September 11, 2023
Submitted Electronically via www.regulations.gov
The Honorable Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re: Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program (CMS-1784-P)
Dear Administrator Brooks-LaSure:
The Center for Medicare Advocacy (the Center) is a national, non-profit law organization that works to ensure access to Medicare, health equity, and quality healthcare. The organization provides education, legal assistance, research and analysis on behalf of older people and people with disabilities, particularly those with long-term conditions. The Center’s policy positions are based on its experience assisting thousands of individuals and their families with Medicare coverage and appeal issues. Additionally, the Center provides individual legal representation and, when necessary, challenges patterns and practices that inappropriately deny access to Medicare and necessary care. We appreciate the opportunity to submit these comments to the above referenced proposed rule.
The Center welcomes the opportunity to submit these comments. Our comments focus on the following provisions of the proposed rule:
- II.E. Valuation of Specific Codes – (26) Payment for Caregiver Training Services
- II.J. Advancing Access to Behavioral Health Services
- II. K. Proposals on Medicare Parts A and B Payment for Dental Services Inextricably Linked to Specific Covered Medical Services
- III.A. Drugs and Biological Products Paid Under Medicare Part B
- 2. Request for Information (RFI): Drugs and Biologicals Which Are Not Usually Self-Administered by the Patient, and Complex Drug Administration Coding
Comments to the Proposed Rule
II.E. Valuation of Specific Codes
(26) Payment for Caregiver Training Services
Addressing payment for Caregiver Training Services (CTS) in the proposed rule, CMS states that caregivers may have an important role in a patient’s overall care. (FR 52322). Such a role includes assisting with behavioral health and physical health care needs. (FR 52322-53323). CMS further states as follows:
We believe that, in certain circumstances, caregivers can play a key role in developing and carrying out the treatment plan or, as applicable to physical, occupational, or speech-language therapy, the therapy plan of care (collectively referred to in this discussion as the ‘‘treatment plan’’) established for the patient by the treating practitioner (which for purposes of this discussion could include a physician; nonphysician practitioner such as a nurse practitioner, physician assistant, clinical nurse specialist, clinical psychologist; or a physical therapist, occupational therapist, or speech-language pathologist). In this context, we believe Caregiver Training Services (CTS) could be reasonable and necessary to treat the patient’s illness or injury as required under section 1862(a)(1)(A) of the Act.FR 52323
The practitioners CMS identifies (above) deliver services Medicare beneficiaries may receive through Medicare-covered home health care. If CTS is finalized, CMS must make it abundantly clear that CTS would not replace, or be a substitute for, existing Medicare coverage of home health aides as required by 42 C.F.R. 409.45 (b)(3)(iii) and Medicare Benefit Policy Manual Chapter 7, Section 20.2, for individuals qualifying for Medicare-covered home health care services.
Medicare payment for home health care is made through a consolidated billing process and the Patient Driven Groupings Model (PDGM) and payments such as proposed for CTS would not be allowed to directly benefit home health agencies (HHAs). However, HHAs should not be allowed to violate the presumption in Medicare regulation and policy, that there is no willing and able caregiver in the home, and require a beneficiary to have a caregiver or, even if they do have a caregiver, to require that individual receive CTS in order for the HHA to provide home health services.
The Center for Medicare Advocacy hears regularly from Medicare beneficiaries who are inappropriately told by providers: 1. The patient must have a caregiver before the HHA will consent to serve them, and 2. The HHA will not provide home health aides included in the plan of care, but the HHA will only consent to teach a caregiver. If the patient does not consent to these HHA rules, they likely will not receive any home health services. In the event CMS finalizes coverage of Caregiver Training Services (CTS), HHAs should be reminded of the presumption that there is no willing and able caregiver, and that the application of CTS does not apply in the home health setting and the requirements of 42 C.F.R. 409.45 (b)(3)(iii) and Medicare Benefit Policy Manual Chapter 7, Section 20.2 (for a caregiver to be both willing and able to perform caregiver/aide services) continue in home health care regulations and policy. CMS should provide the same reminder on behalf of beneficiaries receiving hospice services. This will avoid significant, unintended consequences in home health care and hospice settings.
