The Centers for Medicare & Medicaid Services (CMS) released a for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide 鈥渢ransparent, predictable, and expedited national coverage鈥� for eligible devices designated as 鈥溾�� by the U.S. Food & Drug Administration (FDA). FDA-designated breakthrough devices are devices that FDA has determined provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. As CMS noted in the background section to the Final Notice, the TCET pathway is intended to provide a clear, transparent, and consistent coverage process for these devices.聽

The Goal of the TCET Pathway is to Expand Access to Critical Technology

Interestingly, just because FDA has approved or cleared a medical device does not mean that CMS will cover (and reimburse) the device for Medicare beneficiaries. The Final Notice states that the time between when a device is approved or cleared by FDA and when a device obtains a generally takes nine to twelve months. For certain FDA-designated breakthrough devices, this gap can significantly delay access to critical and innovative technology for Medicare beneficiaries. Because some commercial payers follow Medicare coverage guidelines, the delay may impact more than just Medicare beneficiaries.

The much-anticipated Final Notice implements a new voluntary TCET pathway that provides manufacturers of FDA-designated breakthrough devices an opportunity to expedite the Medicare coverage process and reduce uncertainty about coverage through a pre-market evaluation of potential harms and benefits of devices. This approach will allow product manufacturers to identify evidence gaps and address those gaps early in the process to obtain Medicare coverage. The TCET pathway is intended to provide Medicare patients with more timely and predictable access to these new, innovative technologies. 

CMS made between the proposed notice and the Final Notice, such as (1) providing an opportunity for manufacturers to submit a non-binding letter of intent; (2) revising the nomination review process; (3) revising interim reporting requirements; and (4) clarifying anticipated CMS communication throughout the process. CMS has also expressed intent to release certain proposed factors that CMS will use to prioritize TCET nomination.

TCET Program Eligibility

Interested manufacturers must submit a self-nomination packet. Due to CMS resource constraints, the agency anticipates accepting approximately five devices per year as TCET candidates. 

The Final Notice finalizes the four criteria for program eligibility as previously proposed. The pathway will be available to devices that:

• have breakthrough designation from FDA,
• are determined to be within a Medicare benefit category,
• are not already subject to an existing Medicare NCD, and
• are not otherwise excluded from coverage through statute or regulation.

Whether diagnostic laboratory tests are eligible for the program will be determined on a case-by-case basis. In addition, if a device has already received FDA market authorization (or such authorization is anticipated within six months), it is not eligible for the program.

Evidence Preview

CMS typically begins review of whether a device is eligible for coverage after FDA completes its market authorization process. In order for Medicare to cover an item or service, the item or service: (1) must fall within at least one Medicare benefit category established by statute, (2) must not be specifically excluded by statute, and (3) must be 鈥渞easonable and necessary鈥� for the diagnosis or treatment of a disease or impairment as determined through an evidence-based process. 

To facilitate this evidence-based process, the TCET pathway finalizes CMS鈥檚 ability to conduct an 鈥淓vidence Preview鈥�, where CMS will review evidence provided with a TCET nomination package, via third-party contractors, to provide early feedback on the strength and weaknesses of the evidence before FDA decides on marketing authorization. In addition to the proposed process, the Final Notice adds additional policies that allow CMS to preemptively conduct a clinical endpoint review and potentially include a Medicare Coverage Advisory Committee (MedCAC) assessment to align on evidence gaps in the Evidence Preview stage. Once the Evidence Preview is finalized, the manufacturer may choose to pursue national coverage by submitting a formal NCD request 鈥� or withdraw from the TCET program. If a manufacturer withdraws at this point, CMS will still publish the Evidence Preview. The Final Notice, however, clarifies that CMS will provide a summary of the evidence rather than sharing the full Evidence Preview with the Medicare Administrative Contractors (MACs) as initially proposed. If CMS finds evidence gaps, manufacturers may propose an 鈥淓vidence Development Plan (EDP)鈥� to address the gaps. CMS will meet with the manufacturer to discuss the EDP and the manufacturer will have 60 business days to revise its submission before finalizing.   

Temporary Coverage

The proposed notice stated that temporary coverage would be provided for three to five years; however, the Final Notice declines to provide a time frame and instead suggests that coverage will be tied to the EDP and whether the manufacturer sufficiently addresses any identified evidence gaps. 

The proposed notice also stated that CMS intends to finalize a TCET NCD for TCET program participants within six months after FDA market authorization; however, the Final Notice notes that this timeframe may be impossible depending on the proposed EDP.

CMS also finalized a policy to apply coverage under a TCET NCD to 鈥渟imilar devices.鈥� CMS does not define 鈥渟imilar devices鈥�; however, the devices must be breakthrough devices and are subject to the same coverage conditions (including a requirement to propose an EDP). CMS also declined to establish a 鈥渇irst-to-market鈥� exclusivity period.

Timeline

In the Final Notice, CMS changed the timeframe for reviewing TCET nominations. The Final Notice states that CMS will review nominations on a quarterly basis, as opposed to within 30 days of submission as previously proposed. In addition, CMS will permit manufacturers to submit a non-binding letter of intent to nominate a potentially eligible device between 18-24 months before FDA authorization is expected and will continue to consider nominations approximately twelve months before the anticipated date of market authorization. The TCET process, however, will begin approximately one year before the anticipated FDA marketing authorization.

CMS provides the below timeline summarizing the TCET process:

Source: 89 Fed. Reg. 65724, 65753 (Aug. 12, 2024).

Next Steps for Manufacturers Interested in the TCET Pathway

As noted above, CMS will accept only a very small number of applicants into the TCET pathway. Manufacturers will need to assess their strategic options as to whether the TCET pathway is one they wish to pursue. If so, manufacturers should begin at an early stage in their product development to assure that they have identified an applicable Medicare benefit category allowing coverage, and that they are assembling evidence sufficient to convince CMS to accept them into the pathway. 

Manufacturers interested in the TCET pathway can notify CMS of their interest electronically via the Coverage Center Web site using the 鈥淐ontact Us鈥� link . To be considered for the first quarterly review, nominations will need to be submitted by October 31, 2024. The deadlines for the next three quarterly review cycles are January 31, 2025, April 30, 2025, and July 31, 2025.

麻豆传媒 is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.

On September 26, 2024, the Centers for Medicare & Medicaid Services鈥� (CMS) Durable Medical Equipment (DME) Medicare Administrative Contractors (DME MACs), Noridian Healthcare Solutions, LLC and CGS Administrators, LLC, revised their (the 鈥淧olicy Article鈥�) regarding documentation that constitutes a patient鈥檚 鈥渕edical record鈥� for purposes of demonstrating medical necessity and justifying payment for covered DME items.

