Sunshine Act

MediSpend to Present at The National Disclosure Summit February 19 – 21, 2013 in Washington, DC

Michaeline Daboul, MMIS, Inc.’s President & CEO, will present the results of a recent physician opinion survey at The 5th Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies to be held February 19 – 21, 2013 at The Ritz-Carlton in Washington, DC. The conference is offered by The Health Care Conference Administrators, LLC.

Ms. Daboul will present physicians’ awareness and attitudes of the Sunshine Act, specifically focusing on proactive notification and dispute resolution workflows.

Join us at 8:50 AM EST on February 20th to learn about physician opinions and currently available workflows to meet the Sunshine rules, released on February 1, 2013.

In addition, visit our MediSpend® booth between sessions to learn more about our scalable Software-as-a-Service solution for aggregated spend and notification and dispute resolution while you snack on a treat from Georgetown Cupcake!

Other key agenda highlights:

  • Keynote speaker Niall Brennan, Director of CMS Office of Information Products and Data Analytics, will lead the opening plenary session and Q&A
  • Erika Smith, Senior Investigator, Senate Judiciary Committee, United States Senate, will present "The Continuing Role of Congress in the Implementation of the Sunshine Act"
  • Katrina Cahill from Biogen Idec, Rore Middleton, Esq. from Purdue Pharma LP, and Trudy Seeley from Sanofi US will discuss their disclosure and aggregate spend implementations 
  • Jeremy Lazarus, MD from the American Medical Association will share perspective on "The Implications of the Sunshine Rule for Physicians"
  • Seth Lundy, Esq. from King & Spalding will present "Dealing with the Consequences of Public Disclosures"
  • Day III will focus around global transparency and provide updates on Australia, China, Japan, Latin America, France, Netherlands, and Slovakia  

Go to www.DisclosureSummit.com to register. Enter discount code “Grantor” to receive $600 off of any new onsite registration and $800 off for webcast participation.

Minnesota Board of Pharmacy Requests Repeal of State Regulations

On January 8, 2013, Cody Wiberg, the Executive Director of the Minnesota Board of Pharmacy, wrote a letter requesting repeal of the requirement for pharmaceutical manufacturers to report on payments and transfers of value to physicians for the 2012 calendar year. The Board of Pharmacy will ask the Minnesota Legislature to repeal state regulations since the forthcoming Physician Payment Sunshine Act will preempt the relevant provisions of Minnesota state law.  

The board will not be asking the Legislature to repeal the partial gift ban.  This will remain in effect.  See the full letter to read more.

Powerful Healthcare Advocates Push OMB to Issue Sunshine Act Regulations

On January 14, 2013, the AARP, AFL-CIO, and 17 other healthcare advocacy groups wrote a letter urging the Office of Management and Budget (OMB) to issue the Physician Payments Sunshine Act regulations. The letter expressed the urgency to approve these regulations in that they are expected to protect patients and eliminate fraud in Medicare and Medicaid.

See the full article on thehill.com to read more.

Common Disclosure Processes for Health Care and Life Sciences

A November 2012 forum involving the IOM Best Practices Innovation Collaborative and the Board on Health Sciences Policy Council addressed the issues surrounding harmonized reporting on potential conflicts of interest.

Areas of discussion included: 

  • Common disclosure process for health care and life sciences in order to lessen the burden of compliance requirements.
  • Developing a standard for content, format, procedures for data entry, storage for use in reporting relationships and meeting the needs of health care and life science compliance reporting.
  • Harmonized reporting and developing a common disclosure process that simplifies data collection, storage, maintenance and retrieval.
  • Improving the accuracy of data, and reduction for the need of clarification and revision.

For a complete review of discussion points regarding approaches to harmonizing the process of reporting relationships, go to the Harmonizing Reporting PDF.

On February 12th, beginning at 1 PM EST, Timothy Robinson, Esq., President, Regulatory Law Group PLLC and General Counsel, of MMIS, Inc. will host a free, on-line forum, sharing his thoughts around harmonized reporting and creating a common disclosure process. To join this conversation, request to register for the forum at www.medispend.com.

