical science, clinical, medical economic or social) topics to patients or health care providers, where the physician presents him/herself as a clinician and not as an inventor or product developer.
  4. Publish (original research, reviews or editorials) on medical (basic medical science, clinical, medical economic or social) topics via publication media (peer- and non-peer-reviewed medical journals, internet websites, local, national or international media outlets) intended to inform patients or healthcare practitioners.

Medtronic’s press release can be found here.

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AstraZeneca CIA includes Sunshine Disclosure provision

April 27th, 2010

A press release from the Department of Justice today announced the $520 million settlement agreement with AstraZeneca related to allegations that the company marketed its anti-psychotic drug Seroquel for off-label uses. Included in the Corporate Integrity Agreement (at page 37) is another transparency requirement, although this is the first to require disclosure using the criteria (and eventual regulations) of the Sunshine Act (§ 1128G(e)(10).

Department of Health and Human Services Inspector General Daniel Levinson noted in the release that, ”As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed–all leading to better protection for patients.”

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Aggregate Spend Consultants Wanted

April 12th, 2010

Life Compliance Solutions is seeking consultants with experience in the following areas related to Aggregate Spend implementation:

  1. Financial Analyst
  2. State law compliance expert

Select the appropriate link for a job description and contact information.

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Pfizer’s Posh Aggregate Spend Disclosure Site

April 1st, 2010

Pfizer has published their on-line Aggregate Spend Disclosure website. Take a look here–if you have to report this spend ahead of Sunshine, I recommend contacting Pfizer to get the name of their designer.

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Healthcare passes, includes Sunshine provision

March 21st, 2010

On Sunday, the House approved the Senate version of the Patient Protection and Affordable Care Act (H.R. 3590), which was signed into law by President Obama today. Included in the Act is the Senate version of the Physician Payments Sunshine Act (see section 6002), which will require manufacturers to report payments and “transfers of value” to reportable recipients. The first report is due March 31, 2013 for the calendar year 2012.

The Senate version excludes payments of less than $10, unless the aggregate amount transferred to the covered recipient during the calendar year exceeds $100.”

The House also passed the Health Care and Education Affordability Reconciliation Act (H.R. 4872), which reconciled proposed changes to H.R. 3590.

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From the desk of Sen. Grassley

March 17th, 2010

On Thursday, March 11, Senator Grassley continued his efforts to promote transparency with letters to CVS Caremark, Express Scripts, and the Pharmaceutical Care Management Association. The letters, citing Senator Grassley’s “continuing efforts to bring more transparency regarding the payments made by pharmaceutical companies to pharmacy benefit managers,” asked the companies to provide:

  1. Comments and position with regard to MedPAC’s recommendation that Pharmaceutical Benefit Managers (PBMs) be subject to the disclosure requirements under the Physician Payments Sunshine Act;
  2. An explanation of any position that does not fully support MedPAC’s recommendation; and
  3. A detailed description of “any and all activities your company has initiated for enhancing the transparency of financial benefits, if any, that your company receives from pharmaceutical companies.”
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