DME Suppliers are among the most heavily audited provider types and are required to maintain medical records and other documentation that demonstrate medical necessity and compliance with all CMS coverage requirements. Until now, any information contained in a patient鈥檚 prescription documentation was not considered part of the patient鈥檚 medical record. The prescription documentation was ignored for purposes of demonstrating compliance with CMS鈥檚 coverage requirements even though prescription documentation is completed and signed by the prescriber.

How Did the Rules Change?

Retroactively effective to January 1, 2024, the DME MACs deleted the following sentence from the Policy Article:

鈥淎 prescription is not considered to be part of the medical record, except in the case of documenting medical necessity for replacement prosthetic limbs.鈥�

Prescription documentation often succinctly articulates a patient鈥檚 clinical conditions and diagnoses and documents the items of DME prescribed with relevant settings/requirements for use. These categories of information (clinical conditions and diagnoses) are almost always primary elements of CMS coverage criteria for DME items.

Previously, DME suppliers were required to ignore all the information on the prescription when determining whether the patient鈥檚 medical records qualified the patient for coverage. This often resulted in DME suppliers contacting prescribers to request additional, or amendments to, medical records/progress notes, which caused delays in patients鈥� access to care.

Why is This Important?

Based on the Policy Article revisions, DME suppliers may now rely on the information included in the prescription documentation to demonstrate compliance with CMS鈥檚 coverage criteria. Importantly, and as noted above, this change was made effective retroactive to January 1, 2024. DME suppliers currently under audit, or appealing claims with dates of service after January 1, 2024, must consider whether inclusion of prescription documentation now allows a patient鈥檚 medical record to demonstrate compliance with coverage requirements where it previously did not. Additionally, DME suppliers may consider updating internal policies and procedures regarding prospective review of medical records for compliance with CMS鈥檚 coverage criteria to include information in the prescription documentation. Lastly, DME suppliers should remember the Policy Article still contains language that records generated by the DME supplier 鈥� as a supplier with a financial interest in the claim outcome 鈥� are not considered sufficient to demonstrate an item is reasonable or necessary.

麻豆传媒 is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act () and proposes new payment policies relating to Opioid Use Disorder (OUD) treatment. Since enactment of the SUPPORT Act in 2018, CMS has consistently implemented reforms and added covered substance use disorder (SUD) treatment services through its annual update to the Medicare Physician Fee Schedule. The Proposed Rule keeps with that theme and builds on this progress. Investors in and providers of SUD treatment services should examine the impacts of the Proposed Rule and consider submitting comments to CMS 鈥� the deadline is September 9, 2024. The Proposed Rule features the following specific to SUD services:

• Telecommunication Flexibilities for Periodic Assessment and Initiation of Treatment with Methadone
• Establishing payments to Opioid Treatment Programs for Social Determinants of Health risk assessments
• Establishing payment for new U.S. Food & Drug Administration (FDA)-approved Opioid Agonist and Antagonist Medications

Permanent Telecommunication Flexibilities

CMS proposed two changes which seek to expand access and reduce barriers for patients of Opioid Treatment Programs (OTPs) by permanently allowing telecommunication technologies for certain services.

First, CMS proposes that OTPs may furnish periodic assessments using audio-only communications technology when video is not available on a permanent basis beginning January 1, 2025. This method had been allowed on a temporary basis during COVID-19. By making this flexibility permanent, CMS aims to promote access to care and prevent disruptions in treatment for Medicare beneficiaries as data suggests that audio-only visits (or the demand therefor) increases with age of the patient, and many subpopulations of Medicare including racial/ethnic minorities, dual enrollees in Medicare and Medicaid, and those with low broadband access are more likely to use audio only telemedicine services. As CMS acknowledged, telehealth services via telephone have become regular services offerings for SUD treatment facilities since the COVID-19 pandemic.

Second, CMS proposes permitting OTPs to use audio-visual telecommunication for initiation of treatment with methadone. Specifically, CMS proposes that an OTP intake add-on service (HCPCS G2076) may be furnished via two-way audio-video technology. In February 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) made several reforms to allow audio-visual telehealth initiation for any new patient who will be treated by the OTP with methadone if a practitioner or primary care provider determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform. The Proposed Rule would conform the Physician Fee Schedule with SAMHSA reforms (previously discussed in our recent blog post: Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities) and allow for Medicare reimbursement. CMS hopes these reforms will reduce barriers to care, promote positive health outcomes, and advance health equity among Medicare beneficiaries.

Establishing Payments to Opioid Treatment Programs for Social Determinants of Health Risk Assessments (Reforms to 42 C.F.R. Part 8)

The Proposed Rule includes reforms to 42 C.F.R. Part 8 that would expand coverage under the Medicare OTP benefit by establishing payment for Social Determinants of Health (SDOH) risk assessments under several conditions. Primarily, the SDOH risk assessment must be part of any intake activities for treatment of OUD, the assessment must be medically reasonable and necessary for the diagnosis or treatment of OUD, and OTP providers must believe that unmet health-related social needs (HRSN) or the need for services identified in the assessment could interfere with the OTP鈥檚 ability to diagnose or treat the patient鈥檚 OUD.

Relatedly, CMS requests information related to the payment of coordinated care and referrals to community-based organizations that address unmet HRSN, provide harm reduction services, and/or provide recovery support services. CMS notes that under the Medicare OTP benefit, payment has been established for some services like overdose education furnished in conjunction with opioid antagonist medication or social support via group therapy. 聽CMS acknowledges that other types of important services such as any work the OTP may undertake to coordinate care or link patients to community-based organizations is not currently reimbursed. Specifically, CMS requests information to understand if OTPs frequently work with transportation agencies, local support groups, syringe service programs, and nonprofits that provide financial supports and the types of collaborative arrangements an OTP may have with community-based organizations. CMS requests feedback on whether OTPs already receive funding for coordinated care or referral services from other public or private services.

Payment for New FDA-approved Opioid Agonist and Antagonist Medications

Finally, the Proposed Rule proposes the creation of payment codes for several new drugs under the Medicare OTP benefit, including a new Nalmefene Hydrochloride product called Opvee and a new injectable formulation of buprenorphine, Brixadi. Both of these products were recently approved by the FDA for OUD treatment and significantly expand OUD treatment options for patients.

Call to Action

The Proposed Rule should be celebrated, by beneficiaries and providers alike, as it seeks to expand Medicare coverage and payment for SUD treatment services. CMS will consider stakeholder input before finalizing these important reforms and is also seeking information about collaborative arrangements and funding for community-based providers to address HRSNs. Stakeholders in SUD should consider submitting comments and responsive information to CMS to support continued reforms to expand access and payment pathways for SUD treatment services. 

