Senate Summary



National Academies report on America’s medical product supply chain security

Directs the National Academies to study the manufacturing supply chain of drugs and medical devices and provide Congress with recommendations to strengthen the U.S. manufacturing supply chain.

 HHS Secretary and NASEM to enter into an agreement to report on security of US medical product supply chain.


To assess and provide recommendations regarding the reliance of the US on foreign sources for critical drugs and devices, as well as the condition of the medical supply chain in general.


HHS and NASEM will consider input from agencies and stakeholders in completing report.


Definitions of “device” and “drug” are as per Federal Food, Drug, and Cosmetic Act


Requiring the strategic national stockpile to include certain types of medical supplies

Clarifies that the Strategic National Stockpile can stockpile medical supplies, such as the swabs necessary for diagnostic testing for COVID-19.

Amends the Public Health Service Act to allow the Strategic National Stockpile to include PPE, and certain ancillary medical supplies.


Treatment of respiratory protective devices as covered countermeasures

Provides 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.

Grants certain immunity from suit or liability for makers of qualifying respiratory devices according to the provisions of 42 U.S.C. 247d–6d(i)(1)(D)


 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.

Makes the prioritization of certain drug applications mandatory during a drug shortage as defined in 21 U.S.C. 356c




 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.

Expands 21 U.S.C. 356c to include shortages of drugs which are critical to the public health during a public health emergency; expands notification requirements to provide Fed. Govt. with information required to act.


Requires makers of critical drugs (as described in 21 U.S.C. 356c(a)), or associated manufacturers of active ingredients or devices integral thereto to develop a risk management plan.


Requires the FDA to report on critically short drugs to CMS within 180 days after enactment and every 90 days thereafter.


Requires “prompt” sharing by the FDA of inspection reports (under 21 U.S.C. 374) with the “appropriate” offices of the FDA with expertise regarding drug shortages.


Requires manufacturers of certain drugs and medical devices to annually report the amount of drug or device made available for commercial distribution. Secretary may require extra reporting during public health emergencies. Ref. 21 U.S.C. 360(j).


FDA shall not disclose trade secrets or other confidential information as a result of these amendments.


Effective Date is 180 days after enactment of the Act.


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.

Requires manufacturers of medical devices which are critical for public health during a health emergency, or for which the Secretary determines that information  on supply disruptions of the device is needed in advance or during a public health emergency, to notify the Secretary during or in advance of a public health emergency of any discontinuance or disruption of the supply of the device.

Notice must be at least 6 months in advance of the disruption or as soon as practicable


Manufacturers should make the notice specified in (a) available to “appropriate” organizations (as described in (g)) unless the Secretary chooses not to make the information public.


Establishes procedures for Secretary to issue a letter identifying noncompliance, and for manufacturer to provide required information.


Allows Secretary to “Prioritize and expedite” the inspection of an establishment, or the approval of a product, that may mitigate the shortage.


Establishes a list of devices which the FDA determines to be in shortage; Includes information such as the name of the device, the name of the manufacturer, the reason for the shortage, and the estimated duration of the shortage.  Provides that the list should be public barring certain exceptional circumstances.


Does not affect the authority of the Secretary to expedite review under other acts.


Definitions for “meaningful disruption” and “shortage”


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 EUA by the FDA.

 As per the summary.


Pricing of diagnostic testing

For COVID-19 testing 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.

 If a health plan negotiated a rate with respect to COVID-19 testing before the public health emergency, requires that rate to apply. If no negotiated rate, the insurer must reimburse at a cash price publicly listed by the provider or at a lower negotiated rate.


Requires providers to publicize their cash reimbursement rate for COVID 19 testing for the duration of the crisis. Allows a penalty of up to $300 per day for noncompliance.


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 (ACIP).

HHS, Labor, and Treasury shall require health plans to cover qualifying COVID-19 treatments.  


Defines qualifying COVID-19 treatment and related terms (See summary).


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.

Appropriates 1.32B in funding for FY 2020 for the detection of SARS-CoV-2 or the prevention, diagnosis and treatment of COVID-19.


Requires amounts to be appropriated to be subject to Public law 115-94 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254 through 256).


Telehealth network and telehealth resource centers grant programs.

Reauthorizes Health Resources and Services Administration (HRSA) 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.

