Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health, 5529-5567 [2016-01585]
Agencies
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)] [Rules and Regulations] [Pages 5529-5567] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2016-01585] [[Page 5529]] Vol. 81 Tuesday, No. 21 February 2, 2016 Part II Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- 42 CFR Part 440 Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health; Final Rule Federal Register / Vol. 81 , No. 21 / Tuesday, February 2, 2016 / Rules and Regulations [[Page 5530]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 440 [CMS-2348-F] RIN 0938-AQ36 Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to- face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit. DATES: Effective date: This rule is effective on July 1, 2016. Compliance date: Based on public comments, we recognize that there may be operational and budgetary implications with this rule and that states and providers may need time to implement this provision. To ensure that states and providers are implementing the rule appropriately, we are delaying compliance with this rule for up to one year if legislature has met in that year, otherwise 2 years. Exception for State Legislation.--In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), which the Secretary determines requires state legislation in order for the respective plan to meet one or more additional requirements imposed by this rule, the respective state shall not be regarded as failing to comply with the requirements of this rule solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the state legislature that begins after the date of enactment of this rule. For purposes of the previous sentence, in the case of a state that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the state legislature. States will be expected to be in compliance by July 1, 2017 or July 1, 2018 based on legislative timeframes as described above. FOR FURTHER INFORMATION CONTACT: Ali Smilow, (410) 786-0790. SUPPLEMENTARY INFORMATION: I. Executive Summary and Background A. Executive Summary 1. Purpose This final rule implements section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) (Pub. L. 111- 148), which adds the requirement that physicians document the occurrence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes when ordering home health services. More specifically, section 6407(b) of the Affordable Care Act applies to Medicaid face-to- face encounter requirements set forth in the Medicare statute. Additionally, on April 16, 2015, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), became law. Section 504 of this law amended the underlying Medicare requirements at section 1834(a)(11)(B)(ii) of the Social Security Act (the Act) to allow certain authorized non-physician practitioners (NPP) to document the face-to-face encounter. This final rule adopts in large part the provisions proposed in the proposed rule issued on July 12, 2011 (76 FR 41032), but includes conforming changes to the provisions of the proposed rule to reflect the revisions made by MACRA to the underlying Medicare face-to-face encounter requirements. In addition, this final rule clarifies that Medicaid home health services and items are not limited to home settings, and makes additional changes to the requirements for coverage of medical supplies, equipment and appliances under the home health benefit. 2. Summary of the Major Provisions The final rule requires that for the initial ordering of home health services, the physician must document that a face-to-face encounter that is related to the primary reason the beneficiary requires home health services occurred no more than 90 days before or 30 days after the start of services. The final rule requires that for the initial ordering of certain medical equipment, the physician or authorized NPP must document that a face-to-face encounter that is related to the primary reason the beneficiary requires medical equipment occurred no more than 6 months prior to the start of services. The face-to-face encounter for home health and medical equipment may be performed by the physician or certain authorized NPPs. The final rule maintains the role of the physician in ordering Medicaid home health services and medical equipment. The rule also codifies current Medicaid policies for coverage of home health services, including clarifying in the definition of medical supplies, equipment, and appliances that items must be suitable for use in any setting in which normal life activities take place, other than a hospital; nursing facility, intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board. Additionally, the rule defines home health supplies, equipment, and appliances, to better align with the Medicare program's definition of durable medical equipment (DME) at Sec. 414.202. The rule codifies the policies set forth in September 4, 1998 guidance, about the use of lists or other presumptions in determining coverage of items under the home health benefit for medical equipment, including the following three points: (1) States may have a list of preapproved medical equipment, supplies and appliances for administrative ease, but not as an absolute limit on coverage; (2) States must provide and make available to individuals a reasonable and meaningful procedure for beneficiaries to request medical equipment, supplies or appliances not on the list based on a showing of medical necessity; and (3) Individuals must be informed of their [[Page 5531]] right to a fair hearing to appeal an adverse action. Additionally, the rule clarifies our interpretation that the Medicaid statute does not permit absolute exclusions of coverage as medical equipment, supplies, or appliances. These clarifications reflect the principles embodied in the holdings of the Skubel v. Fuoroli, 113 F.3d 330 (2d. Cir. 1997) and Detsel v. Sullivan, 895 F.2d 58 (2d Cir.1990) decisions into the requirements for the provision of home health services by clarifying that Medicaid home health services may not be limited to services furnished in the home and revising the current regulatory language to specify that home health services may be provided, as appropriate, in any setting in which normal life activities take place, other than a hospital, nursing facility; intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board. 