evekhm/cms_iom_500 huggingface dataset:
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of-network provider. We explained that this includes enrollees who are new to an MA coordinated care plan having either been enrolled in a different MA plan with the same or different parent organization, or an enrollee in Traditional Medicare and joining an MA coordinated care plan, and beneficiaries new to Medicare and enrolling in an MA coordinated care plan. We explained that under our proposal, during the initial 90 days of an enrollees enrollment with an MA coordinated care plan, the MA coordinated care plan would not be permitted to subject any active course of treatment (as defined at the proposed  422.112(b)(8)(ii)(B)) to additional prior authorization requirements, even if the service is furnished by an out-of- network provider. We explained how we expect any active course of treatment to be documented in the enrollees medical records so that the enrollee, provider, and an MA plan can track an active course of treatment to avoid disputes over the scope of this proposed new requirement. We also explained that we intended that an active course of treatment covered by the proposal could include scheduled procedures regardless of whether there are specific visits or activities leading up to the procedure. We explained that under the proposal, if an enrollee has a procedure or surgery planned for January 31st at the time of enrollment in a new MA coordinated care plan effective January 1st, the new MA coordinated care plan would be required to cover the procedure without subjecting the procedure to prior authorization because it is within the 90-day timeframe. In this example, the planned surgery is a part of an active course of treatment and thus would not be subjected to prior authorization by the MA coordinated care plan in which the beneficiary has newly enrolled under the proposed new  422.112(b)(8)(B). In proposing to limit the way MA coordinated care plans use prior authorization for enrollees undergoing an active course of treatment, CMS seeks to ensure the availability and accessibility of basic benefits, which is consistent with section 1852 of the Act. CMS proposed to use a 90-day transition policy here because it mirrors Part D transition requirements and using the same period will ensure consistency across the MA and Part D programs. In addition, use of one consistent transition period will likely make it easier for new enrollees to understand their transition coverage. We solicited public comment on alternative timeframes for transition periods of ongoing treatment, including the clinical and economic justification
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programs. In addition, use of one consistent transition period will likely make it easier for new enrollees to understand their transition coverage. We solicited public comment on alternative timeframes for transition periods of ongoing treatment, including the clinical and economic justification for alternative proposals. We outlined in the proposed rule CMSs authority to adopt the proposed new requirements for MA coordinated care plans. In addition, we noted and briefly explained how CMS implemented a similar policy regarding coverage during a transition period using CMSs authority to negotiate bids and with a similar explanation in the 2005 final rule (70 FR 4193); CMS has similar negotiation authority in the MA program. As explained in the December 2022 proposed rule, we believe it is appropriate to incorporate a similar beneficiary protection and coverage requirement in the MA program to address the transition for new enrollees. Coordinated care plans are already required to ensure continuity of care and integration of services through arrangements with contracted providers at 422.112(b). Therefore, some MA organizations may already be exercising discretion to eliminate or waive prior authorization for enrollees undergoing an active course of treatment. However, prior to our proposed rule, CMS received anecdotal feedback from stakeholders that care transitions can be difficult for enrollees due to MA plan processes that require new coverage decisions when an enrollee transitions from one MA plan to another. We are not aware of the extent to which current MA plans are already ensuring continuity of care in the way our proposals would require, nor do we have a strong basis upon which to quantify how often this type of transition occurs. Therefore, we solicited stakeholder input on both of these assumptions: that some MA plans are providing continuity of care, as defined in the proposed  422.112(b)(8) today and the lack of available data by which to quantify it. In summary, CMS proposed to add new continuity of care requirements to  422.112(b)(8), to require that approval of a prior authorization be valid for the entire duration of the approved course of treatment, and that plans provide a minimum 90-day transition period when an enrollee who is currently undergoing an active course of treatment switches to a new MA plan. We thank commenters for their input on CMSs proposed new MA continuity of care requirements. We received the following comments on this proposal, and our response follows: Comment: A majority of commenters expressed support
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switches to a new MA plan. We thank commenters for their input on CMSs proposed new MA continuity of care requirements. We received the following comments on this proposal, and our response follows: Comment: A majority of commenters expressed support for the proposal to require that any plan approval of a prior authorization request from a provider on behalf of an enrollee, or from an enrollee directly, for a course of treatment be valid for the entire duration of the approved course of treatment. Supporters cited that MA plans often approve treatments in increments that may not be clinically supported or medically appropriate, which can be disruptive to care. Other commenters requested clarification as to whether a plan is required to approve the exact course of treatment included in the original coverage request, or whether an MA plan may approve a course of treatment that differs from what was ordered or prescribed by the provider. Several commenters requested that CMS give deference to providers VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00088 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222207 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations when establishing a course of treatment. Several other commenters expressed concern that requiring a prior authorization be valid for an entire duration of the approved course of treatment is overly broad, and could lead to the continuation of treatments that are no longer medically necessary. Several commenters stated that the requirement conflicts with MA plans obligations to ensure access to medically necessary care, and impedes MA plans ability to manage care through strategies that ensure quality and control unnecessary cost. Some commenters suggested that there are situations where a prior authorization and plan of care should be revisited, and the course of treatment be revised, if the patient is not responding as expected. Some commenters suggested that CMS allow limitations on the duration of approvals to ensure there are opportunities to reassess medical necessity at reasonable intervals. One commenter suggested that CMS modify the proposal to allow limits on the duration of the prior authorization that are consistent with guideline- suggested reassessment of disease, in cases where treatments may be indefinite (for example, in cases of chronic
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One commenter suggested that CMS modify the proposal to allow limits on the duration of the prior authorization that are consistent with guideline- suggested reassessment of disease, in cases where treatments may be indefinite (for example, in cases of chronic illnesses). Another commenter suggested that the definition of active course of treatment should be aligned with industry standards, specifically: (1) a course of treatment for a serious and complex condition, which includes a condition that is serious enough to require specialized medical treatment to avoid the reasonable possibility of death or permanent harm, or a condition that is life threatening, potentially disabling, degenerative, or congenital, and requires specialized medical care over a prolonged period of time; (2) course of institutional or inpatient care; (3) scheduled nonelective surgery, including related postoperative care; (4) a course of treatment for a pregnancy; and (5) treatment for a terminal illness. Several commenters requested clarification as to whether there 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
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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
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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
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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
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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
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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