The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Advantage (MA) and Part D proposed rule for contract year 2024 (the “Proposed Rule”), which represents the Biden administration’s broadest effort to date to reshape the Medicare managed care programs. (See Figure A.)
The administration specifically notes its focus on addressing health equity concerns as a driving factor underlying a number of the proposals. This Insight summarizes CMS’s proposals in the following areas: (i) MA prior authorization; (ii) Quality/Star Ratings; (iii) MA network adequacy for behavioral health; (iv) MA provider directory requirements; (v) the marketing of MA/Part D products; (vi) overpayment standards for Medicare Parts A, B, C, and D; and (vii) the Program for All-Inclusive Care for the Elderly (PACE). CMS is accepting comments on the Proposed Rule until February 13, 2023.
Medicare stakeholders, including plans, providers, vendors, and others, should review the Proposed Rule to assess the potential impact that CMS’s proposals may have on their policies and operations. Stakeholders should further assess whether there are aspects of the proposals on which they would want to submit comments.
Figure A: Key Regulatory Proposals
Prior Authorization and Utilization Management Practices
In what appears to be a reaction to recent criticism of prior authorization practices under MA from the Department of Health & Human Services Office of Inspector General (OIG), as well as related discussions by Congress, CMS proposes to implement regulatory provisions that would restrain or “provide less flexibility for MA organizations to deny or limit coverage of basic benefits.”
In April 2022, the OIG released a report regarding prior authorization in MA, which, among other things, recommended that CMS issue new guidance on the appropriate use of clinical criteria in medical necessity reviews by MA plans. Proposed legislation under discussion during the recently concluded session would have required MA plans to (i) establish an electronic prior authorization program that could provide real-time decisions in response to requests for items and services that are routinely approved; (ii) annually publish specified information on prior authorization determinations, including the percentage of requests approved and the average response time; and (iii) meet other CMS-defined quality and timeliness standards.
CMS now proposes to provide that, only in those cases where basic benefit coverage criteria are not clearly established in statute, regulation, National Coverage Determination, or Local Coverage Determination, an MA plan may create its own internal coverage criteria so long as the criteria are made publicly available and are based on current evidence in widely used treatment guidelines or clinical literature. CMS further proposes standards for plans to operate Utilization Management Committees, led by the plan medical director, which would be required to annually review all plan prior authorization policies for compliance with these standards.
These prior authorization proposals should be read in conjunction with a separate rule proposed by CMS and released on December 13, 2022, that would affect prior authorization as implemented across multiple programs (the “Dec. 13th proposed rule”).  The Dec. 13th proposed rule would require that MA organizations, Medicaid and State Children’s Health Insurance Program (CHIP) fee-for-service programs, Medicaid and CHIP managed care plans, and qualified health plan issuers on the federally facilitated exchange include information about prior authorizations in the data that they must make available through the Patient Access Application Programming Interface (API). The Dec. 13th proposed rule would also require that impacted payers implement and maintain a Provider Access API that “can be used to exchange current patient data from payers to providers, . . . adjudicated claims and encounter data . . . and the patient's prior authorization decisions.”
The new regulatory provisions in the Proposed Rule would limit the use of the prior authorization process by MA health maintenance organizations, preferred provider organizations, and special needs plans (SNPs) to these select enumerated purposes: (i) to confirm diagnoses or other medical criteria that are the basis for coverage determinations for a specific item or service; (ii) to ensure basic benefits are medically necessary using the standards of Traditional Medicare; and (iii) to ensure the furnishing of supplemental benefits is clinically appropriate. In response to stakeholder complaints to CMS that MA plans require repetitive prior approvals for needed services within an enrollee’s previously approved plan of care, CMS proposes to require plans to include, as a part of their arrangements with contracted providers, agreements that approved prior authorizations are valid for the duration of an enrollee’s entire approved course of treatment or service. As a corollary, CMS would require plan policies to provide a minimum 90-day transitional period of authorization for any ongoing courses of treatment for new enrollees who have already commenced a course of treatment with an out-of-network provider.
