Coronavirus update for Thursday, April 30 as of 4:00 p.m.

Major New Regulation From CMS

CMS this afternoon published a 279-page interim final rule with comment period covering Medicare and Medicaid, the Basic Health Program, and additional policy and regulatory revisions in response to the COVID-19 emergency and delaying certain reporting requirements for the skilled nursing facility quality reporting program.  The CMS news release announcing the policy changes describes them as a “…round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens.  These changes include making it easier for Medicare and Medicaid beneficiaries to get tested for COVID-19 and continuing CMS’s efforts to further expand beneficiaries’ access to telehealth services.”

If you would like to explore the changes, you can do so through the following resources:

• the CMS news release announcing the changes
• the document COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, which includes the policy changes
• the posted interim final rule itself

As of this writing we believe the following are the highlights, which are taken directly from CMS’s compendium document on blanket waivers and from the interim final rule posted today.

Flexibility for Medicare Telehealth Services

• “When a registered outpatient of the hospital is receiving a telehealth service, the hospital may bill the originating site facility fee to support such telehealth services furnished by a physician or practitioner who ordinarily practices there.”
• CMS is increasing reimbursement for the audio-only E/M codes 99441-99443 that were temporarily recategorized as reimbursable under the last IFC.  Reimbursement for CPT Codes 98966-98968 is not being increased.  CMS describes the revised RVUs for these codes as follows:
• “Specifically, we are crosswalking CPT codes 99212, 99213, and 99214 to 99441, 99442, and 99443 respectively. We are finalizing, on an interim basis and for the duration of the COVID-19 PHE the following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We are also finalizing the direct PE inputs associated with CPT code 99212 for CPT code 99441, the direct PE inputs associated with CMS-5531-IFC 140 CPT code 99213 for CPT code 99442, and the direct PE inputs associated with CPT code 99214 for CPT code 99443.”
• Eligible Practitioners. Pursuant to authority granted under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that broadens the waiver authority under section 1135 of the Social Security Act, the Secretary has authorized additional telehealth waivers. CMS is waiving the requirements of section 1834(m)(4)(E) of the Act and 42 CFR § 410.78 (b)(2) which specify the types of practitioners that may bill for their services when furnished as Medicare telehealth services from the distant site. The waiver of these requirements 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.
• Audio-Only Telehealth for Certain Services. Pursuant to authority granted under the CARES Act, CMS is waiving the requirements of section 1834(m)(1) of the ACT and 42 CFR § 410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services, to the extent they require use of video technology, for certain 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 (see designated codes https://www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/Telehealth-Codes). Unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

Physician Services

• Quality Assurance and Performance Improvement (QAPI). (New since 4/21 Release) CMS is modifying certain requirements in 42 CFR §483.75, which requires long-term care facilities to develop, implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI program. Specifically, CMS is modifying §483.75(b)–(d) and (e)(3) to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This will help ensure facilities focus on aspects of care delivery most closely associated with COVID-19 during the PHE.
• In-Service Training: (New since 4/21 Release) CMS is modifying the nurse aide training requirements at §483.95(g)(1) for SNFs and NFs, which requires the nursing assistant to receive at least 12 hours of in-service training annually. In accordance with section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes.
• Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities. (New since 4/21 Release) CMS is waiving the discharge planning requirement in §483.21(c)(1)(viii), which requires LTC facilities to assist residents and their representatives in selecting a post-acute care provider using data, such as standardized patient assessment data, quality measures and resource use. This temporary waiver is to provide facilities the ability to expedite discharge and movement of residents among care settings. CMS is maintaining all other discharge planning requirements, such as but not limited to, ensuring that the discharge needs of each resident are identified and result in the development of a discharge plan for each resident; involving the interdisciplinary team, as defined at 42 CFR §483.21(b)(2)(ii), in the ongoing process of developing the discharge plan address the resident’s goals of care and treatment preferences.
• Clinical Records. (New since 4/21 Release) Pursuant to section 1135(b)(5) of the Act, CMS is modifying the requirement at 42 CFR §483.10(g)(2)(ii) which requires long-term care (LTC) facilities to provide a resident a copy of their records within two working days (when requested by the resident). Specifically, CMS is modifying the timeframe requirements to allow LTC facilities ten working days to provide a resident’s record rather than two working days.

Medical Education

• Hospitals may expand their number of beds without affecting their resident to bed ratios for IME (they will use the ratio from before the public health emergency) and , in a significant departure from normal policy, residency programs can count time of residents sent to other hospitals.
• On an interim basis for the duration of the PHE for the COVID-19 pandemic, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through virtual means via audio/video real time communications technology.