The Department of Public Health Holds Public Hearing in Boston to Discuss Proposed Regulations for Massachusetts

On October 19, 2012, the Department of Public Health will hold a public hearing at 10 AM ET in the Public Health Council Room at 250 Washington Street in Boston Massachusetts to discuss the proposed regulations for the state of Massachusetts; emergency amendments to 105 CMR 970.000, Pharmaceutical and Medical Device Manufacturer Conduct.

See the notice for details on the hearing.

See the proposed Massachusetts regulations.

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 prove the lack of awareness among physicians regarding this Act and their expressed concerns. Timothy Robinson, MMIS General Counsel and President of the Regulatory Law Group, PLLC. will be representing MMIS, Inc. at the Roundtable event in Washington DC this afternoon.

See the full response to 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 participant, including the cost of food, refreshments and other items of economic value provided at the presentation. 

In addition to easing restrictions on meal related expenditures, the revised budget expands the ability for medical device manufacturers to provide training on medical devices.  Specifically, the amendments remove the requirement that medical device training occur as part of the vendor’s purchase agreement for a device. Medical device manufacturers will now have the ability to provide training to health care providers prior to a decision to purchase a device. 

While the amendments provide pharmaceutical and medical device manufacturers with additional opportunities to provide modest meals and refreshments to health care providers, they do so with enhanced reporting requirements.

See the Chapter 111N Pharmaceutical and Medical Device Manufacturer Conduct to read more. 

By Timothy Robinson, General Counsel, MMIS, Inc. 

 

 

CMS Delays Industry Data Collection of Physician Payments

On May 10, 2012, the Centers for Medicare and Medicaid Services (CMS) announced that federal requirements for drug and device manufacturers to collect information on gifts and payments to physicians would not begin until 2013 due to the proposed transparency rules needing further revision and clarification. Creating physician awareness and developing a proactive disclosure of spend data to covered recipients are mentioned.

See the full article on amednews.com to read more.

Senators Kohl and Grassley Push CMS to Implement the Sunshine Act by June 2012

Legislative Watch

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.

Vermont Amends Gift Ban and Aggregate Spend Reporting Requirements . . . Again.

A new legislative biennium in Vermont means further changes to the Vermont Gift Ban (18 V.S.A. §4631a) as well as the aggregate spend reporting requirements (18 V.S.A.§4632). On May 6, 2011, the Vermont House and Senate approved Senate Bill 104 which is currently awaiting the signature of Governor Shumlin. See the MediSpend Legislative Watch for a summary of how the revised legislation will affect Pharmaceutical and Medical Device Manufacturers.

The legislation, a copy of which is available here, will change the reporting dates from a fiscal year to a calendar year. Commencing in 2012, the Vermont aggregate spend disclosure form will be due on or before April 1st. Additional changes include:

  • The definition of a "Manufacturer" - now exempts from the gift ban and reporting requirements a manufacturer whose only prescribed products are classified as Class I by the FDA, are exempt from pre-market notification under Section 510(k) of the federal Food, Drug and Cosmetic Act, and are sold over-the-counter without a prescription;
  • Market Research and Surveys – bans payments for market research or surveys, other than a bona fide clinical trial or "systematic investigation";
  • Patient Assistance Programs – prescribed products distributed pursuant to a Patient Assistance Program are now permitted gifts and not subject to reporting;
  • Payments in conjunction with clinical trials – payments must be reported after the earlier of FDA approval or clearance or 4 calendar years from payment (used to be 2 years);
  • Loans of medical devices – the allowable trial period is extended from 90 days to 120 days;
  • Over the counter drugs and medical devices provided to health care providers for distribution to patients must be reported.

Stay tuned for a conference call on June 16th at 1pm EST. with the Vermont Attorney General's Office to discuss the draft 2011 Guide which should be issued in early June.