Coronavirus: Updates and Developments

March 20, 2020

Economic Stimulus

On the legislative front, the Senate passed March 18 by a 90-8 margin a measure unveiled by House Democrats last week that includes free coronavirus testing, paid emergency sick leave for some workers, enhanced unemployment insurance, and a temporary increase in federal funding for Medicaid. The House cleared H.R. 6201 by a 363-40 vote after securing the White House’s backing. The President signed the measure into law on March 18.

Senate Majority Leader Mitch McConnell (R-KY) is working on a broader package of measures to help shore up the health care system, provide direct assistance to American workers and families, and stabilize the U.S. economy. “[I]t is my intention that the Senate will not adjourn until we have passed significant and bold new steps, above and beyond what the House passed,” McConnell said.

On March 19, McConnell unveiled the Coronavirus Aid, Relief, and Economic Security Act. The massive economic stimulus package is expected to cost at least $1 trillion, according to published reports. McConnell said talks on the measure would begin March 20, but Democratic leaders already were signaling concerns with the bill.

“We are beginning to review Senator McConnell’s proposal and on first reading, it is not at all pro-worker and instead puts corporations way ahead of workers,” Pelosi and Senate Minority Leader Chuck Schumer (D-NY) said in a joint statement.

Congress previously cleared an emergency spending package devoting $8.3 billion in funding for efforts to combat the coronavirus, which President Trump signed into law. The third wave of economic relief is expected to be far broader in scope.

The American Hospital Association (AHA) and American Nursing Association sent a letter March 19 to congressional leaders urging them to include in the economic relief package $100 billion in direct funding “to front line health care personnel and providers, including physicians, nurses, hospitals and health systems, and direct the federal agencies to begin to infuse funds immediately.”

According to the groups, hospitals are losing up to $1 million per day related to COVID-19 expenses. Non-critical surgeries are being postponed to free up inpatient beds and conserve supplies, which also “results in serious financial hardship for many hospitals and physician practices.”

The groups outlined three immediate priorities: creating a stabilization fund for emergency expenses related to COVID-19, including covering lost revenues from suspending elective services, testing costs, and additional training, staffing, and supply expenses; providing critical childcare for frontline health care personnel; and ramping up surge capacity to care for COVID-19 patients with less serious conditions in alternative care sites, such as outpatient and temporary facilities, to free up space for sicker patients requiring more intensive care.

According to published reports, one option Congress is likely considering is suspending Medicare sequestration cuts, which amount to a 2% across-the-board payment reduction for most benefits. AHA, along with the Association of American Medical Colleges, and the Federation of American Hospitals, asked Congress in an earlier letter to suspend Medicare sequestration at least through the duration of the pandemic.

The American Clinical Laboratory Association (ACLA) also sent a letter to Congress asking for an emergency lab surge capacity fund of $5 billion. “We are growing increasingly concerned that the federal government is not recognizing the strain on the laboratory industry to meet the demand for testing for COVID-19,” ACLA President Julie Khani said in the March 19 letter to congressional leaders.

“The laboratory industry wholeheartedly supports no-cost testing but is in critical need of additional support from Congress to ensure we have the necessary staffing, supplies and equipment to fulfill that vital promise,” Khani said.

Commercial labs have significantly ramped up testing in recent weeks, Khani said. At the end of February, the Food and Drug Administration (FDA) issued guidance providing an accelerated path for commercial laboratories to perform COVID-19 testing, the letter noted.

In a March 19 letter, America’s Health Insurance Plans and the Blue Cross Blue Shield Association asked Congress to allow a one-time special enrollment period for the Affordable Care Act individual marketplace.

The groups also pressed Congress to establish a temporary, emergency risk mitigation program to counter likely spikes in health insurance premiums. “This should be structured as a backstop contingency program that is triggered only if real-world health insurer costs are significantly higher than expected,” the letter said. The groups recommended the program cover a portion of related costs for 2020 and 2021 for the individual, employer, Medicare, and Medicaid markets.

