Updated February 12, 2021

Issues for Hospitals and Other Health Care Providers

The impact of coronavirus disease (COVID-19) on the nation’s hospitals and other health care providers cannot be understated. Operational challenges abound—making room for a significant influx of new patients, managing cancellations or postponements of elective procedures, maintaining a healthy and available cadre of caregivers, shoring up the supply chain, paying physicians and other workers in the face of diminished revenues, etc. Unfortunately, many necessary actions will be at odds with some aspect of the myriad federal and state laws, regulations and agency guidance that govern the American health care system. And while it might be tempting to follow the axiom “Just Do It,” Monday morning quarterbacking is inevitable, and in health care this often comes in the form of False Claims Act or malpractice lawsuits. Thus, even now, navigating the sea of health care regulations and the steps taken by government to remove impediments remains critical. 

We recognize that the health care trade press is providing as close to real-time reporting as possible on government action to waive or modify regulatory impediments, and we will not attempt to duplicate those efforts. Instead, we provide below a listing and access to further information regarding some of the more significant actions that have been taken at the federal and state levels. Hunton Andrews Kurth has been providing guidance to its health care clients on these issues, and we believe it is important to remember that in one sense there is nothing new here—successfully meeting this challenge requires application of “first principles” of health care law in a new paradigm. We have been doing that for years, and welcome the opportunity to speak with you about the particular issues you may be facing.

Commentary

Federal Actions

  • For additional discussion of federal actions, please see the issues of Three Key Things in Health Care linked above.
  • General Distributions From CARES Act Provider Relief Fund, Round 2: On April 24, 2020, HHS began to distribute the second $20 billion of general distributions from the Provider Relief Fund, augmenting providers’ allocations “so that the entire $50 billion general distribution is allocated proportional to providers’ share of net patient revenue.” HHS issued separate terms and conditions applicable to the second $20 billion, available here, and is requiring for the first time, submission (after the fact) of certain financial information as a form of “application” (see the Provider Relief Fund Application Portal user guide, available here).

