On April 30^th, the Centers for Medicare and Medicaid Services (CMS) announced a second interim final rule (IFC) aimed at addressing the ongoing COVID-19 public health emergency (PHE). The rule has not yet been submitted to the Federal Register.

The rule include flexibilities for a variety of areas including infection control in long-term care facilities, relocation of provider-based departments (PBDs), home health services, quality data reporting, telehealth, and testing.

Below are many of the new flexibilities and capabilities included in the waivers and rule.

CMS Looks to Expand Diagnostic Testing Capacity

• COVID-19 tests may be covered when ordered by any health care professional authorized to do so under state law; Currently, COVID-19 diagnostic laboratory tests are only covered when ordered by a physician or health care practitioner who is treating the beneficiary.
• The treating physician ordering requirement is also removed for diagnostic laboratory tests for influenza virus and respiratory syncytial virus when they are furnished in conjunction with a COVID-19 diagnostic laboratory test.
• FDA-authorized COVID-19 serology test are coverable by Medicare for beneficiaries with known or suspected current or prior COVID-19 infection.
• Laboratories and clinicians are expected to report testing results to state and local public health officials within 24 hours.
• New HCPCS code, C9803, is created to describe hospital outpatient clinic visit specimen collection for SARS-CoV-2 (COVID-19), any specimen source.
• Physicians and other practitioners can bill CPT code 99211 for a level 1 E/M visit and furnished for COVID-19 assessment and specimen collection for both new and established patients.
• New HCPCS code, C9803, hospital outpatient clinic visit specimen collection for SARS-CoV-2 (COVID-19), any specimen source. The code will be reimbursed at $22.98 and it will be retired after the public health emergency ends.
• As required by the CARES Act, there is no cost-sharing for beneficiaries that receive COVID-19 testing under Medicare Part B.
• The CARES Act also requires Medicaid coverage for in-vitro diagnostic products for detection of SARS-CoV-2, antibodies to the virus, or diagnostic of the COVID-19 virus. CMs is permitting flexibility for testing coverage, including testing administered in non-office settings and self-collection tests authorized by the FDA for home use.
• CMS is seeking comments on the application of testing flexibilities for future public health emergencies and any subsequent period of active surveillance.

Infection Prevention & Control Procedures for Long-Term Care Facilities Immediately Updated to Require Reporting of COVID-19 Infections

• CMS is immediately updating conditions of participation for long-term care facilities (including skilled nursing facilities and nursing facilities) to require all facilities receiving payments for Medicare or Medicaid to establish explicit reporting requirements for confirmed or suspected cases of COVID-19 among residents and staff, personal protective equipment and hand hygiene supplies in the facility, ventilator capacity and supplies, access to COVID-19 tests, and staffing shortages.
• Data must be submitted at least weekly to the Centers for Disease Control (CDC) National Healthcare Safety Network (NHSN).
• Additionally, facilities must inform residents, their representatives, and families of suspected or confirmed cases of COVID-19 among residents or staff within one calendar day.

CMS Outlines Requirements for Relocating Provider-Based Departments During the PHE

• CMS is temporarily adopting an expanded version of the extraordinary circumstances relocation policy during the COVID-19 PHE to include on-campus provider-based departments (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 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 COVID-19 PHE can involve a single excepted PBD relocating 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 under the main hospital, no additional provider enrollment actions are required for the off-campus relocated site during the COVID-19 PHE.

Audio-Only Telephone Visits to be Reimbursed at Same Level as Face-to-Face Visits

• CMS is increasing reimbursement for audio-only telehealth visits to make it on par with similar office and outpatient visits for evaluation and management services.
• Payments will apply retroactively to March 1, 2020

Scheduled Reductions in DME Payment Pushed to After Public Health Emergency

• The CARES Act prevents scheduled reductions in Medicare payments for durable medical equipment (DME) during the length of the COVID-19 public health emergency.
• To implement this, CMS is revising the fee schedule amounts for certain DME and enteral nutrition and supplies furnished in non-Competitive Bidding Areas (non-CBAs).
• CMS will continue paying for DMEPOS items furnished in rural and non-CBAs based on a 50/50 blend of adjustment and unadjusted fee schedule amounts through December 31, 2020 or until the end of the PHE, whichever is longer.
• In non-CBAs other than rural areas, CMS will pay an increase amount of 75/25 blend of adjusted and non-adjusted fee schedule amounts through the end of the public health emergency, increasing these payments by about 33%.
  • This provision is retroactive to March 6, 2020.

Changes to Home Health Services as Required by CARES Act Retroactively Effective to March 1, 2020

• Non-physician practitioners (nurse practitioners, physician assistants and clinical nurse specialists) are now able to certify, establish and review beneficiary care plans for home health services, a role previously reserved for a physician
  • Independent practice authority remains conditional on state law.

Changes to Certification of Home Health Services in Medicaid to be Permanent, Includes Durable Medical Equipment

• The same CARES Act language that expanded the ability of non-physician practitioners to certify, establish, and review beneficiary care plans for home health services also applied that ability to providers working with Medicaid beneficiaries.
• However, the statutory language for Medicaid was not time-limited to the period of the COVID-19 PHE; therefore, these revisions will be permanently in effect.
• The Medicaid home health benefit also provides coverage of part-time or intermittent nursing, home health aide services, and durable medical equipment (DME); states are permitted to include therapy services at their discretion.
• Therefore, non-physician practitioners will now be able to order DME, when practicing in accordance with state law, for Medicaid beneficiaries, including dual-eligibles.

