Background
This proposed rule makes changes to the Physician Fee Schedule (PFS), which governs payment policy in Medicare Part B for ambulatory care practice. The proposed rule also encompasses changes to related programs, including the Quality Payment Program, the Diabetes Prevention Program, and the Medicare Shared Savings Program among others. CMS updates these rules annually, so many of the policy changes outlined for 2021 build on existing policies.
Major Proposed Changes for CY 2021
- Incident-To Billing by Pharmacists: In the proposed rule, CMS explicitly states that pharmacists can provide incident-to services, including medication management services under Part B. CMS noted that it hopes the clarifications “encourage pharmacists to work with physicians and [non-physicians practitioners] in new ways where pharmacists are working at the top of their training, licensure and scope of practice.” CMS made similar statements in its COVID-19 regulatory flexibility rule, so while ASHP was pleased that the agency is making consistent statements regarding pharmacists’ contributions, it is frustrating that CMS has yet to respond to some of our specific questions regarding incident-to billing.
Specifically, ASHP has repeatedly requested that CMS clarify, in writing, that physicians can bill the highest level evaluation and management (E/M) codes for services provided by pharmacists if all incident to requirements are met. In the 2015 PFS rule, CMS did explicitly state that E/M codes could be billed just this way. However, since 2015, some Medicare Administrative Contactors have independently interpreted CMS requirements to allow physicians to bill only the lowest level E/M codes for pharmacist-provided incident to services. These conflicting MAC interpretations make it difficult to implement innovative pharmacist care models and to ensure patient access. ASHP will continue to seek an explicit written statement from CMS that reinforces its 2015 interpretation and directs MACs to allow E/M billing accordingly.
- Telehealth Services: CMS proposes to add new services to the telehealth list, including a new add-on code for prolonged E/M services and new home visit codes, and provides new clarifications regarding virtual supervision of incident-to services. Virtual supervision is critical to creating and sustaining care models that fully integrate pharmacists. In the proposed rule, CMS extends virtual supervision until December 31, 2021. While we are very supportive of the extension, ASHP will continue to advocate aggressively to make virtual supervision a permanent option for services reimbursed under the PFS . ASHP recently spearheaded a sign-on letter to CMS and the Administration advocating permanent virtual supervision, which included nearly 100 health system, pharmacy association, and provider association signatories.
- Payment Changes for E/M Codes and Analogous Visits: CMS is proposing changes to E/M codes in order to implement site neutral payment and recognize the challenges of taking care of Medicare patients, particularly those with chronic conditions.
- Coding Changes: Effective January 1, 2021, CMS is moving forward with its proposal from last year to implement new payment and documentation requirements based on the American Medical Association’s CPT Editorial Panel. Specifically, CMS will allow clinicians to report E/M codes using either the current 1995/1997 documentation guidelines, by medical decision making alone, or by time alone. These documentation requirements should reduce administrative burden for physicians and practices.
- E/M Reimbursement Changes: Due to the changes to E/M coding levels described above, some providers, such as primary care physicians, will see substantial pay bumps of up to 17%. Other specialties, including radiology, orthopedics, occupational therapy, physical therapy, and speech language pathology, will see reimbursement decrease anywhere from 5 – 11%. Providers who are facing cuts are asking Congress to step in and legislate to restore previous payment rates.
- Increased Payment for AWVs and TCM: CMS is also proposing to increase payments for a number of related services, including transitional care management (TCM) and annual wellness visits (AWVs). Further, to improve and streamline uptake of TCM, CMS is removing 14 End-Stage Renal Diseased related HCPCS codes and the chronic care management (CCM) code from the list of codes that cannot be billed concurrently with TCM.
- Coding Changes: Effective January 1, 2021, CMS is moving forward with its proposal from last year to implement new payment and documentation requirements based on the American Medical Association’s CPT Editorial Panel. Specifically, CMS will allow clinicians to report E/M codes using either the current 1995/1997 documentation guidelines, by medical decision making alone, or by time alone. These documentation requirements should reduce administrative burden for physicians and practices.
- Opioid Treatment Program (OTP) Changes: CMS is proposing a number of enhancements to OTPs, including new add-on codes for nasal naloxone and auto-injector naloxone, as well as new enrollment flexibilities to allow submission of institutional claims.
- Medicare Diabetes Prevention Program (DPP): The proposed rule includes new policy for DPP patients during emergency periods, including the current public health emergency. Patients currently enrolled in DPP and who cannot attend in-person sessions can either opt to restart the DPP services at a later date or continue their course virtually. Patients who opt for virtual DPP services are prohibited from retaking in-person session at a later date. For patients who opt to resume sessions only once in-person services are available, patients in the first 12 months of the DPP course may restart the course from the beginning or pick up from their most recently-attended session. After the first year of DPP, patients cannot restart the program and must resume sessions from where they left off when the emergency began.
CMS is also proposing that beneficiaries receiving DPP services can only stop and restart services once during a declared emergency to allow for better tracking, given that Medicare covers the full set of DPP services only once per beneficiary. CMS also clarifies that during an emergency period, virtual sessions will be treated as in-person sessions for billing and documentation purposes and that providers may obtain weight measurements remotely via digital technology (e.g., Bluetooth) or through an audio-visual feed of the patients home scale. Finally, the proposed rule also introduces flexibility for providers to offer beneficiary engagement incentives during an emergency period.
- Electronic Prescribing of Controlled Substances (CIIs) in Medicare Part D: In the proposed rule, CMS offers a detailed overview of the evolution of e-prescribing in Part D and the new SUPPORT Act requirements of e-prescribing of CIIs in Medicare Part D. The agency sets out a number of statutory exemptions of the e-prescribing of CIIs, including when the practitioner and the dispensing pharmacy are the same entity and when the prescription cannot be sent using the most recent NCPDP Script. Although the SUPPORT Act requires e-prescribing for CIIs by January 2021, CMS will not mandate it until January 1, 2022. CMS is requesting additional feedback from physician practices about the practical impacts and potential difficulties of mandatory e-prescribing of CIIs as well as the feasibility of the proposed implementation timeline.
Applicability and Timing
In general, policy proposals adopted in a PFS proposed rule become effective on January of the next calendar year (so January 1, 2021 for this proposed rule). However, the timeframe for adoption of certain policies set forth in this year’s proposed rule is likely to be extended due to COVID-19. For instance, the CII e-prescribing policy is slated to take effect in 2022. Similarly, it is likely that CMS will provide more flexibility than usual around implementation of new policies, particularly those that receive substantial pushback from stakeholders. We strongly encourage members to submit feedback, questions, or concerns to ASHP to assist in the development of our written comments on the proposed rule. Comments are due to CMS on October 5, so please send any input to Jillanne Schulte Wall at [email protected] by September 21. We will update members when CMS releases a final rule in late fall 2020.