The following is an excerpt from our full comments on the 2022 Physician’s Fee Schedule.
II.L. Proposals and Request for Information on Medicare Parts A and B Payment for Dental Services
I. Comment on Proposal to Clarify Interpretation of the Statutory Dental Exclusion.
The Center strongly supports CMS’ proposal to clarify and codify its interpretation of section 1862(a)(12) of the Act to recognize Medicare payment for dental services that are essential to certain covered medical services. For decades now, the cost of dental care has hindered Medicare beneficiaries from being able to safely undergo or see optimal outcomes from important medical treatments. Historically minoritized and under-resourced populations have faced disproportionate barriers in affording medically-related dental care. The agency’s proposal paves the way toward ameliorating disparities in access to critical health services and bringing Medicare’s dental coverage policy up to date with clinical standards of care.
We have concern, though, about the proposed wording of the legal standard exempting from the statutory exclusion “[d]ental services that are inextricably linked to, and substantially related and integral to the clinical success of, a certain covered medical service[.]” We anticipate that uncertainty about the meaning of the phrase “inextricably linked to” could lead to inconsistent decisions on claims, appeals, and prior authorizations, and create frustrations for patients, medical providers, and adjudicators alike.
Oxford Languages defines the term “inextricably” to mean “in a way that is impossible to disentangle or separate.” Merriam-Webster defines “inextricable” as “forming a maze or tangle from which it is impossible to get free.” The phrase “inextricably linked” thus connotes an absolute inseparability, and could be unduly restrictive if employed as a coverage standard without guiding criteria. In evaluating whether a dental service is inextricably linked to a medical service, a contractor might incorrectly deny coverage if the two services could, as a practical matter, ever be considered independently. Another contractor might construe the standard as a temporal one, akin to the current “same time/same dentist” rule requiring that the two services be furnished simultaneously. This would not align with the fact that Medicare payment is allowed in some scenarios where dental services are performed separate from the covered medical service (e.g., extraction of teeth to prepare the jaw for radiation treatment, oral or dental exam prior to kidney transplant). A legal standard that raises ambiguity or inconsistency would demand further clarification from the agency in the future.
The policy goals of CMS’ proposal can be effectively achieved just by narrowly tailoring payment to dental services that are “substantially related and integral to the clinical success of certain covered medical services.” This is a rigorous, yet clearer and workable, standard that contractors, plans, and adjudicators can apply in analyzing claims. They will be able to determine, without speculation, if a claim meets this requirement based on whether the clinical evidence demonstrates that the standard of care for a covered medical treatment necessitates dental clearance, or the provision of appropriate remedial measures to address dental infections and other oral problems, to avoid undue risk and promote a positive outcome.
II. Proposals to Clarify and Codify Current Payment Policies
- Covering medically-related dental services in inpatient and outpatient settings
The Center agrees with codifying that payment for dental services falling outside of the exclusion can be made whether furnished on an inpatient or outpatient basis. Situations may arise, whether because of a patient’s condition or the need for certain equipment or accommodations, when it will be clinically appropriate for such dental services to be furnished in a hospital setting rather than a dental office.
These situations still raise the question of whether a patient will be admitted as an inpatient or treated and billed as a hospital outpatient. Since dental treatments are not included on the “Inpatient Only” list, and rarely are dental patients expected to need 2 or more midnights of medically necessary hospital care, most or many of these patients will not be admitted and billed as hospital inpatients. This may have a significant impact on how much they will pay for their hospital services.
For example, there are beneficiaries who must receive treatment in hospital because no dental office within reasonable distance has the proper modalities or adaptive equipment to accommodate their special needs. Although their physician services and hospital outpatient services are covered by Part B, if they are not admitted as inpatients then these beneficiaries could incur liability for other hospital costs that may exceed the Part A deductible. Thus, we request that CMS examine the impact of how services are billed in these scenarios, and develop policy and guidance to both ensure adequate reimbursement and that Medicare beneficiaries do not experience undue financial burden if their medically necessary dental procedures need to be performed in a hospital setting.
