FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Facepiece Respirators Manufactured in China

The US Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for certain filtering facepiece respirators (FFRs) that are manufactured in China and not approved by the CDC’s NIOSH. Recognizing there is still a shortage of FFRs, the FDA is continuing the EUA for respirator models already included in Appendix A of the reissued EUA to provide additional capacity as needed.

What You Should Know About COVID-19 and the Americans with Disabilities Act, the Rehabilitation Act, and Other EEO Laws

The Equal Employment Opportunity Commission (EEOC) recently updated its guidance on workplace discrimination issues relevant to the COVID-19 pandemic. It focuses on disability discrimination, employee confidentiality, and return-to-work issues and is in a Q&A format.

New York Court Decision on FFCRA Health Care Worker Exemption has Limited Impact on GNYHA Members

Members may have seen news reports about an August 3 New York district court decision vacating parts of the US Department of Labor’s (DOL) final rule implementing the Families First Coronavirus Response Act (FFCRA). The court found that DOL exceeded its authority in issuing an expansive definition of the term “health care worker” for the purposes of a health care worker exemption to the FFCRA requirement to provide mandatory paid leave under certain circumstances. The upshot of this decision is that potentially many more health care workers may be entitled to such leave under FFCRA. However, since FFCRA applies to employers with 500 or fewer employees, it has minimal impact on GNYHA members.

DOH Emergency Regulations on Hospital and Laboratory Reporting of Highly Contagious Communicable Diseases

The New York State Department of Health (DOH) published a notice of emergency adoption clarifying reporting requirements for highly communicable diseases such as COVID-19. The amendments mandate that hospitals report syndromic surveillance data during an outbreak of a highly contagious communicable disease and clarify that laboratories are required to report both positive and negative results for diseases identified as requiring prompt attention. Additionally, the amendments enable the DOH Commissioner to direct hospitals to take patients during outbreaks of a highly contagious communicable disease and establish specific actions that local health departments must take to investigate, isolate, and quarantine a suspected case of a highly communicable disease.

DOH intends to adopt the provisions of this emergency rule on a permanent basis and will publish a notice of proposed rulemaking in the State Register in the future. The emergency rule will expire on September 2, 2020.

Administrative Order Cancellation

On June 22, Chief Administrative Judge Lawrence Marks cancelled an Administrative Order that prevented the courts from compelling the personal attendance of physicians or other medical personnel who perform services at a hospital that is actively treating COVID-19 patients. Judge Marks issued a new order that strongly encourages parties to pursue discovery cooperatively and employ remote technology whenever possible.

Price Gouging

Earlier this month, New York Governor Andrew Cuomo signed A.10270/S.8189 into law, which amends the New York State General Business Law (GBL) to broaden the application of the law to include goods and services that are vital and necessary for the health, safety, and welfare of consumers or the general public. Previously, the GBL protected only consumer goods and services, such as those for personal, family, or household purposes. In this regard, the bill also broadens the definition of goods and services to include essential medical supplies and services used for the care, cure, mitigation, treatment, or prevention of any illness or disease, and any other goods and services used to promote the health or general welfare of the public. The New York State Office of the Attorney General (OAG) has the authority to promulgate rules and regulations under this amendment. Members can report instances of price gouging to the OAG here.

US Office of Inspector General Provides COVID-19-related FAQs

In response to the COVID-19 public health emergency, the Office of Inspector General (OIG) periodically publishes FAQs from the health care community. The FAQs provide guidance “…regarding the application of OIG’s administrative enforcement authorities, including the Federal anti-kickback statute [AKS] and civil monetary provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP)” during the COVID-19 outbreak. Under normal circumstances, each factual scenario addressed by OIG’s FAQs would implicate the AKS and/or Beneficiary Inducements CMP. However, through its FAQs and considering the COVID-19 public health emergency, OIG has reported that it views the subject scenarios as presenting a “…low risk of fraud or abuse,” provided certain conditions are met. Among these conditions is the requirement that the subject’s goods or services are only available prior to the termination of the COVID-19 public health emergency declaration.

Health and Human Services (HHS)

HHS Guidance FAQ on PHI

The HHS Office for Civil Rights (OCR) recently issued a FAQ document on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits the sharing of protected health information (PHI) for blood and plasma donation. OCR instructs the following:

  • A health care provider may use PHI to identify patients who have recovered from COVID-19 to provide them with information on how they can donate blood and plasma to treat COVID-19
  • Generally, this use of PHI does not require patient authorization because OCR considers it a population-based health care operations activity. The use and disclosure, however, must be limited to the minimum necessary to accomplish this purpose.
  • A health care provider cannot use or disclose PHI to the extent the activity constitutes marketing, as defined by HIPAA
  • Regarding marketing, HIPAA prohibits communications that inform or encourage patients on the means and benefits of donating blood and plasma and that encourage patients to use a particular blood or plasma center for donation. But, under an exception to the marketing definition, a health care provider can communicate about population-based case management and related health care operation activities if the provider does not receive direct or indirect payment from or on behalf of the third party described in the communication.
  • Without patient authorization, a health care provider generally cannot disclose PHI to a third party for the third party to make marketing communications about products or services, unless the third party is making the communication on behalf of a health care provider (i.e., as the provider’s business associate)

HHS OIG Application of Administrative Enforcement Authority

The OIG at HHS updated its FAQs on the application of the OIG’s administrative enforcement authority over arrangements directly connected to the COVID-19 public health emergency. For example, pursuant to certain safeguards, both the provision of telecommunications technologies by a mental health or substance use disorder provider to a patient and free access to a hospital’s telehealth platform by physicians on its medical staff likely present a sufficiently low risk of fraud and abuse.

