Title III – Supporting America’s Healthcare System in the Fight Against Coronavirus, Subtitle A – Health Provisions
April 1, 2020
Early in the morning on Thursday, March 26, 2020, the Senate passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). On Friday, March 27, 2020, the House of Representatives also passed the CARES Act and President Trump quickly signed it into law the same day.
In this continuing series of blogs by lawyers at Forrest Firm, P.C., we will examine the most important, relevant, and impactful provisions of the CARES Act. Our goal is not to provide you with a granular level examination of each provision of the CARES Act, but rather to provide a macro view of the CARES Act in clear, concise, and understandable language that will enable readers to move forward with their businesses and lives with confidence. These are trying times, and here at Forrest Firm we want these articles to support our clients, positively impact our communities, and be available to help you with questions and concerns raised by the CARES Act.
This portion of the CARES Act is separately titled the “Coronavirus Aid, Relief, and Economic Security Act.” It addresses the critical medical issues facing the United States in the face of the coronavirus emergency: personal protective equipment and other supply shortages, access to healthcare for individuals suffering from the coronavirus, innovation, and the support of healthcare workers.
Part 1 – Addressing Supply Shortages
Requiring the Strategic National Stockpile to Include Certain Types of Medical Supplies. Section 3202 of the CARES Act amends the Public Health Service Act to include personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the Strategic National Stockpile.
Treatment of Respiratory Protective Devices as Covered Countermeasures. Section 3103 of the CARES Act amends the Public Health Service Act to provide that “covered countermeasures” includes approved respiratory protective devices as a priority for use during a public health emergency.
Prioritize Reviews of Drug Applications; Incentives. Section 3111 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act to expedite and prioritize the review of drug applications to mitigate emergency drug shortages.
Additional Manufacturer Reporting Requirements in Response to Drug Shortages. Section 3112 of the CARES Act requires a manufacturer of a drug or a part of a drug which is critical to a life-saving drug to notify the Secretary of Health and Human Services of any interruption in, or permanent discontinuance of, the manufacture of an active pharmaceutical ingredient of a drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of the drug.
This provision also requires manufacturers of certain drugs critical to public health during a public emergency to develop, maintain, and implement a redundancy risk management plan that identifies and evaluates risks to the supply of the drug.
Discontinuance or Interruption in the Production of Medical Devices. Section 3121 of the CARES Act contains similar provisions for “critical to public health” medical devices as Section 3112 provides for drugs.
Part 2 – Access to Health Care for COVID-19 Patients
Coverage of Diagnostic Testing for COVID-19. Section 3201 of the CARES Act amends the recently enacted Families First Coronavirus Response Act to require group health plans and insurers to cover diagnostic testing relating to the coronavirus.
Pricing of Diagnostic Testing. Section 3202 of the CARES Act permits group health plans and insurers to reimburse providers of diagnostic testing relating the coronavirus at pre-emergency-period negotiated rates and sets reimbursement rates in instances without previously negotiated rates equal to the cash price for services listed on a publicly-available website or the plan or insurer can negotiate with a provider for a rate lower than such cash price. All providers of a diagnostic test for the coronavirus are required to publicize cash price for such tests. Failure to comply with these requirements could result in the Department of Health and Human Services assessing a civil monetary penalty of up to $300 per day.
Rapid Coverage of Preventive Services and Vaccines for Coronavirus. Section 3203 of the CARES Act requires health plans and issuers to provide for rapid coverage of “qualifying coronavirus preventative services” – an item, service, or immunization intended to prevent or mitigate coronavirus—and vaccines for coronavirus.
Supplemental Awards for Health Centers. Section 3211 of the CARES Act contains an appropriation provision of $1.32 billion dollars of funding under the Public Health Service Act to healthcare centers to prevent, diagnose, and treat the coronavirus.
Telehealth Network and Telehealth Resource Centers Grant Programs. Section 3212 of the CARES Act amends the Public Health Service Act, relating to Telehealth Network and Telehealth Resource Centers Grant Programs, that part of the Public Health Service Act relating to the Rural Healthcare Services Outreach, Rural Health Network Development, and Small Healthcare Provider Quality Improvement Grant Programs.