3--Summary of Costs and Benefits ------------------------------------------------------------------------ Provision description Total costs Total benefits ------------------------------------------------------------------------ Physician and certain non- Although this The overall benefit physician practitioners provision applies of this rule is the (NPP) for DME documentation to Medicaid in the expected increase of face-to-face encounter same manner and to in program with the Medicaid eligible the same extent as integrity resulting beneficiary within the Medicare in more quality reasonable timeframes when program, no home health ordering home health estimates (costs or services for services. savings) were noted Medicaid for the Medicaid beneficiaries. program as data to Additionally, this determine these rule will estimates is potentially serve unavailable. For to provide Medicare, the individuals with overall economic disabilities a impact of this greater ability to provision is an engage in normal estimated $920 activities of daily million in savings living. to the Medicare program from 2010- 2014 and $2.29 billion in savings from 2010-2019. ------------------------------------------------------------------------ B. Background Title XIX of the Act requires that, to receive federal Medicaid matching funds, a state must offer certain basic services to the categorically needy populations specified in the Act. Home health care is a mandatory services for Medicaid-eligible individuals who are entitled to nursing facility services, which includes the basic categorically needy populations who receive the standard Medicaid benefit package, and can also include medically needy populations if nursing facility services are offered to the medically needy within a state. Home health services include nursing services, home health aide services, medical supplies, equipment, and appliances, and may include therapy services (physical therapy, occupational therapy, speech pathology and audiology services). For a state to receive federal Medicaid matching payments for such services, current Medicaid regulations require a beneficiary's physician to order home health services as part of a written plan of care reviewed every 60 days. At section 6407 of the Affordable Care Act, new Medicare requirements were set forth for face-to-face encounters to support claims for home health services, and for DME, which were also made applicable to Medicaid. Specifically, sections 1814(a)(2)(C) of the Act under Part A of the Medicare program, and section 1835(a)(2)(A) of the Act under Part B of the Medicare program were amended to require that the physician, or certain allowed NPPs, document a face to-face encounter with the individual (including through the use of telehealth, subject to the requirements in section 1834(m) of the Act), before making a certification that home health services are required under the Medicare home health benefit. Section 1814(a)(2)(C) of the Act indicates that in addition to a physician, a nurse practitioner (NP) or clinical nurse specialist (CNS) (as those terms are defined in section 1861(aa)(5) of the Act) who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a physician assistant (PA) (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician, may conduct the face-to- face encounters before the start of home health services. Section 6407 of the Affordable Care Act also amended section 1834(a)(11)(B) of the Act to require that physician orders for DME must be supported by documentation by the physician of a similar face-to- face encounter with a physician or specified NPPs. The NPPs authorized to conduct a face-to-face encounter on behalf of a physician are the same for DME as for home health services, except that certified nurse- midwives are not included. The timing of the face-to-face encounter for either home health or DME is specified as being within the 6-month period preceding the written order for DME, or other reasonable timeframe specified by the Secretary. Section 6407(d) of the Affordable Care Act, provides that the requirements for face-to-face encounters in the provisions described above shall apply in the case of physicians making certifications for home health services under title XIX of the Act in the same manner and to the same extent as such requirements apply in the case of physicians making such certifications under title XVIII of such Act. The purpose of this regulation is to implement this statutory directive in the Medicaid program. II. Summary of Provisions of the Proposed Rule 1. New Home Health Face-to-Face Requirements In the proposed rule, we sought to implement the face-to-face requirements of section 6407 of the Affordable Care Act in a manner consistent with existing Medicaid requirements and practices. For example, in implementing the face-to-face encounter requirements of section 6407 of the Affordable Care Act with respect to home health services generally, we took into consideration the longstanding regulatory requirements under Sec. 440.70 that provide that a physician must order an individual's services under the Medicaid home health benefit. We read the term ``order'' to be synonymous with the Medicare term ``certify.'' For purposes of this rule, we used the term ``order'' in place of the Affordable Care Act's use of ``certify.'' We did not view implementation of section 6407 of the Affordable Care Act as supplanting these existing Medicaid regulatory requirements related to physician orders; the new face-to-face process is consistent with those requirements. We proposed amending the Medicaid regulations at Sec. 440.70 to incorporate both the general home health and the medical equipment face-to-face requirements. Because DME is [[Page 5532]] not a term used in Medicaid in the same manner as in Medicare, we proposed to use the Medicaid term ``medical supplies, equipment, and appliances'' or the shortened version ``medical equipment.'' Additionally, we proposed that the face-to-face encounter can be performed through the use of telehealth, which is described in more detail in section I. of this final rule. As previously indicated, we proposed that for home health services, the face-to-face encounter occurred no more than 90 days before or 30 days after the start of services. To align with Medicare timing requirements at Sec. 424.22(a)(1)(v), we revised the timeframes for medical equipment and the final rule requires that for the initial ordering of medical equipment, the physician must document that a face- to-face encounter that is related to the primary reason the beneficiary requires medical equipment occurred no more than 6 months prior to the start of services. These timeframes are applicable to face-to-face encounters performed through telehealth. 2. Specification of Non-Physician Practitioners (NPPs) Authorized To Perform Face-to-Face Encounters Under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act, face-to- face encounters for home health services may be conducted by a NP or CNS (as those terms are defined in section 1861(aa)(5) of the Act) who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a PA (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician. A similar definition of NPPs applies for DME under section 1834(a)(11)(B) of the Act, with one exception: Certified nurse-midwives are not included in the list of NPPs. 3. Other Medicaid Home Health Policy Changes a. Codification That Home Health Services Cannot Be Restricted to Individuals Who Are Homebound or to Services Furnished Solely in the Home We proposed that home health services may not be subject to a requirement that the individual be ``homebound.'' In addition, we proposed that home health services cannot otherwise be restricted to services furnished in the home itself. These policies reflect longstanding CMS interpretations of the scope of the home health policy and were discussed in a July 25, 2000 letter to State Medicaid Directors, Olmstead Update No. 3 setting forth federal interpretations of applicable law relevant to state efforts to comply with the requirements of the Americans with Disabilities Act (ADA) in light of the Supreme Court decision in Olmstead v. L.C., 527 U.S. 581 (1999). In Attachment 3-g to that letter, we set forth our interpretation that a requirement that home health recipients be homebound was inconsistent with the mandatory nature of the home health benefit, and the longstanding regulatory provisions at 42 CFR 440.230 and 440.240. These regulatory provisions provide that mandatory benefits must be sufficient