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Newsletter

March 30, 2020

Health Headlines – March 30, 2020


Key Provisions of the CARES Act for Healthcare Providers – On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) was signed into law by President Trump. This historic legislation contains over $2 trillion in relief, including numerous healthcare related provisions. The CARES Act allows the HHS Secretary to make billions of additional dollars available to the healthcare providers, suppliers, and manufacturers. The CARES Act also increases flexibility under the Medicare program for providers to respond to COVID-19, including changes around telehealth, home health certifications, inpatient rehabilitation facility services, and long-term care hospital discharges and payments. Below is a summary of the key policy and funding provisions relevant to the healthcare provider community.

Assistance to Healthcare Providers

Medicare Payment Changes

  • Suspension of Medicare Sequestration Cuts: Suspends the 2% Medicare sequestration payment reduction from May 1 through December 31, 2020 and extends the Medicare sequestration payment reduction through fiscal year 2030, instead of fiscal year 2029.
  • Medicare Hospital Inpatient Prospective Payment System Add-On Payment For COVID–19 Patients During Emergency Period: Increases the weighting factor for each diagnosis-related group with a COVID-19 principal or secondary diagnosis by 20 percent during the COVID-19 public health emergency. This adjustment would not be considered in applying budget neutrality.
  • Expansion of Accelerated Payment Program: Expands the existing Medicare accelerated payment program for the duration of the COVID-19 emergency period. Specifically, qualified facilities would be able to request up to a six-month advanced lump sum or periodic payment. This advanced payment would be based on net reimbursement represented by unbilled discharges or unpaid bills. Most hospital types could elect to receive up to 100 percent of the prior period payments, with Critical Access Hospitals able to receive up to 125 percent. Finally, a qualifying hospital would not be required to start paying down the loan for four months and would also have at least 12 months to complete repayment without a requirement to pay interest.

New Funding

  • Public Health and Social Services Emergency Fund: $100 billion grant program to reimburse healthcare providers for lost revenue and COVID-19 related expenses.
    • Limitation: “funds may not be used to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse”
    • Timing: 
      • “[T]he Secretary of Health and Human Services shall, on a rolling basis, review applications and make payments under this paragraph in this Act[.]”
      • “[P]ayments under this paragraph shall be made in consideration of the most efficient payment systems practicable to provide emergency payment[.]”
    • Eligible Use of Funds: “…for building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity”
    • Audits/Reporting:
      • Within three years after final payments made under this program, HHS OIG is directed to transmit to Congress a final report on audit; HHS OIG and the Government Accountability Office may conduct audits of interim payments before that date. 
      • HHS Secretary is directed to provide a report to Congress, within 60 days of enactment, on distribution of funding, summarized by state; these reports shall be updated every 60 days until the funds are expended.
  • Public Health and Social Services Emergency Fund:
    • Vaccine, Therapeutics, Diagnostics, and other Medical or Preparedness Needs: Provides $11 billion, including at least $3.5 billion to advance construction, manufacturing, and purchase of vaccines and therapeutic delivery.
    • Hospital Preparedness: Provides $250 million to improve the capacity of healthcare facilities to respond to medical events.
  • Health Resources and Services Administration (HRSA):Provides $275 million to expand services and capacity for rural hospitals, telehealth, poison control centers, and the Ryan White HIV/AIDS program.

Delay of Medicare and Medicaid Payment Cuts

  • Medicare: Prevents scheduled payment adjustments for durable medical equipment (DME) in rural and noncontiguous areas from going into effect until December 31, 2020 (as scheduled) or until after the COVID-19 public health emergency ends.
  • Medicaid: Disproportionate Share Hospital (DSH) cuts are delayed through November 30, 2020.