Home Health

• 12-hour Annual In-Service Training Requirement for Home Health Aides. (New since 4/21 Release) CMS is modifying the requirement at 42 C.F.R. §484.80(d) that home health agencies must assure that each home health aide receives 12 hours of in-service training in a 12-month period. In accordance with section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full 17 04/29/2020 quarter after the declaration of the PHE concludes. This will allow aides and the registered nurses (RNs) who teach in-service training to spend more time delivering direct patient care and additional time for staff to complete this requirement.
• Detailed Information Sharing for Discharge Planning for Home Health Agencies.  (New since 4/21 Release) CMS is waiving the requirements of 42 CFR §484.58(a) to provide detailed information regarding discharge planning, to patients and their caregivers, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, (another) home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long-term care hospital (LTCH) quality measures and resource use measures. o This temporary waiver provides facilities the ability to expedite discharge and movement of residents among care settings. CMS is maintaining all other discharge planning requirements.
• Clinical Records: (New since 4/21 Release) In accordance with section 1135(b)(5) of the Act, CMS is extending the deadline for completion of the requirement at 42 CFR §484.110(e), which requires HHAs to provide a patient a copy of their medical record at no cost during the next visit or within four business days (when requested by the patient). Specifically, CMS will allow HHAs ten business days to provide a patient’s clinical record, instead of four.

Home Health and Hospice

• Training and Assessment of Aides: (New since 4/21 Release) CMS is waiving the requirement at 42 CFR §418.76(h)(2) for Hospice and 42 CFR §484.80(h)(1)(iii) for HHAs, which require a registered nurse, or in the case of an HHA a registered nurse or other appropriate skilled professional (physical therapist/occupational therapist, speech language pathologist) 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.
• Quality Assurance and Performance Improvement (QAPI). (New since 4/21 Release) CMS is modifying the requirement at 42 CFR §418.58 for Hospice and §484.65 for 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 issues, while retaining the requirement that remaining activities should continue to focus on adverse events. This modification decreases burden associated with the development and maintenance of a broad-based QAPI program, allowing the providers to focus efforts on aspects of care delivery most closely associated with COVID-19 and tracking adverse  events during the PHE. The requirement that HHAs and hospices maintain an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement program will remain.

Hospice

• Annual Training. (New since 4/21 Release) CMS is modifying the requirement at 42 CFR §418.100(g)(3), which requires hospices to annually assess the skills and competence of all 19 04/29/2020 individuals furnishing care and provide in-service training and education programs where required. Pursuant to section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes. This does not alter the minimum personnel requirements at 42 CFR §418.114. Selected hospice staff must complete training and have their competency evaluated in accordance with unwaived provisions of 42 CFR Part 418.

Physical Environment for Multiple Providers/Suppliers

• Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: 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.
• CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.
• Specific Physical Environment Waiver Information: o 42 CFR §482.41(d) for hospitals, §485.623(b) for CAH, §418.110(c)(2)(iv) for inpatient hospice, §483.470(j) for ICF/IID; and §483.90 for SNFs/NFs all require these facilities and their equipment to be maintained to ensure an acceptable level of safety and quality. CMS is temporarily modifying these requirements to the extent necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment. o 42 CFR §482.41(b)(1)(i) and (c) for hospitals, §485.623(c)(1)(i) and (d) for CAHs, §482.41(d)(1)(i) and (e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs, and §483.90(a)(1)(i) and (b) for SNFs/NFs require these facilities to be in compliance with the Life Safety Code (LSC) and Health Care Facilities Code (HCFC). CMS is temporarily modifying these provisions to the extent necessary to permit these facilities to adjust scheduled ITM frequencies and activities required by the LSC and HCFC. The following LSC and HCFC ITM are considered critical are not included in this waiver:
• Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing.
• Portable fire extinguisher monthly inspection.
• Elevators with firefighters’ emergency operations monthly testing.
• Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing.
• Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency. o 42 CFR §482.41(b)(9) for hospitals, §485.623(c)(7) for CAHs, §418.110(d)(6) for inpatient hospices, §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs require these facilities to have an outside window or outside door in every sleeping room. CMS will permit a waiver of these outside window and outside door requirements to permit these providers to utilize facility and non-facility space that is not normally used for patient care to be utilized for temporary patient care or quarantine.