For Medicare beneficiaries who do not meet home health care or hospice coverage qualifications, CTS may provide additional support for caregivers to benefit the patient. The patient and caregiver should understand that CTS is intended to benefit the patient. The caregiver should enter CTS voluntarily, to gain competence and confidence. However, in order for CTS to be successful, the provider must acknowledge and respect that the caregiver is often an important, trusted person to the patient. The provider should deliver professional, non-judgmental training. In many circumstances, the caregiver may live with the patient day-in and day-out and know the patient and the daily needs of the patient, better than the provider ever could. Finally, the Center for Medicare Advocacy agrees with the proposed rule that the patient, or patient’s representative, must consent for the caregiver to receive CTS.
II.J. Advancing Access to Behavioral Health Services (p. 52361)
A. Coverage of Marriage and Family Therapists and Mental Health Counselors
The Center supports CMS’ proposal to create new regulations to define marriage and family therapists (MFTs) and mental health counselors (MHCs), and to specify the services these practitioners can provide. §§ 410.53, 410.54. We also support CMS’ proposals to add these providers to the list of practitioners eligible to provide BHI services, order diagnostic tests, deliver Medicare telehealth services, and be subjected to limited-risk screening.
We strongly support CMS’ proposal to allow Addiction Counselors who meet all the applicable requirements of a MHC to enroll in Medicare as MHCs and bill Medicare for MHC services. However, we urge CMS to explicitly codify this inclusion at § 410.54 to ensure that these providers and Medicare beneficiaries are aware of such coverage. As CMS has previously noted in its proposed Medicaid Managed Care Access Rule when amending its regulations to specify MH and SUD instead of behavioral health, “It is important to use clear, unambiguous terms in regulatory text.” As such, we believe it is necessary to include “addiction counselor or alcohol and drug counselor” at §§ 410.54(a)(1) and (3); “addiction counseling” at § 410.54(a)(2); and “substance use disorders” at § 410.54(b)(1).
F. Comment Solicitation on Expanding Access to Behavioral Health Services
Use the terms “mental health” and “substance use disorder” rather than “behavioral health.”
In its recently proposed Medicaid Managed Care Access Rule (CMS-2439-P), CMS stated that, while it uses “behavioral health” to mean MH and SUD, “it is an imprecise term that does not fully capture the full array of conditions that are intended to be included…It is important to use clear, unambiguous terms in regulatory text.” Accordingly, CMS changed “behavioral health” throughout its regulations to clarify when it meant MH and SUD. For consistency across federal programs, and for much needed clarity for Medicare providers and beneficiaries, we urge CMS to make similar changes throughout the Medicare regulations.
Remove administrative barriers to reimbursement for dually eligible beneficiaries when Medicare does not cover the practitioners, services, and settings that Medicaid covers.
We appreciate CMS’ requests for comment throughout the proposed rule on unique considerations for beneficiaries who are dually eligible for Medicare and Medicaid. One key way to improve access to MH and SUD care for beneficiaries who are dually eligible is for CMS to develop a more user-friendly and seamless administrative process for providers to get denials from Medicare to allow them to bill Medicaid without delay. Freestanding community-based SUD treatment facilities are able to bill Medicaid in every state, and many states also allow certified SUD counselors (who do not have master’s degrees and the requisite number of clinical hours to qualify as a MHC), and certified peers to do so as well, but they first need to obtain a denial from Medicare. Facing a Catch-22 dilemma – as they cannot bill Medicare for these services – the cost of that care is shifted to state funds and, absent other resources, their patients face unnecessary barriers and delays to treatment and recovery. We urge CMS to work with these providers and states to remove these administrative barriers to care for dually eligible beneficiaries.
Urge Congress to apply the Mental Health Parity and Addiction Equity Act to Medicare.