Telehealth Services

  • Exemption for Telehealth Services: Allows a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible.
  • Increasing Medicare Telehealth Flexibilities During Emergency Period: Removes the requirement that a beneficiary receiving telehealth during the COVID-19 emergency period from a qualified provider under Medicare, Medicaid or the Children's Health Insurance Program (CHIP) have a prior relationship with a provider during the previous three years.
  • Enhancing Medicare Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics During Emergency Period: Allows the Secretary of HHS to pay for telehealth services furnished by a Federally Qualified Health Center (FQHC) or a Rural Health Clinic (RHC) during the COVID-19 Public Health Emergency. This section would allow FQHCs and RHCs to furnish telehealth services to beneficiaries in their home. Medicare would reimburse for these telehealth services based on payment rates similar to the national average payment rates for comparable telehealth services under the Medicare Physician Fee Schedule. It would also exclude the costs associated with these services from both the FQHC prospective payment system and the RHC all-inclusive rate calculation.
  • Temporary Waiver of Requirement for Face-To-Face Visits Between Home Dialysis Patients and Physicians: Authorizes the Secretary of HHS to waive the requirement that end-stage renal disease (ESRD) patients can receive monthly ESRD-related clinical assessments via telehealth only if they received a face-to-face clinical assessment without the use of telehealth services during the COVID-19 public health emergency.
  • Use of Telehealth to Conduct Face-To-Face Encounter Prior To Recertification of Eligibility for Hospice Care During Emergency Period: Permits the use of telehealth for a face-to-face encounter prior to recertifying eligibility for hospice care under Medicare during the COVID-19 public health emergency.
  • Improving Care Planning for Medicare Home Health Services: Permits providers other than physicians (e.g., nurse practitioners, clinical nurse specialists, and physician assistants under the supervision of a physician) to certify that an individual is confined to his or her home and requires certain home health services.

Emergency Measures

  • Post-Acute Care Access During Emergency Period: Provides acute care hospitals flexibility, during the COVID-19 emergency period, to transfer patients out of their facilities and into alternative care settings in order to prioritize resources needed to treat COVID-19 cases. Specifically, this section would waive the Inpatient Rehabilitation Facility (IRF) 3-hour rule, which requires that a beneficiary be expected to participate in at least three hours of intensive rehabilitation at least five days per week to be admitted to an IRF. It would allow a Long-Term Care Hospital (LTCH) to maintain its designation even if more than 50 percent of its cases are less intensive. It would also temporarily pause the current LTCH site-neutral payment methodology.

Personal Protective Equipment (PPE) for Healthcare Workers and Patients

  • Strategic National Stockpile:
    • Clarifies the Strategic National Stockpile (SNS) includes certain types of medical supplies such as personal protective equipment and supplies necessary for administering drugs, vaccines, and diagnostic tests.
    • Authorizes $16 billion to procure personal protective equipment, ventilators, and other medical supplies for federal and state response efforts. When combined with the first supplemental, the Committee has provided approximately $17 billion for the Stockpile.
  • Liability Protection: Grants permanent liability protection for manufacturers of personal respiratory protective devices where such devices are determined to be a priority for use during a public health emergency.
  • Defense Production Act (DPA): Authorizes $1 billion for the DPA, to increase access to materials necessary for national security and pandemic recovery.

Diagnostic Tests

  • Coverage of Testing and Preventive Services:
    • Clarifies all testing for COVID-19—including tests without an Emergency Use Authorization (EUA) from the FDA—be covered by commercial insurance plans without cost sharing.
    • Requires insurers to pay providers either a contracted rate or a cash price posted by a provider (if no contracted rate exists) for COVID-19 tests covered at no cost to patients. Providers that do not post their cash price for the test on their website are subject to civil monetary penalties.
    • Requires insurers to cover any COVID-19 vaccine that meets certain qualifications without imposing any cost-sharing on patients.
  • New Funding: Authorizes $1.32 billion in supplemental FY2020 funding for community health centers for testing and treating COVID-19.

A copy of the CARES Act can be found here.

Reporter, William Clarkson, Washington, D.C., + 1 202 626 8997, wclarkson@kslaw.com.

CMS Approves Emergency Medicaid Waivers for 34 States; More States to Come  –  Following President Trump’s declaration of a national emergency related to COVID-19 on March 13, 2020, CMS has been swiftly approving states’ requests for flexibilities for their Medicaid programs as they continue to battle the virus.  Section 1135 of the Social Security Act permits CMS to temporarily waive or modify Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient healthcare items and services are available during a national and public health emergency such as the COVID-19 pandemic.  CMS approved the first two states’ Section 1135 waivers (for Florida and Washington) on March 19, 2020 and followed it with 11 additional waiver approvals for various states on March 23.  CMS then approved numerous other Medicaid Section 1135 waiver requests last week, with an average approval time of less than six days, bringing the current total to 34 states.  CMS has credited its use of a “streamlined template to facilitate expedited application and approval” of the waivers given the threat of COVID-19.  The full and current list of Section 1135 waivers and other details are available here.