in amount, duration and scope to reasonably achieve their purpose, may not be arbitrarily denied or reduced in scope based on diagnosis, type of illness, or condition, and that the same amount, duration and scope must be available to any individual within the group of categorically needy individuals and within any group of medically needy individuals. We also proposed that Medicaid home health services may not be limited to services furnished in the home. This policy reflects the principles set forth in prior court cases on whether home health services and private duty nursing can be limited to services furnished in the home. In Skubel v. Fuoroli, 113 F.3d 330 (2d. Cir. 1997) the court found that the Medicaid statute did not address the site of care for the mandatory home health benefit. The court found that the state could not limit coverage of home health services to those provided at the individual's residence. Previously, in 1990, the Second Circuit had applied similar principles to invalidate a regulation that limited the provision of private duty nursing services to an individual's residence. The case, Detsel v. Sullivan, 895 F.2d 58 (2d Cir. 1990), involved children suffering from severe medical conditions. Following the Detsel case, CMS, then the Health Care Financing Administration, adopted the court's standard and issued nationwide guidance eliminating the at-home restriction on private duty nursing. To date, we have not issued similar guidance requiring nationwide adoption of the Skubel ruling. b. Clarification of the Definition of Medical Supplies, Equipment, and Appliances An important component of the Medicaid home health benefit is coverage of medical supplies, equipment, and appliances, under Sec. 440.70(b)(3). The current regulation does not further define the terms, except to indicate that the items should be suitable for use in the home. Although CMS has read this phrase to refer only to the type of items included in the benefit (excluding those types of items that are only furnished in institutional or provider settings), it has been susceptible to reading as a prohibition on use of covered items outside the home. We proposed revisions to this section to clarify that it is not a limitation on the location in which items are used, but rather refers to items that are necessary for everyday activities and not specialized for an institutional setting. Thus, we proposed to indicate that the items must be suitable for use in any non-institutional setting in which normal life activities take place. This would clarify that although states may continue to establish medical necessity criteria to determine the authorization of the items, states may not deny requests for the items based on the grounds that they are for use outside of the home. Current Medicaid regulations do not contain any specific definition of medical supplies, equipment, and appliances under the home health benefit, other than the language discussed in the prior paragraph. States have adopted reasonable definitions of those terms, for example, based on the Medicare definition. But in the absence of a generally applicable definition of the term, there has been confusion as to the proper scope of the benefit. We believe that greater alignment of the definitions of home health medical supplies, equipment and appliances with the Medicare definition of DME will help to streamline beneficiaries' access to receive needed items and provide clear and consistent guidance to states to ensure the use of the appropriate benefit category. Therefore, we proposed to define home health supplies, equipment, and appliances, to better align with the Medicare program's definition of DME at Sec. 414.202, as items that are primarily and customarily used to serve a medical purpose, generally not useful to an individual in the absence of an illness or injury, can withstand repeated use, and can be reusable or removable. Unlike Medicare, however, we did not propose to define the expected life of a piece of equipment and did not propose to limit equipment to items used in the home. We also proposed to define supplies as health care related items that are consumable or disposable, or cannot withstand repeated use by more than one individual, based loosely on Medicare principles, but we did not propose to require that supplies be incidental to other covered services. The proposed standard definitions were intended to ensure that such items [[Page 5533]] will be available to all who are entitled to the mandatory home health benefit, and not restricted to individuals receiving targeted benefits through section 1915(c) home and community-based services (HCBS) waivers or the section 1915(i) HCBS state plan option. Items that meet the criteria for coverage under the home health benefit would be covered as such. c. Other Issues In the proposed rule, we noted that we were considering whether other clarifications to the home health regulations were warranted. In particular, we invited comments on whether it would be useful to include language to reflect the policies set forth in a September 4, 1998 letter to State Medicaid Directors, responding in part to a Second Circuit decision in DeSario v. Thomas, 139 F. 3d 80 (1998), about the use of lists or other presumptions in determining coverage of items under the home health benefit for medical equipment. In that letter, we indicated our interpretation of the mandatory coverage provisions to mean that a state could use such lists or presumptions as an administrative convenience but not as an absolute coverage limitation, and must provide individuals the opportunity to rebut the list or presumption using a process that employs reasonable and specific criteria to assess coverage for an item based on individual medical needs. In addition, in the May 5, 2010 Federal Register (75 FR 24437), we issued the ``Medicare and Medicaid Programs: Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements'' interim final rule which was effective on July 6, 2010. Although we did not incorporate changes in the proposed rule to the scope of providers that may order medical supplies, equipment, and appliances in the Medicaid program, as section 6405(a) of the Affordable Care Act was not applicable to Title XIX of the Act, we specifically solicited comments through this rule on the merits of doing so. We will address comments received below. III. Analysis of and Responses to Public Comments We received a total of 94 timely items of correspondence from home health provider representatives and other professional associations, State Medicaid Directors, states, beneficiaries, and other individuals. Comments ranged from general support or opposition to the proposed rule, to specific questions and detailed comments and recommendations regarding the proposed changes. A summary of the public comments and our responses are set forth below. A. General Comment: Some commenters expressed general support for the rule. One commenter supported CMS' goal of promoting accountability and program integrity. Other commenters supported the efforts of the Department to move toward consistency between the Medicare and Medicaid programs and ensure that home health services are delivered in accordance with sound clinical guidelines and recommendations. Response: We appreciate the commenters' support. Comment: Many commenters recommended that CMS specify that Medicaid home health services cannot be contingent upon a beneficiary