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COVID-19: HRI’s guide to rapid deregulation by HHS

Crystal Yednak Senior Manager, Health Research Institute, PwC US April 17, 2020

A rush of deregulatory actions by HHS has temporarily expanded telehealth for Medicare beneficiaries no matter where they live, allowed hospitals to expand into alternate facilities, loosened licensing and reporting requirements, and widened the pool of potential healthcare providers who can participate in the COVID-19 emergency response effort.

In addition to blanket waivers, HHS has approved 50 Section 1135 waivers as of April 15, 2020 to provide states and territories flexibility in responding to the COVID-19 emergencies through Medicaid. The flood of guidelines, fact sheets and waivers has quickly altered the regulatory landscape for US healthcare, at least temporarily, through the duration of the public health emergency. HRI has highlighted some key actions.


  • Reimbursement increased, covered services expanded. To keep vulnerable populations protected from virus exposure, CMS is reimbursing providers the same amount for a telehealth visit as it does for an in-person visit for Medicare beneficiaries, covering 80 additional services through telehealth. The agency also is allowing more types of practitioners to deliver telehealth services to beneficiaries. Remote patient monitoring is allowed for both COVID-19 patients and those with chronic conditions.
  • More tools allowed. HHS has said it would use its enforcement discretion to not penalize providers for HIPAA violations for using “widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose.” Telehealth services can be provided to beneficiaries who have only a regular phone and no ability to connect virtually.
  • More virtual check-ins. CMS is allowing providers to conduct virtual check-ins with new as well as established patients.

Surge capacity: Where patients can go


  • Special testing sitesCMS guidelines allow healthcare systems, hospitals and communities to set up testing and screening sites exclusively for COVID-19. Also, HHS has said it will use its enforcement discretion to not penalize covered entities such as healthcare systems and large retail pharmacy chains, and their business associates, for violations of HIPAA rules if they are acting in good faith by providing services through drive-thru and mobile COVID-19 testing sites.
  • Licensed pharmacists can order and administer COVID-19 tests (including serology tests) that have been authorized by the FDA, according to new guidance.
  • In-home testsMedicare will pay laboratory technicians to travel to a beneficiary’s home to collect a specimen for COVID-19 testing so the beneficiary does not have to go to a hospital and risk exposure. Under certain circumstances, according to CMS, “some entities will also temporarily be able to perform COVID-19 tests on individuals at home and in other community-based settings.”


  • Out-of-state practitioners who have a valid license do not also have to be licensed in the state where they are providing services to Medicare beneficiaries.
  • Provider enrollment eased. The change enables healthcare systems to tap local private practices and their staffs for temporary employment. CMS waivers also allow physicians whose privileges will expire to continue working, and for new physicians to start before going before a full review by a governing body.
  • Hospitals can provide benefits and support to their medical staffs, such as daily meals, laundry service for personal clothing or child care. (See HRI’s piece on the importance of caring for the caregiver.)
  • Hospitalized Medicare patients do not have to be under the care of a physician, according to a CMS waiver. This is to allow hospitals to deal with staffing challenges by maximizing the use of nurse practitioners and physician assistants.
  • Verbal order requirements have been relaxed to allow providers to focus on care. Providers in outbreak areas are also released from certain timelines on making copies of medical records available, and do not have to have written policies on visitation.
  • A Physician Self-Referral (Stark) Law waiver applies to physician financial relationships and referrals related to the COVID-19 outbreak to allow for healthcare systems to arrange for proper space and services in the response to the pandemic. Examples include a hospital renting space from an independent physician practice at below fair market value or no charge to make sure they have enough room for patients during a surge.

Rules/reporting: Paperwork requirements reduced

  • Quality Payment Programs reporting deadlines easedThe 2019 MIPS data submission deadline has been extended to April 30. MIPS-eligible clinicians who have not submitted data by April 30 will receive a neutral payment adjustment. Those in the hospital inpatient and outpatient quality reporting programs will not have to submit data for January through June.
  • Additional information requests suspended. CMS said it will continue to conduct oversight “but will suspend requesting additional information from providers, healthcare facilities, Medicare Advantage and Part D prescription drug plans, and states,” according to CMS.
  • Scheduled program audits. CMS is also “reprioritizing scheduled program audits in Medicare Advantage, Part D plans, and Programs of All-Inclusive Care for the Elderly organizations to allow for organizations to focus on patient care,” according to CMS.
  • Part C and D Star Ratings. CMS is “modifying the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic,” according to the agency.


  • Insurers with catastrophic plans will not face enforcement actions for providing coverage without imposing cost-sharing requirements for COVID-19-related services before an enrollee meets the deductible. 
  • COVID-19 cost-sharing waived. In addition to waiving cost-sharing for COVID-19 tests and treatments, Medicare Advantage and Part D plans can also remove prior authorization and prescription refill limits while allowing prescriptions by mail, according to guidance issued by CMS on flexibilities in an emergency.

HRI impact analysis

Providers who needed to suddenly reorient their facilities, staffs and supplies for the COVID-19 pandemic had been pressing for many of the temporary changes CMS has made. The relaxed requirements help them keep COVID-19 patients separate to contain the spread and to expand bed capacity.

Staffing has been a concern for healthcare systems as they try to keep workers from being exposed while dealing with a lack of testing. The measures by CMS will give some flexibility to expand the workforce by calling on healthcare workers from other areas that are not experiencing a surge, bringing back retired medical professionals and activating medical residents.

The efforts to expand telehealth will enable healthcare systems to keep vulnerable patients, such as the elderly and those with chronic conditions, from needlessly risking exposure to the virus by going into healthcare facilities for treatment. The telehealth services can also keep COVID-19 patients who are experiencing mild symptoms in their homes to reduce the spread of the virus.

While providers and patients adjust to the COVID-19 reality and become accustomed to expanded telehealth and more healthcare services delivered in the home, will parts of these changes take root in the healthcare landscape and be made permanent? That is a key question for the industry and regulators going forward.

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Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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