Providers and clinical personnel interested in changes to the behavioral health codes for 2025 should consider providing comments to the proposed rule. The comment period will close on September 9, 2024, 5:00 p.m. ET. Anyone may submit comments via electronic submission at . Additionally, commenters may submit comments by mail to:

• Regular Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, P.O. Box 8016, Baltimore, MD 21244-8016.
• Express or Overnight Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If submitting via mail, please allow time for comments to be received before the closing date.

Want to Learn More?

• Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities
• Health-Related Social Needs: Three Trends in Leveraging Community Partnerships
• Behavioral Health: CMS Innovation Model Outlines Changes for the Delivery of Integrated Behavioral and Physical Health Care
• 2023 Going Digital Health鈥檚 Behavioral Health Tech Conference: Key Investment Takeaways

For more information on behavioral health, substance use disorder treatment, mental health, and other health innovations, including the team, publications, and representative experience, visit 麻豆传媒鈥檚聽Behavioral Health and Substance Use Disorder group.

The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act, 42 U.S.C. 1320a-7k(d), referenced below as the 鈥�60-day Refund Rule.鈥� Failure to comply with the 60-day Refund Rule can result in the imposition of a civil monetary penalty under 42 C.F.R. 搂 1003.210(a)(8) with a maximum penalty of $24,164 for 2023 (2024 updates are not yet available). In addition, improper retention of an identified overpayment may provide grounds for allegation of a violation of the Federal False Claims act, which includes potential recoveries for whistleblowers, treble damages, per claim penalties, and in some cases a Corporate Integrity Agreement as part of a settlement.

Regulations implementing the application of the 60-day Refund Rule for overpayments under Medicare Parts A and B were effective in March 2016, and can be found in 42 C.F.R. Parts 401 and 405 (the 2016 regulations). In 2022, CMS issued proposed revisions to the 2016 regulations (the 2022 Revisions), which have not yet been finalized. As discussed below, the 2022 Revisions proposed a notable change as to what it meant to 鈥渋dentify鈥� an overpayment.

What鈥檚 New. In Section III.O of the recently released advance copy of the (2025 PFS Proposed Rule), scheduled for publication in the Federal Register on July 31, 2024, the Centers for Medicare & Medicaid Services (CMS) added an additional provision to the still pending 2022 Revisions. Specifically, in the 2025 PFS Proposed Rule, CMS proposed an additional regulatory subsection formalizing the six-month period for investigation of an overpayment during which the 60-day overpayment refund deadline would be temporarily suspended. 

As summarized by CMS in the preamble discussion to the 2025 PFS Proposed Rule,

New proposed 搂 401.305(b)(3) would specify the circumstances under which the deadline for reporting and returning overpayments would be suspended to allow time for providers to investigate and calculate overpayments. Proposed 搂 401.305(b)(3)(i) provides that the deadline to report and return an overpayment would be suspended if: (1) a person has identified an overpayment but has not yet completed a good-faith investigation to determine the existence of related overpayments that may arise from the same or similar cause or reason as the initially identified overpayment; and (2) the person conducts a timely, good-faith investigation to determine whether related overpayments exist. Proposed 搂 401.305(b)(3)(ii) provides that, if the conditions for proposed 搂 401.305(b)(3)(i) are met, the deadline for reporting and returning the initially identified overpayment and related overpayments that arise from the same or similar cause or reason as the initially identified overpayment will remain suspended until the earlier of the date that the investigation of related overpayments has concluded and the aggregate amount of the initially identified overpayments and related overpayments is calculated, or the date that is 180 days after the date on which the initial identified overpayment was identified.

Currently, the six-month period contemplated for completion of a good faith investigation before the 60-day deadline is triggered appears in the preamble discussion to the 2016 Regulations, not in any regulation. See , There had been concern in the provider community that CMS might not continue that six-month investigation period upon finalization of the 2022 Revisions. Adding the provision as a regulation required notice and a public comment period which is satisfied by the 2025 PFS Proposed Rule.

What does it mean to 鈥渋dentify鈥� an overpayment? Not yet finalized from the 2022 Revisions is the critical delineation of when an overpayment has been 鈥渋dentified鈥� such that the 60-day refund rule is triggered. The statute itself does not define what it means to be 鈥渋dentified.鈥� 

The existing regulation (at 42 C.F.R. 搂 401.305(a)(2)) explains that:

[a] person has identified an overpayment when the person has, or should have through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment. A person should have determined that the person received an overpayment and quantified the amount of the overpayment if the person fails to exercise reasonable diligence and the person in fact received an overpayment.

A similar provision issued by CMS relating to overpayments under Parts C and D was rejected by a court, following which CMS essentially abandoned that provision. As noted in guidance on the CMS website titled 鈥�Status of December 2022 Proposed Rule,鈥� 鈥淐MS views the District Court鈥檚 ruling as having invalidated the definition of 鈥渋dentified鈥� set out in 42 C.F.R. 搂 422.326(c). However, Medicare Advantage Organizations (MAOs) remain obligated to report and return all overpayments that they have identified within the meaning of the statute, 42 U.S.C. 搂 1320a-7k(d)(2)(A).鈥� .

The 2022 Revisions, which if adopted will apply to Medicare Parts A, B, C and D, provide that 鈥淸a] person has identified an overpayment when the person knowingly receives or retains an overpayment. The term 鈥渒nowingly鈥� has the meaning set forth in 31 U.S.C. 搂 3729(b)(1)(A),鈥� consistent with the False Claims Act鈥檚 knowledge standard. Although the 2022 Revisions are still pending finalization, the time for comment on the 鈥渋dentification鈥� language has long closed.

What Providers and Suppliers Should Do Now  

Anyone with comments on the 2025 PFS Proposed Rule, including the new provisions of Section 401.305(b), should make them by September 9, 2024, as indicated in the process described in the 2025 Proposed PFS Rule.

Moreover, providers and suppliers should be prepared to revisit their overpayment policies upon finalization of the 2022 Revisions and the addition from the 2025 PFS Proposed Rule. As noted repeatedly above, the 2022 Revisions have not yet been finalized; however, in the April 2024 Medicare Advantage Final Rule, CMS noted that it intended to issue a final rule revising the definition of 鈥渋dentified鈥� 鈥渁s soon as it is reasonably possible.鈥� See 89 Fed. Reg. 30448, 30457 (Apr. 23, 2024).   

It seems reasonably likely that CMS will finalize its proposed overpayment regulations as part of the finalization of the 2025 PFS Proposed Rule, with an effective date relatively soon thereafter.   

 麻豆传媒 is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, our Health Care & Life Science Sector, or to our Health Care Practice Group with any questions.