needing skilled nursing care or therapy. Other commenters suggested revising Sec. 441.15(c) to specify that Medicaid home health services cannot be contingent upon the beneficiary needing skilled nursing care or therapy. Response: We have revised Sec. 440.70(b) to clarify that coverage of Medicaid home health services cannot be contingent upon the beneficiary needing nursing or therapy services. We do not believe it is an accurate reading of section 1902(a)(10)(D) or the Act, or Sec. 441.15 to impose such a requirement; the language of those provisions requires that the state provide the home health benefit to individuals whose benefit package includes nursing facility services, but does not require that the individual actually need such services. While it is beyond the scope of this rule to clarify and revise Sec. 441.15(b), the clarification in Sec. 440.70(b) will inform the reading of Sec. 441.15(b). Comment: Many commenters proposed that CMS amend Sec. 440.230, which governs amount, duration, and scope to include language that reflects the policies set forth in the 1998 State Medicaid Director's letter related to the Desario case. Response: We agree with commenters that the principles set forth in that letter should be incorporated into Medicaid regulations, although we disagree that these principles should be incorporated into Sec. 440.230 as opposed to the Medicaid home health regulation at Sec. 440.70. Accordingly, we are revising Sec. 440.70 to include the three points made in that letter: (1) States may have a list of preapproved medical equipment, supplies, and appliances for administrative ease but not as an absolute limit; (2) States must provide and make available to individuals a reasonable and meaningful procedure for individuals to request items not on the list; and (3) Individuals are informed of their right to a fair hearing. Comment: Several commenters requested that CMS specify that states cannot require a 60-day plan of care for medical supplies, equipment and appliances. The commenters also requested that CMS specify that states may not impose additional state restrictions that are not part of the federal requirements for supplies, equipment, and appliances such as requiring that they be limited to services for temporary recovery from specific incidents, be limited to non-routine supplies necessary for the delivery of a participant's nursing care and described in the plan of care, or any other state requirement that is not a federal requirement for receiving equipment and supplies. Response: As stated in the existing provisions of Sec. 440.70(a)(2), home health services are required to be provided to a beneficiary on his or her physician's orders as part of a written plan of care that the physician reviews every 60 days, except as specified in paragraph (b)(3). That exception states that a beneficiary's need for medical supplies, equipment, and appliances need only be reviewed on an annual basis, with more frequent review to be determined on a case-by-case basis based on the nature of the item prescribed. It would be inappropriate for states to require additional review of medical equipment, supplies, and appliances except where indicated on a case- by-case basis (for example, for supplies that are needed on a short term basis). Additionally, states may place limits on the amount and duration of medical equipment, supplies and appliances, but the limits must meet sufficiency requirements set forth at Sec. 440.230. And, as with all Medicaid services, states are not required to cover medically unnecessary services, and have the discretion to develop medical necessity criteria, but these must be based on accepted medical practices and standards. Comment: Some commenters suggested that CMS apply the proposed prohibition on applying a ``homebound'' limitation to all Medicaid home care related program benefits, with one commenter suggesting that CMS audit state Medicaid programs for noncompliance with the homebound prohibition rule. That commenter stated that CMS should specifically review whether those state programs that [[Page 5534]] utilize a medical necessity standard as proxy for homebound. Response: It is beyond the scope of this regulation to revise the requirements or definitions applicable to services other than home health care services. We are prohibiting the application of a homebound requirement for Medicaid home health because we have concluded that the resulting benefit would be insufficient to meet the needs of the population, and would not achieve the purposes of the mandatory benefit. We appreciate the commenters' suggestion and will take under advisement as part of our overall compliance strategy. We are revising Sec. 440.70(c)(1) to codify the homebound prohibition for Medicaid home health services. Comment: One commenter requested that CMS pursue the expansion of the Medicaid provision of home health services to meet the needs of our elderly citizens. Response: Medicaid enrollees, regardless of their eligibility category, are not required to be homebound to qualify for home health benefits. Therefore, the clarification of the definition of medical equipment and supplies, and the requirement that home health services cannot be restricted to the home helps support the ability of Medicaid to best meet the needs of all eligible individuals, including the elderly. Comment: One commenter believed that models for health care homes that compensate medical practices for complex care of chronically ill Medicaid beneficiaries should be promoted. Response: We agree with the commenter. We have provided states with guidance and technical assistance on many initiatives that promote better care for the beneficiaries with chronic illness, including disease management strategies, health homes, and primary care case management systems. In 2014, we established the Medicaid Innovation Accelerator Program to support and focus resources on such models. More information can be found on our Web site at https://www.medicaid.gov/state-resource-center/innovation-accelerator-program/innovation-accelerator-program.html. Related guidance is also found on our Web site at https://www.medicaid.gov/state-resource-center/innovation-accelerator-program/related-tools-and-guidance/related-tools-and-guidance.html. Such models are beyond the scope of this regulation but we intend to continue our efforts to provide technical assistance and guidance on these models. Comment: One commenter recommended that states be required to cover certification of home health care (at least initial certification) and ongoing care plan oversight as a medical benefit for Medicaid beneficiaries and to compensate physicians consistent with Relative Value Units for such work. Response: Physician certification of the need for home health care could be covered by the state as a physician service or could be covered as a component part of home health care services. States have substantial flexibility to design payment methodologies for covered services. These payment methodologies can be tailored to the service delivery system in each state. Comment: One commenter indicated that the rule should note that states must develop a strategy to educate physicians about the extension of the face-to-face requirement to Medicaid. Response: We recognize the importance of education and expect states to educate the physician community on the new requirements implemented through the Affordable Care Act. We disagree