The Centers for Medicare and Medicaid Services (CMS) recently announced changes that will affect how life sciences organizations report data when complying with the U.S. Open Payments transparency program. The Open Payments program was established in 2010 as part of the Patient Protection and Affordable Care Act.
These latest modifications were enacted as part of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, better known as the SUPPORT Act, signed by President Trump on Oct. 24, 2018.
The SUPPORT Act, an increasingly rare example of bipartisan legislation, is meant to address the American opioid crisis. It includes provisions to educate on addiction medicine, standardize the delivery of addiction medications, expand access to care, and coordinate treatment, according to the American Society of Addiction Medicine (ASAM).
Section 6111 of the SUPPORT Act modifies the Open Payments program by expanding the definition of a Covered Recipient to include five more provider types:
- Physician assistants
- Nurse practitioners
- Clinical nurse specialists
- Certified registered nurse anesthetists
- Certified nurse midwives
The expanded definition of Covered Recipient will apply to data submitted on or after Jan. 1, 2022. This means organizations will be collecting the necessary data beginning on Jan. 1, 2021. In addition, the SUPPORT Act enabled CMS to publish National Provider Identifiers (NPIs), the 10-digit pin numbers used to identify healthcare providers.
In addition, pursuant to sections 1102 and 1871 of the Social Security Act, which provide general authority for the Secretary to prescribe regulations for the efficient administration of the Medicare program, CMS is proposing further changes to the Open Payments program. Should the proposed rules take effect, these changes would also apply to data collected beginning in January 2021 and reported in January 2022. For one, CMS is suggested an update to the Nature of Payment categories. They would now include debt forgiveness, long-term medical supply or device loans, and acquisitions.
Also, CMS is proposing the standardization of data on reported covered drugs, devices, biologicals, and medical supplies. CMS is considering requiring inclusion of unique device identifiers for devices and medical supplies. There is also a proposal to consolidate medical education programs nature of payment into one category.
CMS posted the calendar year 2020 Medicare Physician Fee Schedule Proposed Rule on the Federal Register with a comment period. CMS will be accepting comments until Sept. 27, 2019, and users will be able to see a response to comments along with the promulgation of the final rule.
Following promulgation of the final rule, Applicable Manufacturers will need to revise their systems, processes and policies to reflect changes to the Open Payments requirements. In addition, change management will be critical to ensure that all those who interact with healthcare providers on the manufacture’s behalf understand the expanded reporting requirements.