Title III of the CARES Act focuses on support for the U.S. Healthcare System:

• Subtitle A – Health Provisions
• Part I: Addressing Supply Shortages
  • Subpart A Medical Product Supplies
    • Section 3101. National Academies report on America’s medical product supply chain security – Within 60 days of the enactment of the CARES Act the Secretary of Health and Human Services shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to examine the security of the U.S. medical product supply chain (e.g. international dependencies).
    • Section 3102. Requiring the strategic national stockpile to include certain types of medical supplies – Amended Public Health Service Act to require the “strategic national stockpile” to include personal protective equipment, ancillary medical supplies and other supplies required for the administration of several treatment materials including drugs, vaccines and diagnostic tests.
    • Section 3103. Treatment of respiratory protective devices as covered countermeasures – Amended Public Health Service Act to provide permanent liability protection for manufacturers of personal respiratory protective equipment, such as masks and respirators, in the event of a public health emergency, to incentivize production and distribution.
  • Subpart B Mitigating Emergency Drug Shortages
    • Section 3111. Prioritize reviews of drug applications; incentives – Requires the Food and Drug Administration (FDA to prioritize and expedite the review of drug applications and inspections to prevent or mitigate a drug shortage.
    • Section 3112. Additional manufacturer reporting requirements in response to drug shortages – Requires drug manufacturers to submit more information when there is an interruption in supply, including information about active pharmaceutical ingredients, when active pharmaceutical ingredients are the cause of the interruption. Requires manufacturers to maintain contingency plans to ensure back-up supply of products. Requires manufacturers to provide information about drug volume.
  • Subpart C Preventing Medical Device Shortages
    • Section 3121. Discontinuance or interruption in the production of medical devices – Clarifies that during a public health emergency, a medical device manufacturer is required to submit information about a device shortage or device component shortage upon request of the FDA.
  • Part II: Access to Health Care for COVID-19 Patients
  • Subpart A Coverage of Testing and Preventive Services
    • Section 3201. Coverage of diagnostic testing for COVID-19 – Clarifies that all testing for COVID-19 is to be covered by private insurance plans without cost sharing, including those tests without an exam under anesthesia by the FDA.
    • Section 3202. Pricing of diagnostic testing – For COVID-19 testing to be covered with no cost to patients, requires an insurer to pay either the rate specified in a contract between the provider and the insurer, or, if there is no contract, a cash price posted by the provider.
    • Section 3203. Rapid coverage of preventive services and vaccines for coronavirus – Provides free coverage without cost-sharing of a vaccine within 15 days for COVID-19 that has in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force or a recommendation from the Advisory Committee on Immunization Practices.
    • Subpart B Support for Health Care Providers
      • Section 3211. Supplemental awards for health centers – Provides $1.32 billion in supplemental funding to community health centers on the front lines of testing and treating patients for COVID-19.
      • Section 3212. Telehealth network and telehealth resource centers grant programs – Reauthorizes Health Resources and Services Administration grant programs that promote the use of telehealth technologies for health care delivery, education and health information services. Telehealth offers flexibility for patients with, or at risk of contracting, COVID-19 to access screening or monitoring care while avoiding exposure to others.
      • Section 3213. Rural health care services outreach, rural health network development and small health care provider quality improvement grant programs – Reauthorizes HRSA grant programs to strengthen rural community health by focusing on quality improvement, increasing health care access, coordination of care, and integration of services. Rural residents are disproportionately older and more likely to have a chronic disease, which could increase their risk for more severe illness if they contract COVID-19.
      • Section 3214. United States Public Health Service Modernization – Establishes a Ready Reserve Corps to ensure we have enough trained doctors and nurses to respond to COVID-19 and other public health emergencies.
      • Section 3215. Limitation on liability for volunteer health care professionals during COVID-19 emergency response – Makes clear that doctors who provide volunteer medical services during the public health emergency related to COVID-19 have liability protections.
      • Section 3216. Flexibility for members of National Health Service Corps during emergency period – Allows the Secretary of Health and Human Services (HHS) to reassign members of the National Health Service Corps to sites close to the one to which they were originally assigned, with the member’s agreement, in order to respond to the COVID-19 public health emergency.
    • Subpart C Miscellaneous Provisions
      • Section 3221. Confidentiality and disclosure of records relating to substance use disorder – Allows for additional care coordination by aligning the 42 CFR Part 2 regulations, which govern the confidentiality and sharing of substance use disorder treatment records, with Health Insurance Portability and Accountability Act (HIPAA), with initial patient consent.
      • Section 3222. Nutrition services – Waives nutrition requirements for Older Americans Act (OAA) meal programs during the public health emergency related to COVID-19 to ensure seniors can get meals in case certain food options are not available.