- Professional services during and prior to a dental-related hospitalization
The Center lacks expertise to address CMS’ separate inquiry about what professional services may occur during Part A-covered hospitalizations in connection with the provision of excluded dental procedures due to (1) the patient’s underlying medical condition and clinical status or (2) the severity of the dental procedure. However, we similarly suspect that such covered hospitalizations may be a rarity under the “2-Midnight Rule” since most patients who must have dental services performed in the hospital are now placed on outpatient observation status post-procedure and stay less than two midnights. We respectfully request that CMS evaluate current billing practices in these scenarios, the resulting impact on beneficiaries’ out-of-pocket costs, and whether the statutory goal of minimizing liability for such beneficiaries is being achieved.
- Setting of oral examinations and treatment prior to covered medical treatments
Under current policy, Medicare pays for an oral or dental examination performed on an inpatient basis as part of a comprehensive workup prior to renal transplant surgery. The Center supports CMS’ proposed revision of 42 C.F.R. § 411.15(i) to make Medicare coverage and payment available for such examinations in either an inpatient or outpatient setting prior to Medicare-covered organ transplant, cardiac valve replacement, or valvuloplasty procedure.
- “Direct supervision” requirement on services of allied dental professionals
The Center welcomes the proposal to amend § 411.15(i) to provide that payment can be made for ancillary services and supplies that are furnished incident and integral to covered (non-excluded) professional dental services. But, we question CMS’ suggestion that the services of auxiliary practitioners — such as a dental hygienist, dental therapist, or registered nurse — must be “under the dentist’s or physician’s direct supervision.” By our understanding, legislation in 42 states authorizes licensed and certified dental hygienists and dental therapists to perform appropriate services without the directing physician being physically present. Such laws have served to increase access to dental care and improve health outcomes among low-income, tribal, and disabled populations and communities of color.
Providing that the professional services of auxiliary personnel be furnished under the physician’s “general supervision” within the meaning of 42 C.F.R. §§ 410.26(a)(3) and 410.32(b)(3)(ii), rather than “direct supervision,” would advance health equity while aligning more closely with state scope of practice and supervision laws.
III. Proposed Updates to Current Payment Policies for Dental Services.
- Services to identify and eliminate infection prior to covered organ transplant
The Center applauds and urges CMS to finalize its proposal to provide Medicare payment for a dental or oral examination as part of a comprehensive workup and the medically necessary dental diagnostics and treatments to eliminate identified oral and dental infections prior to an organ transplant, whether furnished in an inpatient or outpatient setting. If finalized, this rule will ease a barrier to life-saving transplants that has disproportionately impacted systemically marginalized groups.
During a listening session hosted by CMS this year, transplant surgeon Dr. Matthew Cooper stated unequivocally that in order to ensure optimal outcomes, “everybody who presents for a transplant…requires a dental evaluation and certainly treatment, if indicated.” Dr. Cooper serves as President of the Board of Directors for the United Network for Organ Sharing (UNOS), the organization that manages the U.S. organ transplantation system under contract with the federal government. He described the extensive screening of transplant candidates to identify risk factors for complications, such as cancers and infections that may later necessitate reduction in immunosuppression and lead to organ graft rejection and loss. Dr. Cooper stressed the importance of remedial oral/dental care because “even minimal inflammation, in combination with immune suppression, portends a very poor outcome.” As support for this, he referenced a recent study showing that patients presenting with even one dental problem pre-kidney transplant had 7.23 times greater chance of being hospitalized in the first 2 months post-transplant, and that risk of rehospitalization increased with patient age.
We humbly request that CMS reconsider its position that “[n]o payment would be made for services that are not immediately necessary prior to surgery to eliminate or eradicate infection.” First, dental clearance may be needed to be placed on the wait list, well in advance of actual transplant surgery. Second, as pointed out by Dr. Cooper and in comments submitted by the Society for Transplant Social Workers (STSW), Santa Fe Group, and the Oral Health Nursing Education and Practice Program (OHNEP), care for transplant patients does not end after the operating room. They reference several studies demonstrating the importance of post-transplant oral care to clinical outcomes. Older adults especially are at increased risk for infectious complication following solid organ transplants. (Hemmersbach-Miller, et al., 2021). We therefore echo their recommendations to continue coverage for dental treatment as appropriate during immunosuppression therapy, to prevent sepsis and organ rejection.
