Perspective

CMS issues final rule on Physician Payment Sunshine Act

CMS recently announced in a press release its final rule on the National Physician Payment Transparency Program: Open Payments, also known as the Sunshine Act, aimed to increase transparency among physicians, drug and device manufacturers and health care providers.

As part of the Affordable Care Act, the rule calls for manufacturers of drugs, devices, biologics and medical supplies reimbursed by Medicare, Medicaid or Children’s Health Insurance Program to disclose payments made to doctors and teaching hospitals to CMS. According to the release, these manufacturers and group purchasing organizations must also report physician ownership and investments in these enterprises. This data will be publicly available on a CMS website by September 30, 2014, and entities required to report information under the rule will be able to review and correct reported data before it is released to the public. Collection of this information will begin August 1 of this year, according to the release.

 

Jeremy Lazarus

“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” Peter Budetti, MD, CMS deputy administrator for Program Integrity, stated in the press release. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

AMA President Jeremy Lazarus, MD, stated that the AMA will carefully review the new rule.

“Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients,” Lazarus stated in an AMA press release. “Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies. As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process.”

Click to view a chart from Arnold & Porter LLC that provides more detailed information on key aspects of the rule, including comparisons between the proposed and final rules and brief summaries of CMS’ stated rationale for its decisions.

Reference:

https://www.federalregister.gov/public-inspection

CMS recently announced in a press release its final rule on the National Physician Payment Transparency Program: Open Payments, also known as the Sunshine Act, aimed to increase transparency among physicians, drug and device manufacturers and health care providers.

As part of the Affordable Care Act, the rule calls for manufacturers of drugs, devices, biologics and medical supplies reimbursed by Medicare, Medicaid or Children’s Health Insurance Program to disclose payments made to doctors and teaching hospitals to CMS. According to the release, these manufacturers and group purchasing organizations must also report physician ownership and investments in these enterprises. This data will be publicly available on a CMS website by September 30, 2014, and entities required to report information under the rule will be able to review and correct reported data before it is released to the public. Collection of this information will begin August 1 of this year, according to the release.

 

Jeremy Lazarus

“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” Peter Budetti, MD, CMS deputy administrator for Program Integrity, stated in the press release. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

AMA President Jeremy Lazarus, MD, stated that the AMA will carefully review the new rule.

“Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients,” Lazarus stated in an AMA press release. “Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies. As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process.”

Click to view a chart from Arnold & Porter LLC that provides more detailed information on key aspects of the rule, including comparisons between the proposed and final rules and brief summaries of CMS’ stated rationale for its decisions.

Reference:

https://www.federalregister.gov/public-inspection

    Perspective
    Jack M. Bert

    Jack M. Bert

    The potential for conflict certainly exists for a physician to utilize a product that he or she has developed but most implant manufacturers do not allow direct compensation to that developing physician for personal utilization of that product for internal compliance reasons. Thus, when a physician recommends a specific implant regardless of whether he or she has developed it, the surgeon truly believes that it is the best product on the market for a particular case and the additional necessity of the physician declaring that he or she was involved with the manufacture of the implant should not be a hindrance to its utilization. My experience in this situation has been that the patient is pleased with the notion that his treating surgeon has been involved in a technology which will be utilized during the upcoming surgery as long as it is explained appropriately to the patient.

    • Jack M. Bert, MD
    • Section Editor, Business of Orthopedics, ORTHOPEDICS TODAY Minnesota Bone & Joint Specialists St. Paul, Minn.

    Disclosures: Bert has no relevant financial disclosures.

    Perspective
    Michael X. Repka

    Michael X. Repka

    The Academy is in the process of reviewing the final rule released by the Centers for Medicare and Medicaid Services implementing the Sunshine Act. We are encouraged in our initial read to see that CMS adopted proposals from the Academy and other medical associations that will give physicians more time to dispute information before it is made available to the public.

    As a result of medicine's advocacy, physicians will have a total of 60 days to resolve any disputes. The Academy also was successful in convincing CMS to exclude funds used to support continuing medical education activities as long as they are provided free of any commercial interests.

    • Michael X. Repka, MD
    • American Academy of Ophthalmology

    Disclosures: Michael X. Repka, MD, is the American Academy of Ophthalmology Medical Director for Governmental Affairs.