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CMS Issues Additional Waivers & Interim Final Rule (CMS-5531-IFC) for COVID-19 04.30.2020

On the afternoon of April 30th, the Centers for Medicare and Medicaid Services (CMS) announced that it submitted a second interim final rule (IFC) to the Federal Register and that it released an additional set of blanket waivers under section 1135 of the Social Security Act aimed at addressing the ongoing COVID-19 public health emergency (PHE). Below are many of the new flexibilities and capabilities included in the waivers and rule:  

Interim Final Rule

  • Adopting an extraordinary circumstances relocation exception policy for on-campus and excepted off-campus provider-based departments of hospitals that relocate for the PHE; 
  • Discussing the hospital outpatient services and community mental health care services that can be furnished in temporary expansion locations of a hospital; 
  • Modifying the policy to allow a teaching hospital to claim, towards its resident fulltime equivalent count, residents that it sends to another hospital during the PHE;  
  • Updating Extraordinary Circumstances Exceptions policy under the HVBP Program to allow us to grant an exception to hospitals affected by an extraordinary circumstance without request form; 
  • Granting exceptions under our updated policy to all hospitals participating in the HVBP Program with respect to certain 4q2019 measure data that hospitals would otherwise be required to report in April or May of 2020, and measure data that hospitals would otherwise be required to collect during the 1st and 2nd quarters of 2020; 
  • Incorporating changes for ACOs participating in the Medicare Shared Savings Program;  
  • 1 year delay for certain qualified clinical data registry measure approval criteria under MIPS;  
  • Addressing the waiver of the IRF “3-hour rule” required by section 3711(a) of the CARES Act and modifying the IRF coverage and classification requirements for freestanding IRF hospitals to exclude patients admitted solely to relieve acute care capacity during the PHE;  
  • Changing Medicare regulations to revise payment rates for certain DME and enteral nutrients, supplies, and equipment to implement section 3712 of CARES Act;  
  • Delaying the compliance date by which IRFs, LTCH, and HHAs must collect and report data on two Transfer of Health (TOH) Information quality measures and certain Standardized Patient Assessment Data Elements (SPADEs) adopted for the IRF QRP, LTCH QRP, and HH QRP; and  
  • Finally, this IFC delays by 60 days, when individual market qualified health plan issuers offering non-Hyde abortion services must comply with the separate billing provision. 

 

E. Treatment of Certain Relocating Provider-Based Departments During the PHE1 

  • CMS is temporarily adopting an expanded version of the extraordinary circumstances relocation policy during the COVID-19 PHE to include on-campus PBDs that relocate off-campus during the COVID-19 PHE for the purposes of addressing COVID-19. 
  • On-campus departments that relocate on or after March 1, 2020 through the remainder of the PHE for the purposes of addressing the COVID-19 pandemic may seek an extraordinary circumstances relocation exception so that they may bill at the OPPS rate, as long as their relocation is not inconsistent with the state’s emergency preparedness or pandemic plan. 
    • Hospitals may divide their PBD into multiple locations during a relocation.  
    • Hospitals may relocate part of their excepted PBD to a new off- campus location while maintaining the original PBD location  
  • Hospitals that choose to permanently relocate these PBDs off- campus would be considered new off-campus PBDs billing after November 2, 2015, and therefore, would be required to bill using the PN modifier for hospital outpatient services furnished from that PBD location and would be paid the PFS-equivalent rate following the end of the COVID-19 PHE.  
  • The relocation or partial relocation of an excepted PBD for the extraordinary circumstance of the COVID-19 PHE could involve a single excepted PBD that relocates (or partially relocates) to a patient’s home (for purposes of furnishing a covered OPD service), which under the Hospitals without Walls initiative, can be provider-based to the hospital during the COVID-19 PHE.  
  • If Medicare-certified hospitals will be rendering services in relocated excepted PBDs, but intend to bill Medicare for the services under the main hospital, no additional provider enrollment actions are required (for example, hospitals do not need to submit an updated CMS- 855A enrollment form) for the off-campus relocated site during the COVID-19 PHE.  

F. Furnishing Outpatient Services in Temporary Expansion Locations of Hospital/CMHC

  • Hospital/CMHC staff can furnish certain outpatient therapy, counseling, and educational services incident to a physician’s service during the COVID-19 PHE to a beneficiary in their home or other temporary expansion location using telecommunications technology.  
  • Hospitals can furnish services to a beneficiary in a temporary expansion location (including the beneficiary’s home) if that beneficiary is registered as an outpatient; and the CMHC can furnish services in an expanded CMHC (including the beneficiary’s home) to a beneficiary who is registered as an outpatient.  
  • Hospitals can furnish clinical staff services (for example, drug administration) in the patient’s home, which is considered provider-based to the hospital during the COVID-19 PHE, and to bill and be paid for these services when the patient is registered as a hospital outpatient.  
  • CMS clarified that when a patient is receiving a professional service via telehealth in a location that is considered a hospital PBD, and the patient is a registered outpatient of the hospital, the hospital in which the patient is registered may bill the originating site facility fee for the service. 
  • CMS clarified the applicability of section 603 of the BBA 2015 to hospitals furnishing care in the beneficiaries’ homes (or other temporary expansion locations), and whether those locations are considered relocated, partially relocated, or new PBDs.  

G. Medical Education

  • For the duration of the PHE related to COVID-19, CMS has waived certain requirements under the Medicare conditions of participation at §§ 482.41 and 485.623, and the PBD requirements at § 413.65 in order to allow hospitals to establish and operate as part of the hospital any location meeting those non-waived conditions of participation for hospitals that continue to apply during the PHE. Time spent by residents at these locations is not treated any differently from time spent by residents at locations established and operated by the hospital prior to the COVID-19 PHE.  
  • For the duration of the PHE related to COVID-19, CMS has adopted a policy that if routine services are provided under arrangements outside the hospital to its inpatients, these services are deemed to have been provided by the hospital (85 FR 19280). Similarly, time spent by residents at these locations is not treated any differently from time spent by residents at locations established and operated by the hospital prior to the COVID-19 PHE. 

