Coronavirus – CMS Guidance Part Three

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

This update follows our previous updates regarding COVID-19 on March 12 and March 18.  Needless to say, both federal and state governments have taken significant steps since March 18.   As detailed below, besides the stimulus bill that is currently pending, there has been additional guidance issued on the expansion of telemedicine and the relaxation of the HIPAA rules.   In addition, numerous bills and orders have passed and been executed expanding insurance coverage in connection with COVID-19, waiving cost-sharing, and delaying reporting requirements to the Centers for Medicare & Medicaid Services ("CMS").  To the extent guidance is needed on any of the issues below, Riker Danzig is available to assist. 

FEDERAL LEVEL

March 16:  The Drug Enforcement Agency (“DEA”) waived the requirement that a licensee conduct an in-person examination before prescribing controlled substances II-IV, and issued guidance to assist licensees.  DEA-registered licensees may continue this telemedicine practice for as long as the public health emergency is in effect, if all required conditions are met: (1) the prescription is issued for a legitimate medical purpose by a licensee acting in the usual course of his/her professional practice; (2) the telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and (3) the practitioner is acting in accordance with applicable federal and state law.  The latter part is important because New Jersey has not relaxed its rule requiring a licensee to have an in-person examination of the patient before prescribing controlled substances.  As a result, until New Jersey changes its rules, the DEA’s relaxation of this rule will not assist New Jersey licensees. 

March 18:   President Trump invoked the Defense Production Act, 50 U.S.C.A 4501, to increase production of medical supplies and equipment in response to COVID-19. 

March 20:  CMS issued toolkits on telehealth to help providers navigate through the new regulations.   In addition to expanding telehealth capabilities for Medicare beneficiaries, President Trump allowed HHS to waive federal licensing regulations so out-of-state physicians can treat patients through telehealth in states with large outbreaks. The toolkits are specific to general practitioners as well as providers treating patients with end-stage renal disease.

March 21:  The FDA rapidly approved a new COVID-19 test that delivers results within 45 minutes. 

March 22:  CMS announced that it was delaying the reporting requirements that clinicians, providers, and facilities must provide if they are participating in Medicare quality reporting programs including the 1.2 million clinicians in the Quality Payment Program.  Please review CMS’ press release identifying the new reporting dates for providers and facilities.   

March 23:  CMS rolled out an amended inspection process, with a fact sheet, for state survey agencies to ensure that facilities are prepared to prevent the spread of COVID-19. Although the inspection changes affect all types of healthcare providers, CMS is focusing on nursing homes since at least 147 nursing homes across 27 states currently have at least one resident with COVID-19.

March 23:  CMS issued four waiver options to reduce red tape in an effort to accelerate relief to State Medicaid and CHIP Programs.    These options will allow states to access emergency administrative relief, make temporary modifications to Medicaid eligibility and benefit requirements, relax rules to ensure that individuals with disabilities and the elderly can be effectively served in their homes, and modify payment rules to support health care providers impacted by the outbreak.  CMS is allowing these waivers to be made effective to, at least, March 1, 2020.

March 23:   CMS announced that it issued eleven 1135 Waivers to various states, including New Jersey.  New Jersey’s waiver includes, among others, temporarily suspending prior authorization requirements, extending the existing authorizations for services through the end of the public health emergency, modifying certain timeline requirements for state fair hearings and appeals, and relaxing provider enrollment requirements.

March 23:  President Trump executed an executive order to prevent hoarding of vital medical equipment and supplies.

March 23:  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 with law enforcement, paramedics, or other first responders if doing so is needed to provide treatment. The guidance clarifies when entities covered under the Health Insurance Portability and Accountability Act can disclose patient data to first responders amid the new coronavirus pandemic.  Providers can share identifiable health data such as names and addresses without the patients’ permission when that information would help emergency staff provide treatment, is required by law, or when first responders could be at risk of infection.  This guidance follows the guidance issued in February and March 15

March 24:  CMS issued guidance to states that want to increase their federal matching rate during the Covid-19 outbreak. The Families First Coronavirus Response Act, signed into law on March 18, provides a temporary 6.2 percentage point increase to a state’s Federal Medical Assistance Percentage, or federal Medicaid matching rate. The guidance from CMS provides states with information for determining which expenditures qualify for the enhanced rate, and what they must do to qualify for the temporary increase.