CMS can further expand access to MH and SUD care by working with Congress to apply the Mental Health Parity and Addiction Equity Act to all parts of Medicare. The lack of parity in Medicare causes significant harm to beneficiaries. The U.S. Departments of Health and Human Services, Labor, and the Treasury have recently proposed regulations that would strengthen the Parity Act in commercial insurance plans, and CMS and Congress should take advantage of this opportunity to establish consistency across all plans to ensure that individuals ages 65 and older and those with disabilities are not subjected to discriminatory plan features that pose additional barriers to accessing SUD and MH treatment. This proposal is consistent with CMS’s objective to ensure parity in access, coverage, and quality for physical and MH and SUD services, as a way to meet its goal of strengthening equity and quality in behavioral health care. At the same time, CMS should continue to identify and address disparities in access to and coverage of SUD and MH care in the Medicare program and remove discriminatory treatment barriers.
II.K. Proposals on Medicare Parts A and B Payment for Dental Services Inextricably Linked to Specific Covered Medical Services
As an advocacy organization, the Center receives calls and emails on a daily basis from Medicare beneficiaries across the country. For decades now, the absence of coverage for medically related dental care has been one of the pressing problems that we most frequently hear about. The individuals who contact us experience high risks to their health and health care treatment, as well as very compromised quality of life because they cannot readily afford this dental care.
The Center reiterates its praise of the current Administration and the team at Centers for Medicare & Medicaid Services (CMS) for their diligent efforts to improve treatment outcomes for Medicare beneficiaries who require medically essential dental care. We appreciate last year’s clarification by CMS that Medicare payment may be made for dental services that are inextricably linked to, and substantially related and integral to the clinical success of a covered medical service. We commend the agency’s revision of the regulation at 42 C.F.R. § 411.15(i)(3)(i) to permit payment for necessary diagnostic and treatment services to eliminate dental infections in the context of Medicare-covered organ transplant, cardiac valve replacement, and valvuloplasty procedures. We now applaud CMS’ current proposal to recognize payment for dental services that are integral to certain additional clinical treatments.
A. Dental Services Inextricably Linked to Certain Cancer Treatments
The Center strongly urges CMS to finalize its proposal to allow payment for dental services that are inextricably linked to chemotherapies, CAR T-Cell therapy, and the administration of high-dose bone-modifying agents (antiresorptive therapy) when used in the treatment of any type of cancer. Careful dental management is imperative for patients experiencing immunosuppression and the toxic effects of these critical therapies. We have spoken to individuals who likely could have benefited from such management in the course of treatment for lymphoma and cancer of the prostate, thyroid, breast, colon, anus, vocal chords, and other cancers. We have also heard from Medicare beneficiaries who urgently required but could scarcely afford treatment to eliminate oral infections as a precondition to receiving lifesaving cancer treatment. If finalized and effectively implemented, CMS’ proposed policy will be of enormous help to such patients in the future.
It is more often the case, though, that we hear from patients who, in the aftermath of successful chemotherapy, radiation, and bisphosphonate therapies, are suffering severe dental and oral side effects. They typically report of how all of their teeth began breaking off in jagged pieces, of painful inflammation and sores erupting throughout their mouth, and of developing frequent oral infections that became resistant to antibiotics over time, spreading into their bloodstream and to other tissues and organs in their body. Tales of lost employment, multiple hospital stays, speech impairment, inability to chew food, drastic weight loss, electrolyte imbalance, malnutrition, and need for parenteral nutrition also figure into their stories. While some of these individuals did not have the benefit of dental care before initiating or contemporaneously with cancer treatment, some reported that their oral health had been fine prior to and their oral hygiene impeccable during cancer treatment. We therefore urge CMS to consider whether payment may appropriately be made in certain instances when dental care is clinically advised and justified in the post-treatment phase of cancer.
Moreover, we encourage CMS’ consideration of radiation therapy in the treatment of cancer more broadly and not just in conjunction with chemotherapy. On rare occasions, the Center hears from patients requiring dental treatment in relation to radiation treatment alone — usually post-surgical dissection of head and neck cancer. But we have also heard from patients who suffered devastating dental complications in the treatment of other cancers (e.g., thyroid) with surgery and radiation alone.