Agency Guidance

Federal agencies also are continuing intensive efforts to address the coronavirus pandemic. Below is a non-exhaustive list and summary of agency guidance and other developments related to the coronavirus from this week.

Centers for Medicare & Medicaid Services (CMS)

March 18—CMS issued guidance on Adult Elective Surgery and Procedures Recommendations. The guidance recommends that health care providers “[l]imit all non-essential planned surgeries and procedures, including dental, until further notice.” The guidance includes a tiered framework “to inform health systems as they consider resources and how best to provide surgical services and procedures to those whose condition requires emergent or urgent attention to save a life, preserve organ function, and avoid further harms from underlying condition or disease.” The guidance notes that health care providers, in consultation with state and local health officials, retain decision-making responsibility, but should consider resource conservation as well as the clinical situation in the risk-benefit analysis in determining whether to move forward with a planned procedure. The guidance includes factors for providers to consider in making those determinations.
March 18—CMS updated Frequently Asked Questions (FAQs) for state Medicaid and Children’s Health Insurance Program (CHIP) agencies. The FAQs reflect questions and concerns raised by state Medicaid and CHIP agencies, including those related to the flexibilities CMS is affording states in managed care, benefits, financing, Section 1115 demonstrations, and leveraging Section 1135 waivers offered under the President’s national emergency declarations. CMS will continue to update the FAQs as more questions are submitted.
March 17—CMS issued guidance to Programs of All-Inclusive Care for the Elderly (PACE) Organizations, which serve older adults many with serious chronic medical conditions who are at higher risk of serious illness from the virus. PACE is a Medicare and Medicaid program that helps seniors receive health care in the community rather than an institutional setting. The guidance advises PACE Organizations on infection control policies and procedures. The guidance also indicates that CMS will exercise discretion in monitoring and oversight activities if PACE centers need to implement mitigation strategies (e.g., telehealth for patient assessments) that don’t fully comply with program requirements.
March 17—CMS granted the first Section 1135 waiver to Florida, which gives the state additional flexibilities in administering its Medicaid program, including to waive prior authorization requirements, streamline provider enrollment processes, allow care in alternative settings, suspend certain nursing home screening requirements, and extend appeals deadlines. CMS granted a second Section 1135 waiver to Washington state on March 19.
March 16—Exercising its authority under Section 1135, CMS moved to expand telehealth services for Medicare beneficiaries. Clinicians can bill for telehealth services immediately for dates of service starting March 6. Under the new waiver, Medicare beneficiaries can receive various services through telehealth—such as office visits, mental health counseling, and preventative health screenings—across the country in their homes. Patients also can access their physicians through a wider range of communication tools including telephones with audio and video. The HHS Office of Inspector General also issued a Policy Statement notifying physicians and other practitioners that they will not be subject to administrative sanctions for reducing or waiving any cost-sharing obligations federal health care program beneficiaries may owe for telehealth services furnished consistent with the then applicable coverage and payment rules, subject to certain conditions. For more information on the telehealth waivers, see Federal and State Government Responses: How Telehealth Is Being Harnessed to Address the Coronavirus Pandemic, on AHLA’s Coronavirus Pandemic Hub.

Department of Health and Human Services

March 15—Using authorities under Section 1135 of the Social Security Act, as authorized by President Trump’s emergency declaration, HHS Secretary Alex Azar issued a limited waiver of sanctions and penalties for covered hospitals that are non-compliant with certain provisions of the Health Insurance Portability and Accountability Act (HIPAA). Specifically, the waiver applies to Privacy Rule requirements for obtaining a patient's agreement to speak with family members or friends involved in the patient’s care; honoring a request to opt out of the facility directory; distributing a notice of privacy practices; and to the patient's right to request privacy restrictions and to request confidential communications. The waiver is effective March 15 but only applies (1) in the emergency area identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. HHS' bulletin on the waiver also that notes that "[e]ven without a waiver, the HIPAA Privacy Rule always allows patient information to be shared for the following purposes and under the following conditions," including treatment and public health activities. "In addition, while the HIPAA Privacy Rule is not suspended during a public health or other emergency, the Secretary of HHS may waive certain provisions of the Privacy Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act."