The Centers for Medicare & Medicaid Services (CMS) published two significant updates to its Medicaid regulations on May 10, 2024. The two Final Rules, a and a , impose new requirements on states and Medicaid managed care plans that will enhance and standardize reporting, monitoring, and evaluation of Medicaid access to services. This summary highlights the key provisions of the two Final Rules that are likely to impact Medicaid reimbursement.

1. New Medicaid Access Reporting and Enforcement May Put Upward Pressure on Medicaid Reimbursement

Federal law requires Medicaid programs to assure that payments are sufficient to enlist enough providers so that care and services are at least as available under other programs. In the Medicaid Managed Care Rule, CMS emphasized the connection between reimbursement and access, stating that payment rates are 鈥渋nextricably linked with provider network sufficiency and capacity.鈥� In the new Final Rules, CMS requires both states and Medicaid managed care plans to report and analyze payment rates as well as access to services. If access issues are identified, the state and Medicaid managed care plans will be required to make timely changes to address the issues, such as by enrolling new providers, increasing rates to providers, expanding telehealth, or addressing other barriers.

• Corrective Action Plans for Access Deficiencies. When access deficiencies are identified in the state fee-for-service delivery system or in a Medicaid managed care plan network, CMS will require the State to submit for federal approval a corrective action plan (CAP) within 90 days of identification. Fee-for-service CAPs must be completed within 12 months, such as through increases to payment rates, improving outreach to providers, reducing barriers to enrollment, additional transportation to services, providing for telehealth, or improving care coordination. Similarly, a 鈥渞emedy plan鈥� for a Medicaid managed care access issue must identify specific steps the managed care plan will take to address the identified issues within 12 months.
  
  Implementation and enforcement of these remediation requirements will be an important area for Medicaid plans and providers to monitor in forthcoming years, as the Rules create new access standards and expand areas where Medicaid access deficiencies can be identified. For example, states are required to establish new mechanisms for beneficiary and provider feedback to ensure access to care, using tools like hotlines, surveys, ombudsmen, or reviews of grievance and appeals data. In addition, states are required to take data on proposals to modify Medicaid reimbursement rates and must establish interested parties advisory groups for provider rates and access to care issues. It remains to be seen what CMS, states, and plans will require in areas with persistent Medicaid access shortages.

• Managed Care Appointment Wait Time Standards and Secret Shoppers. The Medicaid Managed Care Rule also imposes specific new requirements for measuring access in the form of new federal 鈥渁ppointment wait time鈥� standards. CMS promulgated these requirements in response to data indicating that enrollees in Medicaid plans are significantly less likely to successfully schedule a primary care or specialty appointment when compared to private insurance. Beginning with plan rating periods that begin on or after July 9, 2027, Medicaid managed care plans will be expected to meet the following minimum federal standards: for primary care and obstetrical and gynecological (OB/GYN) services, routine appointments must be held within 15 business days of a requests, and routine appointments for mental health or substance use disorder services must be within 10 business days. Compliance with these standards will be established if the plan achieves a rate of appointment availability of at least 90%, as determined by a survey conducted by 鈥渟ecret shoppers.鈥�
  
  Meeting the federal appointment wait time standards are likely to pose a challenge. In finalizing its proposal, CMS acknowledged that longer time frames, such as 30 to 45 calendar days, 鈥渕ay be a realistic timeframe currently for some specialist appointments,鈥� but finalized the 10- or 15-day requirements for the identified categories of service. These services were selected because they are 鈥渋ndicators of core population health鈥� and may prevent urgent or emergent issues.
  
  CMS declined to define what is included as a 鈥渞outine鈥� appointment subject to the wait time standards, leaving some flexibility for states. States may also establish an exception process, such as for plans operating in areas with a health provider shortage, if the process is specified in the plan contract and includes evaluation of payment rates offered to providers of the identified service types. Appointments offered via telehealth will only count toward compliance with the appointment wait standards if the provider also offers in-person appointments to the plan鈥檚 enrollees.
• Fee-for-Service Rates. In the Medicaid Access Rule, CMS for the first time establishes a numerical floor for fee-for-service Medicaid rates, requiring them (in the aggregate, including base and supplemental payments) to equal at least 80% of the comparable Medicare rate. In addition, fee-for-service payments for a benefit category may not be reduced by more than 4% per year. Proposals to change fee-for-service rates must also be accompanied by documentation analyzing the impact of the rate change on access to providers, including ways the state will reasonably respond to or mitigate concerns raised by providers or patients.

• Comparative Rate Analyses for Certain Services (Managed Care and Fee-for-Service). Both states and Medicaid plans will be required to conduct and report comparative rate analyses for certain core services. For primary care services, OB/GYN services, and outpatient mental health and substance use disorder services, rates for evaluation and management (E/M) codes must be compared to Medicare physician fee schedule payments for the same services. In addition, states will need to publish the 鈥渁verage hourly Medicaid fee-for-service schedule payment rates鈥� for certain unique Medicaid services, namely personal care, home health aide, homemaker and habilitative services, and the number of Medicaid claims and beneficiaries served. Medicaid plans must publish their rates for these same services as a comparison to the state fee-for-service rate. State comparative rate analyses must be reported no later than July 1, 2026, and plan analyses are required for plan rating years beginning on or after July 9, 2026.

2. CMS Permits States to Increase Medicaid Managed Care Reimbursement to Achieve Parity with Commercial Plans

The Medicaid Managed Care Rule includes groundbreaking new authority that codifies the ability of states to direct payments to Medicaid providers to enhance payment rates to equal the 鈥渁verage commercial rate鈥� for the same services. This authority is specific to services reimbursed through Medicaid managed care plans, and marks a significant policy change, as fee-for-service payments for many categories of services are capped at Medicare rates, which are typically lower than commercial rates. CMS introduced this authority by emphasizing the need for Medicaid managed care plans to compete with commercial plans for providers to participate in their network, so that they can furnish comparable access to care. Payment parity between Medicaid and commercial plans would represent an enormous shift in the industry and would undermine the long-standing narrative of Medicaid as a poor payer. However, the ability of states to take up this new authority will depend on state and federal determinations related to the identification of a permissible sources of the non-federal share of the enhanced payments.

• State Directed Payments based on Average Commercial Rates. Many Medicaid managed care delivery systems include significant 鈥渄irected payment鈥� programs where the state enhances reimbursement to a class of providers for services furnished through a Medicaid managed care plan. In the preamble to the Managed Care Final Rule, CMS estimates that nearly $52 billion in directed payments are paid each year. Directed payments are unique to the Medicaid program and have been used to enhance rates (often with a different source of non-federal share) for providers beyond the base rates that otherwise would be paid by Medicaid managed care plans. Providers receiving directed payments may be subject to additional requirements, including participation in delivery system reform of value-based payment initiatives.
  