Amends 42 U.S.C. 254c-14 to refocus telehealth resource grant programs away from demonstrating the benefits of telehealth and more towards increasing access to, and the quality of telehealth. Expands the grant period from 4 to 5 years. Refocuses resources towards substance use disorders and rural, in addition to medically underserved areas. HHS to report to congress on the activities and outcomes of this section 4 years after the date of enactment and every 5 years thereafter. Grant amounts are 29M/year for FY2021 through 2025.


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.

Expands HHS grant authority to improve, and not just expand, rural health networks. Expands grant terms to five years. Strikes the limitation that a receiving entity ‘‘shall be a rural public or rural nonprofit private entity’’ and inserts ‘‘be an entity with demonstrated experience serving, or

the capacity to serve, rural underserved populations.’


Appropriates 79.5M/yr for each of FY 2021 through 2025.


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.

See summary.  


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.

Exempts volunteer health care professionals from state or federal liability for acts or omissions so long as these acts are committed: A) in the course of providing health care; in the scope of the professional’s license; and in good faith that the individual treated requires health care services.


Health care professional still liable if acts committed are under the influence, criminal, willful, grossly negligent or similar.


Expressly preempts inconsistent state or local law.


Defines health care services as only relating to the diagnosis and treatment of COVID-19.


Takes effect on the date of the act, and harm must have occurred after the effective date.


Only lasts as long as the Public Health Emergency.


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.

 See summary.


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.

Amends 42 U.S.C. 290dd-2 is amended replace references to “substance abuse” with “substance use disorder.”


Essentially allows a patient to consent for records use until patient revokes.


Allows disclosure of de-identified records to a health authority so long as the records meet the requirements of 45 CFR 164.514(b).


Certain defined terms as per HIPAA.


Provides that certain records may not be used in civil or criminal proceedings without the patient’s consent.


Applies certain penalties from Sections 1176 and 1177 of the Social Security Act to violations of this section.


May not discriminate in certain situations against an individual based on substance abuse health records inadvertently or intentionally provided.


42 U.S.C. 13402 applies in the case of a breach of the above-mentioned information.


HHS to shall update 45 CFR 164.50 within 1 year to accommodate these changes.


Does not limit a patient’s right to consent under 45 CFR 164.522 or an entity’s choice to obtain consent under 45 CFR 164.506.


Generally, encourage providers to access state-based prescription drug monitoring program and respect patient’s rights to limit disclosures of specified records.


Certain Allowances for the elderly.  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.

 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. (3222). 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 (3223)


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.

 See summary; HHS is granted 180 days to issue guidance.


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.

See summary. Also note that GAO will conduct an evaluation of Healthy Start within 4 years; See 3225(f) for report criteria.


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.

Requires HHS to carry out a national campaign regarding the need for blood donations during the public health emergency.


Authorizes HHS to enter contracts in support of national campaign (i.e. for advertising).


Obligates HHS to consult with certain federal agencies for campaign.


Obligates HHS to submit to congress a report on the activities and results of the campaign within 2 years.


Removing the cap on OTA for public health emergencies.

Allows the Biomedical Advanced Research and Development Authority (BARDA) 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.

See summary; Also note that contracts entered into during the emergency do not terminate at the end of the emergency. Directs HHS to issue report regarding the use of expanded OTA after the end of the emergency.  


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.

Directs the Secretary to expedite the approval of animal drugs which treat diseases which have “the potential to cause serious adverse health consequences for… humans.” Generally, a “zoonotic animal drug.”


Allows the sponsor of an animal drug to request the drug be designated a priority animal zoonotic animal drug.


Directs the Secretary, if the request above meets the provided criteria, to expedite the development of the zoonotic animal drug.


 Reauthorization of health professions workforce programs

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.

See summary. Appropriation of 23.7M dollars per year from FY 2021 through FY2025. Places additional focus on authorizations for “innovative models of providing care.” Also allows priority to be given to applicants which train residents in rural areas.


 Health workforce coordination.

Directs the Secretary of 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.

Requires HHS to develop a comprehensive and coordinated plan with respect to HHS health care workforce development programs. HHS is directed to develop performance metrics, identify gaps in the healthcare system and identify actions to address those gaps.


Requires HHS to coordinate with other agencies which fund healthcare workforce development programs to evaluate the performance and consistency of those programs.


Requires HHS to issue report on its activities not later than two years from enactment.


Education and training relating to geriatrics.