- Services to identify and eliminate oral or dental infection prior to Medicare-covered cardiac valve replacement or valvuloplasty procedures
The Center similarly lauds and urges finalization of CMS’ proposal to recognize Medicare payment for a dental or oral examination as part of a comprehensive workup and the necessary dental treatments and diagnostics to eliminate oral or dental infections prior to cardiac valve replacement or valvuloplasty procedures. Statements issued by The American College of Cardiology, American College of Emergency Physicians, American College of Physicians, and The Society of Thoracic Surgeons highlight the risk of life-threatening complications that dental infections pose to cardiac patients.
This risk, though, is not confined to valve replacement and valvuloplasty surgeries. We thus encourage CMS to extend dental coverage under the proposed standard to patients undergoing other cardiothoracic, vascular, and cardiovascular invasive procedures, where there is general agreement that dental bacteria sources should be eliminated to prevent serious medical complications. These may include ventricular assisted device (VAD) and extracorporeal membrane oxygenator (ECMO) procedures, which involve implantation of a large component of prosthetic material into a patient that could seed infection. We also ask that CMS not limit coverage to only those dental services “immediately necessary prior to surgery” in contexts where clinical studies and accepted standards of practice recommend perioperative dental management.
IV. Other Clinical Scenarios that CMS May Consider or Has Not Yet Identified
CMS seeks comment and evidence regarding other examples of where dental care may be vital to the clinical success of covered medical treatments and approved for payment under the proposed exception. As an organization that strives to advance quality health care for Medicare beneficiaries, we urge CMS to exercise its authority to cover medically necessary dental care in as broad a range of clinical situations as possible.
Not a week passes that the Center does not hear from beneficiaries who are facing serious health challenges that require the provision of dental treatment. We talk to people who are forced to delay vital chemotherapy and/or radiation of Stage 4 breast cancer and other cancers until their dental infections have been addressed. We get many calls from beneficiaries whose disease conditions, traumatic injuries, treatments, and/or medications have resulted in extreme oral devastation that makes it a daily struggle for them to chew, swallow, speak clearly, smile, and manage ongoing oral infections and pain. We hear of others who have been repeatedly hospitalized for pneumonia or sepsis seeding from odontogenic infections.
While their health conditions are diverse, those who contact us have in common a medically urgent need for dental care that they cannot readily afford, either because of limited income and resources, lack of coverage, or underinsurance. We believe the agency has legal authority to advance a dental policy that can address the most medically pressing dental needs, and directly improve care delivery to the least advantaged patients. Thus, we endorse the expanded coverage recommendations and clinical data shared by the California Dental Association (CDA), and elaborate on the scenarios below.
- Joint replacement surgery
Many if not most orthopedic surgery practices require dental clearance before elective total joint arthroplasty (TJA), a common surgery among Medicare beneficiaries. This is because bacteria from caries and periodontal disease, a common condition among Medicare beneficiaries (76% of adults over 65 have some degree of gum disease), can enter and travel through the bloodstream and infect the vulnerable tissue around joint and surgery sites. Since blood does not circulate through replacement joints, antibiotics may not effectively treat site infections. In such circumstances, the options would be to surgically excise the infected tissue surrounding the new joint, flush the site, and aggressively administer antibiotics to the patient, or to remove the entire prosthesis and reattempt the joint replacement after the infection has resolved. Failure of revision surgeries to eradicate infection can necessitate amputation. All of these results come at great cost to the patient, the health care system, and the Medicare program.
Notwithstanding that very limited research has been conducted on whether pre-operative dental clearance decreases the incidence of prosthetic joint infections, it is axiomatic that active infections, regardless of their source, should be identified and eliminated safely in advance of arthroplasty, just as with organ transplant and cardiac valve surgeries, to minimize the risk of serious complication. The orthopedic community recognizes that patients who have active oral infections are at higher risk for sepsis and joint infection, and should have their TJA procedures delayed until dental clearance is obtained. As marginalized patient populations are disproportionately burdened by the cost of dental clearance and longer delays in receiving TJA, we urge CMS to consider allowing payment under Medicare for recommended dental examinations and treatment necessary to safely undergo TJA.