There are studies concluding that periodontal examination and therapy are even recommended prior to surgical treatment of certain cancers. See, e.g., Jia C, Luan Y, Li X, Zhang X, Li C. Effects of periodontitis on postoperative pneumonia in patients with lung and esophageal cancer, Thorac. Cancer. 2021 Mar; 12(6); 768-774. doi: 10.1111/1759-7714.13828. (Periodontitis is an important predisposing factor for post-operative pneumonia after open thoracotomy, and periodontal treatment is associated with a lower incidence of pneumonia following lung and esophageal cancer surgery); Nishikawa M, Honda M, Kimura R, et al. Clinical impact of periodontal disease on postoperative complications in gastrointestinal cancer patients. Int. J. Clin. Oncol. 2019 Dec; 24(12): 1558-1564. doi: 10.1007/s10147-019-01513-y. (Periodontal disease is an independent risk factor for infectious complications after gastrointestinal cancer surgery). Such studies suggest that addressing dental infections even at the surgical stage could help avoid health complications that may ostensibly delay or otherwise hamper subsequent stages of cancer treatment.
Although we cannot provide the supporting medical evidence requested by CMS, we encourage the agency’s consideration of whether dental services may be inextricably linked to the clinical success of other immunotherapies that may have a similar lymphodepleting component as CAR-T cell therapies.
B. Dental Services Integral to Covered Cardiac Interventions
The Center has gotten calls from cardiac patients who urgently required treatment to address dental infections before their surgeons would agree to operate. We therefore urge CMS to permit payment for dental screenings and, when clinically justified, medically necessary dental treatment that a patient may need in order to undergo, or to avoid complicating or compromising the following covered cardiac procedures.
- CPT 33206, 33207, 33208 (pacemaker insertion or replacement)
- CPT 33249 (insertion or replacement of ICD – implantable cardioverter defibrillator)
- CPT 33361-33364 (transcatheter aortic valve replacement)
- CPT 33405 (surgical procedure on aortic valve)
- CPT 33430 (mitral valve replacement)
- CPT 33894 (endovascular stent repair)
- CPT 33975, 33990, 33991, 33995 (cardiac assist procedures)
- CPT 37236, 37237 (endovascular stent placement)
- DRG 218 (cardiac valve and other major cardiothoracic procedures)
- DRG 222-227 (cardiac defibrillator implant)
- DRG 242-244 (cardiac pacemaker implant)
- DRG 266-267 (endovascular cardiac valve replacement)
- DRG 319-320 (other endovascular cardiac valve procedures)
Dental treatment will certainly not be integral to the success of a covered cardiac intervention in every case. The determination of whether an individual patient’s diagnosed dental issues risk compromising the outcome of the particular cardiac procedure will depend on various factors particular to the patient and to the procedure. Further, because dentally-sourced infections can cause serious complications at the site of intracardiac or intravascular stents and devices even after the surgical procedure, we urge CMS to extend payment, when clinically advised and justified, to dental treatment following the cardiac procedure.
C. Dental Services Inextricably Linked to Treatment for Head and Neck Cancer
We fully support CMS’ proposal to clarify that Medicare Parts A and B payment may be made for examination and medically necessary diagnostic and treatment services to eliminate oral or dental infection prior to the initiation of, or during, treatments for head and neck cancer, whether primary or metastatic, regardless of the site of origin, and regardless of initial modality of treatment. Respectfully, we ask CMS to adopt a definition of “during” or “contemporaneously with” that recognizes the patient-specific clinical decisions in head and neck cancer treatment, while adhering to the agency’s interpretation of its authority under the Medicare statute. The following case example illustrates why dental services may be integral to the clinical success of a course of treatment for head and neck cancer that has technically ended:
The Center recently heard from a beneficiary who was diagnosed with sinus cancer at the end of 2022. The oncology team determined that the best course of action for this patient was immediate surgical removal of his tumors followed by prompt initiation of chemotherapy and radiation. No time could be spared for a dental examination and treatment, nor would it have been clinically advisable while he was immunosuppressed. Shortly after the completion of chemotherapy and radiation this February, most of the patient’s teeth began to break off above the gumline. He is in considerable pain and can no longer chew food. While tooth extractions normally would have been appropriate (and covered by Medicare) prior to chemo and radiation, they are contraindicated now, six months post-treatment, due to risk of bone loss from radiation. He must instead have root canals, the cost of which will nearly deplete his and his wife’s retirement savings. Without the recommended dental treatment, however, he is susceptible to ongoing infections and inflammation, complicating his successful recovery from cancer and increasing the risk of relapse.
