backCMS Proposes Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Intended to Improve Beneficiary Protections and Access to Care
On December 14, 2022, CMS released a pre-publication version of a proposed rule (the Proposed Rule) that is set to publish in the Federal Register on December 27, 2022 and amends the regulations governing Medicare Advantage (MA or Part C), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans and Programs of All-Inclusive Care for the Elderly (PACE). According to CMS, the Proposed Rule aims to increase beneficiary protections, improve access to care, and encourage equity in coverage and care. The following discussion highlights some of the proposed changes. Comments to the Proposed Rule are due by 5:00 p.m. on February 13, 2023.
Utilization Management Requirements
The Proposed Rule seeks to address concerns about the use of prior authorization by MA plans and the effect on beneficiary access to care by proposing several regulatory changes. To ensure prior authorizations are used appropriately, CMS proposes: (1) prior authorization policies for coordinated care plans may only be used to confirm the presence of diagnoses or other clinical criteria and/or ensure that an item or service is medically necessary; (2) plans must provide a minimum 90-day transition period when an enrollee currently undergoing treatment switches to a new MA plan; and (3) all MA plans must establish a Utilization Management Committee to review policies annually and ensure consistency with Medicare’s national and local coverage decisions and guidelines.
Marketing Requirements
The Proposed Rule also seeks to address concerns regarding the increase in television advertisements generically promoting enrollment in MA plans by prohibiting ads that do not mention a specific plan name and advertisements that use words and imagery, such as the Medicare name or logo, that may confuse or mislead beneficiaries.
The Proposed Rule would codify past guidance that CMS has adopted with the stated goal of increasing beneficiary protections against allegedly high-pressure and misleading marketing. CMS proposes to prohibit: (1) sales presentations that immediately follow an educational event; (2) agent distribution and collection of scopes of appointment and business reply cards at educational events; (3) agents conducting personal appointments with beneficiaries within 48 hours after obtaining the scope of appointment; and (4) use of the Medicare name or CMS logo in advertisements that mislead Medicare enrollees into believing these advertisements are from the government.
To ensure Medicare beneficiaries receive accurate information about Medicare coverage, CMS proposes to require agents to: (1) disclose to beneficiaries all the plans the agent sells; (2) inform beneficiaries that they can obtain complete Medicare options/information from 1-800-MEDICARE, State Health Insurance Assistance Programs, or Medicare.gov; (3) discuss a standardized list of topics or questions that address a beneficiary’s health care needs, current providers, and prescriptions, prior to enrolling a beneficiary, and provide the pre-enrollment checklist to prospective enrollees; and (4) thoroughly review the pre-enrollment checklist with prospective enrollees prior to completing telephonic enrollments.
Star Ratings Program
CMS proposes new methodological changes to the Star Ratings program including: (1) offering a health equity index (HEI) reward for the 2027 Star Ratings to incentivize MA and Part D plans to improve care for enrollees with social risk factors; (2) reducing the weight of patient experience/complaints and access measures by half; (3) removing guardrails when determining measure-specific-thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures; (4) modifying the Improvement Measure hold harmless policy; (5) adding a rule for removing Star Ratings measures; and (6) removing the 60% rule related to the adjustment for extreme and uncontrollable circumstances.
Health Equity
CMS states that the Proposed Rule aims to advance health equity by expanding the list of populations to which MA organizations must provide services in a culturally competent manner. CMS also proposes to require MA organizations to develop and maintain procedures to offer digital health education to enrollees, include providers’ cultural and linguistic capabilities in provider directories, and incorporate activities into their overall quality improvement program that reduce disparities in health and health care among enrollees.