CMS Grants Flexibility in Scope of Practice to Allow Some Non-Physicians Practitioners to Order and Provide Diagnostic Tests

• CMS is granting flexibility during the declared PHE to allow certain non-physician practitioners (NPP) to order, furnish directly, and supervise the performance of diagnostic tests payable under the Physician Fee Schedule (PFS), within their state scope of practice.
  • These practitioners include nurse practitioners (NPs), physician assistants (PAs), certified nurse midwifes (CNMs), and clinical nurse specialists (CNSs)
• Physician therapists and occupational therapists who establish a maintenance program for a patient may delegate the performance of maintenance therapy services to PTAs or OTAs when clinically appropriate.
• Any practitioner that has a separately benefit under Medicare that allows them to furnish and bill for services may review and verify notes in the medical record.
• CMS is clarifying that pharmacists fall under the regulatory definition of auxiliary personnel, allowing them to provide services incident to services billed by a physician or NPP, in accordance with state scope of practice and state law.

Certain Outpatient Therapy and Counseling May Be Provided in Temporary Expansion Locations, Including a Patient Home

• Hospital and community mental health center (CMHC) staff can furnish certain outpatient therapy, counseling, and educational services incident to a physician’s service to a beneficiary in their home or other temporary expansion location using telecommunications technology.
• Hospitals and CMHCs can furnish services to a beneficiary in a temporary expansion location expanded CMHC (including the beneficiary’s home) if that beneficiary 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.

Data Reporting Deadlines Extended for Certain Post-Acute Care Requirements

• Home health agencies (HHAs) in the Home Health Value-based Purchasing Model will not have to report quality data for Q4 2019, Q1 2020, and Q2 2020 since all exceptions and deadline extensions granted to HHAs for reporting quality data will apply to the HH VBP Model.
• Under the Merit-based Incentive Program (MIPS), CMS is delaying implementation of two policies for qualified clinical data registries (QCDRs) to the 2022 performance period:
  • All QCDR measures be fully developed and tested prior to submitting the measure at the time of self-nomination.
  • QCDRs will collect data on a QCDR measure prior to submitting the measure for CMS consideration during the self-nomination period.
• CMS is delaying the release of updated versions of the IRF Patient Assessment Instrument (IRF-PAI), LTCH CARE Data Set, HHA’s Outcome and Assessment Information Set (OASIS), and the Minimum Data Set (MDS) used by SNFs to reduce provider burden.
  • As these impact collection and data reporting for recently adopted transfer of health (TOH) information measures and SPADEs, CMS is delaying data collection for these until one full fiscal year after the end of the PHE. For SNFs, the delay is 2 full fiscal years after the end of the PHE.
• The extraordinary circumstances exception policy for the Hospital value-based purchasing (VBP) Program is being modified to allow CMS to grant exceptions to hospitals which have not requested it should the agency determine that an extraordinary circumstance, i.e. COVID-19, affects an entire region or locale, including if that is the entire United States.

Medical Resident Time Will Be Treated the Same for Locations Established and Operated as Part of the Hospital

• Time spent by residents at locations established and operated as part of the hospital that meet non-waived conditions of participation will not be treated any different than time spent at locations established and operated prior to the PHE.
• For the duration of the PHE, CMS has adopted a policy that routine services provided to inpatients under arrangements outside the hospital are deemed to have been provided by the hospital and time spent by residents at these locations is not treated any differently.
• 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]

States May Revise Basic Health Plan Blueprints Retroactive to March 1, 2020

• CMS will allow states to make temporary significant changes to the state’s Basic Health Plan Blueprint in order to respond to the COVID-19 PHE without going through the full CMS certification process, including a public comment period, as long as the changes are not more restrictive in nature (e.g. increase cost-sharing, reduce benefits or limit or reduce eligibility for coverage).

Implementation of Separate Billing for Coverage of Pregnancy Termination Services Delayed

• In an effort to free-up resources for qualified health plans, CMS is delaying implementation of the requirement that QHPs offering coverage of pregnancy termination services provide two separate bills to enrollees to the first billing cycle following August 26, 2020.
• Previously, QHPs were required to begin charging two premiums (one for non-pregnancy termination coverage and one for the coverage) to enrollees following the first billing cycle following June 27, 2020.

CMS Updates Definition of Primary Care Services for Certain Medicare Shared Savings ACOs

• The following policies apply to Track 1+ Model ACOs:
  • The definition of primary care services used in beneficiary assignment will 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.
  • 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.
  • Expenditure calculations will be adjusted to remove expenditures for episodes of care for treatment of COVID-19.
• CMS will also adjust revenue calculations to remove expenditures for episodes of care for treatment of COVID-19 for Track 1+ Model ACOs through an amendment to the model participation agreement.

CMS Grants Flexibility for Rural Health Clinics, Remote Physiological Monitoring, Evaluation and Management Services

• CMS will use a subregulatory process to modify the services included on the Medicare telehealth list during the declared PHE.
• For rural health clinics (RHCs), CMS will use the number of beds from the cost reporting period prior to the start of the PHE as the official hospital bed count for application of the per-visit payment limit.
• For the duration of the PHE, remote physiologic monitoring (RPM) services can be reported to Medicare for periods of time fewer than 16 of 30 days but no less than 2 days, as long as other requirements of the billing code used are met.
• For the duration of the PHE, CMS clarified that the typical times for the purposes of level section for an office/outpatient evaluation and management (E/M) are the times listed in the CPT code descriptor.
• Similar to policies in previous COVID-10 rulemaking for infusion pump NCD and LCDs, CMs will not enforce the clinical indications for therapeutic continuous glucose monitors (CGMS) in LCDs during the public health emergency.