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In the Federal Register posted on August 14, 2019,
the Centers for Medicare and Medicaid Services (CMS) published
proposed regulations that, if finalized, would expand the Open
Payments reporting requirements initially introduced under the
Physician Payments Sunshine Act.1 The Open Payments program
sheds light on some of the payments (and other transfers of value)
made from certain drug, device, biologicals and medical supply
manufacturers to covered recipient physicians and teaching
hospitals. Under the Physician Payments Sunshine Act, the
applicable manufacturers must report certain payments made to the
covered recipients through the Open Payments program on an annual
basis.2 Such disclosures are available to the
public. The categories of payments or transfers of value that must
be disclosed include: research, honoraria, gifts, grants, travel
expenses, and marketing, education or research for a specific
covered drug or device.
As one of the measures to fight the opioid crisis, the Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment
for Patients and Communities Act (SUPPORT for Patients and
Communities Act) expanded the definition of covered recipient to
include physician assistants, nurse practitioners, clinical nurse
specialists, certified registered nurse anesthetists and certified
nurse midwives.3 The additional reporting requirements are
set to begin with Open Payment submissions made on or after January
1, 2022. The purpose of the recently proposed CMS regulations is to
align the regulations with the revisions to the statute and to make
other modifications to the Open Payments program.
Under the proposed regulations, CMS is expanding the covered
recipient definition to include those categories of individuals as
identified in the SUPPORT for Patients and Communities Act,
expanding the payment categories and standardizing data on covered
drugs and devices. If finalized, these changes will be effective
for data collected beginning January 1, 2021, and reported on or
after January 1, 2022. Additionally, CMS is proposing a correction
to the national drug codes (NDCs) reporting requirements that would
be effective 60 days following publication, if finalized.
As for the change regarding the definition of covered recipient,
the CMS proposed rule mimics the additional provider categories as
required by the SUPPORT for Patients and Communities Act and
supplements the definition section to include a definition for each
additional category of professional. The effect of this change
would require applicable manufacturers to report transfers of value
to these additional provider types.
Next, the proposed change to the payment categories consolidates
and adds to the available categorizations in the "nature of
payment" selection that is required when reporting payments in
the Open Payments program. CMS is proposing to consolidate two
separate categories for continuing education programs (one for
accredited/certified programs and the other for
unaccredited/noncertified programs) into one "medical
education programs." It also proposes to add: "debt
forgiveness" for forgiving a debt of a covered recipient;
"long-term medical supply or device loan" for loans
exceeding 90 days; and "acquisitions" for characterizing
buyout payments made to covered recipients. Definitions for these
new categories are proposed as well.
Further, CMS proposes standardizing the use of identifiers for
reporting payments made related to medical devices. The proposal
requires applicable manufacturers and group purchasing
organizations to provide the device identifiers component, if any,
when identifying reported devices in the Open Payment program. CMS
explicitly states that it is not proposing the inclusion of the
full unique device identifiers.
Finally, the references to nonresearch NDCs were erroneously
removed in a previous amendment to the rule text and CMS is
correcting the error in this proposed rule. CMS reiterated that
reporting NDCs are required for both research and nonresearch
payments.
Footnotes
1 84 Fed. Reg. 40482, 40713-16 (Aug. 14, 2019). See
our previous alert about the subject
here.
2 Section 1128G of the Social Security Act (42 U.S.C.
§ 1320a-7g).
3 Section 6111 of the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (SUPPORT Act) (Pub. L. 115-270).
Disclaimer:This Alert has been
prepared and published for informational purposes only and is not
offered, nor should be construed, as legal advice. For more
information, please see the firm's
full disclaimer.
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