  • Supplemental Appropriation to the Provider Relief Fund: On April 24, 2020, the Paycheck Protection Program and Health Care Enhancement Act(Pub. L. 116-139) was enacted. Division B of the act included a supplemental $75 billion appropriation to the $100 billion Provider Relief Fund established by the CARES Act.  
  • Stark Law Waiver Explanatory Guidance: On April 21, 2020, CMS issued Explanatory Guidance regarding the March 30, 2020, Blanket Waivers of the Stark Law. The Explanatory Guidance reflects (among other things) that financial relationships or referrals, depending on the waiver at issue, must satisfy all non-waived requirements of an applicable exception in order to avoid the Stark Law’s billing and referral prohibitions; reiterated prior interpretations that allow amendments of the remuneration terms of a compensation arrangement within less than a year under certain circumstances; and rejected calls for the waivers to apply to indirect compensation arrangements. The Explanatory Guidance is available here.
  • General Distributions From CARES Act Provider Relief Fund: On April 7, 2020, CMS Administrator Seema Verma announced that $30 billion of the $100 billion fund (the Provider Relief Fund) created by the CARES Act would be distributed to providers via direct deposit and with “no strings attached,” despite applicable requirements in the CARES Act appropriations language. The Department of Health and Human Services (HHS) began making disbursements on April 10, delivering $26 billion to providers (the remaining $4 billion was distributed April 17). These distributions were made based on providers’ Medicare fee-for-service reimbursement in 2019. Also on April 10, HHS issued the initial version of terms and conditions applicable to payments from the fund, available here . These terms and conditions were revised to include “deemed acceptance” language in the event providers retained Provider Relief Fund payments for more than 30 days (available here), and then again in an attempt to address the statutory requirement for an application process and to create a separate version applicable to the first $30 billion of payments (available  here). “General Distribution Portal FAQs” are available via a link on the CMS COVID-19 webpage (the link has appeared and disappeared in the past week, but the FAQs are available here .  The HHS CARES Act Provider Relief Fund website (which is updated frequently) can be accessed here
  • OIG Policy Statement on Enforcement of Antikickback Statute: On April 3, 2020 the US Department of Health and Human Services Office of Inspector General (OIG) issued a Policy Statement regarding enforcement of the Medicare and Medicaid Antikickback Statute.  Recognizing the Blanket Waiver of the Stark Law that had been issued on March 30 (see below) and that “in the current public health emergency resulting from the COVID-19 outbreak, the health care industry must be focused on delivering needed patient care,” OIG announced that it “will not impose administrative sanctions under sections 1128(b)(7) or 1128A(a)(7) of the Act [42 U.S.C. §§ 1320a-7(b)(7) and 1320a-7a(a)(7)], as those sections relate to the commission of acts described in the Federal anti-kickback statute, with respect to remuneration that is covered by section II.B.(1)-(11) of the Blanket Waivers.”  The OIG Policy Statement applies to conduct occurring on or after April 3, 2020, and can be found here.
  • HIPAA Waiver – Public Health & Health Oversight Activities: On April 2, 2020, the HHS Office for Civil Rights (OCR) announced that it will exercise enforcement discretion regarding uses and disclosures of protected health information (PHI) by covered health care providers or their business associates for public health or health oversight activities.  The HIPAA Privacy Rule permits a business associate (BA) of a covered entity (CE) to use and disclose PHI to provide services to or conduct certain activities on behalf of the covered entity, but only if the use or disclosure is authorized pursuant to the business associate agreement (BAA) between the CE and BA or is required by law.  The COVID-19 pandemic has caused federal and state public health officials and health oversight agencies to request PHI from BAs and to request Bas to perform public health data analytics on PHI.  In some instances the uses or disclosures contemplated by such requests are not required by law and are not covered by the BAA between the CE and BA.  To facilitate prompt response to such requests, OCR is exercising enforcement discretion and will not impose penalties against a BA or CE under the HIPAA Privacy Rule if (i) the BA “makes a good faith use or disclosure of the [CE’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 (ii) the BA “informs the [CE] within ten (10) calendar days after the use or disclosure occurs (or commences, with respect to uses or disclosures that will repeat over time).”  A copy of the OCR statement to be published in the Federal Register can be found here.
  • CMS Stark Law Waiver:  On March 30, 2020, CMS issued a blanket waiver of the Stark Law (42 U.S.C. § 1395nn) in response to the COVID-19 pandemic.  The waiver protects from sanctions otherwise applicable under the Stark Law and its implementing regulations only the eleven types of financial relationships and seven types of referrals specified in the waiver.  The waiver is further limited to direct financial relationships between an entity that provides designated health services and a physician, the physician organization in whose shoes the physician stands under 42 C.F.R. § 411.354(c), or the physician’s immediate family member.  A copy of the waiver can be found here.
  • On March 30, 2020, CMS published summaries of the numerous actions taken pursuant to the Section 1135 blanket waivers issued on March 13 and other authorities. These actions include waiver of enforcement of the Emergency Medical Treatment & Labor Act (EMTALA); numerous operational, credentialing, recordkeeping and other requirements for hospitals, home health agencies, long-term-care facilities, hospices, end-stage renal dialysis facilities and other providers and suppliers. The comprehensive CMS summary is available here. Targeted CMS summaries by provider type (including teaching hospitals, teaching physicians and medical records; hospitals; and physicians and other clinicians) are available here.
  • The Families First Coronavirus Response Act (Public Law 116-127) (Families First Act) was enacted on March 18, 2020. Among other provisions, the Families First Act provides for coverage of COVID-19 testing and waiving of certain cost sharing relating to COVID-19 treatment under the Medicare, Medicare Advantage, Medicaid and Children’s Health Insurance Programs. The Families First Act also deems personal respiratory protective devices as covered countermeasures, protecting certain manufacturers, distributers and others from claims of loss under federal or state law. The Coronavirus Aid, Relief, and Economic Security Act (Public Law 116-136) (CARES Act) was enacted on March 27, 2020. The CARES Act provides $2 trillion of relief to individuals, large and small business and state and local governments in response to the COVID-19 pandemic, including $100 billion for eligible health care providers and additional funding for community health centers, drug access, CDC programs, health care for veterans, telehealth and increased availability of drugs and supplies, including ventilators and personal protective equipment. The Healthcare Financial Management Association has published a combined summary of the health care provisions of the Families First Act and CARES Act, available here.
  • HIPAA Waiver – Telehealth Remote Communication: On March 17, 2020, the HHS Office for Civil Rights (OCR) announced that it will exercise enforcement discretion regarding the provision of telehealth during the COVID-19 emergency. Thus, a covered health care provider that wants to use audio or video communication technology to provide telehealth to patients can use any non-public-facing remote communication product that is available to communicate with patients. OCR is exercising its enforcement discretion to not impose penalties for noncompliance with HIPAA rules in connection with the good faith provision of telehealth using such non-public-facing audio or video communication products during the COVID-19 nationwide public health emergency. This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19. Additional details are available here.  
  • Section 1135 Waiver: On March 13, 2020, Secretary Azar exercised his Section 1135 authority to waive or modify certain requirements under titles XVIII (Medicare), XIX (Medicaid) and XXI (SCHIP) of the Social Security Act, to the extent necessary as determined by the Centers for Medicare and Medicaid Services (CMS), and to waive sanctions and penalties arising from certain noncompliance with the HIPAA privacy regulations for a limited period following implementation of a hospital disaster protocol, retroactively effective as of March 1, 2020.
  • Stafford Act Emergency Determination: On March 13, 2020, President Trump issued a determination under the Robert T. Stafford Disaster Relief and Emergency Assistance Act that a nationwide emergency exists in respect of the COVID-19 pandemic. 
  • National Emergencies Act Declaration: On March 13, 2020, President Trump issued a declaration of national emergency under the National Emergencies Act, beginning March 1, 2020. The declaration authorized Secretary Azar to exercise authority under Section 1135 of the Social Security Act (42 U.S.C. § 1320b-5) to waive or modify requirements of the Medicare, Medicaid and State Children’s Health Insurance (SCHIP) programs and of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule “throughout the duration of the public health emergency declared in response to the COVID-19 outbreak.” 
  • DEA Telemedicine Prescriptions Waiver: For as long as the public health emergency determination issued by Secretary Azar remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided (i) the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; (ii) the telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and (iii) the practitioner is acting in accordance with applicable federal and state law. Additional details are available here.
  • Medicare Telemedicine Waiver: Effective for services starting March 6, 2020, and for the duration of the COVID-19 Public Health Emergency, Medicare will pay for Medicare telehealth services furnished to patients in broader circumstances than previously permitted. These visits are considered the same as in-person visits and are paid at the same rate as regular, in-person visits. To the extent the Secretary’s waiver authority under Section 1135(b) of the Social Security Act (42 U.S.C. § 1320b-5(b)) requires an established physician-patient relationship, HHS has indicated that it will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency. Additional details are available here.
  • Public Health Emergency Determination: On January 31, 2020, Secretary of Health and Human Services (HHS) Azar issued a determination that a public health emergency exists in respect of the coronavirus, retroactive to January 27, 2020. 