that this administrative activity should be included as a requirement in the regulation. It is implicit with any regulation change to a benefit or to provider responsibilities that states educate impacted providers and beneficiaries about the new requirements. Comment: One commenter endorsed adding the phrase ``medically necessary'' to Sec. 440.70(b), to read as ``Home health services include the following medically necessary services and items.'' Response: We agree that states may limit covered services to only include medically necessary services. This flexibility is already provided in regulation at Sec. 440.230(d). Medical necessity is not determined by us, but is determined by medical professionals. Many states employ medical professionals to establish medical necessity criteria and then review individual circumstances in light of those criteria. The phrase suggested by the commenter suggests that we would review medical necessity determinations. We do not intend to do so, and thus we are not accepting the suggestion. Comment: One commenter indicated that there are no Current Procedural Terminology (CPT) or International Classification of Diseases (ICD) codes that specifically represent an evaluation for home health services; therefore, another model of demonstrating that a face- to-face encounter took place is needed. Response: The face-to-face encounter can be demonstrated through the pre-existing ``evaluation and management'' codes. Comment: One commenter expressed concern about how this provision will be implemented for those that are dually eligible for Medicare and Medicaid. Another commenter urged CMS to consider regulatory waivers, demonstrations or other initiatives to consolidate services for a dual eligible into a separate program for those beneficiaries with proportional funding from the existing federal and state programs. The commenter also indicated that CMS should undertake a significant education and outreach campaign to reach state officials, physicians, hospitals, home health providers, and organizations representing beneficiaries. The focus of the campaign would include Medicaid face- to-face requirements, and important similarities and differences with the Medicare face-to-face requirements. Response: To the maximum extent possible, we have intentionally aligned the Medicaid rule with the Medicare requirements to reduce disparities in care and coverage for individuals who are eligible for both programs and to make it easier for providers to understand and implement the applicable rules. Currently, we are working on and publicizing a number of initiatives that speak directly to dual eligibles, increasing their continuity of care, and addressing ways in which Medicaid and Medicare rules might be better aligned. Such initiatives are out of the scope of this rule. Comment: One commenter requested that CMS clarify or amend the definition of home health services such that this rule would not be applicable to non-medical services such as personal care attendant services. Response: Personal care services are separately defined at Sec. 440.167. We recognize the potential overlap between personal care services and home health aide services authorized under Sec. 440.70. However, we disagree with the commenter's suggestion that this rule should not be applicable to services qualifying as home health aide services. Comment: One commenter requested that CMS provide a significant amount of time before making effective, or enforcing, the final rule so that the state may prepare an accurate budget with sufficient funds for implementation and compliance. Response: The requirements of section 6407 of the Affordable Care Act were effective upon enactment, and applied for home health services certified after January 1, 2010, as [[Page 5535]] specified in the Affordable Care Act and CMCS Informational Bulletin dated July 13, 2011; https://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-7-13-11.pdf. However, we will be delaying compliance for up to one year from the effective date of the rule if the state's legislature has met in that year, otherwise 2 years. Our expectation is that states and providers are compliant with the requirements of the final rule within the timeframes explained above. We intend to work collaboratively with states to ensure compliance with these requirements within a reasonable timeframe. Comment: One commenter recommended that more productive emphasis be placed on training physicians in the home health assessment process so that physicians are held accountable for ordering appropriate services. The commenter also recommended that a process be put into place to audit home health services, and if a home health agency is abusing the system by providing questionable services, then a heightened authorization system be put into place for those identified high-risk agencies. Response: As previously stated, it is implicit with any regulation change to a benefit that states inform impacted providers of new requirements and procedures. In response to the second comment, home health agencies must meet conditions of participation as determined through our survey process. The structures are designed to ensure that such agencies are qualified to furnish high-quality services that are medically necessary. To the extent that any provider, including a home health agency, is determined through the survey process to be furnishing inappropriate or unnecessary services, compliance actions can be pursued. Comment: One commenter believed that home health services should be delivered in a consumer directed manner; the individual should be allowed to choose an agency or a consumer directed delivery option. Response: A service plan based on a person-centered philosophy will support the beneficiary in achieving personally defined outcomes in the most integrated community setting available. This approach will reflect what is important to the individual receiving the services in terms of personal preferences and choices to meet identified support needs. Formal participant direction requirements for a home health service plan may be required by states as they determine appropriate, and consistent with the service delivery and payment system used by the state. We did not propose to change the requirement that certain components of the home health benefit (specifically nursing, home health aide services, and therapy services) must be furnished by a home health agency. This requirement is based on the premise that these services must be properly supervised and coordinated, consistent with the beneficiary's plan of care. Changing this requirement is beyond the scope of this rulemaking. Comment: One commenter sought CMS guidance on the responsibility of the Medicaid Agency as it relates to oversight and monitoring of home health agencies to ensure compliance with the regulations. Response: Overall compliance with home health agency certification requirements is conducted by the state's survey agency, in partnership with us. It is expected that State Medicaid Agencies collaborate with State Survey Agencies to ensure compliance of all home health providers with appropriate requirements, including all aspects of this regulation. Comment: Some commenters discussed transportation costs. One commenter requested clarification on Medicaid coverage of physician non-medical transportation costs for face-to-face encounters. One commenter stated that the increased need to provide