Quality Rating System
CMS proposes to adopt a new health equity index (HEI) reward, starting with the 2027 Star Ratings, to incentivize Parts C and D plans to focus on improving care and reducing disparities for enrollees with social risk factors (SRFs). Currently, SRFs are addressed in the Part C and Part D Star Ratings program through the Categorical Adjustment Index (CAI), which adjusts for within-contract performance disparities associated with the percentages of plan members who receive the low-income subsidy (LIS), are dually eligible, and/or have disability status. The goal of the CAI is to ensure that plans are not inappropriately penalized or rewarded for factors that are difficult for the plans to control. The Proposed Rule would define the term “health equity index” as “an index that summarizes contract performance among those with specified SRFs across multiple measures into a single score.” The proposed HEI would reward contracts for obtaining high measure-level scores for the subset of enrollees with the specified SRFs, which would initially include beneficiaries who receive a LIS, who are dually eligible, or who have a disability. These are the same factors currently used for the CAI, but they may be expanded over time for the HEI. CMS proposes no changes to the current CAI but would remove the existing reward factor (after the 2026 Star Ratings) and replace it with the new HEI reward.
CMS also proposes to reduce the weight it assigned to patient experience/complaints and access measures in calculating plans’ star ratings, to begin with the 2026 Star Ratings. Currently, process measures receive a weight of 1, outcome measures receive a weight of 3, and the Part C and D Improvement measures receive a weight of 5. The weight of the patient experience/complaints and access measures was originally increased from 1.5 to 2, starting with the 2021 Star Ratings, and then was increased again from 2 to 4, starting with the 2023 Star Ratings. Based on consideration of additional stakeholder feedback regarding the devaluing impact that the higher weight applied to patient experience/complaints and access measures has on other measures, the potential for adverse incentives for plans to not focus as much on patient outcomes, screenings, and preventive care, and the effect of the policy on the 2023 Star Ratings, CMS reconsidered its position and now believes that these measures currently receive an undue weight in the Star Ratings program. Accordingly, CMS proposes to reduce the weight of the patient experience/complaints and access measures back down to 2 in order to more appropriately balance the value that these measures contribute to achieving high-quality care without weighting them higher than clinical outcome measures and to better align the total contribution of patient experience and outcome measures with other CMS quality reporting programs and the current CMS Quality Strategy.
CMS is also proposing to remove guardrails (that is, bi-directional caps that restrict the upward and downward movement of a measure’s cut points for the current year’s measure-level Star Ratings compared to the prior year’s measure-threshold specific cut points) when determining measure-specific thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures. CMS is proposing this change because it believes, based on experience over the past few years, that bi-directional guardrails can inappropriately limit the ability of cut points to shift when there are unanticipated shifts in industry performance, causing misclassification in the measure-level Star Ratings assignments. Instead, CMS would rely on a combination of approaches to provide sufficient predictability and stability of cut points from one year to the next when there are not significant changes in overall industry performance, but at the same time, allow cut points to adjust when there are significant changes in industry performance as there was during the COVID-19 pandemic. Under this proposal, the guardrails for non-CAHPS measures would be effective through the 2025 Star Ratings and would not apply for the 2026 Star Ratings or beyond.
CMS proposes to make certain changes in the specific measures used in the Star Ratings System for the star ratings calculations for the next several years, as reflected in Figure B.