March 24:  As we previously reported, OIG is now allowing the waiver of telehealth cost-sharing as a result of COVID-19.  The OIG issued an FAQ related to this policy with some helpful information.  

STATE LEVEL

A3860 – Approved – This bill relaxes some of the telemedicine requirements in New Jersey but, unlike the federal relaxation, the New Jersey modification does not relax the rule on establishing a licensee-patient relationship.  It also does not eliminate the need for in-person visits when prescribed for controlled substances.  The original telemedicine statute required a practitioner to be licensed in New Jersey if they engaged in telemedicine with a patient located in New Jersey.  This bill eliminates that requirement, but limits the telemedicine engagement to COVID-19.   Thus, the bill provides the following: (1) the practitioner must be licensed or certified to practice in another state or territory of the United States, and is in good standing in that jurisdiction; (2) the services provided by that practitioner are consistent with the practitioner’s authorized scope of practice in the jurisdiction; (3) unless the practitioner has a preexisting provider-patient relationship with the patient that is unrelated to COVID-19, the services provided are limited to services related to screening for, diagnosing, or treating COVID-19; and (4) if the encounter is not related to COVID-19, and the practitioner does not have a preexisting provider-patient relationship with the patient, then the practitioner must advise the patient that the practitioner is not authorized to provide services to the patient.

Just as important, the bill requires the Commissioner of Health and the Director of the Division of Consumer Affairs to waive any requirement of state law or regulation as may be necessary to facilitate the provision of health care services using telemedicine and telehealth during the COVID-19 public health emergency, including any privacy requirements that would limit the use of electronic or technological means that are not typically used in the provision of telemedicine and telehealth.  The Director has not issued those waivers to date.

A3862 – Approved – This bill provides that the Director of the Division of Consumer Affairs could expedite the professional and occupational licensing process for out-of-state individuals when the New Jersey Governor has declared a state of emergency in connection with COVID-19. The out-of-state individual must have a corresponding license, certificate of registration or certification in good standing from another jurisdiction. The bill also gives the Director and applicable Boards under the Division the ability to waive certain requirements normally required in the licensure process, such as a criminal history record, background checks, and payment of certain fees.

A3854 – Approved – This bill provides that, for the duration of the declared state of emergency in connection with COVID-19, all licensed health care facilities and clinical laboratories will be authorized to collect specimens for the purposes of testing for COVID-19.   The bill also authorizes the Commissioner of Health, during the state of emergency, to waive mandatory staffing ratio requirements for health care facilities.

A3843 – This bill mandates that, during the state of emergency, health insurance carriers, the State and School Employees’ Health Benefits Programs and the State Medicaid program, provide coverage for expenses incurred in: (1) the testing for COVID-19, provided that a licensed medical practitioner has issued a medical order for that testing and (2) the delivery of health care services through telemedicine or telehealth.  The bill requires the coverage to be provided to the same extent as for any other services under the health benefits plan, except that no cost-sharing may be imposed on the coverage provided pursuant to the bill.

March 23:  Governor Murphy issued an executive order suspending all adult elective surgeries effective 5:00 pm on Friday, March 27.   An elective surgery is defined in the order as any surgery or invasive procedure that can be delayed without undue risk to the current or future health of the patient as determined by the patient’s treating physician or dentist.  The executive order requires ambulatory surgery centers to coordinate possible post-surgery admissions with local hospitals and to draft guidelines that comport with the order.   Excluded from the order, however, are the full range of family planning services and procedures, including termination of pregnancies.