Limitation on Liability for Volunteer Healthcare Professionals During COVID-19 Emergency Response. Section 3215 of the CARES Act limits the liability of volunteer healthcare professionals acting in good faith during the coronavirus emergency and is the scope of the healthcare professional’s license, subject to limited exceptions such as gross negligence; this provision expressly preempts more restrictive state or local law.
Confidentiality and Disclosure of Records Relating to Substance Use Disorder. Section 3221 of the CARES Act provides changes to the Federal rules governing disclosure of substance use disorder records.
Nutrition Services. Section 3222 of the CARES Act permits States to transfer, without prior approval, up to 100% of the funds received to meet the needs of the State or area served.
Continuity of Service and Opportunities for Participants in Community Service Activities Under Title V of the Older Americans Act of 1965. Section 3223 of the CARES Act authorizes flexibility and waivers during the public health emergency with regard to requirements of the Older Americans Act with regard to nutrition and community services programs to allow continuity of services and opportunities and to treat those social-distancing as if they were homebound.
Guidance on Protected Health Information. Section 3224 of the CARES Act provides that within 180 days of March 27, 2020 the Department of Health and Human Services must issue guidance regarding the sharing of patient-protected health information related to the coronavirus, including guidance regarding complying with HIPAA regulations and applicable policies.
Reauthorization of Healthy Start Program. Section 3225 of the CARES Act reauthorizes the Healthy Start program.
Importance of the Blood Supply. Section 3226 of the CARES Act authorized the Department of Health and Human Services to carry out a public awareness campaign regarding the importance and safety of blood donations.
Part 3 – Innovation
Removing the Cap on OTA During Public Health Emergencies. Section 3301 of the CARES Act authorizes the use of competitive procedures when entering into transactions to carry out projects funded for the purposes of a public health emergency, prohibits termination of such transactions solely due to the expiration of the public health emergency, and requires reporting by the Department of Health and Human Services to the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee regarding the use of funds pursuant under this provision.
Priority Zoonotic Animal Drugs. Section 3302 of the CARES Act includes provisions to expedite development and approval of certain new animal drugs if preliminary clinical evidence indicates that the new drug has the potential to prevent or treat a serious or life-threatening disease in animals, including a vector-borne disease, which has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.
Part 4 – Health Care Workforce
Reauthorization of Health Professions Workforce Programs. Section 3401 of the CARES Act authorizes appropriations to enhance the primary healthcare workforce. In awarding these appropriations, priority may be given to the improvement of the quality of health care services in rural or medically underserved communities.
Health Workforce Coordination. Section 3402 of the CARES Act requires the Department of Health and Human Services to develop a comprehensive and coordinated plan with respect to the healthcare workforce development programs, including education and training programs, in order to strengthen the nation’s healthcare system, identify gaps that exist between the outcomes of these programs and projected healthcare workforce needs identified in workforce projection reports conducted by the Health Resources and Services Administration, identify actions to address these gaps, and identify barriers to identifying these gaps.
By March 27, 2022, the Department of Health and Human Services is required to submit to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce a report describing this plan and the actions taken to implement such plan.
Education and Training Related to Geriatrics. Section 3403 of the CARES Act provides for an amendment to the Public Health Service Act to increase funding and training for the establishment of a Geriatrics Workforce Enhancement Program to support the training of health professionals in geriatrics, including traineeships or fellowships, with an emphasis on patient and family engagement, integration of geriatrics with primary care and other appropriate specialties, and collaboration with community partners to address gaps in healthcare for older adults.
Nursing Workforce Development. Section 3404 of the CARES Act provides for an amendment to the Public Health Services Act to establish and fund nurse-practice arrangements, managed by advanced practice nurses, which provide primary care or wellness services to underserved or vulnerable populations and which are associated with schools, colleges, universities, or departments of nursing, federally qualified health centers, or independent nonprofit health or social services agencies to address national nursing needs.
If you have any questions, please do not hesitate to contact Brian Bernhardt for more information.