  The new rule codifies CMS鈥� practice of approving state proposals to direct payments so that total reimbursement to a provider equals the average commercial rate for inpatient and outpatient hospital services, nursing facility services, and qualified practitioner services at academic medical centers. Directed payments for other categories of services may also potentially be paid at rates that increase reimbursement to equal to the average commercial rate, if those rates are approved as 鈥渞easonable, appropriate, and attainable.鈥� While CMS had considered developing an aggregate cap on state reliance on directed payments, no such limitation was finalized.
• Some State Directed Payments will Need to be Restructured. While the Medicaid Managed Care Rule cements the role of state directed payments as a critical component of Medicaid managed care, it made some changes to how directed payments can be distributed that will require many states to revise their programs. Effective for rating periods beginning on or after July 9, 2027, states will no longer have flexibility to distribute funding to Medicaid plans through 鈥渟eparate payment terms鈥� that are paid outside of Medicaid capitation rate processes. Instead, funding for the directed payments will need to be paid as an adjustment to monthly capitation rates that are based on plan enrollment that is reviewed and certified as part of the state actuarial process. Distribution of funding in this manner may introduce new uncertainty for plans, provider classes receiving funds, and for state budgets.

•  Attestation Requirements for Directed Payments Funded by Health-Care Related Taxes. While the new Medicaid rules do not modify the law with regard to permissible sources of the non-federal share of Medicaid payments, CMS has finalized its proposal to require recipients of a state directed payment to submit an attestation that they do not participate in an impermissible 鈥渉old harmless arrangement鈥� for any health care related tax, starting January 1, 2028. This requirement is part of an ongoing legal dispute between CMS and multiple states that operate health care related tax programs that fund provider taxes, based on CMS鈥� concerns that the states had failed to demonstrate to its satisfaction that the tax programs meet applicable legal requirements, due to the existence of arrangements among private entities to redistribute Medicaid funding.
  
  The new attestation requirement would provide CMS greater information about the existence of these private arrangements. To submit the attestation, Medicaid providers would need to evaluate and attest to whether they participate in an arrangement that constitutes a 鈥渉old harmless,鈥� notwithstanding the ongoing disputes between CMS and states. An issued contemporaneously with the Managed Care Rule announces that CMS will not enforce the hold-harmless provisions against states with respect to arrangements that were in place as of April 2024 until January 1, 2028; CMS expects states to use the time to transition the existing arrangements.
• Inclusion of Out-of-Network Providers. Historically, CMS has not allowed state directed payment arrangements to benefit providers that did not have a network provider contract with a Medicaid managed care plan, even if they furnish services to plan enrollees. The revised rules remove this restriction, allowing states to expand their programs so that funding is distributed to all providers of a service.

3. CMS Continues Authority for Medicaid plans to Cover Alternative Services and Settings to Address Health-Related Social Needs

In prior rulemaking, CMS authorized states to work with Medicaid plans to cover 鈥渋n-lieu of services鈥� (ILOS), which are alternative services and settings that are not covered by the State plan, but which may be covered by plans. These alternative services and settings include items such as payment for sobering centers, medically tailored meals (less than three meals per day), supportive housing assistance, or personal care services. The provision of ILOS can help address health-related social needs of individuals, provide greater 鈥渨hole person care,鈥� and reduce the incidence of traditional covered services such as inpatient or emergency room utilization. The Medicaid Managed Care Rule builds on this authority, further establishing ILOS as part of the Medicaid program and establishing new fiscal and programmatic requirements.

• Aggregate Cap on ILOS. Beginning with rate years starting on or after July 9, 2024, states will be required to calculate an ILOS cost percentage and ensure that no more than 5% of total plan capitation payments are associated with ILOS. While this caps total investment in ILOS, 5% would represent a significant expansion of the current incidence of ILOS in most states, and CMS encourages states approaching this limit to transition some ILOS to services it covers as benefits.

• Enhanced Reporting, Evaluation and Oversight. The new rule would significantly expand state responsibility for reporting and evaluating the use of ILOS. States whose ILOS cost percentage exceeds 1.5% must submit cost information and conduct retrospective evaluations of the ILOS, including its impact on utilization of State plan approved services or settings and associated cost savings, and its impact on health equity efforts.

4. Minimum Reimbursement for Home-and-Community-Based Service (HCBS) Direct Care Workers

In addition to services furnished by home health agencies, most Medicaid programs cover home and community-based services for Medicaid beneficiaries, which include various service components, such as homemaker services, personal care services, and home health aide services, intended to allow individuals with medical needs to remain in the community and out of institutional settings. In the Medicaid Access Rule, CMS鈥� updated requirements applicable to HCBS programs.

• Sharing of Medicaid Rates with Direct Care Workers. The Medicaid Access Rule will require states to ensure that Medicaid HCBS providers spend at least 80% of the Medicaid payments they receive on total compensation for the direct care workers who furnish the services. This requirement is the first time CMS has distinguished the adequacy of rates paid to a provider agency from those which are passed on to employees or contractors who perform the services. States have the authority to exempt small providers from the 80% requirement and subject them to alternate minimum performance levels. States can also exempt some providers facing extraordinary circumstances from the requirement through a hardship exemption request. These requirements do not take effect until July 9, 2030.

Conclusion

The compliance date for the changes made by the Medicaid Access Rule and the Medicaid Managed Care Rule are staggered and will take effect over the next several years. Health care providers, health plans, states, and other entities involved in the financing of the Medicaid program should begin planning for these changes, which will shake up the Medicaid landscape in ways designed to expand access to services for Medicaid patients.

麻豆传媒 is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, our Health Care & Life Science Sector, or to our Health Care Practice Group with any questions.

In its November 2023 Proposed Rule[1] and in its recently issued Final Rule that was published in the Federal Register on April 23, 2024,[2] the Centers for Medicare & Medicaid Services (CMS) addressed concerns related to agent and broker compensation as well as how payments from Medicare Advantage (MA) plans to third party marketing organizations (TPMOs) may further influence or obscure the activities of agents and brokers.

Background

In its 2023 Proposed Rule, CMS started the discussion of agent and broker compensation by noting that pursuant to section 1851(j)(2)(D) of the Social Security Act, the Secretary has a 鈥渟tatutory obligation to establish guidelines to ensure that the use of agent and broker compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage (MA) plan that is intended to best meet beneficiaries health care needs.鈥�[3] In 2008, CMS published the first regulation to establish requirements for agent and broker compensation, which was driven by concerns that the previously permitted compensation resulted in financial incentives for agents to strategically market and enroll beneficiaries in some plan products and not others due to larger commissions.[4] Based on the CMS commentary, the revised rules regarding agent and broker compensation are trying to address similar concerns, along with TPMO concerns.