Office for Civil Rights (OCR)

March 17—OCR announced it will exercise enforcement discretion and waive potential penalties for HIPAA violations against health care providers that serve patients through telehealth technologies during the COVID-19 public health emergency. The discretion applies to apps like FaceTime or Skype when used “in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to COVID-19,” the agency said.

Food and Drug Administration/National Institutes of Health (NIH)

March 18—FDA postponed all domestic routine surveillance facility inspections. “[A]ll domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical,” the agency said. Earlier this month, FDA postponed most foreign facility inspections through April, with mission-critical inspections to be considered on a case-by-case basis.
March 18—FDA issued Guidance on Conduct of Clinical Trials of Medical Products during the Coronavirus Pandemic. In the non-binding guidance, FDA recognizes that the COVID-19 pandemic may affect how clinical trials for drugs and devices are conducted including potential difficulties following protocol-specified procedures such as administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. While emphasizing that safety is paramount, the FDA signaled that changes in protocol or investigational plan may be implemented without Investigational Review Board approval, although the changes but must be reported afterward. Sponsors and investigators should document the reason for the contingency measures as well as the trial participants impacted. The guidance is being implemented immediately. NIH similarly issued Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19.

Other Developments

March 19—California Governor Gavin Newsom issued a broad directive requiring the state’s 40 million residents to shelter in place. Similar restrictions already were in place in the San Francisco area, but California is the first to order residents statewide to isolate at home, except for necessities like groceries, pharmacies, gas, banking, and laundry services. Newsom’s executive order exempts “federal critical infrastructure sectors,” and “essential state and local government functions” also will remain open. On March 20, New York Governor Andrew Cuomo also said he would be signing an executive order mandating that 100% of workforce must stay home, excluding essential services such as pharmacies, grocery stores, and other.
March 18—During a White House coronavirus task force briefing, Vice President Mike Pence, who is leading the administration’s COVID-19 response efforts, said that HHS will release a new regulation allowing physicians to practice across state lines even if they aren’t licensed in a certain state. As of this writing, HHS has not yet issued additional details.
March 18—Provider organizations including AHA, the American College of Physicians, the Federation of American Hospitals, and the National Association of ACOs (NAACOS), sent letters to House and Senate leaders asking them to shield Accountable Care Organizations (ACOs) and other value-based payment models from financial penalties resulting from costs related to the COVID-19 pandemic. NAACOS and other groups made a more detailed request in a letter to CMS Administrator Seema Verma, asking among other things to hold clinicians harmless from performance related penalties for 2020; to adjust spending targets, performance scores, patient attribution, and risk adjustment; and delay upcoming program deadlines.
March 18—New York Governor Andrew Cuomo signed a measure guaranteeing paid leave for workers in the state under mandatory or precautionary quarantine due to the coronavirus. The measure requires employers of 11 to 99 employers, and employers of ten or fewer employees with $1 million or more in net revenue, to provide at least five days of paid sick leave until the quarantine order is lifted. Employers with 100 employees or more, and public employers, must provide at least 14 days of paid sick leave during the quarantine period.
March 17—California Governor Gavin Newsom signed an emergency funding package that frees up $1.1 billion for the state’s efforts to fight COVID-19, including increasing hospital capacity, cleaning schools, and protecting those most vulnerable to the disease.
March 16—The Joint Commission suspended all regular surveys effective March 16. A small number of surveys, for example those involving high-risk situations, may still continue, the group said. “If any organizations go past their accreditation due date, accreditation will be extended without disruption to their accreditation status.” CMS also has offered assurances that Medicare payment status will not be affected.

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