Helpful Hints

HHS Releases Revised Reporting Requirements and Timeline for Provider Relief Fund Payments

On June 11, 2021, the U.S. Department of Health and Human Services released revised reporting requirements for recipients of Provider Relief Fund ("PRF") payments first authorized by the Coronavirus Aid, Relief, and Economic Security ("CARES") Act, the Paycheck Protection Program and Health Care Enhancement Act, and the Coronavirus Response and Relief Supplemental Appropriations. The announcement, among other things, expands the time to report information, reduces reporting burdens on some providers, and extends deadlines for expending PRF payments received after June 30, 2020. The requirements apply to providers receiving one or more payments exceeding, in the aggregate, $10,000 during a single Payment Received Period from the PRF General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.

HHS, through the Health Resources and Services Administration ("HRSA"), began issuing notices on post-payment reporting requirements in July 2020. In January 2021, HHS issued updated requirements to reflect language in the Coronavirus Response and Relief Supplemental Appropriations Act of 2021. HHS also opened registration for its reporting portal, accessible here. The June 2020 payments revised reporting requirements beginning July 2021 can be found here. HHS believes its revised notice more accurately addresses "the rapidly evolving nature of the pandemic and its impact on health care providers and other stakeholders."

Key revisions include:

• The period of availability of funds is based on the date the payment is received (rather than requiring all payments be used by June 30, 2021, regardless of when they were received).
• Recipients are required to report for each Payment Received Period in which they received one or more payments exceeding, in the aggregate, $10,000 (rather than $10,000 cumulatively across all PRF payments).
• Recipients will have a 90-day period to complete reporting (rather than a 30-day reporting period).
• The reporting requirements are now applicable to recipients of the Skilled Nursing Facility and Nursing Home Infection Control Distribution in addition to General and other Targeted Distributions.
• The PRF Reporting Portal will open for providers to start submitting information on July 1, 2021.

The Notice summarizes reporting requirements under multiple sections, including:

• Period of availability of funds
• Reporting time periods
• Responsibilities for reporting
• Steps for reporting on the use of funds
• Relevant data elements for reporting

These reporting requirements apply to all past and future PRF payments made under the legislative authorities. Commenting on the revised guidance, HRSA Acting Administrator Diana Espinosa said, "From the beginning of this pandemic, health care providers have gone above and beyond to care for their patients in extremely difficult circumstances that caused significant financial hardship. These updated requirements reflect our focus on giving providers equitable amounts of time for use of these funds, maintaining effective safeguards for taxpayer dollars, and incorporating feedback from providers requesting more flexibility and clarity about PRF reporting."

Source: U.S. Department of Health & Human Services (www.HHS.gov)

FDA Grants Emergency Use Authorization to First Saliva-Based COVID-19 Antibody Test

Saliva-based COVID-19 infection testing has been authorized by the U.S. Food and Drug Administration since April 2020. For the first time, the FDA has granted an emergency use authorization ("EUA") for its first antibody test based upon saliva collection and testing. Developed and manufactured by Diabetomics in the US, this rapid, lateral-flow diagnostic test received an agency emergency authorization allowing it to be used at the point of care for adults and children on June 4, 2021.

The CovAb test uses requires an oral fluid sample obtained with a simple swab of the gum line, making it easy and painless. The test is CLIA-waived, is all-inclusive, does not require any additional components or instrumentation, and test results are available within fifteen minutes. The diagnostic test, which detects IgA, IgG and IgM antibodies, previously received a CE mark in Europe. When administered at least fifteen days after the onset of symptoms, the test demonstrated a false-negative rate of less than three percent and a false-positive rate of less than one percent.

