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CMS Offers New Stark Waivers and More Flexibility to Health Care Providers Due to COVID-19

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued several temporary regulatory waivers to further enable the American healthcare system to respond to the COVID-19 pandemic with more efficiency and flexibility. The official publication can be found here: Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19.

The following measures will take effect immediately and will continue through the end of the public health emergency declaration:

  • “Stark Law” waivers. CMS is implementing waivers permitting certain referrals and the submission of related claims that would otherwise violate the Stark Law. A comprehensive list of these waivers can be found here
  • Hospitals or other health care providers may pay above or below fair market value for equipment rental or physician services. Examples:
    • A physician practice may rent or sell needed equipment to hospitals at a price that is below what the practice could charge another party.
    • A hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.
    • Health care providers can support each other financially to ensure continuity of health care operations. For example, a physician owner of a hospital may make a personal loan to the hospital without charging interest at a fair market rate so that the hospital can make payroll or pay its vendors.
    • Hospitals may provide certain benefits to their medical staff while the physicians are at the hospital and engaging in activities that benefit the hospital and its patients. These benefits may include multiple meals, laundry service, or childcare services. 
  • Certain items and services solely related to COVID-19 may be provided even though such provision may exceed the annual non-monetary compensation cap. Examples:
    • A home health agency may provide continuing medical education to physicians in the community on the latest care protocols for homebound patients with COVID-19.
    • A hospital may provide isolation shelter or meals to the family of a physician who was exposed to the novel coronavirus while working in the hospital’s emergency department.
    • Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms, even though such expansion would otherwise be prohibited under the Stark Law. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate an increased number of patients during the COVID-19 pandemic. 
  • Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations like mobile vans in parking lots that the group practice rents on a part-time basis. 
  • Telehealth. Clinicians can now provide more services via telehealth, including home visits, emergency department visits, and therapy services to help mitigate the risk of spreading the virus while still caring for patients. A complete list of these services can be found here
    • Virtual check-ins. Clinicians may now provide virtual check-in services (HCPCS G2012, G2010) to both new and established patients. Previously, these services could only be provided to established patients. 
    • Telephone codes. CMS reimbursement is now available for telephone evaluation and management services (E/M services) provided by a physician (CPT 99441-99443) and telephone assessment and management services provided by a qualified non-physician health care professional (CPT 98966-98968). These services are currently only available for established patients. However, these services may be provided using audio-only devices. 
    • E-visits. Certain non-physician providers, including licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists, can provide e-visits (HCPCS G2061-G2063). These services are only available for established patients. Additionally, these e-visits must be initiated by the patient. 
    • Remote patient monitoring. Clinicians can now provide remote patient monitoring services to both new and established patients. Additionally, these services can be provided for both acute and chronic conditions and for patients with only one disease. 
    • Removal of frequency limitations on Medicare telehealth. Subsequent inpatient visits (CPT 99231-99233), subsequent skilled nursing facility visits (CPT 99307-99310), and critical care consult codes (CPT G0508-G0509) no longer have limitations on the number of times they can be provided by telehealth to Medicare beneficiaries. 
    • Waiver of copayments. Providers may waive copayments for these telehealth services for Original Medicare beneficiaries. 
  • Medicare physician supervision requirements. For services requiring direct supervision by a physician or other practitioner, the physician supervision can be provided virtually using real-time audio/visual technology. Additionally, a physician may now provide a general level of supervision, instead of direct supervision, for non-surgical extended duration therapeutic services provided in hospital outpatient departments and critical access hospitals. This relieves physicians of the requirement to be immediately available in the office suite. 
  • MIPS flexibilities. Two updates to the Merit-based Incentive Payment System (MIPS) in the Quality Payment Program have been made. 
    • Clinicians adversely affected by COVID-19 may submit an application to request reweighting of the MIPS performance categories for the 2019 performance year. 
    • A new Improvement Activity for the CY 2020 performance year has been added that, if selected, would provide high-weighted credit for clinicians within the MIPS Improvement Activities performance category. Clinicians will receive credit for this Improvement Activity by participating in a clinical trial utilizing a drug or biological product to treat a patient with COVID-19 and then reporting their findings to a clinical data repository or clinical data registry. 
  • Signature Requirements. Signature and proof of delivery requirements for Part B drugs and Durable Medical Equipment have been waived when a signature cannot be obtained because of the inability to collect signatures. Suppliers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19.

BMD will continue to educate health care providers as additional waivers and further guidance on COVID-19 are issued. For questions, please contact Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or any member of the BMD Healthcare and Hospital Law group

Update: President Trump Signs Paycheck Protection Program Flexibility Act of 2020

On June 3, 2020, Congress updated the CARES Act by passing the Paycheck Protection Program Flexibility Act of 2020 (“FA”). The legislation, which has not yet been signed into law by President Trump, would provide more flexibility to small businesses who received loans under the Paycheck Protection Program (“PPP”).

Workers’ Compensation Claims and COVID-19

Can one of my employees file a workers’ compensation claim if they claim that they contracted coronavirus at work? We get that question a lot. Yes, they can, but you should oppose any application for coverage if you receive one. Generally, the claim will not be granted unless the employee has a job that poses a special hazard or risk of exposure to the virus and the employee can prove that he or she contracted the virus at work.

Ohio State Dental Board Implements Teledentistry Rules

Ohio law defines “teledentistry” as the delivery of dental services through the use of synchronous, real-time communication and the delivery of services of a dental hygienist or expanded function dental auxiliary pursuant to a dentist’s authorization.[1] The law requires a dentist who desires to provide dental services through teledentistry to apply for a teledentistry permit from the Ohio State Dental Board (“OSDB”).[2] Pursuant to the mandate under Ohio Revised Code 4715.436, the OSDB is implementing the following teledentistry permit rules and requirements (to be set forth under Ohio Administrative Code Chapter 4715-23). These regulations, which were subject of a public hearing on February 19, 2020, are effective on May 30, 2020.

HHS Addresses Drug Manufacturer Coupons on Out-of-Pocket Limits

On May 7, 2020, the US Department of Health and Human Services (“HHS”) announced their Notice of Benefit Parameters for 2021 in which HHS addressed the application of prescription drug manufacturer copay coupons towards a patient’s out-of-pocket limit. Under this guidance, HHS will permit, but not require, plans and insurers to count direct support offered to enrollees by drug manufacturers (i.e., coupons) for specific prescription drugs toward the annual limits on cost-sharing, regardless of whether a generic equivalent is available.

Important Updates, Deadlines, and Clarifications for the HHS Provider Relief Funds

On May 20, 2020, HHS made important updates and clarifications regarding the General Distribution payments to providers. Between April 10, 2020 and April 24, 2020, HHS distributed an initial $30 billion to providers based on the provider’s 2019 Medicare fee-for-service receipts. These funds were distributed automatically and providers did not need to submit an application in order to receive these funds. The funds were originally touted as a “no strings attached” stimulus payment reserved for healthcare providers. But HHS issued a 10-page Terms and Conditions and required that providers sign an attestation confirming receipt of the funds and agreeing to the Terms and Conditions.