CMS accepting comment on Physician Payment Sunshine Act until Feb. 17

The Centers for Medicare and Medicaid Services has delayed the deadline for drug, device and biological companies to report payments to physicians and teaching hospitals under the Physician Payment Sunshine Act.

A proposed rule was issued in December. The reporting deadline was deferred from Jan. 1 to a date to be announced when a final rule is issued later this year.

CMS will accept comments on the preliminary rule until Feb. 17 at 5 p.m. Eastern Standard Time.

The Physician Payment Sunshine Act requires manufacturers of drugs, devices and biologics covered by Medicare, Medicaid or the Children’s Health Insurance Program to annually report payments made to physicians and teaching hospitals to the Secretary of Health and Human Services.

Additionally, manufacturers and group purchasing organizations (GPOs) must report physician ownership or investment interests that apply.

The rule applies to payments and transfers of value including gifts, food, travel, entertainment, consulting fees and honoraria valued at more than $10 each or $100 cumulatively per year. Product samples and educational materials intended for patient use are not subject to the reporting requirements, according to the rule.

Applicable manufacturers and GPOs are subject to civil monetary penalties for failing to meet the reporting requirements, according to the proposed rule published in the Federal Register.

Under the proposed rule, manufacturers would be required to submit a report by March 31, 2013. CMS would aggregate, collate and correct submitted data and make it publicly available on Sept. 30, 2013. Manufacturers would subsequently be required to report applicable payments on the 90th day of each calendar year.

Comments may be submitted electronically at http://www.regulations.gov or sent to the Centers for Medicare and Medicaid Services, Department of Health and Human Services, Attention: CMS-5060-P, P.O. Box 8013, Baltimore, MD 21244-8013.

The reporting requirement is mandated by the Patient Protection and Affordable Care Act, the federal health care reform bill enacted in March 2010.

The proposed rule summary is available at https://www.federalregister.gov/articles/2011/12/19/2011-32244/medicare-medicaid-childrens-health-insurance-programs-transparency-reports-and-reporting-of.

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