transportation services for the face-to-face encounters will result in increased costs. Another commenter raised a concern related to the problem of transportation costs, stating that the mandate of existing Sec. 431.53 ``that the Medicaid agency will ensure necessary transportation for beneficiaries to and from providers,'' when read in connection with the proposed Sec. 440.70(c)(1), significantly increases the states' financial obligation for service delivery. Additionally, the commenter requested that CMS clarify that Sec. 431.53 does not apply for location-independent providers such as home health agencies. Response: States are required under Sec. 431.53 to assure necessary transportation for beneficiaries to and from medical providers, and that applies to transportation costs necessary for face- to-face encounters. This requirement includes transportation to and from an appointment with a physician or allowed NPP to receive an evaluation for home health services. States may reimburse physicians for transportation costs when necessary to make house calls through payment rate adjustments. Physicians cannot claim separately for transportation costs, since Medicaid reimbursement is not available specifically for physician transportation costs. However, many states factor in the costs of doing business into the payment rates for physician services, and may have higher payment rates to reflect physician house calls. Additionally, in response to the commenter's concern about transportation, we would note that the face-to-face encounter can be performed through the use of telehealth, and states may have payment rates that apply specifically for telehealth services and take into account the costs of communication lines and other necessary components of a telehealth encounter (on both sides of the telehealth encounter). Comment: Two commenters requested that CMS specify that medical supplies, equipment, and appliances are a separate stand-alone home health service. The commenter also suggested that CMS emphasize that, even if a particular item cannot be covered as medical equipment, supplies, or appliances, states should determine whether it can be covered under another Medicaid service category, such as prosthetics or rehabilitation services. Additionally, the commenter suggested that CMS should state explicitly that satisfying the criteria of either one of the two definitions (equipment and appliances, or supplies) is sufficient to require coverage when the item is medically necessary. Response: We appreciate the commenter's suggestions. As indicated in the proposed rule, items and services that meet the criteria for coverage under the home health benefit must be covered according to home health coverage parameters. To ensure full coverage for medical equipment and appliances, we will require that, to the extent that there is overlap in coverage with another benefit, states must nevertheless provide for the coverage of these items under the mandatory home health benefit. We understand that this policy may require that some states revise their claims processing systems, and we will work with those states to assist them in meeting this requirement. We reiterate that individuals only requiring medical equipment and appliances, and not other components of the home health benefit, may receive those services from DME providers authorized by the state, without necessitating a relationship with a home health agency. The nature of medical supplies and their ability to be provided in a variety of situations calls for a more flexible approach. Supplies incident to another mandatory benefit, such as physician services or an inpatient benefit such as hospital or nursing facility, may be covered under that benefit category. Additionally, supplies incident to the clinic benefit may be covered under that benefit [[Page 5536]] category. However, regardless of coverage category, the expectation remains that individuals receive all medically necessary medical supplies meeting the definition finalized under this regulation. We are available to provide technical assistance to states to work through operational issues. We added this clarification to the regulatory text at Sec. 440.70(b). Comment: Two commenters indicated that the substantial number of hours required for compliance with this rule, in combination with the relatively low reimbursement typical for care of Medicaid beneficiaries, will lead to barriers to compliance among physicians. Commenters anticipated resistance from practitioners and physicians due to the additional administrative time it will take to meet the face-to- face requirement. One commenter indicated that many doctors are stating that they do not like the additional documentation requirements and are simply not ordering home health services. One commenter stated that early indications from the Medicare requirements are that physicians have been hostile to the new requirement, particularly the documentation standards. Another commenter stated that already there are many doctors who do not accept Medicaid beneficiaries. The commenter believed that adding additional paperwork and documentation requirements like this means there will likely be even more doctors who do not participate or who do not order home health services. One commenter reported that the home health industry is having problems with some doctors not wanting to do the face-to-face, therefore they are refusing to refer any beneficiaries to home health. One commenter indicated that since the Medicare requirement went into effect their members have seen a significant drop in referrals, some as much as 25 percent. The commenter further stated that unlike Medicare, Medicaid is actually 50 different programs with varying sets of rules from state to state. The commenter expressed concern that this will cause uneven application of the rule across the country and could lead to more problems with access to care. Response: We fully expect that physicians will comply with the requirements and that they will be reasonably compensated for the time needed to provide and document the face-to-face encounter. The face-to- face encounters can be performed by NPPs, as well as done through telehealth. Additionally, as previously indicated, for medical equipment, NPPs are now authorized to complete the documentation requirements. To the extent that physicians may be avoiding ordering home health services, or are not cooperating with the home health industry on face-to-face documentation requirements, these may be temporary responses stemming from the unfamiliarity of the requirements. States, home health agencies and DME suppliers may need to work with physicians and NPPs to help them to understand the requirements. In particular, home health agencies and DME suppliers may need to develop ongoing relationships with physicians and NPPs to ensure that face-to-face encounters occur and are properly documented. Comment: We received many comments pertaining to access to care. Commenters expressed that the face-to-face requirement in Medicare seems to be doing little to improve oversight of the benefit and is instead reducing access to home health for otherwise eligible patients, as physicians either refuse to accept the additional paperwork burden or do so only after agencies spend additional time and resources to obtain the documentation. One commenter believed the manner in which CMS is implementing the statutory requirement will significantly