Fraud and Abuse Risks

In several places in the Proposed and Final Rules, CMS noted that, depending on the circumstances, agent and broker relationships can also be problematic under the Federal anti-kickback statute if they involve, for example, compensation in excess of fair market value (FMV), compensation structures tied to the health status of the beneficiary (e.g., cherry picking), or compensation that varies based on the attainment of certain enrollment targets.[5] It seems likely that the upcoming revised Office of Inspector General (OIG) Compliance Program Guidance for Medicare Advantage, which, in February and again in April 2024, OIG announced was forthcoming as the first in the series of its specific compliance guidances, will address this anti-kickback risk.[6] (Note that the prior Compliance Program Guidance for Medicare+Choice was published on November 15, 1999, which predated the agent and broker compensation regulation.[7])

The MA Marketplace Has Changed

CMS noted that the MA marketplace has become increasingly consolidated into a few large national parent organizations, which have more money to spend on sales, marketing and other incentives and bonus payments to agents and brokers than the smaller MA plans. CMS noted advertisements where agents and brokers are offered bonuses and perks (e.g., golf parties, trips and extra cash) framed as allowable administrative add-ons in exchange for enrollments. According to CMS, these payments to agents and brokers are being offered as innocuous bonuses or incentives, but implemented in a way that allows the plan to account for these 鈥渁nti-competitive payments as 鈥榓dministrative鈥� rather than 鈥榗ompensation,鈥� and these payments are therefore not limited by the [fair market value] regulatory limits on compensation.鈥�[8] CMS noted that such payments may implicate and potentially violate the Federal anti-kickback statute. 

With regard to TPMOs, CMS noted its concerns that MA plan payments to TPMOs may 鈥渇urther influence or obscure the activities of agents and brokers.鈥�[9] In particular, CMS is interested in the effect of payments made to Field Marketing Organizations (FMOs), which are a type of TPMO that employs agents and brokers to complete MA enrollment activities and may also conduct additional marketing activities on behalf of MA plans, such as lead generating and advertising. CMS noted that the concerns regarding FMO activities are not new, having been expressed during the first rulemaking on agent and broker compensation (73 Fed. Reg. at 54239). Examples of FMO services include training, material development, customer service, direct mail and agent recruitment. Again, CMS raised the Federal anti-kickback statute, reminding parties to be 鈥渕indful鈥� that their compensation arrangements including arrangements with FMOs and other similar type entities must comply with the fraud and abuse laws including the Federal anti-kickback statute.[10]

A Three-Pronged Approach to Revisions to Payment Structures

In the proposed rule and mirrored in the Final Rule, CMS outlined the following approach for revisions to the agent, broker and TPMO payment structures:

1. generally prohibit contract terms between MA organizations and agents, brokers or other TPMOs that may interfere with the agent鈥檚 or broker鈥檚 ability to objectively assess and recommend the plan which best fits a beneficiary鈥檚 health care needs;
2. set a single agent and broker compensation rate for all plans, while revising the scope of what is considered 鈥渃ompensation鈥�; and
3. eliminate the regulatory framework which currently allows for separate payment to agent and brokers for administrative services.[11]

Contracts Must Encourage Objective Assessments

With regard to the first point 鈥� contract terms 鈥� CMS proposed and finalized an addition at Section 422.2274(c)(13) that beginning with contract year 2025, MA plans must ensure that contracts with agents, brokers and TPMOs including FMOs do not include language that has the 鈥渄irect or indirect effect of creating an incentive that would reasonably be expected to inhibit an agent鈥檚, broker鈥檚 or TPMO鈥檚 ability to objectively assess and recommend a plan that best meets the health care needs of the beneficiary.鈥�[12] CMS provided examples of anti-competitive contract terms that they intend to prohibit including those that:

• specify renewal or other terms of a plan鈥檚 contract with an agent broker or FMO contingent upon preferentially higher rates of enrollment;
• make an MA organization鈥檚 contract with an FMO or reimbursement rates for marketing activities contingent upon agents and brokers employed by the FMO meeting specified enrollment quotas;
• contain terms that provide for bonuses or additional payments from an MA organization to an FMO with the explicit or implicit understanding that the money be passed on to agents or brokers based on enrollment volume in plans sponsored by that MA organization;
• allow an FMO to provide an agent or broker leads or other incentives based on previously enrolling beneficiaries into specific plans for a reason other than what best meets their health care needs.[13]

CMS was deliberate in not being too prescriptive, allowing plans flexibility in how to structure the arrangements.

In the Final Rule鈥檚 comments, with regard to the contract requirements, CMS said that it was important that it be clear in its meaning of 鈥渄irect or indirect effect of creating an incentive that would reasonably be expected to inhibit an agent鈥檚, broker鈥檚 or TPMO鈥檚 ability to objectively assess and recommend a plan that best meets the health care needs of the beneficiary . . . .鈥� If, by way of example, a TPMO or agent was offered a bonus or other payment by a plan or plans, in exchange for declining to represent a competing MA plan, this would be an example of a contract term that would likely violate the rule, as it is inherently anti-competitive in nature and on its face has the effect of encouraging enrollment in one plan over another based largely on the receipt of a financial reward for not representing or promoting a competitor plan鈥檚 product.鈥�[14] Another example provided by CMS was bonuses for hitting volume-based targets for sales of a plan, which although CMS admitted may not be directly anti-competitive if they do not outwardly discourage or preclude a TPMO from marketing other plans, would nevertheless likely have the indirect effect of creating an incentive for the TPMO to prioritize sales of one plan over another based on those financial incentives and not the best interests of the enrollees. Because the indirect effect of volume-based bonuses of this kind would be anti-competitive in nature, they would likely run afoul of the provision, and, like other potential scenarios described herein, could implicate fraud and abuse laws as well 鈥� again, noting Federal anti-kickback risks.[15] CMS noted it would rely on its review of contracts as well as complaints and OIG efforts to enforce this provision.

Compensation

With regard to the second concern raised by CMS in the proposed rule 鈥� compensation rates 鈥� CMS explained that current compensation rates for agents and brokers are set at Section 422.2274(d)(2) at amounts that should not exceed certain fair market value caps, excluding administrative expenses as described in Section 422.2274(e). CMS noted that the total amounts paid to agents and brokers varies significantly, and raised the concern that the lack of a uniform compensation standard across plans can encourage the arrangements that provide financial incentives for agents and brokers to favor some plans over others and that such incentives could result in beneficiaries enrolling in plans that do not best fit their needs. For contract year 2025 (i.e., effective October 1, 2024), CMS proposed and finalized revisions to the definition of 鈥渃ompensation,鈥� requiring that all payments to agents or brokers that are tied to, related to, or are for services conducted as part of the relationship associated with the enrollment into an MA plan or product must be included.