Figure B: Proposed Modifications to Star Ratings Measures
|Reason Given for Change
|Contract Year Change Would Be Effective
|Part C Diabetes Care—Kidney Disease Monitoring measure
|Measure has been retired by the measure steward, NCQA
|2024 Star Ratings
|Part C Kidney Health Evaluation for Patients with Diabetes measure
|To replace Part C Diabetes Care—Kidney Disease Monitoring measure
|2026 Star Ratings
|Stand-Alone Part C Medication Reconciliation Post-Discharge (MRP) measure
|Measure is duplicative of the MRP component of the Transitions of Care measure to be included in the 2024 Star Ratings
|2026 Star Ratings
|Part C Colorectal Cancer Screening measure
|To reflect the expanded age range adopted by the measure steward, NCQA, which followed the U.S. Preventive Services Task Force issuance of updated guidance on the age at which colorectal cancer screenings should begin
|2026 Star Ratings
|Part C Care for Older Adults (COA)—Functional Status Assessment measures
|This measure was posted to the display-only measures page following a substantive measure specification change related to documentation of a complete functional status assessment that was made by NCQA; the COA measure is collected for SNPs and includes three indicators—Medication Review, Functional Status Assessment, and Pain Assessment
|2026 Star Ratings
|Part D Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins) measures
|CMS proposes to risk-adjust the measure results based on sociodemographic status characteristics (including age, gender, dual eligibility / low-income subsidy status, and disability status) and to make other non-substantive changes to the measure specifications, including application of the continuous enrollment (CE) instead of member-years (MYs) adjustment and elimination of the adjustment for stays in inpatient (IP) settings and skilled nursing facilities (SNFs)
|2026 Star Ratings—
• Application of CE instead of MYs adjustment
2028 Star Ratings—
|Part D Concurrent Use of Opioids and Benzodiazepines measure
|Measure analyzes the percentage of Medicare Part D beneficiaries 18 years and older with concurrent use of prescription opioids and benzodiazepines (which can increase the risk of respiratory depression and fatal overdoses)
|2026 Star Ratings
|Part D Polypharmacy Use of Multiple Anticholinergic (ACH) Medications in Older Adults measure
|Measure analyzes the percentage of Medicare Part D beneficiaries, 65 years or older, with concurrent use of two or more unique ACH medications during the measurement period (which can increase the risk of cognitive decline)
|2026 Star Ratings
|Part D Polypharmacy Use of Multiple Central Nervous System (CNS) Active Medications in Older Adults measure
|Measure analyzes the percentage of Medicare Part D beneficiaries, 65 years or older, with concurrent use of three or more unique CNS-active medications during the measurement period (which can increase the risk of falls and fractures)
|2026 Star Ratings
CMS also proposes changes to the administrative review process applied to Quality Bonus Payment (QBP) status determinations. Specifically, CMS proposes to clarify the permissible bases and eligible data sources for a plan to request an administrative review due to a calculation error (miscalculation) or a data inaccuracy (incorrect data), and to specify that the burden of proof is on the MA organization to prove an error was made in the calculation of the QBP status, and the MA organization must prove by a preponderance of evidence that CMS’s calculations of the measure(s) and value(s) in question were incorrect. CMS further proposes to clarify that a reopening of a QBP determination to address a systemic calculation issue that impacts more than the MA organization that submitted an appeal would only be updated if it results in a higher QBP rating for other MA organizations that did not appeal.
CMS estimates that the net impact of all of the proposed changes to the Star Ratings provisions would be $24.97 billion in savings over 10 years.
Network Adequacy Provisions for Behavioral Health
Under current regulations, to meet network adequacy requirements, each MA plan must demonstrate that it has an “adequate contracted provider network that is sufficient to provide access to covered services” in accordance with CMS-defined time and distance standards. However, CMS currently evaluates plans’ compliance with these requirements for 27 provider specialty types and 13 facility specialty types. The only behavioral health-related providers/facilities assessed through this review process are psychiatrists and inpatient psychiatric facility services. The Proposed Rule would strengthen access by broadening CMS’s network adequacy requirements to include as specialty types for review Clinical Psychology, Clinical Social Work, and Prescribers of Medication for Opioid Use Disorder.
CMS Proposes to further amend the regulations to codify standards for wait times that would apply to both primary care and behavioral health services. In addition, the Proposed Rule would clarify that some behavioral health services may qualify as emergency services and, therefore, must not be subject to prior authorization. To further address equity gaps in treatment between physical health and behavioral health, the Proposed Rule would strengthen current requirements for MA plans to establish care coordination programs by amending the regulations to include behavioral health care services programs as among those with which the plan must coordinate. Lastly, CMS proposes to codify in regulation that MA organizations offering coordinated care plans must arrange for any medically necessary covered benefit outside of the plan provider network at in-network cost-sharing levels when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs.
MA Provider Directory Provisions
As part of its focus on health equity, CMS proposes to amend MA provider directory requirements to require plans to list in their directory “each provider’s cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider’s office.” These provisions would codify certain “best practices” identified in the Medicare Managed Care Manual and bring MA rules into alignment with those applicable to Medicaid managed care entities. In an additional effort to support access to behavioral health services, the proposed regulations would require that plans identify those providers who offer medications for opioid use disorder (or “MOUD”). CMS is proposing to add this requirement in response to the increased number of opioid overdose-related deaths during the COVID-19 pandemic. MA plans are currently required to make available on their websites a searchable provider directory, although regulations do not define the elements that must be available to search. The Proposed Rule would require that the provider directory information be searchable by every required element included in CMS’s model provider directory.