In the Medicaid context, Section 1135 waivers give states flexibility to administer their Medicaid programs in a manner that allows healthcare providers who, as a result of a national emergency, are otherwise unable to strictly comply with certain federal Medicaid requirements.  Additionally, providers are exempted from sanctions and reimbursement penalties from noncompliance with those Medicaid requirements, absent fraud or bad faith.  Examples of “flexibilities” that states may seek through Section 1135 waiver requests include:

  • Streamlining processes to ramp up provider enrollment;
  • Allowing care to be provided in alternative settings in the event a facility is evacuated or is filled to capacity;
  • Extending deadlines for appeals and state fair hearing requests;
  • Waving prior authorization requirements in fee-for-service programs;
  • Permitting providers located out of state/territory to provide care to another state’s Medicaid enrollees impacted by the emergency;
  • Suspending certain provider enrollment and revalidation requirements to increase access to care;
  • Waiving requirements that physicians and other healthcare professionals be licensed in the state in which they are providing services, so long as they have equivalent licensing in another state; and
  • Suspending requirements for certain pre-admission and annual screenings for nursing home residents.

As King & Spalding previously reported, Florida and Washington were the first states to receive CMS approval for a Section 1135 Medicaid waiver.  Since then, a flood of requests have been approved, with the current total reaching 34 states.  Most states to date are receiving approvals for their requested flexibilities related to fee-for-service prior authorization requirements, fair hearings and appeals, out-of-state provider enrollment and credentialing requirements, and revalidation processes.

Detailed below are the major features of the Section 1135 Medicaid waiver approvals for particular states. With the COVID-19 virus now affecting all 50 states, CMS expects more states to submit similar 1135 waiver requests.  For example, Texas’s Governor Greg Abbott announced on March 26 that the Texas Health and Human Services Commission (HHSC) submitted a Section 1135 Medicaid waiver to CMS for consideration.  Georgia’s Governor Brian Kemp and the Georgia Department of Community Health (DCH) also announced on March 28 that Georgia has submitted a waiver request for consideration. Beyond these state-specific approvals, CMS has already issued “blanket” Section 1135 waivers for all providers, described in CMS’s Fact Sheet here.  King & Spalding will continue to monitor these developments as additional states seek flexibilities in their Medicaid programs as the COVID-19 response efforts unfold.

Alabama

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  One highlight is that it suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.

Arizona

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Arizona.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Arizona or are otherwise directly impacted by the emergency.

California

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than California.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in California or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Colorado

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Colorado.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Colorado or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State flexibility in its State Plan Amendment (SPA) requirements, including flexibility to modify timeframes associated with tribal consultation.

Connecticut

On March 27, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Connecticut.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Connecticut or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State flexibility in its State Plan Amendment (SPA) requirements, including flexibility to modify timeframes associated with tribal consultation.

Delaware

On March 27, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Delaware.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Delaware or are otherwise directly impacted by the emergency.

Hawaii

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements. 
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Hawaii.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Hawaii or are otherwise directly impacted by the emergency.
  • Allows the State flexibility in its State Plan Amendment (SPA) requirements, including flexibility to modify timeframes associated with tribal consultation.

Idaho

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Idaho.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Idaho or are otherwise directly impacted by the emergency.

Illinois

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Illinois.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Illinois or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Indiana

On March 25, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Indiana.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Indiana or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Iowa

On March 25, 2020, CMS approved the State’s waiver request.  The full text is available here. One highlight includes that it suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.

Kansas

On March 24, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Kansas.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Kansas or are otherwise directly impacted by the emergency.

Kentucky

On March 25, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Kentucky.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Kentucky or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Louisiana

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Louisiana.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Louisiana or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Maryland

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Maryland.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Maryland or are otherwise directly impacted by the emergency.
  • Allows the State flexibility in its State Plan Amendment (SPA) requirements, including flexibility to modify timeframes associated with tribal consultation.

Massachusetts

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Massachusetts.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Massachusetts or are otherwise directly impacted by the emergency.
  • Allows the State flexibility in its State Plan Amendment (SPA) requirements, including flexibility to modify timeframes associated with tribal consultation.

Minnesota

On March 27, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable
  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Minnesota.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Minnesota or are otherwise directly impacted by the emergency.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State flexibility in the submission deadline and public notice requirement for State Plan Amendment (SPA) submissions related to beneficiaries’ access to COVID-19-related items and services.

