On Thursday, April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) revised its blanket waivers under section 1135 and a second interim final rule with comment period (Final Rule), providing health care providers and suppliers with expanded flexibilities to respond to the novel coronavirus 2019 (COVID-19) pandemic. The interim final rule, which will be published in the Federal Register on May 8, 2020, provides additional flexibility for health care providers during the COVID-19 public health emergency (PHE). Like prior waivers and CMS’s first interim final rule, the Final Rule and waiver focus on COVID-19 testing, telemedicine, and alternative care sites, but they also include key provisions concerning accountable care organizations (ACOs), hospital outpatient departments, and teaching hospitals. The following alert explores several significant items included in the Final Rule and waiver. Hospital Outpatient Departments CMS notes the importance of providing hospitals with adequate flexibility to increase capacity. Building off the hospital without walls initiative set forth in the first interim final rule on the COVID-19 PHE, the Final Rule expands the hospital services that can be provided in temporary expansion locations, including beneficiary homes. Expanded Flexibility for Medicare Telehealth Services Throughout the COVID-19 PHE, CMS has exercised its waiver authority to relax its normal billing restrictions concerning “Medicare telehealth services.” After receiving considerable stakeholder input during biweekly calls the agency is calling “Office Hours,” CMS has again used that authority to alter the “Medicare telehealth services” regulatory landscape, both through the second COVID-19 Final Rule and by modifying its 1135 blanket waiver. Expanded Provider Types. “Medicare telehealth services” are typically covered only when provided by certain categories of practitioners listed at 42 C.F.R. Section 410.78(b)(2). During stakeholder calls convened by CMS to discuss telehealth issues during the PHE, many provider organizations have noted that this prevented allied health practitioners, specifically physical therapists, occupational therapists, speech language pathologists, and others, from receiving payment for important treatment provided via telehealth during the PHE. As such, CMS has authorized additional telehealth waivers, waiving the “eligible practitioner” requirement so that the previously mentioned providers may now also provide “Medicare telehealth services.” Audio-Only “Medicare Telehealth Services.” Normally, “Medicare telehealth services” must be furnished through an “interactive telecommunications system,” which Medicare regulations define as including video technology. See 42 C.F.R. Section 410.78(a)(3). For the duration of the PHE, CMS will allow providers to use audio-only equipment to provide telephone evaluation and management (E/M) services, as well as for behavioral health counseling and educational services. (The applicable codes are listed here.) Specifically, CMS further revised 42 C.F.R. Section 410.67 to address Medicare coverage and payment of behavioral health services furnished by opioid treatment programs (OTPs). In addition to allowing the therapy and counseling portions of weekly bundles of services furnished by OTPs to be furnished using audio-only telephone calls, CMS is also revising 42 C.F.R. Section 410.67(b)(7) on an interim final basis to allow OTPs to furnish periodic assessments via audio-only communications for the duration of the PHE, when beneficiaries do not have access to audio/video technology. CMS also announced that it is “cross-walking” CPT codes 99212, 99213 and 99214 to 99441, 99442, and 99443, respectively. The agency explained that it has learned from stakeholders that these audio-only E/M codes are being furnished to replace care that would otherwise be provided in-person or via telehealth and often when beneficiaries do not have access to the audio-video technology needed to furnish a “Medicare telehealth service.“ CMS believes that this change will “better capture” the resources required to furnish these audio-only services during the PHE. In its press release, CMS reported that the change will increase payments for these services from a range of $14-$41 to approximately $46 – $110. These payment rates are retroactive to March 1, 2020. Revised Process for new “Medicare Telehealth Services.” CMS maintains a list of CPT codes which qualify as “Medicare telehealth services” on its website, and typically adds a few new codes each year. Medicare regulations dictate that unless a service is included on the “Medicare telehealth services” list, it is not payable as a “Medicare telehealth service.” However, for the duration of the PHE, CMS will utilize a new “process for adding or deleting services,” to be codified at 42 C.F.R. Section 410.78(f). Specifically, instead of the annual Physician Fee Schedule (PFS) rulemaking process which is typically used to add to the “Medicare telehealth services” list, CMS will use a sub-regulatory process to modify the list. This will significantly speed up the process by which CMS may update the “Medicare telehealth services” list. Hospital billing as originating site for telehealth services even when patient located at home. In the first interim final rule, CMS instructed physicians and other practitioners providing telehealth services to beneficiaries at home to bill as if the services were furnished in person. See 85 FR 19233. While under the rule, the furnishing practitioner would be paid under the PFS at the “facility” rate as if the service was furnished in an outpatient department, the rule neglected to provide for the hospital to submit any claim for such telehealth services. In