Medicare Advantage and Part D Marketing
CMS proposes a significant number of changes to its MA and Part D marketing rules in an effort “to strengthen beneficiary protections and improve MA and Part D marketing.” These are listed in Figure C. Many of the proposed changes continue CMS’s efforts of the past several years to circumscribe the efforts of third-party marketing organizations (TPMOs).
Figure C: Proposed MA and Part D Marketing Changes
|An agent/broker must have an appointment for a specific date and time in order to "contact" a beneficiary at home.
|Door-to-door contact is prohibited without a prior appointment, even if the TPMO or plan has a completed Business Reply Card (BRC) or Scope of Appointment (SOA).
|At and following educational events, plans and TPMOs may not collect beneficiary information, give out SOAs, set up future marketing appointments, or hold a marketing event in the same location within 12 hours of the educational event.
|Personal marketing appointments may not be held until 48 hours after a beneficiary completes the SOA.
|BRCs/SOAs would only be effective for six months.
|Beneficiary contact information may not be transferred between TPMOs—meaning that entities may not sell or transfer leads.
|TPMOs must submit multi-plan materials directly to CMS, but only with prior approval of each MA organization or Part D sponsor on whose behalf the materials were developed.
|The Medicare name, CMS logo, or Medicare card may not be used in a misleading manner.
|Superlatives may not be used in marketing, including in logos and taglines, unless the material provides documentation to support the statement and the documentation is for the current or prior year.
|Benefits and services may not be marketed in a service area where those benefits are not available.
|Marketing materials must include the names of the MA organizations or Part D sponsors that offer the benefits being advertised (i.e., no unbranded marketing).
|Plan names may not be relegated to "fine print"—for print ads, they must be in a 12-point font for print ads; for TV ads, they must either be displayed during the entire ad in the same font size as the benefits and phone numbers or must be read at the same pace as the benefits or phone number; and for radio, they must be read at the same pace as the phone number.
|Information about savings available to potential enrollees referenced in marketing materials may not be based on a comparison with the typical expenses of “uninsured individuals, [the] unpaid costs of dually eligible beneficiaries, or other unrealized costs of a Medicare beneficiary.”
|The TPMO disclaimer must include the names of the carriers available through the related resource and must also add a reference to State Health Insurance Programs (SHIPs) as a source for beneficiaries to contact for plan information (in addition to 1-800-MEDICARE, Medicare.gov).
|TPMOs that offer all available MA or Part D plans will need to list all of those available in their disclaimers.
|All marketing/enrollment calls must be recorded, including those conducted by web-based technology (Zoom, etc.).
|A list of CMS-required questions and topics must be fully discussed prior to an enrollment.
|A pre-enrollment checklist (PECL) must address the effect on a beneficiary’s current coverage, and plans/TPMOs must review the PECL with the prospective enrollee during phone enrollments.
|Plans’ required online provider directories must be searchable by every element of the directory, and organizations must list providers’ cultural and linguistic capabilities and identify those providers able to provide medications for opioid use disorder.
|A Summary of Benefits must include a list of medical benefits in a specific order at the top of this document.
|Plans must establish an agent/broker monitoring and oversight plan and report related noncompliance to CMS; just responding to complaints is not enough.
|The non-renewal notice is a “Standardized Communications Material” that must be used without modifications except where noted in regulation.
|Plans must annually notify their enrollees of their ability to opt out of phone calls regarding MA and Part D plan business.