For patients like this beneficiary, a definition of “during” or “contemporaneously with” that encompasses a clinically-recognized recovery phase for targeted head and neck cancer treatment would advance the goals of the Medicare program without violating the statutory dental exclusion.
D. Dental Services Possibly Inextricably Linked to Other Covered Services
We greatly appreciate CMS’ commitment to considering whether dental services may be inextricably linked to additional Medicare-covered services and evaluating clinical evidence that may support such a linkage. Over the years, we have heard from Medicare beneficiaries who urgently required dental care in order to prevent continuing complications of and most optimally treat their underlying diseases and medical conditions. These have included severe COPD, uncontrolled diabetes, epilepsy, Sjogren’s disease, lupus, rheumatoid arthritis, chronic kidney disease, Ludwig’s angina, and retroperitoneal fibrosis. Dental services certainly would not be inextricably linked to the successful treatment of these conditions in every case. But for these particular individuals, their oral pathologies needed to be addressed because they were clinically determined to be a highly exacerbating factor in the progression and treatment outcome of their medical conditions.
Many of the individuals who contact us have been prescribed therapies with immune-suppressing and dental side effects, such as certain bone-modifying agents, corticosteroids, and anticonvulsant medications. Quite a number of the individuals who have an autoimmune disorder as their primary diagnosis, are also afflicted with other autoimmune disorders – sometimes several. Incidentally, we have observed that many such patients are women and/or members of ethnic or racial minority populations, and a concerning share of them are unable to afford the combined cost of their conditions, prescribed treatments, and urgently needed dental treatment.
We underscore the comment made by our colleagues at FamiliesUSA that “Increasing access to and affordability of dental and oral health services that improve the outcomes of Medicare-covered services related to each of these conditions is an important health equity issue. People who rely on Medicare to treat these conditions should not be unable to afford dental and oral health care that might lead to better disease management and health outcomes.”
E. Implementation of Payment for “Inextricably Linked” Dental Services
The Center understands that several pieces must align in order for Medicare patients to actually access the dental services that are inextricably linked to their covered medical treatments. We also understand that while CMS may be able to guide or influence some of those pieces, the agency does not control all of the pieces. That said, we urge CMS to utilize all available vehicles within its means to educate relevant providers about the payment policy, address concerns and uncertainties they may have about the policy, and encourage dentists to enroll in Medicare.
We created surveys that were recently distributed by The Organization for Donation and Transplant Professionals (NATCO), the American Association of Hospital Dentists (AAHD), and the Special Care Dentistry Association (SCDA) to their members. The surveys are designed to gauge the knowledge that transplant centers and hospital and special care dentists have concerning the dental payment clarification and to gather input from these providers that could help inform implementation of the policy. Preliminary results of the surveys reflect that less than half of the respondents are aware of the clarification and learned of it through advocacy and professional organizations (e.g., ADA, SCDA).
Even those providers who know about the payment clarification still have questions about what dental care could be covered, at what stage of their patients’ medical treatment, and how to code the services and bill Medicare correctly. They are very hesitant to inform or advise their patients without a better understanding of the policy, its particulars and logistics. One transplant provider suggested that information could be disseminated through the United Network for Organ Sharing (UNOS), which sends policy updates to transplant centers and patients. Dentists and transplant providers alike are interested in obtaining clearer directions (something akin to a roadmap) on how to properly submit claims and what can be expected in terms of reimbursement. Some hospital dentists are dissuaded by the challenges they already encounter in trying to bill Medicare for covered oral and maxillofacial surgical (OMFS) procedures, including frequent denials by fiscal intermediaries, time-consuming appeals, and low reimbursement.
Some transplant centers say it would be helpful to know of the local Medicare-participating dentists to whom they could refer their patients. Transplant centers have no prior experience in billing Medicare for dental services as a part of a transplant procedure. It would be entirely novel for them to make arrangements to reimburse a non-participating dentist to furnish care to their transplant candidate/patient. Some asked if this would entail billing directly to Medicare for their patient’s dental services, or through their Medicare Cost Report (Kidney Acquisition).