Antibodies tests are essential to tracking and treating COVID-19. These tests may have already altered the understanding of COVID-19 onset and its risk. For example, the first formal acknowledgment of what was to become the COVID-19 pandemic came on January 9, 2020, when the World Health Organization issued a statement about a mysterious new respiratory disease that had rapidly infected several dozen people in Wuhan, China. The U.S. confirmed its first case of the virus, with the Centers for Disease Control and Prevention ("CDC") announcing on January 21, 2020 that a Washington state resident had returned from a trip to Wuhan with the coronavirus. Now, antibody research from the National Institutes of Health, however, found the virus actually made its way to the U.S. at least as early as the end of December 2019 and reached far beyond the initial hot spots of Washington state and New York City. Similarly, antibody research from the CDC study of archived blood donations suggests cases cropped up in Washington, California and Oregon as early as December 13, 2019.

Similarly, these antibodies tests may still inform medical authorities regarding the transmission and lethality of COVID-19. Forbes by way of example was opining in December 2020 that COVID-19 was five times more deadly than influenza (Forbes, 2020-12-17). These conclusions were based in part on hospitalization outcomes and "excess mortalities" studies. However, subsequent antibodies studies now suggest for every COVID-19 case diagnosed in July 2020, nearly five cases went undiagnosed. The number of Americans actually contracting COVID-19 was thus far higher than originally estimated. Instead of three million active cases in the US in July 2020, antibodies research indicates nearly 20 million active cases (i.e., more than six times as prevalent). While research continues to evolve, medical authorities will presumably continue to monitor and modify diagnoses, therapies, and hospitalizations.

This EUA for saliva-based COVID-19 infection testing will be effective until the FDA declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 is terminated under the Act or the EUA is revoked under the Act.

Source: U.S. Food and Drug Administration (www.FDA.gov)

HHS Announces Rule to Protect Consumers from Surprise Medical Bills

On July 1, 2021, the U.S. Departments of Health and Human Services ("HHS"), along with the Department of Labor and the Department of the Treasury (the "Departments"), and the Office of Personnel Management ("OPM"), issued "HHS Announces Rule to Protect Consumers from Surprise Medical Bills." This interim final rule, the first in an anticipated series of regulations, intends to minimize out of pocket costs to consumers from surprise billing and balance billing, shielding patients from increased financial hardships stemming from surprise medical bills.

According to HHS, "surprise billing" occurs when patients unknowingly receive care from providers outside of their health plan's network. Balance billing occurs when a provider charges a patient the remainder of what their insurance does not pay. Balance billing is currently prohibited in both Medicare and Medicaid. The rule would thus extend similar protections to Americans insured through employer-sponsored and commercial health plans. Surprise billings and balance billings can happen for both emergency and non-emergency care.

Among other things, the interim final rule bans:

• surprise billing for emergency services;
• high out-of-network cost-sharing for emergency and non-emergency services;
• out-of-network charges for ancillary care (like an anesthesiologist or assistant surgeon) at an in-network facility in all circumstances; and
• other out-of-network charges without advance notice.

Under this rule, emergency services, regardless of where they are provided, must be treated on an in-network basis without requirements for prior authorization. Patient cost-sharing, such as co-insurance or a deductible, cannot be higher than if such services were provided by an in-network doctor, and any coinsurance or deductible must be based on in-network provider rates. Health care providers and facilities must provide patients with a "plain-language" consumer notice explaining that patient consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate.

The Administration in its accompanying fact sheet to the announcement cited devastating financial consequences for individuals and their families. HHS offered statistics showing two-thirds of all bankruptcies filed in the United States are tied to medical expenses. It cites air ambulance charges, with more than two-thirds furnished out-of-network, as a driving factor. On the other hand, researchers estimate that less than 20% of emergency room visits and inpatient hospital stays involve care from at least one out-of-network provider, resulting in surprise medical bills. The Administration believes tackling surprise billing is critically important.

The interim final rule, the first of several requirements of the Consolidated Appropriations Act of 2021, will take effect for health care providers and facilities January 1, 2022 and for group health plans, health insurance issuers, and Federal Employees Health Benefits Program carriers for plan, policy, or contract years beginning on or after January 1, 2022.