OCR HIPAA Notice

OCR issued a notice stating that it will exercise its enforcement discretion and will not impose penalties against business associates (BAs) or covered entities under HIPAA for BAs disclosing protected health information for public health authorities or health oversight agencies outside of the scope of a BA agreement. Public health entities and health oversight agencies include the CDC and the Centers for Medicare & Medicaid Services. Under this notice, BAs must share in good faith and inform the covered entity of the disclosure within 10 days. BAs are still subject to the requirements in the HIPAA Security and Breach Notification Rules.

Alert on OCR Investigator Imposters

OCR alerted the public that an individual posing as an OCR investigator has contacted entities covered by HIPAA in an attempt to obtain protected health information without a transaction number or any other verifiable information. OCR recommends that organizations verify identity by asking for the purported investigator’s e-mail address, which will end in @hhs.gov, and then asking for a confirming e-mail originating from that e-mail address. Organizations can also contact ocrmail@hhs.gov with concerns.

First OCR Action Taken

OCR resolved a compliance review for the state of Alabama in response to a complaint that claimed Alabama had violated civil rights laws by discriminating on the basis of disability and age. Specifically, the complaint alleged that Alabama had incorporated a ventilator triage document into its emergency operations plan that purportedly allowed for the denial of ventilator service to individuals with disabilities and appeared to reference age as a potential category for exclusion from services. In noting that the document was dated and should have been replaced, Alabama agreed to remove all links and references to the document and clarify publicly that the criteria were not in effect. This is the first action taken by OCR since publication of a recent OCR bulletin that reminded covered entities of the continued applicability of civil rights laws during the COVID-19 response.

OCR LEP Bulletin

OCR recently issued a bulletin on ensuring the rights of persons with limited English proficiency (LEP) in health care during COVID-19. The bulletin reviews how health care providers can ensure meaningful access for persons with LEP and indicates that providers should use the flexibility under the law, such as the use of remote video or audio interpretation, when in-person interpretation may pose a risk of spreading COVID-19. As a reminder, GNYHA’s resource of translated COVID-19 educational material can be found here.

Health Plans Added to Existing OCR Guidance

The OCR amended guidance about how the HIPAA privacy rule allows covered entities to contact patients and beneficiaries without authorization who have recovered from COVID-19 to inform them about donating plasma. The amendments specify that health plans are also permitted to do this. Without the individual’s authorization, however, covered entities cannot receive any payment from, or on behalf of, a plasma donation center in exchange for reaching out to the individuals.

FTC and DOJ Joint Statement on Collusion in US Labor Markets

The Federal Trade Commission (FTC) and the Department of Justice (DOJ) released a joint statement on anti-competitive conduct regarding collaborations on the COVID-19 response.

Exception Request from the SAHMSA

The Drug Enforcement Administration (DEA) granted an exception request from the Substance Abuse and Mental Health Services Administration (SAMHSA) on March 16 to address the need for DEA registered narcotics treatment programs (NTP) to provide narcotic medication to patients that are quarantined as a result of COVID-19. Specifically, the exception allows for narcotics delivery to the homes of quarantined patients when diversion controls, such as a lock box, are implemented, and also expands the categories of persons who may deliver such narcotics to include NTP staff members, law enforcement, and National Guard members.

Centers for Medicare & Medicaid Services

CMS COVID-19 Emergency Declaration Blanket Waivers

CMS has compiled a list of all blanket waivers provided to date. The waivers apply nationwide and are retroactive to March 1, 2020, through the end of the emergency declaration.

HHS CMS Regulatory Waivers and Rule Changes

CMS issued a round of regulatory waivers and rule changes related to the COVID-19 public health emergency. Of note, CMS stated that any increase in temporary beds in response to this public health crisis will not adversely affect the ratio used as part of the calculation of Medicare’s indirect medical education (IME) payments. Waivers also address testing payments, the application cycle for the Medicare Shared Savings Program, the Outpatient Prospective Payment System, the value-based purchasing program, treatment location, and telehealth. The waivers are generally retroactive to March 1, 2020. The American Hospital Association’s analysis of the waivers can be found here.

ICE Reinforces Sensitive Locations Policy for COVID-19 Outbreak

Consistent with its sensitive locations policy during the COVID-19 crisis, US Immigration and Customs Enforcement (ICE) will not perform enforcement operations at or near health care facilities such as hospitals, doctors’ offices, accredited health clinics, and emergent or urgent care facilities, except in the most extraordinary circumstances. Individuals should not avoid seeking medical care because they fear civil immigration enforcement, as ICE outlined in a March 18 statement that remains in effect.