On February 8, 2013, the Center for Medicare and Medicaid Services issued the Final Rule1 to implement Section 6002 of the Patient Protection and Affordable Care Act (PPACA) referred to as the “Sunshine Law.”2 The Sunshine Law requires applicable manufacturers of drugs, devices, biological or medical supplies (“applicable manufacturers”) covered under Medicare, Medicaid or the Children’s Health Insurance Program (“CHIP”) to report annually certain payments or other transfers of value to physicians and teaching hospitals to the Secretary of Health and Human Services (“HHS”). Applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests held by physicians or their immediate family members in such entities. HHS is required by statute to publish the reported data on a public website.
According to HHS, payments from manufacturers to physicians and teaching hospitals can cause conflicts of interest that may influence research, education and clinical decision-making in ways that compromise clinical integrity, and may lead to health care costs. CMS states that financial ties, alone, do not signify an inappropriate relationship, but the required transparency will give the public information regarding the nature and the extent of the relationship between applicable manufacturers and/or applicable GPOs and physicians.
Timing
The Sunshine Law required that applicable manufacturers and applicable GPOs begin collecting the required data on January 1, 2012. However, CMS stated that because the Final Rule had not been issued on January 1, 2012, applicable manufacturers and applicable GPOs would not be required to begin collecting the required data until after the publication of the Final Rule. Now, with the publication of the Final Rule, CMS has announced that the data collection requirement will begin on August 1, 2013. Applicable manufacturers and applicable GPOs must report this information to HHS by March 31, 2014.
Definition of “Physician”
The definition of “physician,” within the meaning of the Final Rule, includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors who are legally authorized to practice the profession by the State in which they practice. Thus, for the purpose of the Sunshine Law, the term “physician” encompasses other licensed health professions. The definition “physician” does not include a physician who is an employee of the applicable manufacturer.
Payments or other transfers of value to medical residents, whether or not the medical resident is licensed to practice in the state, will not need to be reported.
Identification of Physicians
The Sunshine Law requires that applicable manufacturers report a physician’s name, business address, NPI and specialty. CMS recognizes that not all physicians have an NPI, but expects that applicable manufacturers will make a good faith effort to obtain physicians’ NPI (or lack thereof). CMS stated that a good faith effort includes, but is not limited to, specifically requesting an NPI from the physician or using the National Plan & Provider Enumeration System (NPPES) database. The applicable manufacturer may leave the NPI field blank if the applicable manufacturer is unable, after making a good faith effort, to identify an NPI for the physician.
Required Information to be Reported
A report must contain the following information for each payment or other transfer of value.
- 1Name of the physician.
- 2Primary business address.
- 3Physician’s identifiers: (i) specialty, (ii) NPI, (iii) state professional license number(s) (for at least one state w