- Head and neck cancer treatment
Medicare makes payment for tooth extractions to prepare the jaw for cancer radiation, but no other dental care needed in conjunction with oral, head and neck cancer treatment. The various therapies used to treat these cancers can cause an array of challenging oral problems that have a terrible impact on a patient’s quality of life. These oral problems include rampant radiation caries, mucositis, candidiasis, xerostomia (dry mouth), and osteoradionecrosis (bone cell death) of the jaw. The latter can necessitate surgery that may disfigure and functionally impair the patient’s face and jaw. For these reasons, it is widely understood that dental care is absolutely integral to the clinical success of head and neck cancer treatment and survivorship. We support the comments of the American Association of Oral and Maxillofacial Surgeons (AAOMS) and California Dental Association (CDA) recommending expansion of payment for medically necessary dental examinations, treatments, and follow-up care to address infections impacting or resulting from head and neck cancer therapies.
- Cancers and immunosuppressing diseases and treatments
As reinforced in comments by the Sepsis Alliance, the significance of dental care in the context of immunosuppression cannot be understated:
“A dental abscess or other infection of the teeth and supportive tissues should, like all infections, be treated as quickly as possible to reduce the risk of complications, including sepsis. This is especially important for individuals who are immunosuppressed because of disease (Diabetes, Leukemia, HIV, Chronic Kidney Disease), pharmaceuticals (cancer chemotherapies, biologics for management of autoimmune diseases), and/or natural aging (immunosenescence).”
Leukemia, lymphoma and other cancers. Dr. Gwen Nichols, Chief Medical Officer for the Leukemia & Lymphoma Society (LLS), asserted at a CMS-hosted listening session this year that oral organisms are “the number one or number two most common cause of sepsis in patients who are treated for acute leukemia.” She explained how this was “potentially life-threatening” for patients who do not have normal neutrophils to show that they have infection, which is why “dental evaluation for these patients is critical” before starting therapy. The majority of LLS’ patient population are Medicare-eligible, and they receive weekly calls from patients who “cannot get their life-saving bone marrow transplant (BMT) or CAR T-cell therapy because they cannot afford the dental care they need.” Dr. Nichols explained that oncologists have to be “very careful” prior to CAR T-cell therapy and BMT to ensure that patients are “ready to be immunosuppressed for 100 days.”
BMT patients have a higher risk of infection for almost two years while their immune system returns to full strength. If donated stem cells are transplanted, they usually need to take immunosuppressant medications to reduce the risk of the transplanted cells attacking or being rejected by their body. For this reason,
“A dental clearance is required for all patients prior to BMT. Poor dentation such as dental caries, periodontitis, and other issues may lead to complications such as: delayed healing of mucositis, need for parenteral nutrition and pain medications, increased length of stay, and increased risk for infection, sepsis, and death. Delays in obtaining dental clearance can place patients at a higher risk for relapse creating the need for additional therapy prior to BMT or cancellation of the BMT.”
This was the rationale behind a recent study that found that the percentage of patients who delayed BMT decreased from 4.6% to 1.8%, and the percentage that canceled BMT decreased from 2.8% to 0%, after BMT nurses worked with social workers to identify dental resources in the community that could provide dental work and clearance for those who did not have dental insurance or coverage.
There is also concrete data, as presented in the Santa Fe Group’s comments, to support the recommendation that Medicare coverage for dental services begin prior to cancer therapy and continue as appropriate during and post-treatment until immunosuppression ends, infections are resolved, and restorative interventions when indicated are completed.
Sjogren’s Syndrome and other Autoimmune diseases. Patients with difficult cases of Sjogren’s Syndrome may need to be treated with chemotherapeutic, immunosuppressive, and steroidal drugs that lower their immune response. The use of such agents, in the setting of dry mouth that is the hallmark of Sjogren’s Syndrome, can lead to a host of challenging oral and dental issues, including infections that may compromise their course of treatment. Medications used to treat individuals with other autoimmune diseases, including rheumatoid arthritis and lupus, can have a similar effect.
Individuals with Multiple Sclerosis (MS) are typically treated with Disease Modifying Therapies (DMT) that work by suppressing or modifying the immune system, and many are linked to an increased risk of infection. Comments submitted by the National Multiple Sclerosis Society affirm, “Coverage of dental examinations and treatments is unquestionably needed for beneficiaries requiring long-term use of immunosuppressing medications to help manage MS. It is vital for patients with MS to receive appropriate dental evaluation and prompt treatment so they can continue their DMT use.”