Among the proposals that directly target TPMOs, CMS would greatly expand the TPMO disclaimer that was added to regulations effective with the 2023 contract year. That disclaimer, as originally finalized, requires TPMOs to state, either in written materials, electronically, or verbally, where applicable, that the TPMO does “not offer every plan available in your area. Any information we provide is limited to those plans we do offer in your area. Please contact Medicare.gov or 1-800-MEDICARE to get information on all of your options.” The Proposed Rule would have TPMOs also reference in the disclaimer that State Health Insurance Programs (SHIPs) are an additional option from which beneficiaries could obtain information, would prohibit unbranded advertisements, and would also require that TPMOs “list or mention all of the MA organizations or Part D sponsors that they sell,” even where the TPMO sells all plans available in the beneficiary’s area. This could present a significant problem for TPMOs representing even half of the parent companies offering MA plans in areas such as New York City or South Florida, where more than 40 distinct legal entities offer MA plans, representing approximately 28 different parent companies. Finally, in one brief paragraph expressing concerns with TPMOs allegedly selling or distributing beneficiary contact information to multiple entities, rather than use its authority to constrain this practice, CMS has proposed to wholly prohibit the “transfer” of beneficiary information between TPMOs, a move that would largely wipe out an entire sector of businesses, increase costs for agents/brokers and plans, and impose barriers to beneficiaries’ access to information on available plan offerings.
Medicare Advantage Overpayments
The Affordable Care Act amended the Social Security Act (the “Act”) to add an overpayment requirement for Medicare Part C, requiring an MA organization that has received an overpayment from the federal government to report and return the overpayment within 60 days of identification of such overpayment. An “overpayment” is defined as any funds that a person receives or retains to which the person is not entitled. Section 1128J(d)(3) of the Act specifies that any overpayment retained by an entity after the deadline for reporting and returning an overpayment is an obligation under the False Claims Act (FCA). CMS issued a final rule (“Overpayment Rule”) in 2014, noting that an MA organization “identifies” an overpayment when it has determined, or should have determined, through the exercise of “reasonable diligence,” that the MA organization has received an overpayment.
Recent litigation against CMS challenged the agency’s “reasonable diligence” standard, believing that this standard created FCA liability for mere negligence, which is not considered a standard of liability under the FCA. Under the FCA, the entity must “knowingly” submit a false claim or retain an overpayment. “Knowingly” is defined as “has actual knowledge” or “acts in reckless disregard” or “deliberate ignorance” of the truth and falsity of the information. The FCA has never given negligent behavior standing for purposes of liability as acknowledged by the district court judge. CMS chose not to challenge on appeal the district court’s holding relating to this heightened standard.
In what appears to be a response to this holding, CMS proposes to amend the Overpayment Rule to remove the “reasonable diligence” standard and incorporate by reference the definition of “knowingly” under the FCA. Therefore, if finalized, an MA organization would be considered to have identified an overpayment if it has actual knowledge of the existence of an overpayment or acts in reckless disregard or deliberate ignorance of the overpayment.
Program for All-Inclusive Care for the Elderly
The Proposed Rule also contains substantial technical revisions to the regulations applicable to the PACE program. Among these proposals, CMS would apply stricter application and enrollment requirements for PACE organizations, under which CMS would no longer consider plan applications that are missing signed and dated state assurance documents; instead, the application would be considered incomplete, requiring applicants to wait until the next quarterly submission date to submit an application. CMS would further amend application requirements to include consideration of PACE organizations’ past performance with respect to program compliance. Application denials for past performance would be based on similar factors as applied to MA applicants, which for new or recently approved applicants would include analysis of the fiscal soundness and program compliance behavior of any parent or sibling companies. CMS finds this requirement necessary to protect against the expansion of poorly performing organizations where the program has undergone significant recent growth due to legislative changes that were effective in 2015 permitting for-profit organizations to participate in the PACE program. CMS would further provide in regulation that it may deny a PACE application based on the applicant’s failure to maintain a fiscally sound operation or where the organization has filed for or is currently in state bankruptcy proceedings.
CMS also proposes to require PACE organizations to ensure that contracts with an enumerated list of specialists are in place before the organization may enroll participants in the program. The Proposed Rule would also modify personnel medical clearance requirements, including by requiring personnel to receive an enumerated list of vaccinations and undergo a tuberculosis screening. CMS requests comment on possibly requiring PACE personnel to receive all Advisory Committee Immunization Practices-recommend vaccinations, as well as the possibility of implementing an individual risk assessment exception to medically clearing all staff.
