COVID-19: Updates and Developments (Week of March 29)
- April 03, 2020
President Trump signed March 30 the Coronavirus Aid, Relief, and Economic Security (CARES) Act shortly after the unprecedented $2 trillion stimulus package cleared both the House and Senate unanimously.
Even before the legislation was officially signed into law, lawmakers were gearing up for a possible fourth wave of legislation to help address the coronavirus pandemic and its economic fallout.
“The Coronavirus Aid, Relief and Economic Security Act provides critical assistance and resources to our health care workers and hospitals that are overwhelmed right now trying to save American lives. . . . but we are disappointed that it does not ensure that all patients have access to affordable coronavirus treatment,” House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Chairman Richard E. Neal (D-MA), House Education and Labor Chairman Bobby Scott (D-VA), Senate HELP Ranking Member Patty Murray (D-WA) and Senate Finance Ranking Member Ron Wyden (D-OR) said in a joint statement.
President Trump tweeted March 31 that the next stimulus package could focus on infrastructure. House Speaker Nancy Pelosi (D-CA) said April 1 that House Democrats were pressing ahead on a fourth package, but according to published reports, some Senate Republicans signaled those efforts were premature.
Meanwhile, hospital groups urged the federal government “to directly and expediently distribute” to hospitals and health systems the $100 billion in emergency funding made available under the CARES Act for expenses or lost revenue attributable to COVID-19.
In a March 31 letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma, the American Hospital Association (AHA) asked the agencies to direct Medicare Administrative Contractors to immediately distribute funds to every type of hospital in the United States, including rural and urban short-term acute-care, long-term care, and critical access hospitals, as well as inpatient rehabilitation and inpatient psychiatric facilities, at “the rate of $25,000 per bed, and $30,000 per bed for ‘hot spots.’”
AHA estimated that, with about 924,000 hospital beds nationwide, this approach would distribute about $23 billion, not including the additional funding for hot spots. “Funds distributed in the manner above could be 'reconciled' at a later date using hospital applications that delineate their exact need for funds,” the group said.
Centers for Medicare & Medicaid Services
April 2—CMS issued additional recommendations on mitigating the spread of COVID-19 in nursing homes. Recommendations include that nursing homes should use separate staffing teams for residents and designate separate facilities or units, to the extent possible, for residents based on their COVID-19 status. For example, one facility in Wilmington, MA was designated as a solely COVID-19-positive facility for residents across the region who are infected with the virus, CMS noted. “This approach also eases the challenges of preventing transmission, like extensive PPE usage and isolation practices, for individual facilities,” CMS said. The guidance also recommends enhanced screening of staff and visitors including temperature checks. CMS previously ordered targeted inspections of nursing homes to focus on infection control measures. According to the agency, surveys conducted the week of March 30 found 36% of facilities that were inspected did not follow proper hand washing guidelines and 25% failed to demonstrate proper use of personal protective equipment (PPE).
March 31—CMS has now approved 40 state Medicaid waivers under Section 1135. The Section 1135 waivers give states additional flexibilities to administer their Medicaid programs during the coronavirus outbreak. CMS recently approved waivers for Tennessee, South Carolina, Texas, Montana, West Virginia, and Vermont, among others.
March 30—CMS took a host of far-ranging steps issuing new waivers and guidance aimed at relaxing regulatory requirements to help hospitals and health care systems ramp up capacity to care for patients at alternate sites, quickly expand their workforces, further promote the use of telemedicine, and ease paperwork burdens.
For example, CMS announced new flexibilities for “hospitals without walls” to provide treatment and testing offsite or at temporary locations such as such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories. The new guidance also allows physician-owned hospitals to temporarily increase the number of licensed beds and operating and procedure rooms. Hospitals also can bill for services provided outside the hospital and screen patients at alternative treatment and testing sites that are not subject to the Emergency Medical Treatment and Labor Act for the duration of the national emergency, CMS said.
CMS also is allowing hospitals and health systems to increase their workforce capacity through a series of temporary measures, including expanding their ability to hire health care professionals licensed in other states and issuing waivers so they can use other practitioners such as physician assistants and nurse practitioners to order tests and medications without a physician’s order as allowed under state law. CMS waived the requirement that a certified registered nurse anesthetist is under a physician’s supervision. CMS also is allowing health care providers to enroll in Medicare temporarily.
To eliminate paperwork burdens, Medicare is now covering all respiratory-related devices and equipment for any medical reason; not requiring hospitals to have written policies on processes and visitation of patients who are in COVID-19 isolation; and providing temporary relief from certain audit and reporting requirements.
