On August 4, 2020, the Centers for Medicare and Medicaid Services (“CMS”) posted for inspection the Proposed 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 17, 2020, and among its many proposals, would update and revise: (1) the physician fee schedule relative value units; (2) practice expense relative value units; (3) telehealth service approval and reimbursement policies; (4) the direct supervision requirement; (5) payment for teaching physicians; (6) medical records documentation policies; and (7) policies regarding opioid treatment programs.

Comments to this proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020.Physician Fee Schedule:

CMS is required to establish payments under the physician fee schedule (“PFS”) based on national uniform relative value units (“RVUs”) that account for the relative resources used in furnishing a service.  The Medicare statute requires that RVUs are established for three categories of resources: (1) work; (2) practice expense; and (3) malpractice expense.  In addition, the Medicare statute requires that CMS establish by regulation each year’s payment amounts for all physicians’ services under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas.  In this proposed rule, CMS is proposing to establish RVUs for calendar year (“CY”) 2021 for the PFS to ensure that payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the Medicare statute.  Beyond the general update, the proposed rule addresses the following PFS-related changes:

  • Practice Expense RVUs: CMS specifically proposes to update, and requests comments, regarding the practice expense RVUs for certain equipment and services, including certain scope equipment services, venous and arterial stenting services, myocardial PET equipment inputs, and updating the allocation of indirect PE for some office-based services.
  • Potentially Misvalued Services: CMS received multiple submissions requesting that CMS consider CPT Code 22867 (insertion of interlaminar/interspinous process stabilization/distraction device without fusion, including image guidance when performed with open decompression, lumbar; single level) for nomination as potentially misvalued.  After considering the submitted information, CMS is proposing to nominate CPT Code 22867 as potentially misvalued.

Telehealth and Other Services Involving Communication Technology:

For CY 2021, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2020.  Since that time, and in response to the COVID-19 public health emergency (“PHE”), CMS undertook emergency rulemaking to add a number of services to the Medicare telehealth services list on an interim final basis.  In the proposed rule, CMS proposes to formally add certain services to the list of approved telehealth services, and proposes a mechanism under which it could add additional services to the Medicare telehealth list on a temporary basis, for the duration of the COVID-19 PHE.

Direct Supervision by Interactive Telecommunications Technology:

For the duration of the PHE, CMS adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology.  In this proposed rule, CMS proposes to extend this policy until the later of the end of the calendar year in which the PHE ends or December 31, 2021.  The extension of this flexibility would allow time for clinicians to make adjustments and for CMS to obtain input on services and circumstances for which this policy might be appropriate on a permanent basis.

Payment for Teaching Physicians

During the PHE for the COVD-19 pandemic, CMS implemented various teaching physician and resident moonlighting policies that allowed for PFS payments to be made pursuant to more flexible oversight requirements, including through audio/visual real-time technology.  In the proposed rule, CMS has asked for public comment regarding whether the more flexible PHE measures that had been implemented on an interim basis regarding teaching physician and resident moonlighting payment should continue on either a temporary or permanent basis.  In many instances, CMS expressed its concern that continuing to allow teaching physicians to oversee residents virtually could pose safety risks for patients and would not allow for specific at-risk patient populations to receive sufficient diagnostic care through virtual media.  The agency believes that soliciting comments from the public will allow the agency to determine the appropriate policy decisions going forward after the conclusion of the COVID-19 PHE.

Clarification of medical records documentation

In the CY 2020 PFS final rule, CMS expressed that any person authorized under Medicare to provide and bill for their professional services may review and verify the medical records for services billed, rather than having to document notes in the medical record made by nurses, physicians, residents, or other medical team members.  In the proposed rule, CMS clarified that this previously expressed policy also applies to therapists.  As a result, therapists will be able to spend more time providing therapy services to their patients, rather than documenting care in the medical record.  CMS reemphasized the fact that, although it is allowing any medical team member to document notes in the medical record, only the clinician who bills for the service is the one who must review and verify the documentation.  In addition, CMS notes that information included in the medical record should document that the services are reasonable and necessary.

Opioid Treatment

The proposed rule seeks to extend the definition of Opioid Use Disorder (“OUD”) treatment services to include naloxone and other opioid antagonist medications approved by the FDA for the emergency treatment of an opioid overdose.  By including drugs like naloxone in the definition of OUD treatment services, the proposed rule seeks to increase access to this effective emergency treatment.  In addition, the proposed rule would allow Opioid Treatment Programs (“OTPs”) to be paid under Medicare when dispensing naloxone to Medicare beneficiaries who are receiving OUD treatment from such individuals.  Ultimately, CMS expects that these proposed changes will decrease barriers to access for individuals, as there are no copayments for services provided by OTPs and beneficiaries would not have to go to another provider for such treatment.

In the proposed rule, the agency requests public comment regarding (1) whether the OUD treatment services definition should be further extended to include overdose outreach and education, (2) payment for providing education regarding overdoses to a beneficiary or his/her family should be included in the current payment bundles for episodes of care, or whether CMS should provide an additional payment for education when OTPs provide such services, and (3)  how CMS should determine payment rate inputs if overdose education were to be included in such payment bundles.

The proposed rule also includes a proposed change to the payment rate for bundled payments to reflect the cost of opioid antagonist medications like naloxone.  Specifically, CMS has proposed adjusting the bundled payment rate through the use of an add-on code to account for situations where OTPs administer naloxone to Medicare beneficiaries.  CMS proposes a limitation on the frequency of using such add-on codes to once every 30 days and seeks comment on reasonableness of that proposal.  Furthermore, the agency also invited public comment on its specific proposed pricing methodologies for nasal naloxone, auto-injector naloxone, and creating a code and establishing an add-on payment for injectable naloxone.

The inspection copy of the proposed rule is posted on the Federal Register website and is available at: https://www.federalregister.gov/documents/2020/08/17/2020-17127/medicare-program-cy-2021-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other