The concept of obtaining payment directly from a patient’s medical provider is likewise novel to most dentists, even though medical-dental care coordination is nothing new. As such, there is understandable apprehension and reluctance to attempt such arrangements for Medicare patients. Having more comprehensive information and guidance that offers assurance of a predictable outcome may help encourage these providers to facilitate or furnish care to eligible patients. Several respondents wanted to know if any transplant programs or dentists have had success yet in getting this care paid for their patients.
On a separate implementation topic, the Center believes it is crucial that Medicare Advantage plans fully understand the payment clarification and that they must pay for medically-integral dental services in addition to any supplemental dental benefits they offer. This information should be included in the dental benefits section of their annual Evidence of Coverage (EOC). Moreover, plans should make sure that their customer service representatives have scripts and protocols in order to furnish accurate information about medically-integral dental services to enrollees and providers. If an enrollee may qualify for payment of medically-integral dental services, the plan should help them to locate care from an appropriate dentist.
Responding to CMS’ query about whether “inextricably linked” dental services should be provided in federally qualified health centers (FQHCs), we feel that they should, as FQHCs serve a significant number of dual eligibles. Concerning dual eligibles, the Center also believes Medicare could require that state agreements with MA organizations offering Dual Eligible-Special Needs Plans (D-SNP) do more to ensure care and benefit coordination for their enrollees. This is particularly important for dual eligibles in states that include fairly comprehensive adult dental benefits in their Medicaid plans. For instance, it could be required that D-SNP plans inform their enrollees of in-network dentists who also participate in Medicaid. An enrollee could maximize their benefits by obtaining care from such a provider, and significantly reduce their out-of-pocket liability. This would enhance the care and coverage that dual eligibles receive whether they require routine or medically-integral dental care.
We further believe that greater outreach and education should be made to Medicaid-participating dentists and dental programs about the Medicare dental clarification. Encouraging these providers to enroll in Medicare could facilitate care for dual eligibles and reimbursement for those providers.
III. Other Provisions of the Proposed Rule
A. Drugs and Biological Products Paid Under Medicare Part B
2. Request for Information (RFI): Drugs and Biologicals Which Are Not Usually Self-Administered by the Patient, and Complex Drug Administration Coding
The current process whereby CMS and its contractors establish which drugs and biologicals are usually self-administered by the patient, and therefore are statutorily excluded from coverage under Part B, has caused confusion and substantial financial harm to beneficiaries, including contacts and clients of the Center. In these comments, the Center would like to describe a recent example of this harm to a beneficiary who had long-standing Part B coverage of a drug before it was reclassified through the current self-administered drug (“SAD”) list process. The Center believes this insufficient process has resulted in unjust liability and distress for the beneficiary and has violated their Constitutional right to due process of law. Therefore, in these comments, we provide suggestions for how the current guidance can be adjusted to protect beneficiaries and maintain their right to notice before their benefits are taken away. Current processes also provide insufficient protections for people who cannot in fact self-administer such drugs because of a disability.
Comments on the Process to Determine Drugs and Biologicals which are Usually Self-Administered by the Patient
A recent client of the Center, who requested to remain anonymous, has severe psoriasis and psoriatic arthritis. Specifically, they have a rare, destructive type of psoriatic arthritis called arthritis mutilans with “pencil in cup deformity.” This disease erodes the small bones and joints in the hands and feet, causing intense pain. Arthritis mutilans has disabled them and caused debilitating pain and stress in their day-to-day life.
This beneficiary receives subcutaneous injections of the drug ustekinumab on a quarterly basis in order to manage their arthritis mutilans and alleviate the concomitant debilitating pain. Their rheumatologist administered these injections on an outpatient basis at their local hospital since September 2016. Part B covered these injections of ustekinumab as a drug that was furnished “incident to” a physician’s service. There is no dispute that ustekinumab is medically reasonable and necessary for the treatment of this beneficiary’s psoriatic arthritis.