That revised definition of 鈥渃ompensation鈥� at Section 422.2274(a) includes categories of payments that were previously excluded from the definition including: (a) payment of fees to comply with state appointment laws, training, certification, and testing costs; (b) reimbursement for mileage to, and from, appointments with beneficiaries; and (c) reimbursement for actual costs associated with beneficiary sales appointments such as venue rent, snacks, and materials.

Finally, CMS incorporated previously excluded administrative expenses into the definition of compensation. Agents and brokers will be paid the same amounts from the MA plan directly or by an FMO. (Note: CMS left its discussion of payments for referrals under Section 422.2274(f) as it was, noting that the cap is sufficient to avoid the previously described risks and harms.)

Administrative Expenses Included in Payment Structures

As part of the third discussion point related to payment structures for agents, brokers and TPMOs, CMS addressed the folding in of the administrative expenses into compensation with a flat amount increase to the FMV cap. In the proposed rule, CMS recommended an increase of $31 to reflect call recording, training and testing, but commenters stated that the expenses were broader than those recognized by CMS in the proposed rule, noting plan comparison tools and appointment fees. CMS also acknowledged that it may have undervalued call recording/customer-relationship management (CRM) software.[16] Commenters to the proposed rule provided CMS with different administrative expense calculation methodologies, but CMS stated that the true cost of most administrative expenses can vary greatly from one agent or broker to another and is based on data and contracts that CMS does not have access to, so it would be extremely difficult for them to accurately capture, making a line-item calculation not practicable.[17] CMS accordingly defaulted to a higher flat rate in the Final Rule, noting there is no need to vary administrative payments based on plan type and a flat rate approach is the most appropriate way to achieve the goal of eliminating financial incentives in the form of larger, purported administrative payments which are over and above FMV from a particular plan or plans.[18] CMS decided on a one-time increase of $100 for new enrollments (with 50% of the new enrollment fee being paid for renewals) with annual inflation increases.

In the commentary, CMS was clear that this change in compensation to agents and brokers was intended to focus on enrollment, not all payments related to marketing services. Specifically, CMS stated: 鈥淭hough we are continuing to consider future rulemaking in this space, our current policy does not extend to placing limitations on payments from an MAO to a TPMO who is not an independent agent or broker for activities that are not undertaken as part of an enrollment by an independent agent or broker.鈥�[19]

Applicability to Part D

Finally, CMS also revised the agent and broker compensation regulations related to Part D plans in the same way that it revised the Medicare Advantage regulations.

Conclusion

The CMS Final Rule is a significant change in the way that Medicare Advantage and Part D plans will be allowed to pay agents, brokers and TPMOs related to enrollments and renewals. Although given until October to make the compensation changes, plans should start planning now, as should agents, brokers and TPMOs, because the covering of administrative expenses is now bundled into a flat, FMV cap that is set by the government. Also notable for industry are the multiple references to the Federal anti-kickback statute (and general fraud and abuse analysis), which has been tied more firmly to the analysis of the MAO/PDP payments to agents, brokers and TPMOs, and we should watch for the upcoming OIG Compliance Program Guidance for Medicare Advantage to address those risks.

麻豆传媒 is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, our Health Care & Life Science Sector, or to our Health Care Practice Group with any questions.

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[1] 88 Fed. Reg. 78,476 (Proposed Rule, Nov. 15, 2023).

[2] 89 Fed. Reg. 30,448 (Final Rule, Apr. 23, 2024).

[3] 88 Fed. Reg. at 78,551.

[4] Id. at 78,552.

[5] Id.; see also 89 Fed. Reg. at 30,617, 30,618, and 30,624.

[6] See OIG, Compliance Guidance page, 鈥淔ebruary 21, 2024 update,鈥� available at . 

[7] See OIG, Compliance Program Guidance for Medicare+Choice Organizations Offering Coordinated Plans (Nov. 15, 1999), available at . 

[8] 88 Fed. Reg. at 78,552; 89 Fed. Reg. at 30,617.

[9] 88 Fed. Reg. at 78,553; see also 89 Fed. Reg. at 30,618.

[10] Id. OIG noted in a 2010 report that CMS should issue additional regulations more clearly defining how and how much FMOs should be paid for their services. Id. (quoting Levinson, Daniel R, BENEFICIARIES REMAIN VULNERABLE TO SALES AGENTS鈥� MARKETING OF MEDICARE ADVANTAGE PLANS (March 2010), available at https://oig.hhs.gov/oei/reports/oei-05-09-00070.pdf)

[11] 88 Fed. Reg. at 78,554; see also 89 Fed. Reg. at 30,620.

[12] Id.

[13] Id.

[14] 89 Fed. Reg. at 30,620-621.

[15] 89 Fed. Reg. at 30,621.

[16] Id. at 30,625. While potentially undervalued, CMS also noted that the CRM software could be used for plans outside of the MA plans.

[17] Id.

[18] Id. at 30,625-626.

[19] Id. at 30,626.

On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued its  (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes to improve access to behavioral health care in Medicare鈥檚 history. These changes further the goals of CMS鈥檚  as follows:

• For the first time, CMS allows Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs) to enroll in Medicare Part B and bill for their services.
• CMS expands billing flexibilities through the creation of new codes, modifying some Conditions of Participation and Conditions for Coverage, and allows existing behavioral health codes to be billed by more types of providers.

In an on-going attempt to meet its goals of improving access to and the quality of mental health services, the Final Rule includes a number of changes that modernize and expand Medicare coverage. As a result, provider organizations and investors in the behavioral health sector can plan for additional Medicare revenue opportunities. 

New Provider Types Established; Medicare Enrollment

In our 2023 Physician Fee Schedule rule summary, we noted that CMS acknowledged it did not have the regulatory authority to create new reimbursable practitioner types. However, this changed with the 2023 Consolidated Appropriations Act (CAA), in which Congress established a new benefit category for MFTs and MHCs. The Final Rule implements regulations allowing these providers to bill for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital).

Medicare defines an MFT as an individual who:

• Possesses a master鈥檚 or doctorate degree which qualifies for licensure or certification as a MFT under State law of the State in which such individual furnishes marriage and family therapist services,
• Is licensed or certified as an MFT by the State in which they furnish services,
• Has performed at least two years of clinical supervised experience in marriage and family therapy or mental health counseling after obtaining the degree referenced above, and
• Meets other requirements as the Secretary of Health and Human Services (HHS) determines appropriate.

An MHC as an individual who:

• Possesses a master鈥檚 or doctorate degree which qualifies for licensure or certification as a MHC, clinical professional counselor, or professional counselor under State law of the State in which such individual furnishes MHC service,
• Is licensed or certified as an MHC, clinical professional counselor, or professional counselor by the State in which they furnish services,
• Has performed at least two years of clinical supervised experience in marriage and family therapy or mental health counseling after obtaining the degree referenced above, and
• Meets other requirements as the Secretary of HHS determines appropriate.