In addition, CMS took significant steps to further expand the use of telehealth services by extending Medicare coverage to more than 80 additional services. Notably, CMS also said providers can bill for telehealth services at the same rate as in-person visits. CMS also is allowing virtual supervision by physicians.
CMS issued blanket waivers of sanctions under the Stark Law for COVID-19 purposes. The waivers are effective March 1 and may be used without notifying CMS. For more information, see CMS Issues Blanket Stark Law Waivers to Address COVID-19 Crisis in this issue.
“Front line healthcare providers need to be able to focus on patient care in the most flexible and innovative ways possible. This unprecedented temporary relaxation in regulation will help the healthcare system deal with patient surges by giving it tools and support to create non-traditional care sites and staff them quickly,” said CMS Administrator Seema Verma. For more information on the new guidance, waivers, and interim final rule, click here.
In a statement, AHA President and CEO Rick Pollack said the new waivers “will help ensure hospitals and health systems can provide the right treatment for patients in the right location. This includes providing care in non-traditional settings, remotely through telehealth and in appropriate outpatient facilities through easing of the Stark Law.”
March 28—CMS is expanding its accelerated and advance payment program for Medicare providers and suppliers to help lessen financial burdens from the COVID-19 pandemic, the agency announced. The program typically has been used to help maintain cash flow to health care providers affected by natural disasters. CMS is extending the program to all Medicare providers nationwide during the COVID-19 public health emergency. Medicare Part A and Part B providers are eligible for the program if they have billed Medicare for claims within 180 days; are not in bankruptcy; have not be under active medical review or program integrity investigation; and do not have outstanding delinquent Medicare overpayments. CMS said the agency will start accepting and processing accelerated/advance payment request immediately, with an expected processing time of seven days.
March 27—CMS issued additional guidance on exceptions under certain Medicare quality reporting and value-based purchasing programs that the agency previously announced. CMS separately issued Frequently Asked Questions (FAQs) on the extension of the 2019 Merit-based Payment Incentive Payment System (MIPS) data submission deadline from March 31 to April 30 for clinicians responding to the COVID-19 pandemic. The FAQs also discuss the MIPS “automatic extreme and uncontrollable circumstances” policy that will apply to clinicians who are unable to submit data by the new April 30 deadline.
March 26—CMS is exercising enforcement discretion for some requirements that apply to clinical laboratories under the Clinical Laboratory Improvement Amendments and is focusing inspection efforts on immediate jeopardy situations during the COVID-19 public health emergency, according to an agency memorandum. The policy allows pathologists to review pathology slides remotely if they meet certain conditions; ensures U.S. labs that apply for CLIA certification are able to begin COVID-19 testing as quickly as possible; and allows hospital labs to hold a single certificate for sites within the same physical location or street address.
Department of Health and Human Services
March 31—HHS issued an open letter to hospitals acknowledging that using a single mechanical ventilator for two patients is a potential, though “absolute last resort,” option for some health care providers to consider. “These decisions must be made on an individual institution, care-provider, and patient level. However, we do know that many institutions are evaluating this practice, and protocols are being developed and tested, and in some places, preliminary implemented,” the letter said.
Office for Civil Rights (OCR)
April 2—Effective immediately, OCR will not impose penalties on business associates for “the good faith uses and disclosures of protected health information (PHI) . . . for public health and health oversight activities during the COVID-19 nationwide public health emergency.” The HIPAA Privacy Rule already permits covered entities to provide data to federal public health agencies like the Centers for Disease Control and Prevention and CMS, as well as state health authorities. The latest notice of enforcement discretion now allows business associates to share this information as well. "The CDC, CMS, and state and local health departments need quick access to COVID-19 related health data to fight this pandemic," said Roger Severino, OCR Director. "Granting HIPAA business associates greater freedom to cooperate and exchange information with public health and oversight agencies can help flatten the curve and potentially save lives," Severino added.
March 28—Organizations receiving federal funds, including health care providers, need to make sure they continue to comply with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age, sex, and religion, OCR noted in a recent bulletin. OCR enforces the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, the Age Discrimination Act, and Section 1557 of the Affordable Care Act. “HHS is committed to leaving no one behind during an emergency, and helping health care providers meet that goal,” said OCR Director Roger Severino. “Persons with disabilities, with limited English skills, and older persons should not be put at the end of the line for health care during emergencies,” he added. The bulletin outlines some of covered entities’ ongoing obligations, including providing effective communication for the hearing and visually impaired, offering meaningful access to programs and information for individuals with limited English proficiency, and making emergency messaging available in plain language, in languages prevalent in the affected area, and in multiple formats. The bulletin also notes “[s]ome actions or accommodations may not be required on the basis that they may fundamentally alter the nature of a program, pose an undue financial and administrative burden, or pose a direct threat.”