affect Medicaid beneficiaries' access to care. The commenter further stated that they can cite anecdotal examples of physicians who have simply decided to no longer refer individuals for home health services because of the hassle involved. One commenter believed that Medicaid beneficiaries will be the victims of this proposal because citizens who are elderly and those with disabilities are at risk for not receiving home health services if agencies have concerns about compliance with the face-to-face requirement and cannot deliver care. One commenter supported the need to align Medicare and Medicaid rules whenever possible, but was concerned about requirements that cause barriers to access by requiring a face-to-face encounter to initiate and receive payment for home health services. Another commenter was not supportive of applying the face-to-face requirements under Medicare to Medicaid. Another commenter believed that this requirement will negatively impact access and serve as a barrier to care because of the additional administrative burden to physicians filling out the face-to-face form. One commenter indicated that physicians, hospitals, discharge planners, home health agencies, and beneficiary groups agree that the physician requirements are a barrier to access to home health care for bona fide beneficiaries who meet coverage standards. One commenter believed that the face-to-face requirement is reducing access to home health for otherwise eligible individuals. One commenter was concerned that the face-to-face requirement will impede access and provide marginal benefit as a tool to eliminate ordering of questionable services. Response: The face-to-face requirement is mandated by statute. We have attempted to permit maximum flexibility in how the statutory requirement can be met and believe that the requirement can be accommodated without significant additional burden. We are aligning Medicaid requirements with Medicare requirements to maximize consistency in service delivery, as well as reduce administrative burden on the provider community. As discussed in this final rule, we expect states to offer appropriate provider training and for states and providers to work together to ensure this provision is implemented in a manner that supports the goal of ensuring program integrity while not serving as a barrier to access to medically necessary services. Comment: One commenter stated that well-mom and baby visits do not meet the intent of the physician face-to-face encounter for establishing the primary reason for which home health services are required and which will ultimately result in the development of a home health plan of care. Response: If, in the course of such a visit, the physician or other practitioner determines that home health services or medical equipment is required to address the condition of the mother or child, such a visit could be the basis for a documented face-to-face encounter to the extent that the visit involves examining the condition of the mother or child. Comment: One commenter believed that the proposed rule fails to take into account the fact that a significant proportion of home health services furnished to Medicaid beneficiaries under managed care programs are primarily the financial responsibility of managed care organizations. Another commenter suggested that, given the increased cost associated with the face-to-face encounter requirements, CMS should query states as to how they will be adjusting rates paid to managed care plans to adjust for the increased costs in an actuarially sound manner. Other commenters requested clarification regarding the application of the regulation to home health services [[Page 5537]] provided through Medicaid managed care plans. Response: As previously stated, neither the law nor this rule requires that the face-to-face requirement apply to Medicaid managed care. We defer to states to determine the application of the face-to- face requirement in managed care plans to best meet the needs of their beneficiaries. Comment: One commenter was concerned that more services will be shifted to personal care attendant services resulting in potential Medicare savings at the expense of state Medicaid budgets. Response: We believe that the concern about potential cost shifting between Medicare and Medicaid can be address by ensuring that home health plans of care include all needed home health aide services. Additionally, as indicated in a previous response, to the extent that there is overlap in coverage with an optional benefit, states must provide for the coverage of services that meet the parameters of home health services under the mandatory home health benefit. Comment: One commenter stated that the proposed rule at Sec. 440.70 goes well beyond the scope of statutory authority and should not be issued. This commenter requested that CMS revisit its position that home health services are a mandatory service. Response: We disagree with the commenter. Section 1902(a)(10)(D) of the Act sets forth the requirement that a state plan for medical assistance must provide for the inclusion of home health services for any individual who, under the state plan, is entitled to nursing facility services. Because nursing facility services are mandatory for categorically needy individuals and the medically needy--if a state chooses to cover the medically needy--home health services are mandatory for the populations. Upon consideration of public comments received, we are finalizing Sec. 440.70 with the following revisions:We are revising Sec. 440.70(b) to state that home health services cannot be contingent upon the beneficiary needing nursing or therapy services. We are revising Sec. 440.70(b) to codify that items and services that meet the criteria for coverage under the home health benefit must be covered according to home health coverage parameters. We are incorporating into Sec. 440.70(b)(3)(v), three basic points set forth in our 1998 guidance relating to the DeSario decision: (1) States may have a list of preapproved medical equipment, supplies, and appliances for administrative ease but not as an absolute limit on coverage; (2) States must provide and make available to individuals a reasonable and meaningful procedure for individuals to request items not on the list; and (3) Individuals must be informed of their right to a fair hearing. Additionally, we are including in the final rule the underlying interpretation implicit in these principles that the mandatory coverage of this benefit prohibits absolute exclusions of coverage as medical equipment, supplies, or appliances. We are revising Sec. 440.70(c)(1) to codify our longstanding policy that home health services may not be subject to a requirement that the individual be homebound. B. Introductory Text--Medical Supplies, Equipment, and Appliances (Sec. 440.70(b)(3)) Section 440.70(b)(3) proposed to revise the wording of the regulation to further define medical equipment, supplies, and appliances as suitable for use in any non-institutional setting in which normal life activities take place. We also proposed in Sec. 440.70(b)(3)(i) and (ii) more detailed definitions of the terms ``medical supplies, equipment, and appliances''. Comment: We received many comments in support of revising the introductory text of paragraph (b)(3). Several commenters supported the policy that medical equipment cannot be restricted to items that are useful in the home. One commenter further stated