By Yvonne Tso, PharmD, MBA
On November 6, 2023, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (CMS-4205-P) that would revise the Medicare Advantage Program (MA), Medicare Prescription Drug Benefit Program (Part D), Medicare Cost Plan Program, Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology Standards and Implementation Specifications. The proposed rules focus on promoting access to behavioral health providers, equity in coverage and improving supplemental benefits. CMS is inviting comments on the proposed rules by 5pm January 5, 2024. Meanwhile, some of the proposed changes will take effect as of January 1, 2024.
For starters, beginning January 1, 2024, CMS will allow an estimated 400,000 Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs) to be eligible to enroll in Medicare, and bill Medicare for services. CMS will set network adequacy standards for Outpatient Behavioral Health as a facility-specialty as most of the newly qualified providers practice within outpatient behavioral health facilities, such as mental health centers, substance use treatment centers, and hospitals. Specialists under this category will include not only MFTs and MHCs, but also Opioid Treatment Program providers, Community Mental Health Centers, addiction medicine physicians, and other providers who currently furnish addiction medicine and behavioral health counseling or therapy services in Medicare. 
To safeguard healthy competition in the MA and PDP community and to ensure agents and brokers would not persuade beneficiaries to join plans that compensate them better than others even if those-high-paying plans are not the best fit for beneficiaries, CMS is proposing to set a clear, fixed amount that agents and brokers can be paid regardless of the plan the beneficiary enrolls in. Integritas will have more details on proposed new policy for marketing and communication in a separate blog article.
CMS is proposing a “Mid-Year Enrollee Notification of Unused Supplemental Benefits” to be issued by MA plans annually, personalized to each enrollee, that includes a list of any unused supplemental benefits during the first six months of the year. The requirement has been prompted by the low utilization of these supplemental benefits by beneficiaries and an increasing number of supplemental benefits being offered by MA plans using rebate dollars. The notification would include the scope of the benefit, cost-sharing, instructions on how to access the benefit, any network application information for each available benefit, and a customer service number to call if additional help is needed. Supplemental benefits are funded with taxpayer dollars. CMS wants to ensure these benefits work to the advantage of the beneficiary and not just a marketing ploy.
Another area of focus in the proposed rules is to ensure that MA plans that offer Supplemental Benefits for the chronically ill (SSBCI) are providing the benefits to truly eligible recipients and that the benefits have to be demonstrated, at the time the bids are submitted, to “meet the legal threshold of having a reasonable expectation of improving the health or overall function of chronically ill enrollees and are supported by research” which has to be relevant acceptable evidence. CMS also requires documentation of denials of SSBCI eligibility by the plan rather than approvals.
To ensure health equity, CMS is proposing to require MA plans to analyze their utilization management (UM) policies and procedures so they would not be disproportionately unfavorable for the underserved population. The proposal requires: 1) a member of the UM committee to have expertise in health equity, 2) the UM Committee conducts an annual health equity analysis of prior authorization policies and procedures used by the plan, and 3) to publish results of the analysis on the plan website. The goal of the health equity analysis is to create additional transparency and identify inequitable impacts on enrollees who receive the Part D low-income subsidy, are dually eligible, or have a disability.
One of the proposed rules will allow Part D sponsors to treat formulary substitutions of biosimilar biological products other than interchangeable biologicals for their reference products as “maintenance changes” that would not require prior approval by CMS. Treating these substitutions as maintenance changes would mean that any substitutions would apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day notice, so that enrollees can access equally effective, but potentially more affordable options sooner.
An interchangeable biological product is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy depending on state pharmacy laws. Interchangeable biological products (also called interchangeable biosimilars or interchangeable products) may help increase consumer access to biologics. The FDA Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable biologicals and their reference products.
An example of an interchangeable biological product is insulin-glargine sold under the brand name of Semglee, which is a long-acting insulin to help control high blood sugar levels. It is the first FDA-approved (in 2015) interchangeable biosimilar insulin for diabetes which can be substituted for Lantus (insulin glargine). Another interchangeable biological product for Lantus is Rezvoglar (insulin glargine or insulin glargine-aglr).
A total of twelve (12) provisions are being proposed in CMS 4205 P. Integritas will continue to highlight other proposed changes in subsequent blogs including those for marketing and communication. If you would like to discuss any of the above in preparation for submitting comments to CMS, please contact us at 415-596-5277 or firstname.lastname@example.org Please follow us on https://www.integritasmedicare.com/blog.
 Contract Year 2025 Policy and Technical Changes Fact Sheet November 6, 2023  Id  Id  Proposed Rules 2023-2411B  Contract Year 2025 Policy and Technical Changes Fact Sheet November 6, 2023  www.fda.gov for Interchangeable Biological Products  FDA = Food and Drug Administration  https://purplebooksearch.fda.gov/  https://www.goodrx.com/drugs/biologics/interchangeable-biosimilar-drugs  Id