Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
On April 24, President Trump signed into law H.R. 266, the Paycheck Protection Program and Health Care Enhancement Act, which provides additional COVID-19 relief. Read more about this bill and other news below.
I. Regulations, Notices, & Guidance
- On April 20, 2020, the Food and Drug Administration (FDA), issued guidance entitled, Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by State-licensed pharmacies and Federal facilities, including hospital and health system pharmacies, that are not registered with FDA as outsourcing facilities (referred to collectively in this guidance as “pharmacies”) for the duration of the public health emergency declared by HHS on January 31, 2020, or for such shorter time as FDA may announce through updated guidance. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).
- On April 20, 2020, the Drug Enforcement Administration (DEA) issued an interim final rule entitled, Electronic Prescriptions for Controlled Substances. DEA published an interim final rule in the Federal Register on March 31, 2010, which provides practitioners with the option of writing prescriptions for controlled substances electronically. Since publishing the interim final rule, DEA has received questions and requests for clarification on various issues concerning the implementation and technical requirements for the electronic prescribing of controlled substances. DEA is therefore reopening the March 31, 2010, interim final rule to solicit comments from the public on specific issues outlined below regarding the electronic prescribing of controlled substances in anticipation of subsequently publishing a final rule on these topics.
- On April 20, 2020, the Department of Health and Human Services (HHS) issued a final rule entitled, Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency. This notification is to inform the public that HHS is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with the regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.
- On April 21, 2020, FDA issued guidance entitled, Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a Biologics License Application, New Drug Application, or Abbreviated New Drug Application. For injectable drug or biological products that are intended to treat emergent, life threatening conditions, it is essential to ensure that the emergency-use injector will reliably deliver the drug or biological product as intended. This is particularly critical for drugs when failure of the injector may prevent adequate delivery of a life-saving drug to a patient. The draft guidance describes the technical considerations for demonstrating reliability of emergency-use injectors under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA).
- On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, and Health Care Providers. This final rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve the quality and accessibility of information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected health care providers and payers.
- On April 21, 2020, HHS issued a final rule entitled, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. This final rule implements certain provisions of the 21st Century Cures Act, including Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program, the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The implementation of these provisions will advance interoperability and support the access, exchange, and use of electronic health information. The rule also finalizes certain modifications to the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.
- On April 21, 2020, HHS issued a proposed rule entitled, Grants, Contracts, And Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s Civil Money Penalty Rules. This proposed rule would amend the civil money penalty (CMP or penalty) rules of the HHS Office of Inspector General (OIG) to: incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; incorporate new CMP authorities for information blocking; and increase the maximum penalties for certain CMP violations.
- On April 22, 2020, FDA issued guidance entitled, Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments. FDA is issuing this guidance to comply with the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.
- On April 22, 2020, FDA issued guidance entitled, Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency. During the COVID-19 public health emergency, FDA has received several inquiries from health care professionals concerning the unavailability of propofol drug products used in the treatment and management of patients with complications related to COVID-19. FDA is issuing this guidance to communicate its temporary policy regarding the repackaging or combining of propofol drug products by a licensed pharmacist in a State licensed pharmacy, a Federal facility, or an outsourcing facility registered pursuant to section 503B of the FD&C Act (21 U.S.C. 353b) as outlined in this guidance for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, or for such shorter time as FDA may announce through updated guidance. This policy is intended to remain in effect for no longer than the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
- On April 23, 2020, FDA issued guidance entitled, Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive fetal and maternal monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and potential exposure to COVID-19 during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
- On April 23, 2020, FDA issued guidance entitled, Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability and capability of medical x-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) exposure to COVID-19 for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
- On April 24, 2020, FDA issued guidance entitled, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
- April 30, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Diabetes Mellitus Interagency Coordinating Committee. The purpose of this meeting is to discuss improving cardiovascular outcomes in people with type 1 diabetes.
- May 12, 2020: NIH announced a public meeting entitled, Meeting of the National Cancer Institute. The purpose of this meeting is to go over Director’s Report; RFA, RFP, and PAR Concept Reviews; and Scientific Presentations.
- May 18, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Commission on Childhood Vaccines. During this meeting, the ACCV will discuss a draft National Vaccine Injury Compensation Program Notice of Proposed Rulemaking.
- May 20, 2020: NIH announced a public meeting entitled, Meeting of the National Institute of Biomedical Imaging and Bioengineering. The purpose of the meeting is to go over the Report from the Institute Director and other Institute Staff.
- June 1-2, 2020: CMS announced a public meeting entitled, New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding for Durable Medical Equipment and Accessories, Orthotics and Prosthetics, Supplies and Other Non-Drug and Non-Biological Items. The purpose of this meeting is to discuss CMS’s preliminary coding recommendations for new public requests for revisions to the HCPCS Level II code set for Durable Medical Equipment (DME) and Accessories, Orthotics and Prosthetics (O&P), Supplies, and other non-drug and non-biological items.