Ambulatory Surgical Centers

• Medical Staff. 42 CFR 416.45(b). 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. This will allow for physicians whose privileges will expire to continue practicing at the ambulatory surgical center, without the need for reappraisal, and for ASCs to continue operations without performing these administrative tasks during the PHE. This waiver will improve the ability of ASCs to maintain their current workforce during the PHE.

Community Mental Health Centers

• Quality assessment and performance improvement (QAPI). 42 CFR 485.917(a)-(d) We are modifying the requirements for CMHC’s quality assessment and performance improvement (QAPI). Specifically, we are retaining the overall requirement that CMHC’s maintain an effective, ongoing, CMHC-wide, data-driven QAPI program, while 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). Waiving the requirements related to the details of the QAPI program’s organization and content will make it easier for CMHCs to reconfigure their QAPI programs, as needed, to adapt to specific needs and circumstances that arise during the PHE. These flexibilities may be implemented so long as they are consistent with a state’s emergency preparedness or pandemic plan.
• Provision of Services. 42 CFR 485.918(b)(1)(iii). We are 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. This waiver is a companion to recent regulatory changes (INSERT IFR CITATION WHEN RELEASED) that clarify how CMHCs should bill for services provided in an individual’s home, and how such services should be documented in the medical record. While this waiver will now allow CMHCs to furnish services in client homes, including through the use of using telecommunication technology, CMHCs continue to be, among other things, required to comply with the nonwaived provisions of 42 CFR Part 485, Subpart J, requiring that CMHCs: 1) assess client needs, including physician certification of the need for partial hospitalization services, if needed; 2) implement and update each client’s individualized active treatment plan that sets forth the 25 04/29/2020 type, amount, duration, and frequency of the services; and 3) promote client rights, including a client’s right to file a complaint.
• 40 Percent Rule. 42 CFR 485.918(b)(1)(v) We are 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. Waiving the 40 percent requirement will facilitate appropriate timely discharge from inpatient psychiatric units and prevent admissions to these facilities because CMHCs will be able to provide PHP services to Medicare beneficiaries without restrictions on the proportion of Medicare beneficiaries that they are permitted to treat at a time. This will allow communities greater access to health services, including mental health services.

Centers for Medicare & Medicaid Services

• CMS has published new information for clinicians about multiple flexibilities for its Quality Payment Program in response to the COVID-19 crisis, including extending the 2019 MIPS data submission deadline, information on reporting data from clinical trials, and more.
• CMS has published a memo to state Medicaid programs to clarify the different types of testing available for laboratories, whether the tests are being offered under an emergency use authorization issued by the FDA or as described in the FDA’s COVID-19 Test Guidance for these tests systems, and the CLIA certificates under which testing can be performed.
• CMS has posted a guide to flexibilities for home health agencies in their response to COVID-19.
• CMS has awarded $20 million in grants to combat COVID-19 through greater use of telehealth.
• CMS will host a call on nursing homes on Wednesday, May 6 at 4:30 p.m. (eastern) to provide updates on its latest COVID-19 guidance and leaders in the field will share best practices.  The call-in number is 833-614-0820 and the access passcode is 8899983.  Individuals who cannot get through to the call can follow it on an audio webcast.
• CMS will host an “office hours” call on Tuesday, May 5 at 5:00 p.m. (eastern) during which providers can ask CMS staff questions about the agency’s temporary actions in response to the COVID-19 emergency.  The call-in number is 833-614-0820 and the access code is 3996146.  Individuals who cannot get through to the call can follow it on an audio webcast.
• CMS will host a call on home health and hospice care on Tuesday, May 5 at 3:00 (eastern) to provide updates on its latest COVID-19 guidance and to hear leaders in the field share their best practices.  The call-in number is 833-614-0820 and the access passcode is 7844154.  Individuals who cannot get through to the call can follow it on an audio webcast.

Centers for Disease Control and Prevention

• The CDC has posted new resources on contact tracing, including:
  • a document with information about the role of contact tracing as part of a multi-pronged approach to fighting COVID-19;
  • a guide to contact tracing training;
  • COVID-19 contact tracing training guidance and resources;
  • principles of contact tracing; and
  • preliminary criteria for the evaluation of digital contact tracing tools for COVID-19.

Food and Drug Administration

• The FDA has issued guidance on exemption and exclusion from certain requirements of the Drug Supply Chain Security Act during the COVID-19 emergency.
• The FDA has posted an FAQ on ventilators.

National Institutes of Health

• The NIH has issued a news release announcing the launch of its Rapid Acceleration of Diagnostics (RADx) initiative aimed at speeding innovation, development, and commercialization of COVID-19 testing technologies.