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.

Requires HHS to award grants contracts to establish the Geriatrics Workforce Enhancement Programs.


Provides that a Geriatrics Workforce Enhancement Program shall support the training of health professionals in geriatrics to address gaps in healthcare for older adults. Specifies activities which may be included in the program.


Contracts shall not exceed 5 years.


Directs HHS to create application process. Establishes criteria for which HHS may give priority.

Provides that HHS may choose awardees to support areas of demonstrated need.


Requires entities receiving money to report to HHS, who then reports to Congress.


Establishes program to provide geriatric academic career awards to eligible entities applying on behalf of eligible individuals to promote the career development of such

individuals as academic geriatricians or other academic geriatrics health professionals


 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.

Expands the authority of HHS to award grants to address nursing shortages or projected shortages in affected geographic areas and to increase access and quality of health care services by supporting the training of registered nurses. Also requires HHS to submit a biennial report to congress regarding the program.


Expands the authority of HHS under 42 U.S.C. 296j to support Clinical Nurse Specialist Programs. Expands the authority of HHS under 42 U.S.C. 296p to support the training of nurse assistants, home health aides, and other types of nurses as well as to provide grants for fellowships, internships, and residency programs in connection with accredited nursing schools.


Appropriates $117,135,000/yr for each of the fiscal years 2021 through 2025.


GAO to report on loan repayment within 18 months.


Health Savings Accounts for Telehealth Services

This section would allow 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.

Establishes a safe harbor for the absence of a deductible for telehealth. Essentially, “a plan shall not fail to be treated as a high deductible health plan by reason of failing

to have a deductible for telehealth and other remote care services.’’ 


Over-the-Counter Medical Products without Prescription

This section would allow patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter medical products, including those needed in quarantine and social distancing, without a prescription from a physician.

As per the summary, except that the referenced OTC medicines are menstrual care products.


Expanding Medicare Telehealth Flexibilities


These sections work to expand access to telehealth services by removing restrictions on when telehealth can be used. 3704 allows Federally Qualified Health Centers and Rural Health Clinics to serve as a distant sites for telehealth consultations. 3705 eliminates certain face to face requirements for dialysis patients during the emergency period. 3706 allows qualified providers to use telehealth technologies in order to fulfill the hospice face-to-face recertification requirement during the COVID-19 emergency period. 3707 requires HHS to issue certain guidance on telehealth.



Enabling Physician Assistants and Nurse Practitioners to Order Medicare Home Health Services

This section would allow 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.

Essentially as per the summary, grants “nurse practitioner or clinical nurse specialist, or a physician assistant” many of the same powers as physicians with regards to ordering home health services under certain provisions of 42 U.S.C. 1395 et. seq.


Increasing Provider Funding through Immediate Medicare Sequester

This section would provide 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 would temporarily lift the Medicare sequester, which reduces payments to providers by 2 percent, from May 1 through December 31, 2020, boosting payments for hospital, physician, nursing home, home health, and other care. The Medicare sequester would be extended by one-year beyond current law to provide immediate relief without worsening Medicare’s long-term financial outlook.

Exempts Medicare from sequestration reductions from May 1, 2020 through December 31, 2020. Also extends direct spending reductions through FY 2030 (from FY 2029 previously).


Medicare Add-on for Inpatient Hospital COVID-19 Patients

This section would increase the payment that would otherwise be made to a hospital for treating a patient admitted with COVID-19 by 20 percent. It would build 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 would be available through the duration of the
COVID-19 emergency period.

As per summary, increases payments for COVID-19 treatments by 20 percent for the duration of the emergency period.


Increasing Medicare Access to Post-Acute Care

This section would provide 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 would waive the Inpatient Rehabilitation Facility (IRF) 3-hour rule, which requires that a beneficiary be expected to participate in at least 3 hours of intensive
rehabilitation at least 5 days per week to be admitted to an IRF. It would allow a Long
Term Care Hospital (LTCH) to maintain its designation even if more than 50 percent of
its cases are less intensive. It would also temporarily pause the current LTCH site-neutral
payment methodology.

Waives the requirement under 42 CFR 412.622(A)(3)(iii) relating to the requirement that inpatient rehabilitation facility patients receive 15 hours of inpatient therapy per week during the emergency period.