Access to Behavioral Health Services
CMS states that the Proposed Rule seeks to strengthen network adequacy requirements and reaffirm MA organizations’ obligations to provide behavioral health services by: (1) adding Clinical Psychologists, Licensed Clinical Social Workers, and Prescribers of Medication for Opioid Use Disorder as specialty types that will be evaluated as part of the network adequacy review; (2) including behavioral health services in the general access to services standards; (3) codifying standards for appointment wait times; (4) clarifying that emergency medical services must not be subject to prior authorization; (5) requiring MA organizations to establish programs to coordinate community, social, and behavioral health services; and (6) requiring MA organizations to notify enrollees when their behavioral health or primary care provider(s) are dropped from networks.
Access to Medication Therapy Management and Drug Affordability
The Proposed Rule includes new requirements for Part D sponsors related to Medication Therapy Management (MTM) programs, which CMS states are intended to promote consistent, equitable, and expanded access. CMS proposes to: (1) require plan sponsors to include all core chronic diseases identified by CMS, including HIV/AIDS; (2) lower the maximum number of covered Part D drugs a sponsor may require from eight to five drugs and requiring sponsors to include all Part D maintenance drugs in their targeting criteria; and (3) revise the methodology for calculating the cost threshold ($4,935 in 2023) to be commensurate with the average annual cost of five generic drugs ($1,004 in 2020).
Current regulations permit Part D sponsors to immediately remove from the formulary a brand name drug and substitute its newly released generic equivalent. Consistent with these requirements, CMS proposes to permit Part D sponsors to immediately substitute: (1) a new interchangeable biological product for its corresponding reference product; (2) a new unbranded biological product for its corresponding brand name biological product; and (3) a new authorized generic for its corresponding brand name equivalent.
Expanding Low-Income Subsidies
The Proposed Rule aims to improve access to affordable Medicare prescription drug coverage by proposing to implement section 11404 of the Inflation Reduction Act of 2022, which expands eligibility under the low-income subsidy program. Under the proposal, individuals with incomes up to 150% of the Federal poverty level and who meet statutory resource requirements will qualify for the full low-income subsidy beginning on or after January 1, 2024. This change will provide the full subsidy to those who currently qualify for the partial subsidy.
Making Limited Income Newly Eligible Transition Program Permanent
Since 2010, CMS has been operating the Limited Income Newly Eligible Transition (LI NET) as a demonstration program that provides immediate and retroactive Part D coverage for eligible low-income beneficiaries who demonstrate an immediate need for prescriptions but who have not yet enrolled in a Part D plan or whose enrollment is not yet effective. CMS proposes making the LI NET program a permanent part of Medicare Part D. The Proposed Rule is available here. The CMS Fact Sheet on the Proposed Rule is available here.
Reporter, Jason A. de Jesus, Los Angeles, +1 213 443 4343, jdejesus@kslaw.com.
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Ground Ambulance Surprise Billing Advisory Committee Selected
On December 13, 2022, CMS announced the selection of advisory board members for the Advisory Committee on Ground Ambulance and Patient Billing (GAPB). The purpose of the GABP, which is a product of the No Surprises Act, is to advise the Secretary of HHS, the Secretary of Labor, and the Secretary of the Treasury on options to improve the disclosure of charges and fees for ground ambulance services, to better inform consumers of insurance options for such services, and to protect consumers from balance billing. This 17-person committee is chaired by Asbel Montes and includes designees from HHS; the Departments of Labor, Treasury, and Transportation; various representatives of the provider sector including ground ambulance providers, emergency physicians, and other emergency service personnel; a representative of health insurance providers; representatives of consumer and patient advocacy groups; and representatives of state and local regulators. Loren Adler, the Associate Director of the USC-Brookings Schaeffer Initiative for Health Policy, was also appointed as an additional representative determined necessary and appropriate by the Secretaries.
The creation of the GAPB is one step of many towards achieving the goal of extending No Surprises Act-type protections to ground ambulance services. The committee’s first meeting will be on January 17 and 18, 2023. GABP must issue a report to the Secretaries and to Congress no later than July 17, 2023.
The meeting is open to the public via Zoom, but registration is required here. The Committee’s roster and charter are available here.
Reporter, Alana Broe, Atlanta, +1 404 572 2720, abroe@kslaw.com.