Today’s update focuses on modifications and/or additions to previous guidance, rules and regulations previously issued by the federal government.  In addition, there have been several statutes passed on the State level as well as some proposed regulations.

For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, or Labinot Alexander Berlajolli.

Federal Level

Elective Surgeries: Centers for Medicare & Medicaid Services (CMS) and State authorities previously requested providers to delay non-emergent medical services and procedures to conserve on PPE and other medical equipment.  CMS recently provided a chart, in a tiered framework, with recommendations that providers can use to decide which medical services could be deferred.  Also, the federal government’s new guidelines allow for elective surgeries during Phase One.  In preparation for the re-starting of elective surgeries, the American College of Surgeons, American Society of Anesthesiologists, Association of periOperative Registered Nurses and American Hospital Association issued a roadmap for facility readiness.  The roadmap provides guidance on when and how to safely resume elective surgeries.

$30 Billion Grant:  As a follow up to our previous update regarding the $30 billion in COVID-19 grants to Medicare providers, the federal government revised their terms and conditions.  Under the initial terms, a provider must be "currently" serving individuals with “possible” or actual cases of COVID-19 to keep the grants.  In light of many complaints that providers have closed down their practices because of the virus, HHS removed the word “currently” from the  terms and conditions.  Importantly, HHS views every patient as “possibly” having COVID-19.  HHS updated the provider relief website to address these issues and added this statement:

If you ceased operation as a result of the COVID-19 pandemic, you are still eligible to receive funds so long as you provided diagnoses, testing or care for individuals with possible or actual cases of COVID-19. Care does not have to be specific to treating COVID-19.  HHS broadly views every patient as a possible case of COVID-19.

Reporting Requirements:  CMS extended the reporting requirements that we previously noted in our  update for clinicians, providers, hospitals and facilities participating in quality reporting programs in response to COVID-19.  CMS issued a supplemental memorandum to provide additional guidance and exceptions to healthcare providers with regard to these requirements.

Anti-Kickback Waiver:  OIG issued a Policy Statement that it will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback statute for certain remuneration related to COVID-19 covered by the Blanket Waivers of Section 1877(g) issued by the Secretary of HHS.  As stated in our previous update, CMS issued a Blanket Waiver with regard to the Stark Law as it pertains to certain financial arrangements in order to provide more flexibility in responding to COVID-19.  In many instances, however, financial relationships that implicate the Stark Law also implicate the federal Anti-Kickback statute.  Thus, CMS’ Blanket Waiver of the Stark Law would not be that effective without a waiver applying to the Anti-Kickback Statute.  OIG’s Policy Statement, therefore, is necessary in the event the financial relationship that CMS waived under the Stark Law also implicates the federal Anti-Kickback Statute.

$200 Million For Telemedicine:  We previously noted that the CARES Act allocated $200 million to support healthcare providers' use of telehealth services during the pandemic.   The FCC recently approved the program for the allocation of the funds.  The following healthcare providers are eligible: (1) post-secondary educational institutions offering healthcare instruction, teaching hospitals, and medical schools; (2) community health centers or health centers providing healthcare to migrants; (3) local health departments or agencies; (4) community mental health centers; (5) nonprofit hospitals; (6) rural health clinics; (7) skilled nursing facilities; or (8) consortia of healthcare providers consisting of one or more entities falling into the first seven categories.  The FCC’s website provides details on how to apply for the program.

Additional Telemedicine Flexibilities:  CMS issued a letter to clinicians and a fact sheet outlining more changes to the Medicare program including coding data for testing patients for COVID-19, additional telehealth changes, and additional workforce flexibilities.  The workforce flexibilities add to the flexibilities previously implemented on March 30, 2020, and these additional flexibilities reduce supervision and certification requirements so that practitioners, such as nurse practitioners and occupational therapists, can perform certain tasks without the need for supervision by a physician.  To formalize these waivers, on April 6, 2020, CMS issued 85 FR 19230, an interim final rule that formalizes these changes and makes them effective March 31, 2020.

HIPAA Enforcement Discretion:   We previously noted that the Office of Civil Rights issued guidance on when healthcare providers can share the protected data of patients who have been exposed to COVID-19 without violating HIPAA.  Just recently, OCR issued 85 FR 19392, Notification of Enforcement Discretion, that further protects certain disclosures.  The Notification informs providers and business associates that the OCR will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule for uses and disclosures of protected health information (PHI) by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.  The OCR will exercise its discretion as long as the business associate makes a good faith use or disclosure of the covered entity's PHI for public health activities consistent with 45 CFR 164.512(b), or health oversight activities consistent with 45 CFR 164.512(d) and the business associate informs the covered entity within ten (10) calendar days after the use or disclosure occurs.