Additionally, CMS acknowledged that states use varying terms to define MFTs and MHCs and, importantly, other clinician categories/designations under state law. For example, licensed or certified professional counselors including addiction counselors or drug and alcohol counselors, may enroll in Medicare as MHCs provided they meet applicable requirements for MHCs.

MFTs and MHCs will be able to enroll in Medicare starting November 2, 2023, and begin to bill for their services on January 1, 2024. Note that although providers can enroll in Medicare as of November 2, 2023, MFTs/MHCs will not be granted an effective date for their enrollment earlier than January 1, 2024, so claims with dates of service prior to January 1, 2024, will not be payable. MFT and MHC services can be billed at 80% of the lesser of either (1) the actual charge for the services or (2) 75% of the amount determined for payment of a psychologist.

CMS published a  document for MFTs and MHCs who can enroll with Medicare using the  enrollment application. Note that the paper CMS-855I application does not list MFT and MHC specialties (applicants are advised to select the 鈥淯ndefined Non-Physician Practitioner Specialty鈥� option in section 2H and specify MFT or MHC in the space provided), however, the Medicare Provider Enrollment, Chain, and Ownership System鈥檚 online application will include these specialties as of November 2023.

Expanding Billing Flexibilities

In addition to establishing new provider benefit categories, CMS increased various billing flexibilities to increase access to behavioral health services through the creation of new codes, modifying Conditions of Participation and Conditions for Coverage, and allowing existing behavioral health codes to be billed by more types of providers.

First, CMS is implementing various other sections of the CAA to establish new Healthcare Common Procedure Coding System codes for psychotherapy for crisis services furnished at applicable sites of service. An applicable site of service is considered any place of service at which the non-facility rate for psychotherapy for crisis services applies, other than the office setting. These services can also be furnished at home, a mobile unit or even via telehealth as long as  are met. Specifically, payment for these crisis services shall be equal to 150% of the fee schedule amount for non-facility sites. This change is designed to increase the number of providers willing to provide these services and address issues of access and availability of crisis services. Generally, for services furnished in an office setting, Medicare reimburses physicians and practitioners at a rate based on a full range of resources utilized to deliver the service. On the other hand, services delivered to physicians and other practitioners in a facility setting (e.g., hospital or an ambulatory surgical center) are reimbursed only for those resources typically incurred by the practitioner while furnishing the service, i.e., the clinician receives a lower payment amount to reflect their lower costs.

Next, CMS is finalizing its proposal to modify hospice Conditions of Participation to allow MFTs and MHCs to serve as members of the hospice interdisciplinary group. Relatedly, CMS is finalizing the requirements for the Rural Health Clinics and Federally Qualified Health Centers Conditions for Certification and Conditions for Coverage to allow MFTs and MHCs to provide additional behavioral health services at these locations.

Additionally, CMS has finalized its proposal that Health Behavior Assessment and Intervention (HBAI) services may now be billed by more provider types. Previously only open to clinical psychologists, clinical social workers, MFTs and MHCs may now bill these codes used to identify potential psychological, behavioral, emotional, cognitive, and social factors which may impact the treatment of physical health problems. CMS hopes expanding the range of practitioner types who can furnish these services (and be paid for them) will allow for a better integration of physical and behavioral health care.

Key Takeaways

These changes promise to increase access to quality behavioral health to Medicare beneficiaries across the country. Providers and behavioral health companies should celebrate these investments in improving access to behavioral health services. On a practical level, these changes will allow behavioral health providers to leverage a large sector of qualified clinicians (MFTs and MHCs). Steps can be taken now to enroll and credential these clinicians in Medicare and implement clinical protocols and policies to appropriately integrate these clinicians into the outpatient plan of care for Medicare beneficiaries, as well as hospice interdisciplinary teams, crisis response programs, and HBAI services.

麻豆传媒 is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, or to our Health Care Practice Group with any questions.

The Centers for Medicare and Medicaid Services鈥� (CMS) new program , is anticipated to begin July 1, 2024.

In a previous blog post 麻豆传媒 breaks down major highlights of the new model.

On September 5, 2023, . Eligible providers have until November 30, 2023 to submit their applications to CMS. As identified in the Scope section, CMS is accepting applications from Medicare-enrolled organizations located in the following states: Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, upstate New York, North Carolina, and Washington.

The following types of organizations are eligible to apply to participate in MCP: Medicare-enrolled organizations that provide primary care services to Medicare beneficiaries, including solo primary care practices, group practices, health systems, Federally Qualified Health Centers (FQHCs), and eligible Indian Health (Tribal) Programs. Critical Access Hospitals (CAHs) that have selected 鈥淪tandard鈥� or 鈥淢ethod I鈥� billing may also apply.

To be eligible to apply to participate in MCP, an organization must: (1) be a legal entity formed under applicable state, federal, or Tribal law, that is authorized to conduct business in each state in which it operates; (2) be Medicare-enrolled; (3) serve as the regular source of primary care for a minimum of 125 attributed Medicare beneficiaries; and (4) have the majority (at least 51%) of their primary care site(s) (physical locations where care is delivered) located in an MCP state described in the Scope section of the application.

In addition, applicants that are not FQHCs must bill Medicare for services furnished by primary care clinicians (Doctors of Medicine, Doctors of Osteopathic Medicine, Clinical Nurse Specialists, Nurse Practitioners, Physician Assistants) who provide primary care services as part of their job. CMS defines primary care clinicians for the purposes of the application as a list of National Plan & Provider Enumeration System (NPPES) specialties that represent 鈥減rimary care,鈥� including internal medicine, general medicine, geriatric medicine, family medicine, pediatrics, nurse practitioner, clinical nurse specialist, and physician assistant. Non-FQHC applicants must also have primary care services account for at least 40% of the applicant鈥檚 collective Medicare revenue for the list of primary care clinicians employed by the applicant. Non-FQHC applicants must identify, in the application, each individual primary care that renders services under the Taxpayer Identification Number (TIN) of the applicant 鈥� otherwise known as the MCP Clinician List 鈥� by their National Provider Identifier (NPI).

Applicants that are interested in MCP but aren鈥檛 ready to apply can also complete the short,聽聽(LOI), to signal their interest to the Center for Medicare & Medicaid Innovation (CMS Innovation Center) and sign up to learn more about the model as information is released.

The deadline for eligible providers to submit their applications to CMS has been extended to December 14, 2023.

麻豆传媒 is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your 麻豆传媒 relationship partner, or to our Health Care Practice Group with any questions.