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.
Last night, Governor Andrew Cuomo issued Executive Order (EO) 202.28, which departs from the Governor’s prior orders by recognizing that the worst of the COVID-19 surge is behind us. EO 202.28 allows certain early legal and regulatory waivers to expire and summarily extends until June 6 the rest of the waivers issued up to and including EO 202.14. The waivers that were allowed to expire include those that allowed the suspension of regulations related to the discharge and transfer of patients, the maintenance of medical records, and ones applicable to nursing homes, home care, and facilities under the Office for People With Developmental Disabilities. Also expiring is the EO conferring immunity on certain professionals. Broad immunity for the same health care professionals covered under the EO—along with hospitals and other individuals and entities—is now codified in the Emergency or Disaster Treatment Protection Act, a New York State law that GNYHA was instrumental in advocating for.
HHS OIG Application of Administrative Enforcement Authority
The Office of the Inspector General (OIG) at the US Department of Health and Human Services (HHS) updated its FAQs on the application of the OIG’s administrative enforcement authority over arrangements directly connected to the COIVD-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.
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.
Office for Civil Rights
OCR HIPAA Notice
The US Department of Health and Human Services Office for Civil Rights (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 the Health Insurance Portability and Accountability Act of 1996 (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 the Health Insurance Portability and Accountability Act of 1996 (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 firstname.lastname@example.org 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
The US Department of Health and Human Services Office for Civil Rights (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.
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.