      • Section 3223. Continuity of service and opportunities for participants in community service activities under title V of the Older Americans Act of 1965 – Allows the Secretary of Labor to extend older adults’ participation in community service projects under OAA and make administrative adjustments to facilitate their continued employment under the program.
      • Section 3224. Guidance on protected health information – Requires the Department of Health and Human Services (HHS) to issue guidance on what is allowed to be shared of patient record during the public health emergency related to COVID-19.
      • Section 3225. Reauthorization of healthy start program – Reauthorizes Healthy Start, which is a program that provides grants to improve access to services for women and their families, who may need additional support during the public health emergency related to COVID-19.
      • Section 3226. Importance of the blood supply – Directs the Secretary of HHS to carry out an initiative to improve awareness of the importance and safety of blood donation and the continued need for blood donations during the COVID-19 public health emergency.
    • Part III: Innovation
      • Section 3301. Removing the cap on OTA for public health emergencies – Allows the Biomedical Advanced Research and Development Authority to more easily partner with private sector on research and development, which includes helping to scale up manufacturing as appropriate, by removing the cap on other transaction authority (OTA) during a public health emergency.
      • Section 3302. Priority zoonotic animal drugs – Provides Breakthrough Therapy designations for animal drugs that can prevent human diseases (i.e. speed up the development of drugs to treat animals to help prevent animal-to-human transmission), which is suspected to have occurred with outbreak of novel coronavirus, leading to the SARS-CoV-2 pandemic.
    • Part IV: Health Care Workforce
      • Section 3401. Reauthorization of health professions workforce programs.
      • Section 3402. Health workforce coordination.
      • Section 3403. Education and training relating to geriatrics – 1) Reauthorizes and updates Title VII of the Public Health Service Act (PHSA), which pertains to programs to support clinician training and faculty development, including the training of practitioners in family medicine, general internal medicine, geriatrics, pediatrics, and other medical specialties. 2) Directs the Secretary of Health and Human Services (HHS) to develop a comprehensive and coordinated plan for health workforce programs, which may include performance measures and the identification of gaps between the outcomes of such programs and relevant workforce projection needs. 3) Title VII programs strengthen the health professions workforce to better meet the health care needs of certain populations, such as older individuals and those with chronic diseases, who could be at increased risk of contracting COVID-19.
      • Section 3404. Nursing workforce development – Reauthorizes and updates Title VIII of the PHSA, which pertains to nurse workforce training programs. Updates reporting requirements to include information on the extent to which Title VIII programs meet the goals and performance measures for such activities, and the extent to which HHS coordinates with other Federal departments on related programs. Permits Nurse Corps loan repayment beneficiaries to serve at private institutions under certain circumstances. Title VIII programs help to address current and emerging health care challenges by supporting the development of a robust nursing workforce, as nurses are critical in responding to the COVID-19 pandemic and future public health emergencies.
    • Subtitle D Finance Committee
      • Section 3701. Exemption for telehealth services – Allows a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible, increasing access for patients who may have the COVID-19 virus and protecting other patients from potential exposure.
      • Section 3702. Inclusion of certain OTC medical products as qualified medical expenses – Allows patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter (OTC) medical products, including those needed in quarantine and social distancing, without a prescription from a physician.
      • Section 3703. Increasing Medicare telehealth flexibilities during emergency period – Eliminates the requirement in Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (Public Law 116-123) that limits the Medicare telehealth expansion authority during the COVID-19 emergency period to situations where the physician or other professional has treated the patient in the past three years. This enables beneficiaries to access telehealth, including in their home, from a broader range of providers, reducing COVID-19 exposure.
      • Section 3704. Enhancing Medicare telehealth services for FQHCs and RHCs during emergency period – Allows, during the COVID-19 emergency period, Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to serve as a distant site for telehealth consultations. A distant site is where the practitioner is located during the time of the telehealth service. Allows FQHCs and RHCs to furnish telehealth services to beneficiaries in their home. Medicare reimburses for these telehealth services based on payment rates similar to the national average payment rates for comparable telehealth services under the Medicare Physician Fee Schedule. It also excludes the costs associated with these services from both the FQHC prospective payment system and the RHC all-inclusive rate calculation.
      • Section 3705. Temporary waiver of requirement for face-to-face visits between home dialysis patients and physicians – Eliminates a requirement during the COVID-19 emergency period that a nephrologist conduct some of the required periodic evaluations of a patient on home dialysis face-to-face, allowing these vulnerable beneficiaries to get more care in the safety of their home.
      • Section 3706. Use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care during emergency period – Under current law, hospice physicians and nurse practitioners cannot conduct recertification encounters using telehealth. Allows, during the COVID-19 emergency period, qualified providers to use telehealth technologies in order to fulfill the hospice face-to-face recertification requirement.