CMS proposes timeframes for various actions by PACE plans, including for arranging the provision of Interdisciplinary Team (IDT) approved services, reviewing care recommendations from employees and contractors, creating a plan of care and revising the plan of care if the participant’s condition changes, and investigating and responding to grievances. Comments are specifically requested on the adequacy of the proposed timeframes. The Proposed Rule would clarify the definition and implementation of care coordination services, specifying that IDT must implement care coordination responsibilities for each patient across any care setting, including those in long-term care facilities. The Proposed Rule also would clarify what the IDT is responsible for in coordinating 24-hour care delivery (e.g., ensuring the care provided is effective, is implemented as it was ordered by the IDT, and more). With respect to the plan of care, the Proposed Rule would provide the minimum content that should be contained in a plan of care, including the listing of participants’ chronic conditions and behavioral health conditions, addressing a lengthy enumerated list of potential participant health care needs, describing the interventions needed to meet the participant’s health needs, identifying how the intervention will be implemented, writing measurable goals for each intervention, providing an explanation for how goals will be evaluated, and noting the participant’s preferences and unique goals of care.
CMS has also proposed to extend several new rights to which a participant is entitled, including the right to fully understand the PACE organization’s palliative care, comfort care, and end-of-life care services; the right to receive information in a culturally competent manner; and more. The Proposed Rule describes aspects of treatment options that would need to be delivered to the patient both orally and in writing for palliative care, comfort care, and end-of-life care services.
The Proposed Rule would require PACE organizations to have a formal written grievance process and would provide additional clarity on what that process should look like, including how grievances can be submitted, who can submit grievances, how the PACE organization would be required to conduct a grievance investigation, and how the PACE organization could inform the individual submitting the grievance of the investigation outcome.
Please note that stakeholders should review the PACE provisions of the Proposed Rule itself, as it contains many additional nuanced changes to the PACE program.
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This Insight was authored by Helaine I. Fingold, Philo D. Hall, Kevin J. Malone, Teresa A. Mason, Devon Minnick, William Walters, and Lesley R. Yeung. For additional information about the issues discussed in this Insight, please contact one of the authors or the Epstein Becker Green attorney who regularly handles your legal matters.
 CMS, Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program; Medicare Prescription Drug Benefit Program; Medicare Cost Plan Program; Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act; and Programs of All-Inclusive Care for the Elderly, 87 Reg. 79452 (Dec. 27, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-12-27/pdf/2022-26956.pdf.
 87 Fed. Reg. 79498 (emphasis added).
 Office of Inspector General, OEI-09-18-00260, Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care (April 27, 2022).
 H.R.3173 – Improving Seniors’ Timely Access to Care Act of 2021: Passed House (Sept. 14, 2022) and received in Senate (Sept. 15, 2022); S.3018 – Improving Seniors’ Timely Access to Care Act of 2021: Introduced Oct. 20, 2021. This bill would establish several requirements and standards relating to prior authorization processes applicable to MA plans.
 Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule; 2024 MA/Part D Proposed Rule, 87 Fed. Reg. 76238 (Dec. 13, 2022).
 87 Fed. Reg. 76242.
 SRFs are factors related to health outcomes that are evident before care is provided, are not consequences of the quality of care, and are not easily modified by health care providers.
 42 CFR 422.116(a).
 Medicare Advantage and Section 1876 Cost Plan Network Adequacy Guidance (Last Updated: Aug. 30, 2022), Sec. 2.1 (Accessed Jan. 15, 2023), available at https://www.cms.gov/files/document/medicare-advantage-and-section-1876-cost-plan-network-adequacy-guidance08302022.pdf.
 CMS further proposes to allow new or expanding plans the benefit of the 10 percentage point credit with respect to compliance with time and distances standards for these three new specialty types where the plan includes one or more telehealth providers of that specialty type that provide additional telehealth benefits in its contracted network. See 42 C.F.R. § 422.135.
 87 Fed. Reg. 79454.
 The Medicare Advantage and Section 1876 Cost Plan Provider Directory Model is available at https://www.cms.gov/medicare/health-plans/managedcaremarketing/marketngmodelsstandarddocumentsandeducationalmaterial.
 42 C.F.R. 422.2267(e)(41).
 31 U.S.C. 3729(b)(3).
 79 Fed. Reg. 29844, May 23, 2014 and 81 Fed. Reg. 7654, Feb. 12, 2016.
 United HealthCare v. Becerra, 16 F. 4th 867 (D.C. Cir. 2021).
 42 U.S.C. 1320(a)-7k(d)(3).