Source: Centers for Medicare & Medicaid Services (www.CMS.gov)

EEOC Issues Revised COVID-19 Technical Assistance and Employee Resources

On June 28, 2021, the U.S. Equal Employment Opportunity Commission ("EEOC") posted updated and expanded technical assistance related to the COVID-19 pandemic, addressing questions arising under the federal equal employment opportunity ("EEO") laws. The EEOC also posted a new resource for job applicants and employees, explaining how federal employment discrimination laws protect workers during the pandemic.

The technical assistance answers COVID-19 questions only from the perspective of the EEO laws. Other federal, state, and local laws come into play regarding the COVID-19 pandemic for employers and employees. The new resource for job applicants and employees provides basic information about how federal employment discrimination laws help workers who are being harassed; who need extra protection against getting sick; who are not being allowed to work; or who need a modification of their employer's COVID-19 safety requirements. These publications are provided to help employees and employers understand their rights and responsibilities at work during the pandemic.

The expanded technical assistance provides new information about how the Americans with Disabilities Act ("ADA") and the Genetic Information Nondiscrimination Act ("GINA") apply when an employer offers incentives for employees to provide documentation or other confirmation of vaccination when an employee gets a vaccine in the community or from the employer or its agent.

The key updates to and expansions of the technical assistance include:

• Federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19 (employers must however comply with the reasonable accommodation provisions of the ADA and Title VII of the Civil Rights Act of 1964 and other EEO considerations)
• Federal EEO laws do not prevent or limit employers from offering incentives to employees to voluntarily provide documentation or other confirmation of vaccination obtained from a third party (not the employer)
• Employers administering vaccines to their employees may offer incentives for employees to be vaccinated (any incentives should not be coercive)
• Employers may provide employees and their family members with information to educate them about COVID-19 vaccines and raise awareness about the benefits of vaccination

The employee resource addresses EEOC areas of emphasis relating to employee rights during the COVID-19 pandemic. The fact sheet highlights employee recourse for:

• harassment
• "high-risk" employees
• "reasonable accommodations"
• work furloughs and prohibitions
• modifications to an employer's COVID-19 safety requirements

Employers should remain vigilant to employee discontent and move proactively consistent with EEOC guidelines. For example, if your employee claims harassment at work, the employer should investigate and, if such harassment is indeed taking place, then take prompt steps to stop it. Employers should be alert for and amenable to reasonable accommodation for employees with a health condition deemed a "disability" under the ADA, even if not permanent or severe. Employers should maintain policies and procedures to identify currently infectious employees and vulnerable employees and be prepared to offer reasonable accommodation if work attendance could create a significant risk of substantial harm to employee health. Finally, employers should be open to reasonable accommodation and even prudent modification of existing safety requirements and equipment for employee medical conditions as well as religious beliefs, practices, or observances.

Other laws, outside the EEOC's jurisdiction, may place additional restrictions on employers. Employers should consider some employees may be more likely to be negatively impacted by a vaccination requirement since some individuals or demographic groups may face greater barriers to receiving a COVID-19 vaccination than others. Vaccinations require employees to answer pre-vaccination disability-related screening questions. Employers should not make employees feel pressured to disclose protected medical information. In all cases, employers obtaining vaccination information from their employees, must keep such information confidential pursuant to the ADA.

These EEOC publications follow a hearing on the impact of the COVID-19 pandemic on civil rights in the workplace but were prepared prior to new guidance for fully vaccinated persons from the Centers for Disease Control issued on May 13, 2021. The EEOC will consider any impact new information has on its COVID-19 technical assistance. Additional updates and assistance to the public can be expected.

