However, the issue is not entirely free from doubt: some might argue that the January 1, 2022 effective date applies to payments and other transfers of value made after that date, so that data on the new categories of covered recipients would begin to be collected in calendar year 2022 and would not be reportable until March 2023. CMS will undoubtedly amend its implementing regulations (42 C.F.R. § 403.900 et seq.) through a notice and comment rulemaking, in which we can expect CMS to articulate its position on the effective date.

1 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, §6002, 124 Stat. 119 (2010) (hereinafter PPACA). 2 42 C.F.R. §403.900 et seq. 3 Hospitals and hospital-based entities, such as pharmacies, that manufacture a product solely for use by the hospital or the entity’s patients are not covered by the Act as manufacturers. Entities under common ownership with an applicable manufacturer that assist in the marketing, selling, or distributing a covered product in the United States must comply with the Sunshine Act.

Section 6002 of the ACA (codified at 42 U.S.C. § 1320a-7h etseq.) for which CMS issued a final rule in early February 2013, located at 42 C.F.R. § 403.900 etseq., requires “applicable manufacturers” and “applicable GPOs” to begin reporting certain payments or transfers of value made to certain physicians and teaching hospitals on March 31, 2014. CMS will make this information available to the public through this website on September 1, 2014.