Medicare Physician Fee Schedule Proposed Rule

Background

On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) released the proposed 2018 Medicare Physician Fee Schedule (MPFS).¹ The proposed rule addresses the 2018 Medicare payment and quality provisions for services furnished by physicians and other practitioners in all sites of services, such as visits, surgical procedures, diagnostic tests, therapy services, and specified preventive services. CMS has provided a fact sheet regarding the proposed rule.² Although pharmacists are not recognized Medicare Part B providers except for when providing immunizations, the proposed rule still contains several important provisions that could potentially impact the pharmacy community.

Medicare Diabetes Prevention Program (MDPP)

CMS’s proposed rule, as outlined in the MDPP fact sheet, expands the Diabetes Prevention Program (DPP), which began as a U.S. Centers for Disease Control and Prevention (CDC) model test, to Medicare beneficiaries.³ The MDPP is centered on the provision of “structured health behavior change sessions” that follow a CDC-approved curriculum “with the goal of preventing diabetes among Medicare beneficiaries with prediabetes.” Sessions are focused on a weight-loss goal of at least 5% and may include practical training in long-term dietary change, increased physical activity, and tools for maintaining weight loss and a healthy lifestyle. The program is limited to Medicare beneficiaries who, as of the first core session, have a BMI of at least 25 (if not self-identified as Asian) and who, within 12 months of the first core session, have a hemoglobin A1c test with a value of 5.7–6.4, a fasting plasma glucose of 110–125 mg/dL or a 2-hour plasma glucose of 140–199 mg/dL and who have never received a diagnosis of type 1 or type 2 diabetes (except gestational diabetes) or end-stage renal disease (ESRD). MDPP suppliers must be enrolled in Medicare, but MDPP coaches — the clinicians who actually provide care within the program — need to have only a National Provider Identifier (NPI) to bill for MDPP services.¹

The proposed rule sets forth the MDPP payment structure, setting a maximum lifetime payment per beneficiary of $810 for the complete set of MDPP core and maintenance sessions over three years (Table 1).³ CMS also proposes a two-year time limit on Medicare coverage for ongoing maintenance sessions. The proposal provides more flexibility to MDPP providers in supporting patient engagement and attendance. To ensure program integrity, additional supplier enrollment requirements and supplier compliance standards are also proposed.¹ Both CMS and CDC have indicated a strong interest in engaging pharmacists in the MDPP. ASHP views the MDPP as an opportunity for members, but we have some concerns regarding the sufficiency and structure of proposed payment, as well as some questions regarding compliance with documentation requirements. MDPP is a complex new program with myriad supplier and provider enrollment and documentation requirements, so we anticipate that CMS will continue to refine the program over the coming years.

Table 1. Proposed Performance-based Payments³

* = The required minimum weight loss from baseline must be achieved or maintained during the core maintenance session three-month interval or maintained during the ongoing maintenance session three-month interval.

** = A beneficiary must achieve or maintain the required minimum weight loss at least once during the final core maintenance session three-month interval to have coverage of the first ongoing maintenance session interval.

Evaluation and Management (E/M) Guidelines and Care Management Services

CMS is proposing to undertake a multiyear, multistakeholder revision to the documentation requirements for the E/M codes that pharmacists and other clinicians use for billing in physician-based clinics or physician offices. Currently, there are two versions of the documentation requirements, which sometimes cause confusion and billing errors. With stakeholder input, CMS proposes to consolidate and update the requirements but does not propose a time frame for these efforts. ASHP intends to actively engage in any work CMS undertakes regarding these changes, and we will keep members updated on new developments.

New Care Coordination Services and Payment for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

Chronic Care Management (CCM) and complex CCM represent a significant opportunity for pharmacists to perform the ongoing management of patients’ chronic diseases in physician practices and clinics. CMS is proposing revisions to the CCM payments for RHCs and FQHCs, and to the payment for general behavioral health integration (BHI) services and the psychiatric collaborative care model (CoCM). This includes the addition of two new codes. The first new G code, GCCC1, would be a General Care Management code, and the second new G code, GCCC2, would be a Psychiatric CoCM code.¹ If adopted, these proposed codes will be the only fee-for-service codes available to RHCs and FQHCs outside of their respective payment systems, the all-inclusive rate (AIR) and the prospective payment system (PPS). ASHP strongly supports the implementation of these new codes.

Payment for Biosimilar Biological Products

The Calendar Year (CY) 2016 PFS finalized proposal stated that products that rely on a common reference product’s biological license application are grouped into the same payment calculation for determining a single ASP payment limit and that a single Healthcare Common Procedure Coding System (HCPCS) code is used for such biosimilar products.¹ CMS is soliciting comments on the effects of its payment policy from the CY 2016 PFS final rule. As the number of biological products grows, ASHP will track how payment policy affects pricing, access, and patient use. In general, ASHP has supported a biosimilar regulatory framework that, to the extent possible, treats biosimilars much like other drug classes. Thus, we support the proposed payment mechanism, which mimics that of small-molecule and generic drugs. CMS has also invited general comments on any issues providers are encountering regarding payment for biosimilars and biologics. ASHP is seeking member feedback regarding any potential issues we should flag for the agency, including those related to naming and modifiers for new biosimilars.

ASHP will submit detailed comments to CMS regarding the proposed rule by the September 11, 2017, deadline. In the interim, questions can be submitted to Jillanne Schulte Wall, Director of Federal Regulatory Affairs, at [email protected].

References

1. Centers for Medicare & Medicaid Services. Available from https://www.federalregister.gov/documents/2017/07/21/2017-14639/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions. Accessed August 9, 2017.
2. Centers for Medicare & Medicaid Services. Available from https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-07-13-2.html. Accessed August 9, 2017.
3. Centers for Medicare & Medicaid Services. Available from https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-07-13-3.html. Accessed August 10, 2017.