As part of our ongoing efforts to keep our Health Care clients informed of the rapidly changing regulatory landscape and help them with business and legal implications, Maynard is providing this update on government action taken in the last week in response to the Coronavirus outbreak. The information provided below can also be found on our website at: COVID-19 Task Force and Resources, where we will post future updates. If you have any questions, please do not hesitate to reach out to any member of Maynard’s Health Care Practice.

Governor Kay Ivey issues proclamations to combat COVID-19 in Alabama (April 2, 2020)
Since first declaring a state public health emergency on March 13, Governor Ivey has issued a number of proclamations aimed at combating the spread of COVID-19. In her most recent state of emergency proclamation, the Governor expanded the scope of practice of certain healthcare providers to better meet the surge of COVID-19, paved the way for practice by out-of-state practitioners, and directed the State Health Planning and Development Agency and Board of Pharmacy to issue emergency rules to facilitate the expansion of health care facilities and issuance of temporary pharmacy permits. The proclamation also provides for remote notarizations, corporate shareholder meetings, and public meetings of governmental entities, as well as provisions to reduce county jail populations during the pandemic.

CMS announces sweeping regulatory changes to mitigate COVID-19 patient surge (March 30, 2020)
These temporary waivers will allow local hospitals and healthcare systems to expand into non-hospital buildings and bill for services provided in those settings. Ambulances will be permitted to transport patients to a wider range of locations when other transportation is not medically appropriate. Waivers also allow for rapid expansion of the healthcare workforce. Hospitals may hire clinicians licensed in other states and use mid-level practitioners to the fullest extent possible. Additional benefits may be provided to support medical staffs, including daily meals, personal laundry and child care while providers are at the hospital. Such benefits, along with more than a dozen other types of remuneration to physicians or their immediate family members, are now available, even though they might otherwise violate the physician self-referral (“Stark”) law. Paperwork reduction waivers were also implemented by CMS, allowing clinicians to spend more time with patients. Permissible telehealth services were expanded even further by these waivers. Providers should bear in mind that many of the activities allowed by the blanket waivers are still subject to state regulations.

President Trump signs CARES Act (March 27)
The House passed Friday, and the President signed, the most recent in a series of coronavirus relief measures, providing $2 trillion to address the economic effects of the pandemic. In addition to cash payments to individuals and an expansion in unemployment benefits, the bill includes $350 billion for small business loans and over $130 billion for hospitals and community health centers.

CMS approves 34th state Medicaid waiver (March 27)
As of March 27, CMS had approved 34 state Medicaid waiver requests, providing states with flexibility needed to combat COVID-19. CMS touts an average approval time of less than 6 days using a streamlined template to expedite applications.

CMS releases Clinical Laboratory Improvement Amendments (CLIA) guidance (March 26)
This memorandum provides important guidance to CLIA laboratories regarding the remote review of pathology slides, proficiency testing, alternate collection devices, and requirements for a CLIA certificate during the COVID-19 public health emergency.

CMS issues FAQ on enhanced Medicaid funding for states
This guidance explains the implementation of the enhanced Federal Medical Assistance Percentage (FMAP) to states provided by the Families First Coronavirus Response Act.

CMS issues FAQ on Medicare provider enrollment relief
CMS exercises its 1135 waiver authority to streamline provider enrollment during the COVID-19 national emergency. This FAQ explains implementation of the program and provides hotlines.

Alabama Board of Pharmacy issues guidance on dispensing malaria drugs for COVID-19 (March 25)
In response to a recent spike in prescriptions for anti-malaria drugs, the Pharmacy Board urges pharmacists to provide information to patients about the risks and side of effects of these drugs and their unproven effectiveness against COVID-19.

CMS issues FAQ on telehealth through private health insurance coverage (March 24)
This guidance encourages states to relax licensing laws to expand telehealth and explains CMS policy allowing issuers to expand coverage and reduce cost sharing for telehealth services.

HHS OCR issues guidance on sharing COVID-19 patients’ data to help protect first responders (March 24)
This guidance explains how covered entities may disclose protected health information about COVID-19 patients to law enforcement, paramedics, other first responders, and public health authorities in compliance with the HIPAA Privacy Rule.

ADPH establishes website for COVID-19 related emergency actions of state agencies
The Alabama Department of Public Health has created a website documenting emergency rules and other actions taken by state agencies in response to COVID-19.