The Centers for Medicare & Medicaid Services (CMS) has released the proposed rules for the Hospital Outpatient Prospective Payment System (OPPS) and the Physician Fee Schedule (PFS) for calendar year (CY) 2025, with comments due on Sept. 9.
The rule governs how hospitals are reimbursed under OPPS, as well as changes to associated quality reporting programs. The PFS governs payment policy in Medicare Part B for ambulatory care practice and encompasses changes to related programs, including the Quality Payment Program and the Medicare Shared Savings Program.
Highlights of proposed changes relevant to health-system pharmacy include:
Hospital Outpatient Prospective Payment System
Access to Non-Opioid Treatments for Pain Relief: CMS is proposing to provide temporary additional payments for access to non-opioid pain relief treatments (from 2025-2027). CMS would make seven drugs and one device eligible for additional payment and pay for these products separately in hospital outpatient departments and ambulatory surgical centers.
Payment for Remote Services: CMS proposes aligning OPPS payment for services furnished remotely to patients in their homes with payment under PFS. This includes payment for diabetes self-management training, remote nutrition therapy, and mental health services.
Physician Fee Schedule
E/M Codes: CMS is proposing an Office/Outpatient (O/O) add-on code to Evaluation and Management (E/M) services. The add-on code, G2211, can be used on the same day as an annual wellness visit, vaccine administration, or any Medicare Part B preventive service furnished in the office or outpatient setting.
Virtual Supervision: CMS would make permanent virtual supervision for the lowest level E/M visit (99211) but would discontinue virtual supervision for other codes, absent congressional action. ASHP has advocated aggressively for permanent virtual supervision. Although we are pleased to see progress in making virtual supervision of low-level codes permanent, we will continue to advocate for expanding the list of eligible codes.
Telehealth: Beginning on Jan. 1, 2025, CMS also proposes that an “interactive telecommunications system may include two-way, real-time audio-only communication technology for any telehealth service furnished to a beneficiary” if the beneficiary requires it.” CMS will also allow practitioners to continue to use their practice location rather than their home address when providing telehealth services from their home through 2025.
Opioid Treatment Programs (OTPs): CMS proposes new flexibilities for OTPs, including permanently allowing audio-only periodic assessments and allowing the OTP intake add-on code to be furnished via two-way audio-video communications technology when billed for the initiation of treatment with methadone when clinically appropriate. Additionally, CMS proposes an increase in payment for OTPs, as well as add-on codes for new Food and Drug Administration--approved opioid agonist and antagonist medications.
Part B Preventive Services Payment: Hepatitis B Vaccination: CMS proposes expanding coverage of hepatitis B vaccinations to beneficiaries who have not been previously vaccinated or whose vaccination status is unknown. CMS will no longer require a physician’s order for hepatitis B vaccination to facilitate roster billing.
PrEP and other Drugs Covered As Additional Preventive Services (DCAPS): Additionally, CMS proposes a new payment methodology for supplying and administering DCAPS such as pre-exposure prophylaxis (PrEP) for HIV consistent with ASP methodology (i.e., ASP + 6%). CMS is proposing this PrEP payment methodology as it finalizes its National Coverage Determination (NCD) moving PrEP coverage from Part D to Part B. ASHP continues to advocate for CMS to take steps to ensure that the NCD does not undermine current beneficiary access to pharmacist-provided services.
Inflation Reduction Act Rebate Program Implementation: CMS proposes to codify policies related to the rebates that drug manufacturers must pay when the price of their product increases more rapidly than inflation. Specifically, CMS proposes to remove 340B Drug Pricing Program claims using National Provider Identifiers and/or Medicare Provider numbers from all claims used to determine the rebate amount, to establish a process for reconciling the rebate amount for Parts B and D drugs, and clarifying rebate amounts in specific circumstances such as when drugs are subject to wastage refunds.
In addition to the highlights above, the proposed rules address a number of other issues, including electronic prescribing for controlled substances, single-dose and single-use product discarded amount manufacturer refunds, radiopharmaceutical payment, and quality metrics. A full analysis and summary for each proposed rule will be published in coming days. Questions or concerns should be directed to ASHP's Jillanne Schulte Wall.