However, through the MAC’s issuance of local coverage article A53021 (the “LCA”), CMS decided that ustekinumab qualified as a usually self-administered drug and therefore no longer qualified for Part B coverage as of October 15, 2021. Through the LCA, CMS found that 50% of patients who are prescribed ustekinumab can inject the drug themselves, and therefore it meets CMS’s definition of a SAD. Pursuant to Medicare statutes and CMS policy, SADs are not encompassed in the “incident to a physician’s service” coverage provided by Part B and can only be covered by Medicare under Part D.
This beneficiary received no notice that ustekinumab injections were no longer covered by Part B, and thus received two more outpatient injections at the hospital in December 2021 and March 2022, completely unaware that a change in Medicare’s coverage for this medication had occurred. CMS does not require notification of the beneficiary in these circumstances.
Per a Medicare Summary Notice (“MSN”) received in April 2022, the beneficiary was informed that Part B does not cover ustekinumab. This April MSN was the first notification they received informing them that Part B would not cover the injections – neither Medicare nor the hospital had notified them beforehand. The April MSN also notified them that the hospital could bill the beneficiary nearly sixty thousand dollars for the December 2021 injection.
A similar MSN received in July 2022 informed the beneficiary that her March 2022 injection would not be covered under Part B and, again, that the hospital could bill her nearly sixty thousand dollars for that injection.
Due to the lack of advance notice of noncoverage, the beneficiary was unaware that they could be charged nearly one hundred twenty thousand dollars for these injections where previously the entire bill had been paid by Medicare Part B and their Medigap plan. Without prior notice, they had no reasonable ability to make other arrangements for administration of the injection or to seek out alternative methods of coverage for these injections.
Moreover, CMS has interpreted Medicare’s limitation on liability provisions, which in many situations protect beneficiaries from liability when they have not been notified in advanced of Medicare noncoverage, to be inapplicable when CMS determines that a Part B drug is usually self-administered by the patient. As a result, and despite receiving no notice from either Medicare or the hospital that ustekinumab would no longer be covered in this setting, the beneficiary was found fully liable for the sticker price of these injections.
These circumstances are clearly unfair and have caused undue financial and emotional distress for the beneficiary and their family. Additionally, this insufficient process has violated the beneficiary’s Constitutional right to sufficient due process of law. Ensuring that advance notice of noncoverage was provided would not have been an undue burden for CMS or its contractors in this and any similar case. These entities knew the beneficiary was receiving previous coverage of ustekinumab and made the determinations leading to the termination of that coverage. Providing notice, or requiring that providers issue notice, of the novel non-coverage of ustekinumab would have been at minimal cost in both time and money to help save thousands and perhaps millions of dollars for the beneficiary and all other beneficiaries receiving Part B coverage of ustekinumab before these events occurred.
The Center is also concerned that CMS’s current policies for determining when a drug is “usually self-administered by the patient,” and subsequent non-coverage of drugs that were previously covered under Part B as “incident to” a practitioner’s services, do not take the needs of people with disabilities into account. Specifically, CMS has interpreted “usually self-administered by the patient” to mean when a drug is self-administered by more than 50 percent of Medicare beneficiaries “as a collective whole.” “In evaluating whether beneficiaries as a collective whole self-administer, individual beneficiaries who do not have the capacity to self-administer any drug due to a condition other than the condition for which they are taking the drug in question are not considered.”
Under this policy, beneficiaries who have been receiving a Part B medication incident to a practitioner’s service, and who cannot self-inject due to a disability, such as Parkinson’s disease, are abruptly disadvantaged when the drug can no longer be covered by Part B. Disabled patients may lose their only safe and practical access to the medication in question. The Center has heard of this scenario, and urges CMS to consider reasonable modifications to the Medicare program to account for the needs of beneficiaries with disabilities. This could include continued coverage of administration of the medication by a medical professional.
In light of the foregoing example and similar stories, the Center urges CMS to amend its requirements to protect beneficiaries in the circumstances where, historically, Part B coverage has been provided for a drug or biological and subsequently CMS and its administrative contractors determine that the drug or biological is usually self-administered by the patient. CMS should require that notice is provided at a minimum to beneficiaries who have previously received Part B coverage of the drug in question, and such beneficiaries should be shielded from financial liability if they receive the drug as incident to a physician’s services without notice that it will no longer be covered as such.
