2023-07115.pdf

are a minimum number of days that constitute a course of treatment. Another commenter requested that CMS explicitly define course of treatment in reference to Traditional Medicare coverage and benefits benchmarks (for example, the mean Length of Stay for a given Medicare Severity Diagnosis Related Group). Finally, one commenter requested additional examples of what is and is not permissible to ensure treatments that are not medically necessary under Traditional Medicare guidelines are not required to be covered under this policy. Response: CMS would like to thank all commenters for providing feedback on the proposed regulation. We understand the concerns that the proposal could result in the continuation of medically unnecessary care, which in turn could result in waste and increased costs. However, as highlighted in the preamble, over the past several years, we have received feedback from many stakeholders, including enrollees and providers, that MA plans often require repetitive prior approvals for needed services, even when enrollees have a previously- approved course of treatment, plan of care, or are receiving ongoing treatments for a chronic condition. The feedback we have received consistently outlines how this practice delays medically necessary care and can cause gaps in care delivery that threaten an enrollees health, sometimes leading to negative outcomes. For that reason, we believe this proposal is essential to minimize such delays and disruptions to care for MA enrollees. We agree that clarification of the policy being finalized will help ensure the new regulation is implemented appropriately. Therefore, we are finalizing the revisions at  422.112(8)(i)(A) with modifications from the proposed rule, to require that an approval of a prior authorization request for a course of treatment must be valid for as long as medically necessary to avoid disruptions in care, in accordance with applicable coverage criteria, the patients medical history (for example, diagnoses, conditions, functional status), and the treating providers recommendation. The determination of medical necessity to establish the duration of the approved course of treatment must be made consistent with  422.101(c); any adverse determination on medical necessity, such as approval of a duration that this less than the requested duration for the course of treatment, must be reviewed in accordance with  422.566(d) (and  422.629(k) for an applicable integrated plan) before an MA plan may issue the determination. Further, the coverage policies governing these determinations must also comply with  422.101(b). This will ensure that services delivered during the approved and previously authorized course of treatment remain consistent with Medicare coverage guidelines, are reasonable and necessary for the individual enrollee, and do not overly burden the provider with unnecessary and repeated prior authorization requests. CMS is not requiring a minimum or maximum number of days for a course of treatment, since the necessary scope and duration of a course of treatment can vary widely from enrollee to enrollee and should be based upon the individuals needs and medical necessity. We believe flexibility is necessary to accommodate the varying complexities of a multitude of conditions for which an enrollee may be receiving care, and recognize that many treatment courses last for varying periods of time and may require varying amounts of interventions that are unique to the individual being treated. In response to comments expressing concern over the potential for treatment continuing indefinitely or recommending that treatments should be revisited at certain intervals, we believe that in many cases additional evaluation of the patient to ensure ongoing medical necessity and efficacy of treatment at certain intervals will be required or recommended and supported by the relevant coverage criteria, or by the patients medical needs and the treating providers recommendation. Under this final rule, all decisions for prior authorization, including those involving the authorization of treatment that lasts over a period of time, must be made in accordance with  422.138. This means that prior authorization may only be used to confirm the presence of a diagnosis or other medical criteria that are the basis for coverage or to ensure an item or service is medically necessary based on standards specified in  422.101(c)(1). In order for an approval of a prior authorization request for a course of treatment to last indefinitely, it would have to be medically necessary and supported by the applicable coverage criteria, and the patients medical condition and providers recommendation. Therefore, we believe it would be uncommon that a MA organization would be required to approve a request for a treatment indefinitely. Additionally, where prior authorization is used by fee-for-service Medicare, the use of prior authorization by the MA organization on the same services must apply the fee-for-service Medicare standards based on  422.101(b)(2). Further, pursuant to  422.138(c), if the MA organization approved the furnishing of a covered item or service through a prior authorization or pre-service determination of coverage or payment, it may not deny coverage later on the basis of lack of medical necessity unless the MA organization has the authority to reopen the decision for good cause or fraud or similar fault per the reopening provisions at  422.616. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00089 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222208 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 115https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?NCDId=223&ncdver=2. An MA plan may approve and authorize treatment for a different period of time than the treating providers ordered course of treatment if the plan has determined that what was ordered or prescribed by the treating provider was not medically necessary or appropriate based on the enrollees condition or diagnosis. The following example illustrates how this modification will work in practice: The patient is a type 1 diabetic. The treating provider orders a course of treatment that consists of continuous subcutaneous insulin infusions for a period of 3 months. The treatment is subject to prior authorization. In order to apply prior authorization, the MA plan must follow the requirements of  422.101(b), and apply any applicable coverage criteria for the service. The applicable NCD115for infusion pumps requires that continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating physician at least every 3 months. Additionally, the patients medical history does not indicate a need for more frequent evaluations. Here, it would be appropriate, under our proposal, for the MA plan to issue a prior authorization approval of the service for a period of 3 months because the NCD requires that the patient be evaluated at least every 3 months, and the treating provider ordered the course of treatment for 3 months. If the patients medical history and the treating provider suggests possible complications in treatment, it may be appropriate for the MA plan to authorize approval of the service for a period of less than 3 months. However, MA