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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

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.

Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.

S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio

Just before the end of calendar year 2020 and at the end of its two-year legislative session, the Ohio General Assembly passed Senate Bill 263, which prohibits insurance companies and pharmacy benefit managers (“PBMs”) from imposing on 340B Covered Entities discriminatory pricing and other contract terms. This is a win for safety net providers and the people they serve, as 340B savings are crucial to their ability to provide high quality, affordable programs and services to patients.