This suggested amendment to CMS policy is in accordance with Congress’s intent to protect Medicare beneficiaries from liability for items or services that are not “clearly noncovered.” Drugs or biologicals that Part B has historically covered are not “clearly noncovered services.” The prior coverage of these drugs creates a reasonable expectation that Part B coverage will continue. Changing the coverage status of these drugs without notice to beneficiaries puts them at risk of undue and unfair liability.
The Center also asks CMS to avoid disability discrimination and consider the needs of beneficiaries who cannot self-inject as it formulates its policies regarding SADs.
Thank you for the opportunity to submit these comments. For additional information, please contact David Lipschutz, Associate Director at DLipschutz@medicareadvocacy.org, or Kata Kertesz, Senior Policy Attorney at KKertesz@medicareadvocacy.org, both at (202)293-5760. For additional information about Payment for Caregiver Training Services, please contact Kathy Holt at KHolt@medicareadvocacy.org or (860)456-7790. For additional information concerning Advancing Access to Behavioral Health Services, please contact Kata Kertesz at KKertesz@medicareadvocacy.org at (202)293-5760. For additional information concerning the medically necessary oral health comments, please contact Wey-Wey Kwok at (860)456-7790 or email@example.com. For additional information about Drugs and Biologicals Which Are Not Usually Self-Administered by the Patient, please contact Justin Lalor at firstname.lastname@example.org, or at (860) 456-7790.
David Lipschutz, JD
Associate Director/Senior Policy Attorney
Licensed in CA and CT
 Centers for Medicare & Medicaid Services, “Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality,” 88 Fed. Reg. 28092, 28110 (proposed May 3, 2023).
 Centers for Medicare & Medicaid Services, “Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality,” 88 Fed. Reg. 28092, 28110 (proposed May 3, 2023).
“The Path to Parity: Applying the Parity Act to Medicare to Improve Access to Substance Use Disorder and Mental Health Care,” Legal Action Center (June 23, 2022), https://www.lac.org/assets/files/Path-to-Parity-MAPP-2022.06.14.pdf.
 “Out of Reach: How Gaps in Medicare Coverage of Substance Use Disorder Care Harm Beneficiaries,” Legal Action Center (June 2023), https://www.lac.org/assets/files/MAPP-Stories-2023.06.14-final-1-1.pdf.
“Requirements Related to the Mental Health Parity and Addiction Equity Act,” 88 Fed. Reg. 51552 (Aug. 3, 2023).
 42 U.S.C. § 1861(s)(2)(A) and 1861(s)(2)(B), see also Medicare Benefit Policy Manual, Chapter 15, §50.2.
 See Medicare Benefit Policy Manual, Chapter 15, § 50.2.I (“Advance Beneficiary Notice (ABN) is not required”).
 See Medicare Claims Processing Manual, Chapter 30 § 20.2 (stating that limitation on liability provisions do not apply for “categorical” or “technical” denials, when coverage requirements are not met for a particular item or service, and listing SADs as an example of technical denials); see also Medicare Benefit Policy Manual, Chapter 15 § 50.2.I (stating that SAD denials are “benefit category” denials that do not trigger financial liability protections; advance beneficiary notices are not required and providers may bill the patient for SADs).
 Constitutional sufficiency of the administrative procedures depriving individuals of government benefits for the purposes of due process depends on analysis of the governmental and private interests that are affected. See Mathews v. Eldridge, 424 US 319 (1976). Notice of noncoverage is required in many situations (see, e.g., Medicare Claims Processing Manual Chapter 30 § 20.1.A, listing 20 examples); it would not be burdensome to extend the requirement to this situation. With such a trivial government interest of applying notice of noncoverage provisions to these situations compared to nearly certain (and potentially devastating) financial liability for beneficiaries, the weight clearly balances in favor of the beneficiary’s interests.
 Medicare Benefit Policy Manual, Chapter 15, § 50.2.E.
 See HCFA Ruling 95-1 Sec. III (Dec. 1995). Legislative history suggests that “Congress concluded that there was no need to apply the limitation on liability provision to individuals who had obtained or furnished clearly noncovered services such as those listed in the report” (emphasis added).