- Bisphosphonate Therapy
The Center believes that dental treatment can be essential to preventing complications of bisphosphonate therapy and merits coverage under the proposed exception. Bisphosphonate therapy is used in some cancer treatments, and also widely prescribed in treating osteoporosis and rheumatoid arthritis. A relatively rare but serious side effect of this toxic medication is osteonecrosis (bone and tissue death) of the jaw, which can have devastating health consequences for some patients. Because of this, some individuals taking bisphosphonates may need routine dental management to identify and address symptoms of pain, swelling and infection, loosening of teeth, drainage and exposed bone.
- Dental services associated with stabilizing and/or repairing the jaw after accidental injury or trauma
The Center cannot speak with authority to whether, besides the wiring or immobilization of teeth in connection with the reduction of a jaw fracture, there are other dental services associated with stabilizing and/or repairing the jaw after accidental injury or trauma that similarly would not be subject to the dental exclusion and should be covered by Medicare. However, beneficiaries have shared with us situations where Medicare has covered the immediate, preliminary interventions needed (sometimes in an emergency room) to stabilize and/or repair their jaw, but denied coverage of associated dental services (e.g., treatment of fractured and dislocated teeth) that could only be effectively provided after swelling had significantly gone down. Their coverage denials may have resulted from Medicare dental policy’s restrictive same time/same dentist rule. We respectfully ask that the agency evaluate whether that rule unfairly restricts coverage in circumstances where a course of treatment to completely stabilize and/or repair the jaw after injury or trauma may, for practical or clinical reasons, need to be performed on different days, by different personnel, in different settings.
We also take this opportunity to endorse the American Association of Oral & Maxillofacial Surgeons’ (AAOMS) recommendation, based on its membership’s long experience in furnishing covered care to Medicare beneficiaries, that payment be extended to the “extraction of problematic teeth and incision and drainage when a delay in surgical treatment could result in the impairment of the patient’s condition or a delay in pending treatment that should be performed in a timely manner.”
V. Establishing a Process to Review Additional Clinical Scenarios for Future Updates.
We firmly support the finalization of a process within the annual rulemaking cycle whereby the agency could review and consider for payment additional scenarios in which dental services may be integral to the overall clinical success of a covered medical treatment. An established process will effectively enable Medicare dental coverage policy to adapt to evolving standards of clinical practice, backed by growing medical evidence, data on patient outcome measures, and input from experts across relevant disciplines. We praise CMS’ forethought and initiative in conceiving this strategy to facilitate ongoing progress towards medical-dental integration and evidence-based coverage in this area.
VI. Dental Services Integral to Covered Medical Services Which Can Result in Improved Patient Outcomes.
We commend CMS’s recognition that there may be clinical scenarios where the ongoing disease management of a patient receiving medically necessary care may have an improved outcome or see a clinical benefit from the performance of dental services. We believe there are situations in which dental services should be considered so integral to the standard of care for an otherwise covered medical service that the statutory payment preclusion does not apply. Prime examples are where rampant, untreated periodontal disease is complicating the management of a patient’s diabetes, or recurrent aspiration or nosocomial pneumonia is seeding from oral periodontopathic bacteria. There is also strong evidence to support the provision of dental services to end-stage renal patients. A retrospective study published this year concluded that intraoral surgical and conservative dentoalveolar treatment in end-stage renal disease patients is essential to optimize subsequent kidney transplantation.
The non-profit coalition, Kidney Care Partners, offered the view that “[a]ccess to dental services not only is important for dialysis patients as part of their ability to access kidney transplants, but also to access cardiovascular procedures given that many dialysis patients also live with serious, chronic cardiovascular conditions, and to reduce the risk of systemic infections developing from an oral source.” In company with comments of other organizations, the American Nephrology Nurses Association (ANNA) expressed strong belief that regular dental exams and necessary follow-up treatment curb future complications and “are integral to the standard of care for patients receiving dialysis and therefore should not be precluded from covered services.”