Food and Drug Administration (FDA)
March 31—The FDA listed hydroxychloroquine and chloroquine two malaria drugs that also are used to treat autoimmune disorders as in shortage because of a spike in demand resulting from the coronavirus pandemic. Demand has increased for the drugs since early reports that they may be a potential treatment for COVID-19 patients. The agency said it is working with manufacturers to assess their supplies. Manufacturers also are ramping up production and there currently is some availability of the drugs, according to the FDA’s website.
March 30—The FDA issued final guidance to help expand the availability of medical gowns, hoods, and gloves during the public health emergency. The guidance on personal protective equipment is in effect through the duration of the public health emergency. The FDA issued similar guidance March 29 aimed at expanding the availability of sterilizers, disinfectant devices, and air purifiers.
March 27—The FDA issued an Emergency Use Authorization (EUA) to help increase the supply of ventilators, tubing connectors, and related accessories. The FDA also issued an EUA for certain imported non-National Institute for Occupational Safety and Health (NIOSH)-approved respirators.
April 2—The Federal Communications Commission (FCC) adopted a new $200 million program funded under the CARES Act to support health care providers’ use of telehealth during the coronavirus pandemic. The program will help eligible health care providers purchase telecommunications, broadband connectivity, and devices necessary for providing telehealth services, the agency said. The FCC also adopted final rules for a three-year Connected Care Pilot Program, which will make up to $100 million available under the agency’s universal services fund for health care providers’ costs of offering telehealth services to patients at their homes or mobile locations, particularly low-income Americans and veterans.
April 2—President Trump issued an order under the Defense Production Act (DPA) for the HHS Secretary, in consultation with the Homeland Security Secretary, to facilitate the supply of materials to companies that will be manufacturing ventilators such as General Electric Company; Hill-Rom Holdings, Inc.; Medtronic Public Limited Company; ResMed Inc.; Royal Philips N.V.; and Vyaire Medical, Inc. He also issued an order for the HHS Secretary and the Federal Emergency Management Agency Administrator to use all authority under the DPA to acquire N-95 repirator masks from 3M. President Trump earlier issued an executive order delegating additional authority to the HHS Secretary under the Defense Production Act to expand domestic production of health and medical resources needed to respond to COVID-19, including PPE and ventilators. President Trump previously invoked the DPA but didn’t order any specific action. The March 27 executive order delegates authority “to guarantee loans by private institutions, make loans, make provision for purchases and commitments to purchase, and take additional actions to create, maintain, protect, expand, and restore domestic industrial base capabilities to produce such resources” and “to provide for the making of voluntary agreements and plans of action by the private sector.”
April 1—AHA is urging the nation’s five largest private health insurance companies—Aetna, Anthem, Humana, Cigna and UnitedHealthCare—and industry groups America’s Health Insurance Plans and Blue Cross Blue Shield Association “to support stable cash flow by allowing providers to opt into periodic interim payments and/or accelerated payments for the duration of the public health emergency, much like what is available through the Medicare program.” In letters to company leaders, AHA also asked the insurers to “eliminate administrative processes that cause delays in payment, such as prior authorization and certain payment edits, and provide adequate coverage and reimbursement of services in hospitals and alternative sites of care, including by covering cost-sharing for COVID-19 treatment.” Finally, the group urged insurers “to expedite processing of outstanding claims that have resulted in billions of dollars in accounts receivables.”
March 30—HHS and FEMA created a Supply Chain Stabilization Task Force to help source critically needed PPE, ventilators, and other resources across the country and to surge support to COVID-19 “hot spots.” The task force will use a four-prong approach in its efforts—preservation of current supplies including developing and verifying techniques to clean and recycle PPE; acceleration of industrial manufacturing; expansion of the industry to enhance production capacity; and allocation of critical resources to ensure “the right quantities of supplies get to the right place, at the right time.”
March 29—The administration is asking hospitals to report daily data on testing for COVID-19 performed by in-house laboratories, in addition to daily reports on bed capacity and supplies. Vice President Pence sent the letter to the nation’s hospitals on behalf of the White House Coronavirus Task Force, which already is collecting data from public and private labs on COVID-19 testing.