Mississippi

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Mississippi.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Mississippi or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Missouri

On March 25, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Missouri.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Missouri or are otherwise directly impacted by the emergency.
  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State flexibility in the submission deadline and public notice requirement for State Plan Amendment (SPA) submissions related to beneficiaries’ access to COVID-19-related items and services.

New Hampshire

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than New Hampshire.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

New Jersey

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than New Jersey.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in New Jersey or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

New Mexico

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than New Mexico.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in New Mexico or are otherwise directly impacted by the emergency.

New York

On March 26, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than New York.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in New York or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

North Carolina

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than North Carolina.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in North Carolina or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Temporarily suspends Medicaid fee-for-service prior authorization requirements. 

North Dakota

On March 24, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than North Dakota.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in North Dakota or are otherwise directly impacted by the emergency.
  • Allows the State flexibility in modifying the timeframes associated with tribal consultation related to State Plan Amendment (SPA).

Oklahoma

On March 24, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Oklahoma.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Oklahoma or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Temporarily suspends Medicaid fee-for-service prior authorization requirements. 

Oregon

On March 25, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Oregon.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Oregon or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.
  • Allows the State flexibility in the submission deadline and public notice requirement for State Plan Amendment (SPA) submissions related to beneficiaries’ access to COVID-19-related items and services.

Pennsylvania

On March 27, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Pennsylvania.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Pennsylvania or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Rhode Island

On March 25, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing authorizations for which a beneficiary has previously received prior authorization.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions, and modifies the timeframe for managed care enrollees to exercise their appeal rights.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Rhode Island.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Temporarily ceases revalidation of providers who are located in Rhode Island or are otherwise directly impacted by the emergency.

South Dakota

On March 24, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse otherwise payable claims from out-of-state providers not enrolled in the state Medicaid program if certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than South Dakota.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in South Dakota or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards.

Virginia

On March 23, 2020, CMS approved the State’s waiver request, effective retroactively to March 1.  The full text is available here.  Highlights include:

  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.  Also extends pre-existing prior authorizations for care to be provided without a new or renewed prior authorization through the termination of the emergency.

Wyoming

On March 27, 2020, CMS approved the State’s waiver request.  The full text is available here.  Highlights include:

  • Temporarily suspends Medicaid fee-for-service prior authorization requirements.
  • Suspends Pre-Admission Screening and Annual Resident Review (PASRR) Level I and Level II Assessments for 30 days.
  • Allows the State flexibility in scheduling Medicaid fair hearings and issuing fair hearings decisions.
  • Allows the State to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as certain criteria are met.
  • Allows the State to temporarily enroll out-of-state providers that are already enrolled in Medicare or with a state Medicaid program other than Wyoming.  Also waives certain screening and enrollment requirements for providers not already enrolled with another state Medicaid program or Medicare.
  • Temporarily ceases revalidation of providers who are located in Wyoming or are otherwise directly impacted by the emergency.
  • Allow facilities to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards. The full text is available.

Reporters, Lee T. Nutini, Chicago, + 1 312 764 6910, lnutini@kslaw.com, and Ahsin Azim, Washington, D.C., + 1 202 626 9262, aazim@kslaw.com.

OIG Announces Policy Not to Sanction Providers for Waiving Cost Sharing Obligations for Telehealth Services – On March 17, 2020, OIG issued a policy statement titled, “Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Healthcare Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak.”  In short, OIG will not be subjecting physicians or other practitioners to OIG administrative sanctions if the provider reduces or waives cost-sharing obligations that a patient may owe for telehealth services for the duration of the COVID-19 public health emergency. 

Normally, OIG issues penalties to providers who reduce or waive cost-sharing obligations owed by beneficiaries of federal healthcare programs on the grounds that such waivers or reductions can implicate the federal anti-kickback statute, civil monetary penalty and exclusion laws related to kickbacks, and the civil monetary penalty prohibition on inducements to beneficiaries.  Notwithstanding these concerns, OIG has decided to suspend the imposition of these penalties starting January 27, 2020—the date HHS Secretary Alex Azar determined that a public health emergency exists under the Public Health Service Act.  The suspension of these penalties will continue for the duration of the public health emergency, i.e. until the Secretary declares that the public health emergency no longer exists or upon the expiration of the 90-day period beginning January 27, 2020.  The Secretary may extend the public health emergency declaration for subsequent 90-day periods.