Infection Control:   CMS updated its guidance documents focused on infection control, with a particular focus on nursing homes, where the majority of COVID-19 deaths have occurred.  The guidance documents, based on CDC guidelines, are intended to help infection control in the context of patient triage, screening and treatment, the use of alternate testing and treatment sites and telehealth, drive-through screenings, limiting visitations, and cleaning and disinfection guidelines.

Employee Exposure to COVID-19:  CDC issued new guidelines for monitoring employees who may have been exposed to COVID-19.   Any potentially exposed employee will be allowed to continue to work as long as they are routinely monitored and symptom free.

Cost-Sharing Waivers:   CMS issued guidance regarding new COVID-19 coverage requirements for private health plans. This  guidance implements the Families First Coronavirus Response Act and the CARES Act. These federal statutes require private health plans and employer group health plans to cover COVID-19 testing with no out-of-pocket expenses.  In addition, as explained by the guidance, these federal statutes also require no cost-sharing for "certain related items and services" provided during a medical visit for COVID-19 testing.  As a result, insurers must cover urgent care visits, emergency room visits and in-person or telehealth visits that result in an order for a COVID-19 test.  The guidance also ensures coverage of COVID-19 antibody testing.  These requirements are retroactive for testing and related services provided on or after March 18.

Delay in Emergency Model:  In light of COVID-19, CMS delayed the start date of its Emergency Triage, Treat and Transport model from May 1 until this fall. The new model was to provide ambulance care teams more flexibility in how they triage emergencies. Medicare now pays for emergency ambulance services when beneficiaries are transported to hospitals, skilled nursing facilities and dialysis centers. Under the model, Medicare will also reimburse for transport to an urgent care clinic or primary care office, or for providing care in place or using telehealth.

State Level

Approved Statutes:

S-2333:  This bill provides civil and criminal immunity to certain healthcare professionals and healthcare facilities during a public health emergency and state of emergency.  The bill reinforces earlier directives from the New Jersey Department of Health (NJDOH) and New Jersey Attorney General’s Office (AG), specifically NJDOH Executive Directive 2020-006 and AG Enforcement Directive No. 2020-03, as discussed in our previous update.

Under S-2333, healthcare professionals will not be liable for civil damages for injury or death related to the provision of medical services in support of the State’s response to COVID-19 during New Jersey’s state of emergency.  The bill’s immunity provision also applies to all good faith actions by healthcare professionals to support efforts to treat COVID-19 patients and prevent the spread of the coronavirus during the state of emergency.  Those good faith actions include the practice of telemedicine or telehealth as well as the necessary treatment of patients outside the normal scope of a healthcare worker’s professional license.

The bill also extends to healthcare facilities, granting immunity for imputed acts or omissions of employees and volunteers who would otherwise qualify for individual immunity under the bill.  With critical medical resources in short supply, the bill also provides that healthcare professionals and facilities shall be immune from criminal liability related to the allocation of mechanical ventilators or other scarce medical resources so long as the professional or facility adheres to core principles identified by the Commissioner of Health.

Immunity granted under this bill is not without limitation, however.  Immunity will not apply to acts or omissions constituting a crime, actual fraud, actual malice, gross negligence, recklessness, or willful misconduct of any healthcare professional or facility.  It also will not apply to medical care rendered in the ordinary course of medical practice, unrelated to COVID-19 or the state of emergency.

A-3901: This bill permits professional and occupational licensing boards to reactivate licensure of certain individuals during a state of emergency or public health emergency.  Importantly, the bill also includes a provision waiving compliance for licensees with liability insurance required by statute or regulation for acts or omissions undertaken in the course of providing healthcare services in support of the State’s response to a declared emergency.

Proposed Regulations:

52 N.J.R. 666(a) – The New Jersey Department of Health is proposing a new N.J.A.C. 8:53 to implement the requirements N.J.S.A. 45:1-61 et seq, which requires each telemedicine or telehealth organization operating in New Jersey to register with the Department prior to commencing services. In addition to the registration requirements, the Act sets forth an annual reporting requirement for registered telemedicine and telehealth organizations.  This proposed rule does not address the reporting requirements, but the Department intends to draft a separate notice of proposal for this requirement.  Comments are due by June 5, 2020.

52 N.J.R. 676(a) – In light of the continued abuse of opioids, the BME proposes to amend N.J.A.C. 13:35-7.6 to require prescribers to co-prescribe an opioid antidote under certain circumstances when prescribing opioids.  In addition, the Board proposes to amend N.J.A.C. 13:35-7.6 to implement N.J.S.A. 24:21-15.2, which concerns limitations on prescribing, administering, or dispensing of controlled dangerous substances, with specific limitations for opioid drugs, and establishes special requirements for the management of acute and chronic pain. These limitations shall apply to physicians, podiatrists, physician assistants, and certified nurse midwives. Among others, the revised regulations clarify the timing of the requirement to enter into a pain management agreement, amend the definition of "initial prescription," and revise the definition of "chronic pain" in the rule consistent with the amended statute.  Comments are due by June 5, 2020.