      • Section 3707. Encouraging use of telecommunications systems for HHS furnished during emergency period – Requires the Health and Human Services (HHS) to issue clarifying guidance encouraging the use of telecommunications systems, including remote patient monitoring, to furnish home health services consistent with the beneficiary care plan during the COVID-19 emergency period.
      • Section 3708. Improving care planning for Medicare HHS – Allows physician assistants, nurse practitioners and other professionals to order home health services for beneficiaries, reducing delays and increasing beneficiary access to care in the safety of their home.
      • Section 3709. Adjustment of sequestration – Provides prompt economic assistance to health care providers on the front lines fighting the COVID-19 virus, helping them to furnish needed care to affected patients. Specifically, this section temporarily lifts the Medicare sequester, which reduces payments to providers by two percent, from May 1 through December 31, 2020, boosting payments for hospital, physician, nursing home, home health, and other care. The Medicare sequester is extended by one-year beyond current law to provide immediate relief without worsening Medicare’s long-term financial outlook.
      • Section 3710. Medicare hospital inpatient prospective payment system add-on payment for COVID-19 patients during emergency period – Increases the payment that would otherwise be made to a hospital for treating a patient admitted with COVID-19 by 20 percent. It builds on the Centers for Disease Control and Prevention (CDC) decision to expedite use of a COVID-19 diagnosis to enable better surveillance as well as trigger appropriate payment for these complex patients. This add-on payment is available through the duration of the COVID-19 emergency period.
      • Section 3711. Increasing access to post-acute care during emergency period – Provides acute care hospitals flexibility, during the COVID-19 emergency period, to transfer patients out of their facilities and into alternative care settings in order to prioritize resources needed to treat COVID-19 cases. Specifically, this section waives the Inpatient Rehabilitation Facility (IRF) three-hour rule, which requires that a beneficiary be expected to participate in at least three hours of intensive rehabilitation at least five days per week to be admitted to an IRF. It allows a Long Term Care Hospital (LTCH) to maintain its designation even if more than 50 percent of its cases are less intensive. It also temporarily pauses the current LTCH site-neutral payment methodology.
      • Section 3712. Revising payment rates for durable medical equipment under the Medicare program through duration of emergency period – Prevents scheduled reductions in Medicare payments for durable medical equipment, which helps patients transition from hospital to home and remain in their home, through the length of COVID-19 emergency period.
      • Section 3713. Coverage of the COVID-19 vaccine under Part B of the Medicare program without any cost-sharing – Enables beneficiaries to receive a COVID-19 vaccine in Medicare Part B with no cost-sharing.
      • Section 3714. Requiring Medicare prescription drug plans and MA-PD plans to allow during the COVID-19 emergency period for fills and refills of covered Part D drugs for up to a three-month supply – Requires that Medicare  Part D plans provide up to a 90-day supply of a prescription medication if requested by a beneficiary during the COVID-19 emergency period.
      • Section 3715. Providing home and community-based services in acute care hospitals – Allows state Medicaid programs to pay for direct support professionals, caregivers trained to help with activities of daily living, to assist disabled individuals in the hospital to reduce length of stay and free up beds.
      • Section 3716. Clarification regarding uninsured individuals – Clarifies a section of the Families First Coronavirus Response Act of 2020 (Public Law 116-127) by ensuring that uninsured individuals can receive a COVID-19 test and related service with no cost-sharing in any state Medicaid program that elects to offer such enrollment option.
      • Section 3717. Clarification regarding coverage of COVID-19 testing products – Clarifies a section of the Families First Coronavirus Response Act of 2020 (Public Law 116-127) by ensuring that beneficiaries can receive all tests for COVID-19 in Medicare Part B with no cost-sharing.
      • Section 3718. Amendments relating to reporting requirements with respect to clinical diagnostic laboratory tests – Prevents scheduled reductions in Medicare payments for clinical diagnostic laboratory tests furnished to beneficiaries in 2021. It also delays by one year the upcoming reporting period during which laboratories are required to report private payer data.
      • Section 3719. Expansion of the Medicare hospital accelerated payment program during the COVID-19 public health emergency – Expands, for the duration of the COVID-19 emergency period, an existing Medicare accelerated payment program. Hospitals, especially those facilities in rural and frontier areas, need reliable and stable cash flow to help them maintain an adequate workforce, buy essential supplies, create additional infrastructure and keep their doors open to care for patients. Specifically, qualified facilities are able to request up to a six-month advanced lump sum or periodic payment. This advanced payment is based on net reimbursement represented by unbilled discharges or unpaid bills. Most hospital types could elect to receive up to 100 percent of the prior period payments, with Critical Access Hospitals able to receive up to 125 percent. Finally, a qualifying hospital is not required to start paying down the loan for four months, and also has at least 12 months to complete repayment without a requirement to pay interest.