Source: U.S. Equal Employment Opportunity Commission (www.EEOC.gov)

FDA Announces Draft Guidances on Transparency, Reporting and Completion for Medical Device Studies after FDA Approval or Clearance

On May 26, 2021, the U.S. Food and Drug Administration ("FDA") issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, the FDA believes the guidance will help increase transparency and assist reporting and timely completion of studies on the safety and effectiveness of certain devices. The FDA seeks comment on the guidance by July 26, 2021.

The first draft guidance document was issued under authority of Section 522 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") in connection with postmarket surveillance. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The FDA receives and reviews additional data on certain devices to inform our oversight for the safe and effective use of a device throughout the device lifecycle.

Section 522 affords the FDA with authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. The FDA believes data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device.

When finalized, the draft guidance should assist manufacturers of devices by providing:

• an overview of section 522 of the FD&C Act;
• information on how to fulfill section 522 obligations, including:
  • when postmarket surveillance should be considered commenced;
  • recommendations for achieving an approved postmarket surveillance plan in a timely manner; and
  • recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;
• recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and
• updated surveillance status categories to better reflect progress.

The guidance, describing postmarket surveillance of moderate and high-risk devices and post-approval study procedures, is intended to help manufacturers better understand the FDA's requirements and expectations for ongoing data collection for certain approved or cleared devices. In the end, the FDA seeks increased reporting compliance. Persons wishing to comment on this guidance should do so by submitting comments here, referencing docket number FDA-2011-D-0514.

The second draft guidance relates to procedures for handling post-approval studies imposed by premarket approval application ("PMA") orders. The FDA may consider it acceptable to collect certain data in the postmarket setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device at the time of premarket approval. Evaluation of PMAs is a multi-step process, evaluating whether reasonable assurance of device safety and effectiveness has been demonstrated. To provide such assurance, the FDA can require a post-approval study ("PAS") as a condition of approval in a PMA approval order. The PAS may be a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device.

When finalized, the guidance is intended to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing:

• procedural information;
• recommendations concerning the format, content, and review of PAS-related submissions; and
• updates to the final guidance, including:
  • recommendations for study timelines including enrollment milestones and study completion;
  • revised definitions to PAS status categories that we believe better reflect the progress of the PAS; and
  • revised FDA review time goals for PAS-related submissions.

The FDA, in its mission to ensure devices on the market are safe and effective, believes its review of data from post-approval studies and postmarket surveillance is an important part of that commitment. The two new draft guidance documents will reinforce to device sponsors the importance of engaging early and often with the FDA to ensure data are properly collected and all required postmarket studies are properly implemented. Persons wishing to comment on this guidance should do so by submitting comments here, referencing docket number FDA-2005-D-0027.

Source: U.S. Food and Drug Administration (www.FDA.gov)

Focus

Birmingham Medical News: Five Information Blocking Takeaways

On April 5th, the final information blocking rules issued by the Office of National Coordinator ("ONC") took effect, leaving providers with numerous questions regarding what information has to be released, to whom, and how quickly.

Reprinted with permission from the Birmingham Medical News

Read

Effective Date Announced for New COVID-19 Safety Rule for Healthcare Providers

In January 2021, President Joe Biden issued an Executive Order directing the Department of Labor ("DOL") to consider issuing an Emergency Temporary Standard ("ETS") addressing COVID-19. After numerous delays, the final ETS was issued on June 10, 2021, and addresses what healthcare employers, who are not excluded from its application, must do to protect workers from COVID-19. For more details on applicability of the ETS and its requirements, see the prior Burr Alert on this topic.

Read

Birmingham Medical News: Fraud and Abuse Enforcement Continues Through the Pandemic

Despite the ongoing COVID-19 pandemic and the resulting challenges facing health care providers, compliance with fraud and abuse laws has not been waived. While some enforcement actions have been "paused" due to difficulties in conducting face-to-face interviews and convening grand juries, and the Government has temporarily "relaxed" certain regulatory restrictions to facilitate pandemic response efforts, there appears to be a recent increase in investigations, settlements and convictions.

Read

[View source.]