OIG Responds to FAQs on whether Stark Waivers Nevertheless Implicate the Anti-Kickback Statute

As we reported in our April 17, 2020 Newsletter, the HHS Office of Inspector General (OIG) said that seven of the financial relationships that otherwise implicate Stark but are permitted by CMS under its public health emergency (PHE) blanket waivers may still potentially violate the Anti-Kickback Statute (AKS) and expose providers to sanctions. Since our last report, the OIG has posted FAQs—Applications of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 PHE in response to questions.

The OIG’s responses are a bit of a “mixed bag.” Recognizing the extraordinary need presented by the unique and exigent circumstances resulting from the COVID-19 outbreak, the OIG tells providers who provide free or reduced-rate services to long-term care facilities that the OIG will not pursue enforcement action so long as the services are provided directly in response to need arising out of, and only during the period of, the COVID-19 outbreak, and not contingent on referrals for any items or services that may be reimbursable by a Federal health care program. Similarly, a hospital may provide access to its web-based telehealth platform to independent physicians on its medical staff during the COVID-19 outbreak if such access is necessary for the provision of needed telehealth services in response to the outbreak, not conditioned on past or anticipated referrals, and offered to all physicians on the medical staff. On the other hand, the OIG warned that the remuneration stemming from an arrangement that is neither set forth in writing nor signed by the parties (but otherwise fully complies with an applicable Stark exception) may still implicate the AKS, and the provider should seek further guidance from the OIG.

Other FAQs considered whether the OIG will pursue enforcement against a hospital that suspends rental charges and accrual of interest for a Federally Qualified Health Center Look-Alike, whether a mental health and substance disorder provider can use public and private donations to provide cell phones to financially needy patients, and whether an oncology practice can offer free in-kind local transportation to an alternative site of service. The OIG is still inviting providers to submit questions about the OIG’s views on an arrangement directly connected to the PHE. Questions may be submitted to OIGComplianceSuggestions@oig.hhs.gov.

CMS Announces Additional Waivers and Flexibilities for Healthcare Provider Response to COVID-19

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it had issued additional waivers and flexibilities in response to requests from healthcare providers. Among other updates, Medicare will no longer require an order from a treating physician or other practitioner for coverage of a Medicare beneficiary’s COVID-19 (and related) diagnostic tests. This means pharmacists can administer the tests without a practitioner order (which services can be billed directly by a pharmacist enrolled in Medicare or a laboratory, or by a coordinating provider or practitioner) and make it easier for beneficiaries to be tested at parking lot testing sites operated by pharmacies. Medicare and Medicaid will also cover certain serology (antibody) tests used to determine whether a person may have developed an immune response to COVID-19

1135 Waivers

March 20, 2020

On March 13, 2020, HHS Secretary Alex Azar issued several waivers of certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements pursuant to Section 1135 of the Social Security Act. Click here. CMS published specific “blanket” waivers and encouraged the states to request waivers for federal components and requirements of their Medicaid and CHIP programs. Click here. Several states have already submitted requests to their CMS Regional Offices, and CMS has issued certain 1135 waivers to the states of Florida and Washington. The Kentucky Hospital Association coordinated with many of Kentucky’s health care providers, legal experts, and other contributors to compose Kentucky’s list of most-needed 1135 waivers for consideration by CMS. Wyatt’s Healthcare Law Service Team has assisted several clients in contributions to the state waiver request. CMS has published additional guidance and FAQs for state Medicaid and CHIP Agencies: Click here.

Medicare Quality Reporting Program Waivers

March 27, 2020

On March 22, 2020, CMS announced that it is granting exceptions from reporting requirements and extensions for clinicians, providers, hospitals and facilities who participate in Medicare’s quality reporting programs with regard to upcoming measure reporting and data submissions. Medicare extended the MIPS and ACO deadline of March 31, 2020 to April 30, 2020 but went on to say that MIPS clinicians who have not submitted anything by the new April 30 deadline will qualify automatically for the “extreme and uncontrollable circumstances” policy. The 4th quarter data submission deadline for hospitals and Post-Acute (PAC) programs is optional. Additionally, data submission deadlines in April and May 2020 will be optional for facilities. For additional information about the deadline extensions, automatic hardship qualifications and the impact on CMS’s calculations for the Medicare quality reporting and value-based purchasing programs, see the CMS press release here.

Kentucky Section 1135 Waivers

March 27, 2020

CMS granted several Section 1135 waivers to Kentucky, noted in this letter. The waivers include an allowance for temporary Medicaid enrollment of providers who are enrolled in Medicare or another state’s Medicaid and a waiver of prior authorization and medical necessity processes in Medicaid fee for service. The waivers are effective March 1, 2020, unless noted in the letter. CMS did not address several additional waiver requests that Kentucky made but advised that it is continuing to review them.

Waiver of 3-Day Prior Hospitalization for SNF Part A Admissions

April 3, 2020

Under the Section 1135 waiver authority, CMS has waived the 3-day hospital stay requirement that must immediately precede a covered Part A qualified stay at a skilled nursing facility (“SNF”). During the CMS National Stakeholder Call on March 31, 2020, CMS Administrator Seema Verma confirmed that this waiver is not geographic specific and applies to all SNFs regardless of whether the SNF is in a community then currently experiencing a COVID-19 crisis or surge. Administrator Verma also confirmed that patients admitted to a SNF under this waiver need not have a COVID-19 diagnosis. Additional information about the SNF waivers are available in the CMS “Tear Sheet” for Long-Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities) on the CMS Coronavirus Waivers & Flexibilities website.