Key Takeaways:

• The annual Physician Fee Schedule (PFS) has become a vehicle for CMS to explore expanding Medicare’s dental coverage policies.
• CMS believes there are clinical scenarios where payment could be permitted for dental services that are inextricably linked, and substantially related to the clinical success of, certain covered Medicare services.
• It is incumbent on interested parties to demonstrate the inextricable link through peer-reviewed medical literature and other clinical data.
• In two rulemaking cycles, CMS has proposed and implemented several proposals to expand Medicare dental coverage.

On July 13, 2023, the Centers for Medicare and Medicaid Services (CMS) released the CY2024 Physician Fee Schedule (PFS) proposed rule. This rule addresses changes in Medicare payment policies for physician services. Over the past two years, this rule has become the vehicle for CMS to consider proposals that expand Medicare’s dental coverage policies, which, due to the statutory exclusion for many dental services, have historically been very restrictive. Although most Medicare Advantage plans offer coverage for dental services, the traditional Medicare program has been unable to cover those services.

Access to oral and dental health services is a top public health priority among lawmakers, but cost considerations are often the barrier to greater access. Congressional Democrats have made expanding Medicare dental benefits a top priority, as the Centers for Disease Control and Prevention (CDC) estimate about two-thirds of adults 65 and older have gum disease.

Most seniors without Medicare Advantage coverage have limited or no dental insurance, which can lead to high out-of-pocket costs and worse health outcomes if left untreated. Poor oral health is associated with other chronic diseases, such as heart disease, and can affect other health conditions where Medicare covers certain services to treat that condition.

As Congress struggles to address gaps in dental coverage, the Administration opened this channel with the public to identify scenarios where dental services are inextricably linked to a covered Medicare service and would thus be eligible for Medicare coverage in the traditional Medicare program.

Background
During the CY2023 PFS rulemaking, CMS clarified its interpretation of Section 1862(a)(12) of the Society Security Act (the statutory exclusion for dental services), which resulted in CMS identifying certain scenarios where payment could be permitted under Medicare Part A and B for dental services that are inextricably linked to, and substantially related to the clinical success of, certain other covered services.

Those scenarios include dental or oral examinations prior to any organ transplant surgery, cardiac valve replacement or valvuloplasty procedures, and dental or oral examinations prior to treatment for head and neck cancer. This was seen as a modest expansion and CMS estimates that the annual total spending for this expansion would range from $230,000 to $3 million.

CMS identified other scenarios where payment for dental services might be allowed but opted to collect more information on those proposals. In doing so, they announced a pathway for interested parties to submit recommendations for clinical scenarios where payment would be permitted under Medicare for certain dental services. CMS would then make the determination based on peer-reviewed medical literature and other clinical data.

CY2024 Proposed Dental Coverage Expansions
CMS is proposing to permit payment under Medicare for dental or oral examinations as part of a comprehensive workup prior to Medicare-covered: (1) chemotherapy when used in the treatment of cancer; (2) chimeric antigen receptor (CAR) T-cell therapy when used in the treatment of cancer; and (3) the administration of high-dose bone-modifying agents (antiresorptive therapy) when used in the treatment of cancer.

CMS noted the inextricable linkage between dental services and chemotherapy and CAR T-cell therapy, stating that proceeding without a dental or oral exam prior to chemotherapy could lead to systemic infection or sepsis, which would jeopardize the success of chemotherapy or CAR T-cell therapy and could lead to worse outcomes for the patient. CMS further stated that dental services are a clinical prerequisite to proceeding with the administration of antiresorptive therapy when used in the treatment of cancer, thus establishing an inextricable link.

CMS Seeking Additional Information
CMS highlighted other clinical scenarios where dental services may be inextricably linked to the clinical success of those services, but did not advance these proposals. These included extending Medicare payment to include dental services to eliminate infection prior to all cardiovascular procedures. While a joint CMS and Agency for Healthcare Research and Quality (AHRQ) study concluded the available evidence does not endorse extending coverage at this time, CMS is seeking comment on additional cardiac covered services where the risk of infection posed to beneficiaries is similar to that associated with cardiac valve replacement or valvuloplasty, which CMS did extend Medicare dental coverage for during the last rulemaking cycle.

CMS is seeking specific comments on whether procedures such as the placement of intracardiac or intravascular foreign material, such as a stent or for hemodialysis, or for a vascular access graft, would be considered examples of specific medical services for which dental services are inextricably linked to their clinical success.

Stakeholders also urged CMS to extend dental coverage for individuals with sickle cell disease (SCD) and hemophilia. CMS is seeking comment on whether certain dental services are inextricably linked to other covered services used in the treatment of SCD, such as hydroxyurea therapy. CMS is also seeking information on whether certain dental services are inextricably linked to certain other covered services for hemophilia, but did not identify such services.

Pathway to Consider Stakeholder-Proposed Clinical Scenarios 
CMS acknowledged receiving eight submissions during this rulemaking from interested parties identifying clinical scenarios for which dental services should be covered under Medicare. Most noted that increasing access on the front-end of Medicare eligibility would lower the downstream costs as Medicare beneficiaries age and are managing multiple conditions.

CMS acknowledged and moved forward with certain submissions noted above, but did not move forward with several proposals. Those included for patients with diabetes and treatment for systemic autoimmune diseases, like rheumatoid arthritis, lupus, and Sjögren’s disease. CMS acknowledged that reducing oral infection of the mucosa, teeth, and gums, oral inflammation, and tooth loss through consistent oral management reduces the systemic impact that these dental conditions have on a patient’s systemic autoimmune disease. However, these submissions did not satisfy the conditions CMS identified to move forward with proposed coverage expansions.

Next Steps: Establishing an Inextricable Link
In two rulemaking cycles, CMS has further clarified the types of scenarios it is looking for to expand Medicare coverage within the confines of the Medicare statute. CMS urges interested parties to remain engaged in this process but to consider circumstances for which dental services are inextricably linked to a specific covered service, like chemotherapy, and not a diagnosis, such as Sjögren’s disease or diabetes.

The good news from this rulemaking process is that the Administration is actively exploring ways to improve access to dental services for at-risk populations in ways Congress is unable to act. While CMS is setting a high threshold for stakeholders to meet, that simply may not exist to establish an inextricable link for certain services, they have demonstrated a commitment to work with stakeholders and highlight the impact poor oral health access has on other health outcomes.

Stakeholders are encouraged to submit proposals and define clinical scenarios where there may be an inextricable link between dental services and a covered Medicare service. As noted in the proposed rule, CMS will accept new submissions for the CY2025 rulemaking cycle through February 10, 2024, which can be submitted via email at MedicarePhysicianFeeSchedule@cms.hhs.gov.

Stakeholders who wish to comment on the proposed rule can do so through September 11, 2023.