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Health Industry Transparency Compliance Resource Center Updates and Alerts

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Recent Publications

March 2013 Non-Research Payment Template, Research Payment Template, and Physician Ownership Template

January 16, 2013 The Proposed Rule on Transparency Reports: Shedding Light on the Sunshine Act (Part III), Journal of Health Care Compliance

August 1, 2012 No Change in Course on ACA Federal Antifraud and Transparency Provisions
Healthcare companies should work to comply with current provisions and prepare for those that will be implemented in the near future.

Transparency in industry relations with collaborators such as healthcare professionals and healthcare institutions has been a pronounced and important compliance trend for several years. Many companies voluntarily report the compensation of healthcare professionals for research, education, consulting, and product development. Transparency provisions have been imposed in government healthcare fraud settlements pursuant to deferred prosecution agreements (DPAs) and Health and Human Services (HHS) Office of Inspector General (OIG) corporate integrity agreements (CIAs).

The trend is a legal evolution as well where some states and now federal regulators have imposed reporting requirements for the purposes of revealing compensated relationships that may involve financial conflicts of interest and dissuading inappropriate interactions.

The transparency reporting provisions in the Patient Protection and Affordable Care Act (Affordable Care Act or ACA) and its implementing regulations in the Centers for Medicare & Medicaid Services's (CMS's) proposed rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests," apply broadly to the life sciences industry for transactions related to covered drugs, devices, biologicals, and medical supplies. The regulations will impact physicians and teaching hospitals, and will provide public access to substantial information on industry relationships with healthcare professionals and institutions. The mechanics of reporting the required information will necessitate vigilant attention to and tracking of corporate and affiliated expenditures to ensure compliance with the regulations. The Morgan Lewis Transparency Compliance Resource Center monitors state and federal transparency developments.

Transparency reporting and compliance obligations do not apply exclusively to life sciences industry collaborators. The ACA adopted broad reporting requirements that are applicable to hospitals, physicians, nursing homes, pharmacy benefit managers, and group purchasing organizations. A summary of these industry tracking, collection, and reporting provisions is available. Our Morgan Lewis Transparency Compliance team will post updates regarding health industry transparency compliance, regulations, and industry codes of ethics. If you have questions, please contact our Transparency Compliance Resource Center at TransparencyCompliance@morganlewis.com.

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A New Era of Accountability and Transparency For Long Term Care Professionals (07/16/2014)
Presented during the Direct Supply Clinical Leadership Conference 2014
Transparency Update: U.S. Sunshine Collection Obligations Take Effect (08/06/2013)
Many organizations continue to face challenges with the technology and integration of some of the more complex interpretations.
FDA Taking on Cybersecurity Risks for Medical Devices (06/17/2013)

FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices.

Breaking News

Non-Research Payment Template (03/26/2013)
This proposed template contains detailed information about the data elements to be collected related to all payments or other transfers of value other than research. The template includes information such as field format (text, numeric, alphanumeric), allowable values (such as yes/no), required versus optional fields, and maximum character length. This template is intended to assist applicable manufacturers and applicable group purchasing organizations as they prepare for and commence with data collection processes.
Physician Ownership Template (03/26/2013)
This proposed template contains detailed information about the data elements to be collected related to physician ownership and investment interest. The template includes information such as field format (text, numeric, alphanumeric), allowable values (such as yes/no), required versus optional fields, and maximum character length. This template is intended to assist applicable manufacturers and applicable group purchasing organizations as they prepare for and commence with data collection processes.
Research Payment Template (03/26/2013)
This proposed template contains detailed information about the data elements to be collected related to research payments or other transfers of value. The template includes information such as field format (text, numeric, alphanumeric), allowable values (such as yes/no), required versus optional fields, and maximum character length. This template is intended to assist applicable manufacturers and applicable group purchasing organizations as they prepare for and commence with data collection processes.
Final Rule: Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests (02/08/2013)
The Centers for Medicare and Medicaid Services has posted the final U.S. Sunshine Rule to the Federal Register - 78 Fed. Reg. 9458; February 8, 2013.
Docs Fear For Reputations Under Final Sunshine Rule, Law360 (02/07/2013)
FDA & Healthcare partner Katie McDermott is quoted.
Final U.S. Sunshine Rule Issued Today (02/01/2013)
The Morgan Lewis Transparency team will issue a briefing on the final regulation shortly and will hold a free webinar on the provisions and implementation issues in the near future.

Federal Transparency Resources

Joint Trade Association Sunshine Letter to CMS (08/14/2012)
Life science trade associations AdvaMed, BIO, MITA, and PhRMA recently issued a joint letter to encourage the Centers for Medicare & Medicaid Services (CMS) to promptly publish the final rule implementing the Physician Payments Sunshine Act, section 6002 of the Affordable Care Act of 2010, following complete and thoughtful consideration of comments submitted by stakeholders on the proposed rule.
No Change in Course on ACA Federal Antifraud and Transparency Provisions (08/01/2012)
Healthcare companies should work to comply with current provisions and prepare for those that will be implemented in the near future.
The Proposed Rule on Transparency Reports: Shedding Light on the Sunshine Act, Journal of Health Care Compliance (03/28/2012)
An overview of the most important aspects of the proposed regulations.
CMS Issues Transparency Reporting Proposed Rule (12/21/2011)
The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.

State Transparency Resources

Update: Massachusetts Amends 105 C.M.R. 970.000 “Gift Ban” Law (09/25/2012)
Amendments allow for more relaxed rules regarding the provision of modest meals and refreshments for educational interactions, require new quarterly reporting, provide a sunset date on certain provisions in anticipation of federal reporting requirements, and establish a new mandated disclosure provision to instances of noncompliance.
Massachusetts Adopts Revisions to Health Care Practitioner “Gift Ban” Law (07/11/2012)
Amendments permit pharmaceutical and medical device companies to pay reasonable expenses for medical device training, and for modest meals and refreshments for educational interactions.
MA Legislative Changes to M.G.L. Chapter 111N – July 8, 2012 (07/08/2012)
Amendments to Massachusetts General Law – Chapter 111N as signed into law by Governor Deval Patrick on Sunday, July 8, 2012.
MA Dept of Pub Hlth – Renewal Registration Form (08/09/2011)
Compliance filing form for pharmaceutical and medical device manufacturers – August 31st deadline for submission.
MA Department of Pub Hlth – Implementation Regulation 105 CMR 970.000 (03/11/2009)
Regulation issued by the Massachusetts Department of Public Health regarding pharmaceutical & medical device conduct.
Original M.G.L. Chapter 111N (08/10/2008)
As enacted in 2008 to govern the conduct of pharmaceutical & medical device manufacturers interacting with health care practitioners.