The Center believes that access to targeted dental care can optimize outcomes for patients in the above clinical scenarios, and that the statute does not bar Medicare payment for such care. Medicare’s foot care policy offers a precedent here. Section 1862(a)(13) of the Act unambiguously excludes payment for routine foot care. Nevertheless, there is longstanding policy guidance allowing payment for routine foot care determined to be a necessary and integral part of otherwise covered services (e.g., diagnosis and treatment of ulcers, wounds, or infections), or where an individual has an underlying systemic medical condition (i.e., metabolic, neurologic, and peripheral vascular diseases) that has caused severe circulatory problems or diminished sensation in the individual’s legs or feet. Applying similar authority and clinical justification, CMS could duly cover certain dental treatments integral to the standard of care for patients presenting with certain underlying medical conditions and clinical findings.
VII. Other Potentially Impacted Policies
The Center respectfully asks CMS to consider the thoughtful recommendations offered by the California Dental Association concerning the coding of and reimbursement rates for covered dental items and services under the exception to the statutory exclusion. We have every faith that with the specialized expertise of the agency and continued input from relevant stakeholders, the policies around implementation and payment may be optimized to ensure that Medicare beneficiaries can realize the crucial benefits of the proposed coverage.
VIII. Potential Future Payment Models for Dental and Oral Health Care Services.
We agree that the Innovation Center’s waiver authority under section 1115A(d)(1) of the Act can test ways to integrate the payment for dental and health care services within existing and future payment models – including models focused on equity, care coordination, total cost of care and specific disease conditions. We encourage CMS to consider the models that have been suggested in comments submitted by our cohorts at FamiliesUSA, Justice in Aging, California Dental Association, and the Santa Fe Group.
The Center for Medicare Advocacy values the opportunity to comment on these important dental policy proposals and information requests. The agency’s leadership and vision in this area truly reflects its exemplary aim to build a better health care future on the foundation of six strategic pillars – advancing equity, expanding access, engaging partners, driving innovation, and protecting programs. If finalized, CMS’ proposals will mark a watershed in the effort to integrate dental into overall health care, and equitably reduce the burden of dental disease on Medicare beneficiaries for generations to come.
 DJ Sarmento, R Caliento, R Maciel, P Braz-Silva, JOM Pestana, P Lockhart, M Gallottini. Poor oral health status and short-term outcome of kidney transplantation. Special Care Dentist. 2020 Nov; 40(6); 549-554.
 WV Arnold, J Ottolenghi, M Belzino. Question 24: Should routine dental clearance be obtained prior to total joint arthroplasty (hip/knee/shoulder/ankle)? Orthopaedic Research Society 2019 Delegates Meeting https://www.ors.org/wp-content/uploads/2019/01/Question-24.pdf
 Even in year 2000, the National Institute for Dental and Craniofacial Research (NIDCR) felt there was enough evidence to conclude that given “the severe consequences of radiation-induced osteoradionecrosis, and Medicare’s investment in treating patients with head and neck cancer, it is reasonable for Medicare to cover both tooth-preserving care and extractions, which may be medically appropriate for certain patients.” Extending Medicare Coverage for Preventive and Other Services. Institute of Medicine (US) Committee on Medicare Coverage Extensions; Field MJ, Lawrence RL, Zwanziger L, editors. Washington (DC): National Academies Press (US); 2000. https://www.ncbi.nlm.nih.gov/books/NBK225261/#ddd00104.
 DeNinno M, Cobb D. Impact of Delaying Stem Cell Transplant Related to Dental Work Clearance (abstract). BBMT: Transplantation and Cellular Therapy. Vol. 26:3S (3/1/20). https://www.astctjournal.org/article/S1083-8791(19)31019-5/pdf.
 T Moest, R Lutz, AE Jahn, K Heller, M Schiffer, W Adler, J Deschner, M Weber, MR Kesting. Frequency of the necessity of dentoalveolar surgery or conservative treatment in patients before kidney transplantation depending on the duration of dialysis and causative nephrological disease. Clin Oral Investig. 2022 Mar;26(3): 2383-2390. Data showed that the greatest necessity for conservative treatment (73.3%) and surgical intervention (80%) could be detected for patients in the second and third years of dialysis.