- June 8, 2020: NIH announced a public meeting entitled, Meeting of the Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
II. Congressional Hearings
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On April 22, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, The National Disaster Medical System (NDMS) and the COVID-19 Pandemic. The COVID-19 pandemic has put a spotlight on systemic health capacity and coverage issues in the U.S. As case counts continue to climb, the ability to test and treat all patients, including the uninsured, will continue to be a challenge. Similarly, there are questions about the out-of-pocket costs patients who are uninsured or under-insured may face. One possible mechanism for additional assistance, both in covering certain costs and in providing additional care and disaster planning is the National Disaster Medical System (NDMS). The NDMS is a network of intermittent federal employees made up of health and planning professionals trained to deploy in the event of a natural or manmade disaster, including mass casualty or loss of healthcare infrastructure, and during large public scale events. It also includes a program that can be used to reimburse health care providers for care provided to patients in a disaster. This explainer describes the NDMS, explores how it has been used in the past, and assesses how it is already being used or has been proposed to be used to fill gaps in the current response to the COVID-19 pandemic.
- On April 22, 2020, KFF published an issue brief entitled, A Dozen Facts About Medicare Advantage in 2020. Medicare Advantage enrollment has grown rapidly over the past decade, and Medicare Advantage plans have taken on a larger role in the Medicare program. This data analysis provides current information and trends about Medicare Advantage enrollment, premiums, and out-of-pocket limits. It also includes analyses of Medicare Advantage plans’ extra benefits and prior authorization requirements. The analysis also highlights changes pertaining to Medicare Advantage coverage that have occurred in 2020 in response to the COVID-19 crisis.
- On April 22, 2020, KKF published a report entitled, Urban and Rural Differences in Coronavirus Pandemic Preparedness. The COVID-19 outbreak has hit densely populated urban areas of the United States first and hardest. Some health systems have experienced surges of patients, raising concerns that there are not enough hospital beds, staffing, and equipment. The novel coronavirus was slower to spread to rural areas in the U.S., but that appears to be changing, with new outbreaks becoming evident in less densely populated parts of the country. In this report, the authors analyze variation in hospital bed capacity by region in the U.S. and by metro/non-metro status. In total, 14% of the population lives in a non-metro area. These non-metro areas are largely rural, and, even prior to the pandemic, face different challenges in health system capacity, including further travel times for patients and provider shortages. Lastly, the authors examine metro and non-metro differences in the share of the population that is at increased risk of COVID-19 due to age or health status.
IV. Other Health Policy News
- On April 19, 2020, CMS issued guidance on providing essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low and stable incidence of COVID-19. The new recommendations are specifically targeted to communities that are in Phase 1 of the Guidelines for Opening Up America Again with low incidence or relatively low and stable incidence of COVID-19 cases. The recommendations update earlier guidance provided by CMS on limiting non-essential surgeries and medical procedures. The new CMS guidelines recommend a gradual transition and encourage health care providers to coordinate with local and state public health officials, and to review the availability of personal protective equipment (PPE) and other supplies, workforce availability, facility readiness, and testing capacity when making the decision to re-start or increase in-person care. More information on these updated guidelines can be found here.
- On April 22, 2020, HHS announced additional allocations of the CARES Act Provider Relief Fund. The $100 billion Provider Relief Fund is intended to support health care providers across the U.S. as they deal with COVID-19, including hospitals battling this disease. HHS announced that distribution of the Provider Relief Fund will fall under the following categories as of April 22:
- General Distribution to Medicare Facilities and Providers: $50 billion total
- COVID-19 High Impact Areas: $10 billion total
- Treatment for Uninsured: portion of remaining $29.6 billion plus $1 billion
- Rural Providers: $10 billion
- Indian Health Service (IHS): $400 million
- Additional Allocations: portion of remaining $29.6 billion
- On April 24, 2020, President Donald Trump signed into law H.R. 266, the Paycheck Protection Program and Health Care Enhancement Act. The bill provides additional fiscal year (FY) 2020 emergency supplemental funding to increase amounts authorized and appropriated for commitments for the Paycheck Protection Program authorized under section 7(a) of the Small Business Act, economic injury disaster loans and emergency grants under the CARES Act, to fund hospital and provider recovery and testing, and for other purposes. Specifically, this bill provides an additional $75 billion for the Provider Relief Fund; $25 billion for COVID-19 testing and research; $310 billion for the SBA Paycheck Protection Program; $10 billion for the Economic Injury Disaster Loan (EIDL) emergency grants; expands eligibility for the EIDLs and emergency grants to include agricultural enterprises with 500 or fewer employees; provides $50 billion for the SBA Disaster Loan Program; and sets aside $60 billion for loans made by certain insured depository institutions, credit unions, and community financial institutions.
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