L. Medicare Shared Savings Program

  • Changes to the Shared Savings Program regulations established in this IFC that are applicable to ACOs within a current agreement period will apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 1, so long as the applicable regulation has not been waived.  
  • Similarly, to the extent that certain requirements of the regulations that apply to ACOs under Track 2 or the ENHANCED track have been incorporated for ACOs in the Track 1+ Model under the terms of the Track 1+ Model Participation Agreement, changes to those regulations as adopted in this IFC will also apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 2 or the ENHANCED track.  
  • For example, the following policies apply to Track 1+ Model ACOs:  
    • Revisions to the definition of primary care services used in beneficiary assignment (section II.L.5. of this IFC), to include telehealth codes for virtual check-ins, e-visits, and telephonic communication. These codes are applicable beginning with beneficiary assignment for the performance year starting on January 1, 2020, and for any subsequent performance year that starts during the PHE for the COVID-19 pandemic, as defined in § 400.200.  
    • Clarification that the total months affected by an extreme and uncontrollable circumstance for the COVID-19 pandemic will begin with January 2020 and continue through the end of the PHE, for purposes of mitigating shared losses for PY 2020 (section II.L.3. of this IFC).  
    • Adjustments to expenditure calculations to remove expenditures for episodes of care for treatment of COVID-19 (section II.L.4. of this IFC).  
  • CMS will also apply the following policies established in this IFC to Track 1+ Model ACOs through an amendment to the Track 1+ Model Participation Agreement executed by CMS and the ACO: 
    • Adjustments to revenue calculations to remove expenditures for episodes of care for treatment of COVID-19 (section II.L.4. of this IFC). 

M. Additional Flexibility under the Teaching Physician Regulations

  • CMS clarifies that the office/outpatient E/M level selection for services under the primary care exception when furnished via telehealth can be based on MDM or time, with time defined as all of the time associated with the E/M on the day of the encounter; and the requirements regarding documentation of history and/or physical exam. 
  • During the PHE for the COVID-19 pandemic, Medicare may make PFS payment for teaching physician services when a resident furnishes a service included in an expanded list of services in primary care centers, including via telehealth, and the teaching physician can provide the necessary direction, management and review for the resident’s services using audio/video real-time communications technology. [Expanded list includes: 99441, 99442, 99443, 99495, 99496, 99421, 99422, 99423, 99452, G2012, G2010] 

Z. Time Used for Level Selection for Office/Outpatient E&M Services via Telehealth 

  • For the duration of the PHE for the COVID-19 pandemic, that the typical times for purposes of level selection for an office/outpatient E/M are the times listed in the CPT code descriptor. 

AA. Updating the Medicare Telehealth List

  • CMS is revising their regulation at § 410.78(f) to specify that, during a PHE, as defined in § 400.200 of this chapter, they will use a subregulatory process to modify the services included on the Medicare telehealth list.  

New or Revised Blanket Waivers (4/29/20 Document) 

Telehealth Services  

  • The waiver expands the types of health care professionals that can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services. This allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services, including physical therapists, occupational therapists, speech language pathologists, and others, to receive payment for Medicare telehealth services.  
  • This waiver allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services. 

Home Health and Hospice 

  • CMS is waiving the requirement for Hospice and HHAs, which require a registered nurse, to make an annual onsite supervisory visit (direct observation) for each aide that provides services on behalf of the agency. In accordance with section 1135(b)(5) of the Act, we are postponing completion of these visits. All postponed onsite assessments must be completed by these professionals no later than 60 days after the expiration of the PHE.  
  • CMS is modifying the requirement for Hospice and HHAs, which requires these providers to develop, implement, evaluate, and maintain an effective, ongoing, hospice/HHA-wide, data-driven QAPI program. Specifically, CMS is modifying the requirements at §418.58(a)–(d) and §484.65(a)–(d) to narrow the scope of the QAPI program to concentrate on infection control. 
  • CMS is modifying the requirement at 42 CFR §418.100(g)(3), which requires hospices to annually assess the skills and competence of all individuals furnishing care and provide in-service training and education programs where required. This does not alter the minimum personnel requirements at 42 CFR §418.114.  

Physical Environment 

  • CMS is waiving certain physical environment requirements for Hospitals, CAHs, inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. The physical environment regulations require that facilities and equipment be maintained to ensure an acceptable level of safety and quality.  

Ambulatory Surgical Centers 

  • CMS is waiving the requirement at § 416.45(b) that medical staff privileges must be periodically reappraised, and the scope of procedures performed in the ASC must be periodically reviewed.  

Community Mental Health Centers 

  • CMS is modifying the requirements for CMHC’s QAPI by retaining the overall requirement that CMHC’s maintain an effective, ongoing, data-driven QAPI program but also providing flexibility for CMHCs to use their QAPI resources to focus on challenges and opportunities for improvement related to the PHE by waiving the specific detailed requirements for the QAPI program’s organization and content at § 485.917(a)-(d). 
  • CMS is waiving the specific requirement at § 485.918(b)(1)(iii) that prohibits CMHCs from providing partial hospitalization services and other CMHC services in an individual’s home so that clients can safely shelter in place during the PHE while continuing to receive needed care and services from the CMHC.  
  • CMS is waiving the requirement at § 485.918(b)(1)(v) that a CMHC provides at least 40 percent of its items and services to individuals who are not eligible for Medicare benefits.