CMS and New Jersey Make Significant Changes to Regulations In Light of COVID-19

Late Monday on March 30, CMS made sweeping changes to just about every facet of health care on the Federal level from hospitals to ambulatory surgery centers to nursing homes and ambulances.  The changes are significant and numerous so this update will only focus on several of those changes.   CMS issued a detailed twenty-six page summary of the changes.   CMS also issued fact sheets for each specific provider type regarding the regulatory changes, which can be accessed on CMS’ website

On the State level, Governor Murphy executed Executive Order No. 112, which expanded the roles of advanced practice nurses and physician assistants, and provided immunity to physicians in the course of providing healthcare services in support of the State’s COVID-19 response, whether or not within the scope of their practice.   Governor Murphy executed a corrected version of Order No. 112 that removed any reference to malpractice insurance.   

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeLabinot Alexander Berlajolli, or Brianna J. Santolli.

Federal Regulatory Changes

Waivers of Sanctions Under the Physician Self Referral Law (“Stark Law”)

On March 30, 2020, CMS issued blanket waivers of sanctions under the Stark Law.  The blanket waivers are retroactively effective to March 1, 2020 and may be used without notifying CMS.  The guidance document provides numerous examples of these blanket waivers.  A provider can ask for specific and additional waivers by making an application to 1877CallCenter@cms.hhs.gov and include the words “Request for 1877(g) Waiver” in the subject line.   All requests should include the following minimum information: (a) Name and address of requesting entity; (b) Name, phone number and email address of person designated to represent the entity; (c) CMS Certification Number or Taxpayer Identification Number of the requesting entity; and (d) Nature of request.

Telemedicine Waivers for Physicians and Other Practitioners

As outlined in our previous update, CMS has already expanded telemedicine and telehealth on the Federal level.  CMS’ guidance document regarding waivers for practitioners focuses mostly on the expansion of telemedicine or telehealth.  In that regard, CMS added eighty-five (85) additional telemedicine codes to address services in connection with COVID-19.   This link provides all of the codes for telemedicine, including the additional 85 related to COVID-19.   Practitioners can provide these services to new or established patients, and providers can waive Medicare copayments for these telehealth services for beneficiaries in Original Medicare. 

In addition, the CARES Act allocated $200 million to support healthcare providers' use of telehealth services during the pandemic. The program, if approved, would help eligible healthcare providers buy telecommunications, broadband connectivity and devices needed to support telehealth. 

Importantly, as we previously reported, the Office of Civil Rights (“OCR”) exercised its enforcement discretion to not impose penalties for noncompliance with the HIPAA rule in connection with the good faith provision of telehealth using nonpublic-facing audio or video communication products during the COVID-19 nationwide public health emergency.

Here are the platforms physicians can use during the emergency:

Apple FaceTime
Facebook Messenger video chat
Google Hangouts video
Zoom
Skype

Here are the platforms physicians cannot use:

Facebook Live
Twitch
Tik Tok

Waivers for Hospitals and Surgery Centers

Under Federal requirements, hospitals must provide services within their own buildings.  In the wake of COVID-19, however, CMS has relaxed certain conditions allowing hospitals to provide hospital services outside of their own buildings including ambulatory surgery centers, temporary constructions, hotels, and dormitories while still receiving hospital payments for services provided in these other structures.  These waivers will also allow hospitals to perform COVID-19 tests on people at home and in other community-based settings.  In addition, CMS provided waivers to allow hospitals to provide support, such as child care services and laundry service for personal clothing, to physicians and other staff while providing patient care.

Significantly, the waivers will allow ASCs, subject to New Jersey laws, to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. These new flexibilities will also permit ASCs to offer services typically provided by hospitals, such as cancer procedures, trauma surgeries, and other essential surgeries.  ASCs that wish to enroll to receive temporary billing privileges as a hospital should call the COVID-19 Provider Enrollment Hotline to reach the contractor that serves their jurisdiction, and then complete and sign an attestation form specific to the COVID 19 public health emergency. 

Emergency Use Authorization

On March 28, the FDA granted emergency use authorization to allow patients with COVID-19 to be treated with hydroxychloroquine and chloroquine.  As a result, the authorization means hydroxychloroquine and chloroquine drugs donated to the strategic national stockpile will be distributed to hospitals to be used for certain COVID-19 patients. The authorization does not mean the drugs are approved, but instead, the drugs can be prescribed for COVID-19 for only as long as the pandemic lasts. An emergency use authorization is not an approval.  Emergency use authorization means that the drug may be effective, while approval means there is evidence showing it is effective.   

State Regulatory Changes

Governor Murphy Signs Order to Remove Barriers to Health Care Professionals

On April 1, 2020, Governor Murphy signed a corrected version of Executive Order No. 112, which authorizes the New Jersey Division of Consumer Affairs (“DCA”) to reactivate the license of any healthcare professional previously licensed to practice in New Jersey who retired from active practice within the last five years.  License reactivations shall be on a temporary basis throughout the duration of the State of Emergency or Public Health Emergency for COVID-19, whichever is longer.  Additionally, the DCA is authorized to issue a temporary license to practice medicine and/or surgery to any physician or the plenary-licensed equivalent in another country, who is licensed and in good standing in another country.  Healthcare professionals who wish to reactivate their licenses and physicians who wish to apply for a temporary license shall submit an application on forms adopted by the Director of the DCA.

The order also relaxes statutory provisions that limit the scope of practice of advanced practice nurses (“APNs”), suspending and waiving compliance with provisions that would otherwise require APNs to, among other things, enter into a joint protocol with an individual collaborating physician who is present or readily available through electronic communication and obtain authorization from a collaborating physician to dispense narcotic drugs for maintenance treatment or detoxification treatment.  Compliance with statutory provisions limiting the scope of practice for physician assistants are also suspended and waived, including, but not limited to, requirements to obtain physician supervision and authorization to order or prescribe a controlled dangerous substance.

Critically, Paragraphs 7 and 8 of the order confers immunity from civil liability to services provided by providers in support of the State’s COVID-19 response during the State of Emergency and Public Health Emergency, whether or not those services are within the scope of their practice.   Governor Murphy executed a corrected version of Executive Order No. 112 to remove from Paragraphs 7 and 8 the phrase “to the extent that the practitioner’s existing liability insurance does not provide coverage or an applicable limit is exceeded” making the immunity more clear.   The immunity applies to services provided before the execution of the Executive Order.