this second Final Rule, CMS acknowledged that when a physician or practitioner who ordinarily practices in the hospital outpatient department furnishes a telehealth service to a patient who is located at home, the hospital may nevertheless still provide some administrative and clinical support for that service. As such, for the duration of the COVID-19 PHE and retroactively effective March 1, 2020, CMS is allowing hospitals to bill for services furnished remotely by hospital-based practitioners to Medicare patients registered as hospital outpatients, including when the patient is at home. Note that the patient must be a registered outpatient of the hospital and her home must be made a temporary “provider-based department” of the hospital under the current waivers in effect for the COVID-19 PHE, meaning that all applicable conditions of participation, to the extent not waived, are met. Furthermore, CMS is permitting hospitals to bill the originating site facility fee for the services to reimburse for the administrative or clinical support provided by the hospital. CMS also identified certain outpatient therapy, counseling, and educational services that hospital clinical staff can furnish (using telecommunications technology) incident to a physician’s service during the COVID-19 PHE to a beneficiary who is registered as an outpatient when those services are furnished in the patient’s home. This change greatly expands the types of services healthcare providers that can provide using telehealth technology; for example, hospital clinical staff can now also remotely furnish psychotherapy (for example, HCPCS code 90832) to the patient, as long as the requirements referenced above are met. FQHCs and RHCs as distant site providers. Prior to COVID-19 PHE, rural health clinics (RHCs) and federally qualified health clinics (FQHCs) could not furnish distant site telehealth services to Medicare beneficiaries. Section 3704 of the CARES Act did away with this prohibition, mandating that CMS pay for Medicare telehealth services provided by RHCs and FQHCs to ensure that beneficiaries located in rural and other medically underserved areas can also access care from their home without having to travel. CMS issued the following guidance on this expanded flexibility given to FQHCs and RHCs during the COVID-19 PHE. Telehealth services can be furnished by any health care practitioner working for the RHC or the FQHC, as long as doing so falls within his or her scope of practice. Additionally, practitioners can furnish telehealth services from any distant site location, including their home, during the time that they are working for the RHC or FQHC, and can furnish any telehealth service that is included on the list of Medicare telehealth services maintained by CMS, including those that were added on an interim basis during the PHE. Notably CMS will not be reimbursing FQHC or RHCs at their PPS/AIR rates, respectively, for services furnished via telehealth, but rather using a methodology established by the CARES Act based upon the fee-for-service rates be used to calculate an amount to be paid for telehealth services, currently set at $92.03 (which is the average amount for all PFS telehealth services on the telehealth list, weighted by volume for those services reported under the PFS). Additionally, the Medicare Advantage (MA) wrap-around payment does not apply to these services. COVID-19 and Antibody Testing The Final Rule emphasizes the importance of both COVID-19 testing and antibody testing, and includes a number of regulatory changes to expand the availability and coverage of both tests, as follows: PHP Flexibilities for Hospitals and Community Mental Health Centers (CMHCs) Recognizing the goal of infection control, as well as continuity of behavioral health services, the Final Rule permits providers (hospital or CMHC staff) to furnish certain PHP services remotely to patients in a temporary expansion location of the hospital or CMHC, which may include the patient’s home. The Final Rule provides: Teaching Hospitals CMS, as part of its effort to increase hospital capacity and flexibility during the pandemic, has instituted the following rule changes: Accountable Care Organizations (ACOs) In addition, CMS is making changes to the Medicare Shared Savings Program (MSSP) to provide flexibility to participating Accountable Care Organizations (ACOs). Specifically, CMS is: Non-Physician Practitioners Scope of Practice. In order to expand access to needed care and provide greater flexibility, the final rule expands the scope of practices to permit: Home Health Agency (HHA) Care Planning. The final rule amends Medicare and Medicaid regulations to permit certain non-physician practitioners to perform certain functions in accordance with state licensing laws. Reporting Requirements and Measures The Final Rule also delays or suspends of certain reporting requirements for hospitals, HHAs, skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), long-term care hospitals (LTCHs), and, in the case of skilled nursing facilities, imposes additional reporting requirements. Finally, the Final Rule amends certain measure approval criteria relating to the Merit-Based Incentive Payment System (MIPS). For further information, please contact Katrina Pagonis, Mark Reagan, Jordan Kearney or Andrea L. Frey in San Francisco, Nina Adatia Marsden, Alicia Macklin or Charles Oppenheim in Los Angeles, Mark Johnson in San Diego, David J. Vernon, Martin Corry, or Monica Massaro in Washington, D.C., Jeremy D. Sherer in Boston, or your regular Hooper, Lundy & Bookman contact.CMS Issues Second Interim Final Rule to Expand Provider Flexibility and Coverage During the COVID-19 Pandemic
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