that potentially essential products are necessary not only for individuals to function in the home but to carry out activities of daily living while out of the home and in the community. One commenter stated that such standard is consistent with the requirements under the Americans with Disabilities Act, the Supreme Court Decision in Olmstead v. LC, and good healthcare policy. Another commenter stated that substituting suitable for use in any non-institutional setting in which normal life activities take place will improve understanding of this required characteristic of medical supplies, equipment, and appliances. Another commenter stated that this acknowledges that individuals engage in daily activities in which they may need such equipment not only in their homes, but also as they go about their daily activities in the community. Another commenter suggested including this language not only in the preamble, but also in the final regulations. Additionally, several commenters commended CMS for its statement in the preamble to the proposed rule that ``[i]tems that meet the criteria for coverage under the home health benefit must be covered as such. States will not be precluded from covering items through a section 1915(c) HCBS waiver service, such as home modification, or through a section 1915(i) state plan option. However, the state must also offer those items as home health supplies, equipment, and appliances.'' Response: We appreciate the perspectives the commenters had in support of the proposed revisions to the introductory language in Sec. 440.70(b)(3). This language has been included in the final regulation. Comment: Many commenters requested clarification of the phrase ``normal life activities.'' One commenter requested that CMS clarify or define normal life activities as absent a definition there will likely be considerable confusion between this term and activities of daily living. Another commenter reported that some states include the terminology of activities of daily living in their DME definition which enables a focus on a defined area of medical necessity. The commenter suggested that this standard is more clearly defined and thus preferable. Another commenter indicated that the term ``normal life activity,'' if not clearly defined, will result in duplication of services and increased expenditures. Another commenter indicated that ``in which normal life activities take place'' is a subjective statement where the state's administration may have to continually define and defend its interpretation in utilization management practices. Response: To clarify, the phrase ``normal life activities'' refers to activities that could occur in or out of an individual's home. We proposed to revise the phrase ``suitable for use in the home'' to ``suitable for use in any non-institutional setting in which normal life activities take place'' to clarify that although states may continue to establish medical necessity criteria to determine the authorization of the items, states may not deny requests for the items based on the grounds that they are for use outside of the home. This clarification would not preclude states from continuing to use activities of daily living as medical necessity criteria. Comment: One commenter indicated concern with the proposed ``expansive'' new definition of Medicaid supplies, equipment, and appliances which appears to require states to provide supplies, equipment, and appliances in any non-institutional setting. Thus, states would be required to provide, as just one example, wheelchair ramps in [[Page 5538]] settings outside the home as well as in the home. Response: The new definition of Medicaid supplies, equipment, and appliances establishes a framework to serve as a companion to the requirement that the benefit is not limited to services and/or items suitable for use in the home, rather it is a benefit that is available to people in any setting in which normal life activities take place, other than facilities specified at Sec. 440.70(c)(1). States may not deny requests for the items based on the grounds that they are for use outside of the home. States will continue to have flexibility to establish a reasonable definition of medical supplies, equipment and appliances that is consistent with the regulatory framework, to apply medical necessity criteria, and to have reasonable utilization control standards. We note that we do not regard this definition to expand the scope of medical equipment to include environmental or structural housing modifications. Nor does it include equipment that is designed to have a general use and will serve more people than just the Medicaid beneficiary. And a state's medical necessity and utilization control standards could reasonably preclude coverage of duplicative items or could provide coverage for rental rather than purchase of items when cost effective. Comment: One commenter stated that what CMS characterizes in the proposed rule as clarifying language in Sec. 440.70(b)(3) is a substantive change to the rule that goes well beyond what is statutorily allowed under Medicaid. The commenter stated that the present language of Sec. 440.70(b)(3) correctly sets forth the scope of coverage of medical supplies and equipment as being ``suitable for use in the home'' as home health care is the purpose of this coverage category. Response: We disagree that the proposed changes go beyond the statutory authority for CMS to interpret the meaning of the home health benefit and establish a framework for states to implement that benefit. In addition, while the changes are substantive, the changes incorporate principles that have been applied to Medicaid coverage in a number of court cases and CMS guidance, as discussed in the Background section above. As a result, the changes update the regulations to incorporate principles that are already applicable in practice. Comment: One commenter raised concern regarding DME issues related to abuse of the equipment provided to Medicaid beneficiaries, or requests for equipment that exceeds the practical needs of the member. Response: States may review requests to ensure that only medically necessary equipment is covered. The proposed provisions do not replace the existing Medicaid regulatory requirements at Sec. 440.70(a)(2) and Sec. 440.70(b)(3)(i) related to physician ordering and review of necessary medical equipment. An additional safeguard against unnecessary utilization is the face-to-face requirement and subsequent documentation requirement, which provides that physicians must describe how the health status of the beneficiary at the time of the face-to- face encounter is related to the primary reason the beneficiary requires home health services. This process should identify requests for equipment that exceed the practical needs of the individual. With regard to abuse of equipment provided to Medicaid beneficiaries, we believe it would be reasonable for states to require that the face-to- face encounter include instruction on how to properly use and care for the medical equipment at issue. Comment: One commenter requested clarification as to whether the existing 16-bed or fewer size standard for determining whether a residential setting is an institution will be considered in determining whether supplies are suitable for use in ``non-institutional settings'' and the applicability for DME that would be used in a school setting
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