July 28, 2021

Last week, we published an alert that outlined some of the key provisions of the Medicare Physician Fee Schedule (PFS) Proposed Rule (PR) for 2022 that may affect hospitals. As promised in that alert, this week’s article will provide additional details arising from the 2022 PR. Again, much of this material is based, in part, on summaries provided by the Centers for Medicare and Medicaid Services (CMS) and the American Hospital Association (AHA).

Opioid Treatment Program

The government has placed a major emphasis on treating opioid addiction in recent years, and 2022 promises to be no different. The PR contains several modifications to Medicare Part B opioid treatment program (OTP) regulations. First, CMS proposes to adjust payments for take-home supplies of naloxone (including both the drug and associated services) for geographic and Medicare spending variation. In addition, CMS will create a new G-code describing a take-home supply of a new, higher dose naloxone product, and price the code using the same methodology used for existing codes in the benefit. Finally, CMS proposes to allow OTPs to continue to furnish therapy and counseling using audio-only telephone calls following the end of the public health emergency (PHE). However, this would only be permitted where the beneficiary is not capable of, or has not consented to, the use of audio-visual technology.

Those providing OTP services would be required to append a specific modifier to claims and document in the medical record that the counseling or therapy was furnished via the audio-only modality and the rationale for doing so. While these requirements would take effect on January 1, 2022, they would apply only for services furnished after the end of the PHE.

Electronic Prescribing of Controlled Substances

By way of background, the 2021 PFS Final Rule implemented Section 2003 of the SUPPORT Act, which mandated electronic prescribing of Schedule II-V controlled substances (EPCS) under Medicare Part D, beginning Jan. 1, 2021. However, CMS is now proposing to extend the compliance date for EPCS requirements until Jan. 1, 2023.

The PR also stipulates that, in order for prescribers to be considered compliant, they must prescribe at least 70 percent of their Part D controlled substance prescriptions electronically per calendar year. There are exceptions to this proposal:

Prescriptions issued where the prescriber and dispensing pharmacy are the same entity

Prescribers who prescribe 100 or fewer Part D controlled substance prescriptions per year

Prescribers who are prescribing during a recognized emergency (like a natural disaster or pandemic)

Prescribers who request and receive a waiver from CMS due to extraordinary circumstances
Quality Payment Program

As required by MACRA, eligible clinicians will receive positive or negative payment adjustments of up to 9 percent in 2024 based on 2022 quality performance under the Merit-based Incentive Payment System (MIPS). Key proposed MIPS policy changes under the 2022 PR include the following:

MIPS Value Pathways (MVPs). MVPs organize the reporting requirements for each MIPS category around specific medical conditions, clinical specialties or episodes of care. The 2022 PR calls for seven optional MVPs, beginning with the 2023 performance period. The MVPs include rheumatology, stroke care and prevention, heart disease, chronic disease management, lower extremity joint repair (e.g., knee replacement), emergency medicine and anesthesia.

MIPS Performance Threshold. CMS proposes to increase the performance threshold for the 2022 performance/2024 payment year from 60 to 75 points. As required by law, this threshold is the mean MIPS performance score from a prior payment adjustment year (in this case, 2019).

Promoting Interoperability. The PR would make changes to this category’s objectives and measures that align with changes proposed for the hospital Promoting Interoperability Program. These include revising requirements for the Public Health and Clinical Data Exchange objective, requiring eligible clinicians to attest to an annual assessment of the High-Priority Guide of the Safety Assurance Factors for EHR Resilience Guides (SAFER Guides) and modifying the Prevention of Information Blocking attestation statements.

Medicare Shared Savings Program

The PR also lists changes to CMS’s Medicare Shared Savings Program (SSP):

Quality Measurement. The PR calls for a longer phase-in of the requirement to report the MIPS APM Performance Pathway (APP) measure set. Specifically, accountable care organizations (ACOs) would be permitted to report either the current SSP measure set via the web interface, or the MIPS APP measure set in performance years 2022 and 2023. In 2023, those ACOs that choose to report the web interface measure set also would be required to report at least one measure from the APP measure set. In addition, CMS proposes to delay the increase of the minimum quality standard from the 30th to the 40th percentile until the 2024 performance year.

Changes to Other Program Elements. CMS proposes changing the requirements around establishing repayment mechanisms, the SSP application process, beneficiary notification requirements, and the definition of primary care services that is used for beneficiary assignment.

Reaction from the AHA

According to a statement released by the AHA, the organization is closely evaluating CMS’s proposals. The AHA expressed appreciation for the proposed enforcement delay of the Appropriate Use Criteria (AUC) program, as well as the proposal to expand access to telehealth for behavioral health services. However, the AHA also expressed a few reservations in connection with the 2022 PR, as indicated in the below statement excerpt:

However, we continue to have concerns regarding certain aspects of the pricing methodology for drugs administered as part of the Opioid Treatment Program benefit, including the limitations on take-home supplies of naloxone. Moreover, we remain concerned about the feasibility of the Merit-Based Incentive Payment System (MIPS) Value Pathways, and believe much work remains to ensure they result in fair, equitable performance comparisons across MIPS clinicians and groups.
Next Steps

If you would like to provide feedback to CMS regarding the Proposed Rule, you will need to submit your comments prior to 5 p.m., Sept. 13. If you have further questions about the PR, please go to the CMS website, or you can contact us at info@miramedgs.com.