On March 24, 2020, OIG issued an FAQ statement addressing various questions it has received about this policy.  In particular, the OIG noted that this Policy Statement is not limited to the services governed by 42 C.F.R § 410.78 but is intended to apply to a broad category of non-face-to-face services, including telehealth visits, virtual check-in services, e-visits, monthly remote care management, and monthly remote patient monitoring.  OIG also clarified that this policy applies to physicians and practitioners whether or not they have assigned their right to receive payments to eligible third-party organizations such as a hospital or other entity billing on behalf of the physician or practitioner.

This Policy Statement does not require providers to reduce or waive any cost-sharing obligations owed by beneficiaries of federal healthcare programs for telehealth services.  If providers offer free telehealth services during this period, OIG will not view the provision of free telehealth services alone to be an “inducement” for future referrals.  It may, however, view the provision of free telehealth services as an inducement if there is other evidence of an inducement. 

It should be noted that CMS has its own rules and regulations, which remain unaffected by the OIG’s Policy Statement on this issue, and providers remain under an obligation to bill only for services performed and to comply with legal authorities related to proper billing, claims submission, cost reporting, etc.

The OIG Policy Statement is here, and the FAQ regarding the Policy Statement is here.

Reporter, Ariana Fuller, Los Angeles, +1 213 443 4342, afuller@kslaw.com.

ALSO IN THE NEWS

Trump Administration Requests That Hospitals Report COVID-19 Testing, Bed Count, and Ventilator Usage Data to Federal Agencies

On March 29, 2020, Vice President Pence sent a letter to hospital administrators requesting that all hospitals report data from COVID-19 testing performed “in-house” (rather than through a commercial laboratory) to HHS. Hospitals are asked to fill out a spreadsheet provided by the administration and submit it to HHS every day by 5 p.m. The White House Coronavirus Task Force has been collecting data from public health and commercial laboratories but does not yet have data from hospital laboratories. The letter also requests that hospitals report daily counts of patients with suspected and confirmed COVID-19 diagnoses and current use and availability of hospital beds and mechanical ventilators to the CDC. The letter is available here.

Survey of State Shelter-in-Place / Stay-at-Home Orders

As COVID-19 continues its acceleration, states across the United States are responding with a variety of executive-level orders to protect the public health. While some states have chosen not to issue orders, King & Spalding has compiled a survey addressing the range of orders that have been issued to date, including orders with minimal restrictions up to orders affirmatively ordering individuals to “shelter in place” or “stay at home” with all non-essential business operations ceasing. The survey is available here.

King & Spalding Life Sciences & Healthcare Webinar: Clinical Trials During the COVID-19 Pandemic: Recent FDA and EU Guidance and Recent Court Decision Requiring Reporting of Undisclosed Clinical Trial Results

On Friday, April 3, 2020, from 1:00 p.m. to 2:30 p.m. ET, a panel of attorneys from King & Spalding LLP will host a webinar on recent FDA guidance addressing modifications of drug, biological, and medical device clinical trials that may be required to ensure human subject safety during the COVID-19 pandemic, and recent EU guidance specific to drug and biological clinical trials. In a separate matter important to clinical trial sponsors, the panelists also will address the recent decision by the U.S. District Court for the Southern District of New York in Seife v. HHS, finding that HHS has been erroneously limiting the disclosure requirements for the ClinicalTrials.gov data bank. See the King & Spalding Life Sciences team’s alert about the FDA and EU Guidance here and an alert about the SDNY Decision here. Topics to be addressed include:

  • Whether participant safety in a sponsor’s clinical trials is best served by halting or continuing recruitment, test product administration, or the trial itself;
  • What to consider regarding challenges in monitoring and test product accountability;
  • How to address protocol deviations and changes, including those to minimize immediate hazards from participant or investigational staff exposure to COVID-19;
  • How the new European and FDA guidances differ;
  • Key issues for companies to understand about the basis of the court’s decision about “pre-rule, pre-approval” applicable clinical trials in Seife v. HHS;
  • Act now or wait? – implications for companies considering retroactive submission of basic results to ClinicalTrials.gov.

You do not need to be a client to attend, and there is no charge. For more information and to register, please click here.