For the 3rd year in a row, the Massachusetts state House has voted to repeal the state Code of Conduct for pharmaceutical manufacturers' interactions with physicians (from which marketing research incentives are excluded, thanks to MRA's efforts in 2009) by passing H.B. 1507. Once again, this reinforces why we think S.B. 515 and H.B. 1544 are unlikely to advance in the current political climate.
Unfortunately, at the federal level, some researchers still appear to be bumping up against overly-conservative compliance departments within their pharmaceutical industry clients -- compliance departments that somehow still don't comprehend that marketing research incentives are excluded from the transparency scheme of the Physician Payments Sunshine Act in the Affordable Care Act (again, thanks to MRA's efforts).
Concerns are on hold temporarily, while we wait for a decision from the U.S. Supreme Court on the overall healthcare law. If the whole law is thrown out as unconstitutional, the Sunhine Act will disappear, too.
Should the law survive, MRA will likely seek an Advisory Opinion from the Centers for Medicare and Medicaid Services (CMS), the regulator responsible for it, in order to clarify the treatment of marketing research beyond a shadow of a doubt.
Recognizing some of the difficulties and current chaos, CMS recently announced that the agency would delay any Sunshine data collection until next year: "In order to provide time for organizations to prepare for data submission and to sufficiently address the important input we received during the rulemaking process, CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013."
It is also interesting to note that while the Sunshine Act's original authors, Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), continue to demand faster rollout of the implementing regulations, the "Doctors Caucus" in the House of Representatives sent a letter to CMS expressing serious concerns with the content and impact of the proposed Sunshine Act rules.
The waiting game goes on.