plans should not shorten authorization periods that are outlined in Traditional Medicare coverage criteria. The only instances where an MA plan may use a shorter (or different) periodicity or frequency of evaluation or other such review would be if the change were consistent with the relevant coverage criteria, and supported by the evidence in the patients medical record, and by treatment guidelines or clinical literature that is widely available. This must be clearly documented and referenced by the MA plan in the prior authorization decision. Moreover, in all instances, we expect the MA plan and its contracted provider to coordinate care to ensure that the prior authorization is approved for a period that ensures that care is delivered for as long as is medically necessary and that minimizes disruptions in care for the enrollee. In other words, the MA plan may not establish blanket rules for the duration of an authorization associated with course of treatment decisions for purposes of convenience or simplicity; the duration of a prior authorization must be valid for as long as medically necessary to avoid disruptions in care and not in conflict with applicable coverage criteria. Comment: A few commenters stated that care should not be based solely on a physicians order, but include other provider types when appropriate. Response: As outlined in the preamble and proposed regulatory text, a course of treatment is a prescribed or ordered course of treatment for a specific individual with a specific condition that is outlined and decided upon ahead of time with the patient and the treating provider. The term provider is defined in  422.2 to mean an individual who is engaged in the delivery of health care services in a State and is licensed or certified by the State to engage in that activity in the State and an entity that is engaged in the delivery of health care services in a State and is licensed or certified to deliver those services if such licensing or certification is required by State law or regulation. This definition is not limited to physicians. Therefore, the definition of course of treatment we proposed and are finalizing at  422.112(b)(8)(ii)(A) includes courses of treatment ordered by non-physician health care providers. Comment: Several commenters requested clarification regarding whether and how the continuity of care provisions apply specifically to Part B drugs, and how the entire prescribed or ordered course of treatment would be determined where a drug may be used indefinitely. One commenter requested clarification that the continuity of care proposal include all new enrollees who are actively receiving physician- administered drugs that are covered under Medicare Part B, not just existing enrollees. Response: As discussed in the preamble, these provisions apply two new requirements for the use of prior authorization by MA coordinated care plans for covered Part A and B services (that is, basic benefits as defined in  422.100(c)). This includes relevant Part B drugs. In order to provide additional guidance and clarity, we are finalizing  422.112(b)(8)(i) with changes from the proposal to ensure that enrollees do not have disruptions in care due to additional prior authorization requirements; these changes from the proposal are in response to comments. We are finalizing  422.112(b)(8)(i)(A) to require that an approval of a prior authorization request for a course of treatment be valid for as long as medically necessary to avoid disruptions in care, in accordance with applicable coverage criteria, the patients medical history, and the treating providers recommendation. In cases where a drug being used indefinitely is medically necessary and consistent with the relevant coverage criteria, the patients medical history and the providers recommendation, we encourage MA coordinated care plans to work with the provider to assess continued efficacy and medical necessity as is reasonable; this type of coordination is consistent with how  422.112(b) requires MA organizations offering these plans to have arrangements (which meet the minimum requirements in paraphs (b)(1) through (b)(8)) to ensure continuity of care and integration of services. In response to the comments, we clarify that the transition period required by  422.112(b)(8)(i)(B), as proposed and finalized, applies, beginning with coverage January 1, 2024, to all new enrollees who are undergoing an active course of treatmentincluding where the active course of treatment is taking a physician-administered drug covered under Part B. An MA organization must not disrupt or require reauthorization for an active course of treatment for new plan enrollees for a period of at least 90 days. Comment: Several commenters requested that CMS clarify whether a course of treatment includes inpatient services, skilled nursing facilities (SNF), home health care (HHC), and other post- acute care. One commenter suggested that the regulatory text be amended at 422.112(b)(8)(ii)(B) so that continuity of care applies where an active course of treatment includes transfer of a patient to another inpatient provider. Response: We clarify here that an active course of treatment may include situations when a patient is transferred from an acute inpatient setting to a SNF, HHC, and care in other post-acute care settings. However, this new regulation does not change or affect how section 1853(g) of the Act and  422.318 assign financial responsibility for inpatient services from one of the facilities listed in  422.318(a) (a subsection (d) hospital as defined in section 1886(d)(1)(B) of the Act, a psychiatric hospital described in section 1886(d)(1)(B)(i) of the Act, a rehabilitation hospital described in section 1886(d)(1)(B)(ii) of the Act, a distinct part rehabilitation unit VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00090 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222209 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations described in the matter following clause (v) of section 1886(d)(1)(B) of the Act, or a long-term care hospital (described in section 1886(d)(1)(B)(iv)) that begin before, and carry over to, the effective date of enrollment in a new MA plan. Under section 1853(g) and  422.318, when MA plan coverage begins during an inpatient stay, the previous MA plan or Traditional Medicare if the enrollee is joining an MA plan from Traditional Medicare is responsible for payment. CMS reminds commenters that all other relevant Traditional Medicare regulations must also be followed, including those regarding inpatient admissions and terminations. Comment: One commenter requested that, in addition to ensuring that prior authorizations remain active for a patients entire course of treatment, CMS adopt language to ensure that surgical or other procedures/services performed incident to a procedure that has received prior approval may not be denied for failure to obtain prior approval. Response: We thank the commenter for the suggestion, but decline to explicitly prohibit an MA plans from denying coverage of a service provided incident to a course of treatment but not expressly included in the approved course of treatment, because of a failure to obtain prior approval. In the case where a service is provided