Likewise waives certain portions of 42 U.S.C. 1395ww(m)(6) to allow a long-term care hospital to maintain its designation even if more than 50 percent of its cases are less intensive during the emergency period.


Preventing Medicare Durable Medical Equipment Payment

This section would prevent 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.

As per the summary, prevents the reductions of 34 CFR 414.201(g)(9)(iii) and (iv) from occurring through the emergency period.

3713-3714, 3717

Certain allowances for Medicare Part D

These sections enable Medicare beneficiaries to receive a COVID-19 vaccine with no cost-sharing, and to fulfill prescriptions for 90 day periods under Part D (subject to a safety exception).


Providing Home and Community-based Support Services during Hospital Stays

This section would allow 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.

As per summary, except also includes a carve out for care in an acute care hospital that  is (A) identified in a plan of care;‘(B) provided to meet needs of the individual that are not met through the provision of hospital services; (C) not a substitute for services that the hospital is otherwise obligated to provide; and (D) designed to ensure smooth transitions between acute care settings and home and community based settings, and to preserve the individual’s functional abilities.


Clarification Regarding Uninsured Individuals

This section would clarify 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.

Clarifies that uninsured individuals can receive certain COVID-19 services without cost sharing if offered by any state Medicaid program that so elects.


Preventing Medicare Clinical Laboratory Test Payment Reduction

This section would prevent scheduled reductions in Medicare payments for clinical diagnostic laboratory tests furnished to beneficiaries in 2021. It would also delay by one year the upcoming reporting period during which laboratories are required to report private payer data.

Delays for clinical diagnostic laboratories the imposition of certain reporting requirements and scheduled reductions in payments by one year. Ref. 42 U.S.C. 1395m-1.


Providing Hospitals Medicare Advance Payments

This section would expand, 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 would be able to request up to a six-month advanced lump sum or periodic payment. This advanced payment would be 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 would not be required to start paying down the loan for four months, and would also have at least 12 months to complete repayment without a requirement to pay interest.

Allows qualified facilities to request up to a six-month advanced lump sum or periodic payment. This advanced payment would be 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. Loan payments are not due for four months, and hospitals will not have to pay interest if payments completed within 1 year.  


Providing State Access to Enhanced Medicaid FMAP

This section would amend 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 FMAP increase.

As per summary. Note also that states may not put premiums in place that exceed, or eligibility procedures which are more restrictive, than those in effect on the date of enactment to receive fund.


Extension of Physician Work Geographic Index Floor

This section would increase 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.

Extends physician geographic index floor from May 23, 2020 to December 1, 2020. Essentially grants additional payments to those persons who, according to an index calculated by HHS, where the relative value of the physician’s work is below the national average.


Extension of Funding for Quality Measure Endorsement and Selection

This section would provide funding for HHS to contract with a consensus-based entity, e.g., the National Quality Forum (NQF), to carry out duties related to quality measurement and performance improvement through November 30, 2020.

Earmarks 20M for FY 2020 for HHS to contract with NQF for quality measurement and performance improvement through November 30, 2020.  


Extension of Funding Outreach and Assistance for Low-Income Programs

This section would extend funding for beneficiary outreach and counseling related to low-income programs through November 30, 2020.

Extends funding for beneficiary outreach and counseling related to low-income programs through November 30, 2020. Areas of extended funding include State health insurance programs (Medicaid), aging agencies, disability resource centers, and the National Center for Benefits and Outreach Enrollment.


Certain provisions relating to Medicaid and Nursing Homes

Extends the Medicaid Money Follows the Person demonstration that helps patients transition from the nursing home to the home setting through November 30, 2020. 3811. 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. 3812.


Delay of Disproportionate Share Hospital Reductions

The section would delay scheduled reductions in Medicaid disproportionate share hospital payments through November 30, 2020.

Strikes original dates of May 23, 2020 through September 30, 2020 and substitutes December 1, 2020 through September 30, 2021.


Extension and Expansion of Community Mental Health Services Demonstration

This section would extend 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 would also expand the demonstration to two additional states.

As per the summary, also includes selection criteria for additional states. GAO to release report on the results of the demonstration.


Extension for community health centers, the National Health Services
Corps, and teaching health centers that operate GME 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.

As per summary, note that the funding levels are 4 billion/FY for community health centers, 310M/FY for National Health Service Corps, and 126M annualized for GME.


 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.

As per summary, extends funding for certain diabetes programs.