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Massachusetts Subject to Quarterly Reporting: Public Health Council Approves Out-Of-Office Meal Amendments
On November 21, 2012, the Massachusetts Public Health Council approved amendments to the Pharmaceutical and Medical Device Manufacturer Code of Conduct to allow manufacturers to provide out-of-office meals to health care providers for the purpose of educating and informing attendees about the benefits, risks and appropriate on-label uses of prescription drugs and medical devices.
The venue must be conducive to informational communication and the meals must be "modest." While the Department of Public Health (DPH) was urged to define "modest" as it relates to meals, they choose to avoid imposing a specific dollar cap, and instead allow for the provision of food and drinks that, as judged by local standards, are similar to what an HCP may purchase when dining at their own expense. While the DPH was further urged to ban alcohol, they recognize that it is unrealistic for manufacturers and restaurants to police the contents of a participant's glass.
If companies provide out-of-office meals in conjunction with an educational presentation, they must submit quarterly reports to include:
- The location of the non-CME presentation
- A description of the product(s) discussed
- The total amount expended on the presentation; and
- An estimate of the amount expended per participant, including meals, refreshments and other items of economic value.
A date was not... Read more..
CMS Submitted Final Rule To Implement Physician Payment Sunshine Act
On November 27, 2012, CMS submitted the final rule to implement the Physician Payment Sunshine Act to the Office of Management and Budget for clearance. Stay tuned for a summary when released by OMB. The proposed rule was originally issued by CMS on December 19, 2011. During a 60 day comment period, CMS received over 300 comments from more than 60 stakeholders. The final rule is expected to address some of the more controversial items including, among other matters, the reporting of research payments and meal allocations. Stay tuned for a complete summary of the final rule upon issuance.Read more..
Senate Aging Committee Holds Roundtable in Washington DC to Discuss the Sunshine Act
On September 12, 2012, the United States Senate Special Committee on Aging held a Roundtable Meeting at 2:30 PM ET on CapitolHill to discuss implementation of the Physician Payments Sunshine Act. This meeting will include 10 presentations from various stakeholders to allow the members of the Senate Aging Committee to gain insight on the issues and technical challenges facing the Centers for Medicare and Medicaid Services (CMS). Specifically how transparency data can be effectively collected, posted, and contextually explained to the public and shared with physicians prior to reporting to the public are some of the issues expected to be discussed during the Roundtable.
See the full article on policymed.com for details on the Roundtable.
Together Timothy Robinson, MMIS General Counsel and President of the Regulatory Law Group, PLLC. and Michaeline Daboul, President & CEO of MMIS, Inc., composed a written response to the United States Senate SpecialCommittee on Aging. The response highlights multiple surveys conducted between MMIS, and the Regulatory Law Group in conjunction with the American Medical Association in order to understand the attitudes, awareness, and concerns of physicians as they relate to the Physician Payment Sunshine Act. Results... Read more..
Significant Changes Regulating Pharmaceutical and Medical Device Manufacturer Conduct and Reporting Included in 2012 Mass Budget
On July 8, 2012, Massachusetts Governor Deval Patrick signed the fiscal 2012 budget, which included significant changes to Chapter 111N, regulating pharmaceutical and medical device manufacturer conduct and reporting. Specifically, the 2012 budget expands the ability for pharmaceutical and medical device companies to provide modest meals and refreshments in conjunction with non-CME educational presentations. Prior to the amendments, modest meals and refreshments could only be provided in conjunction with an educational presentation given by a pharmaceutical marketing agent within the health care provider's office or hospital setting. As a practical matter, this amendment now enables pharmaceutical and medical device manufacturers to provide educational presentations outside of a health care providers office or hospital setting in a venue conducive to informational communication, such as a private room at a restaurant.
If a pharmaceutical or medical device manufacturer provides modest meals or refreshments in conjunction with non-CME educational presentations, the manufacturer must file quarterly reports that detail the following:
- The location of the non-CME presentation.
- A description of any pharmaceutical products, medical devices or other products discussed at the presentation.
- The total amount spent on the presentation and an estimate of the amount spent on each... Read more..
Senators Kohl and Grassley Push CMS to Implement the Sunshine Act by June 2012
On April 4, 2012, Senators Herb Kohl and Charles Grassley wrote a letter to the acting administrator, The Honorable Marilyn Tavenner, from the Center for Medicare and Medicaid Services (CMS), requesting that the final ruling of the Physician Payments Sunshine Act (“Sunshine Act”) be released this June so that partial data collection for 2012 can commence. The senators urge CMS to be clear on guidelines and context of the law as well as offer further guidance on the proactive disclosure of spend data to covered recipients.
See the full letter to read more.Read more..