      • Section 3720. Delaying requirements for enhanced FMAP to enable state legislation necessary for compliance – Amends a section of the Families First Coronavirus Response Act of 2020 (Public Law 116-127) to ensure that states are able to receive the Medicaid 6.2 percent Federal Medical Assistance Percentage (FMAP) increase.
    • Subtitle E Health and Human Services Extenders
    • Part I: Medicare Provisions
      • 3801. Extension of the work geographic index floor under the Medicare program – Increases payments for the work component of physician fees in areas where labor cost is determined to be lower than the national average through December 1, 2020.
      • Section 3802. Extension of funding for quality measure endorsement, input, and selection – Provides funding for HHS to contract with a consensus-based entity (e.g. the National Quality Forum) to carry out duties related to quality measurement and performance improvement through November 30, 2020.
      • Section 3803. Extension of funding outreach and assistance for low-income programs – Extends funding for beneficiary outreach and counseling related to low-income programs through November 30, 2020.
    • Part II: Medicaid Provisions
      • Section 3811. Extension of Money Follows the Person rebalancing demonstration program – Extends the Medicaid Money Follows the Person demonstration that helps patients transition from the nursing home to the home setting through November 30, 2020.
      • Section 3812. Extension of Spousal Impoverishment Protections – Extends the Medicaid Spousal Impoverishment Protections program through November 30, 2020 to help a spouse of an individual who qualifies for nursing home care to live at home in the community.
      • Section 3813. Delay of disproportionate share hospital reductions – Delays scheduled reductions in Medicaid disproportionate share hospital payments through November 30, 2020.
      • Section 3814. Extension and expansion of Community Mental Health Services Demonstration Program – Extends the Medicaid Community Mental Health Services demonstration that provides coordinated care to patients with mental health and substance use disorders, through November 30, 2020. It also expands the demonstration to two additional states.
    • Part III: Human Services and Other Health Programs
      • Section 3821. Extension of Sexual Risk Avoidance Education Program – Extends the Sexual Risk Avoidance Education program through November 30, 2020 at current funding levels. This program provides funds to states to provide education exclusively focused on sexual risk avoidance (meaning voluntarily refraining from sexual activity).
      • Section 3823. Extension of demonstration projects to address health professions workforce needs – Extends the Health Professions Opportunity Grants program through November 30, 2020 at current funding levels. This program provides funding to help low-income individuals obtain education and training in high-demand, well-paid, health care jobs.
    • Part IV: Public Health Provisions
      • Section 3831. Extension for community health centers, the National Health Services Corps, and the Teaching Health Centers that operate Graduate Medical Education Programs – Extends mandatory funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education Program at current levels through November 30, 2020.
      • Section 3832. Diabetes programs – Extends mandatory funding for the Special Diabetes Program for Type I Diabetes and the Special Diabetes Program for Indians at current levels through November 30, 2020.
    • Subtitle F— OTC Drugs
    • Part I: OTC Drug Review
      • Section 3851. Regulation of certain nonprescription drugs that are marketed without an approved drug application – Reforms the regulatory process for over-the-counter (OTC) drug monographs by allowing the FDA to approve changes OTC drugs administratively, rather than going through a full notice and comment rulemaking. Currently, FDA can approve all other drugs without going through a full notice and comment rulemaking, and this legislation makes sure OTC medicines receive the same treatment as other drugs. Incentivizes companies to create more innovative products by providing an 18-month market-exclusivity component that rewards a return on investment for new OTC drugs.
      • Section 3852. Misbranding – Clarifies that an OTC drug that does not comply with the monograph requirements is misbranded.
      • Section 3853. Drugs Excluded from OTC drug review – Clarifies that nothing in this bill will apply to drugs previously excluded by the FDA from the OTC Drug Review under a specified Federal Register document.
      • Section 3854. Treatment of Sunscreen Innovation Act – Clarifies that sponsors of sunscreen ingredients with pending orders have the option to see review in accordance with the Sunscreen Innovation Act or to see review under the new monograph review process.
      • Section 3855. Annual update to congress on appropriate pediatric indication for certain OTC cough and cold drugs – Requires an annual update to Congress regarding FDA’s progress in evaluating certain pediatric indications for certain cough and cold monograph drugs for children under age six.
    • PART II: User Fees
      • Section 3861. Finding – Declares that the fees paid pursuant to this section will undergo FDA review of OTC monograph drugs.
      • Section 3862. Fees relating to OTC drugs – Establishes a new FDA user fee to allow the agency to hire additional staff members to ensure there is adequate agency oversight to approve changes to OTC drugs.

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