 

Florida Actions

  • Emergency Rule 59AER20-11:  On November 3, 2020, the Agency for Health Care Administration issued Emergency Rule 59AER20-11.  This rule replaces Emergency Rule 59AER20-8 related to requirements for the discharge of COVID-19 hospital patients to long-term care facilities.
  • Emergency Rules 59AER20-12 and 59AER20-13:  On November 3, 2020, the Agency for Health Care Administration issued Emergency Rule 59AER20-12, which addresses mandatory entry for testing for assisted living facilities, and Emergency Rule 59AER20-13, which addresses mandatory entry for testing and infection control for nursing homes.  These rules replace Emergency Rule 59AER20-9 and Emergency Rule 59AER20-10, respectively. 
  • Curative Testing for Intermediate Care Facilities for the Developmentally Disabled Staff:  On September 23, 2020, the Agency for Health Care Administration announced that, effective September 30, 2020, it will no longer enforce Emergency Rule 59AER20-7, which required biweekly staff testing for intermediate care facilities for the developmentally disabled.
  • Mandatory Entry for Testing and Infection Control for Nursing Homes and Assisted Living Facilities:  On August 6, 2020, the Agency for Health Care Administration issued Emergency Rule 59AER20-9 (Mandatory Entry and Testing for Assisted Living Facilities) and Emergency Rule 59AER20-10 (Mandatory Entry for Testing and Infection Control for Nursing Homes), which supersede Emergency Rule 59AER20-2 and Emergency Rule 59AER20-3, respectively.  The new emergency rules provide that nursing homes and assisted living facilities must comply with Department of Health infection control directives concerning staff and resident testing and allow the Department of Health to enter such facilities for the purpose of conducting COVID-19 infection control duties and testing residents and staff.  Furthermore, when the Department of Health enters such facilities, such facilities must require their staff to submit to a COVID-19 test.
  • COVID-19 Testing for Intermediate Care Facility Staff:  On August 3, 2020, the Florida Agency for Health Care Administration issued Emergency Rule 59AER20-7 (“Mandatory Testing for Intermediate Care Facility for the Developmentally Disabled Staff”).  The Emergency Rule provides that, beginning August 24, 2020, intermediate care facilities for the developmentally disabled shall not admit into such facilities any staff who has not been tested for COVID-19.  Such facilities shall require all staff to be tested every two weeks.  Staff who have already been infected and recovered from COVID-19 do not need to be tested if they can provide medical documentation reflecting same to the facility.   
  • Continuation of Florida Medicaid Flexibilities:  On July 1, 2020, Florida Medicaid announced that flexibilities enacted under the Medicaid program during the COVID-19 state of emergency will continue until the Agency for Health Care Administration notifies providers that such flexibilities are terminated.  As of July 1, 2020, the Agency for Health Care Administration has only discontinued the waiver of prior authorization requirements, which was detailed in a June 12, 2020 Florida Medicaid Health Care Alert.  Click here to view Florida Medicaid’s July 1, 2020 announcement.   
  • COVID-19 Testing for Nursing Home and Assisted Living Facility Staff:  On June 16, 2020, the Florida Agency for Health Care Administration issued Emergency Rule 59AER20-4 (Mandatory Testing for Assisted Living Facility Staff) and Emergency Rule 59AER20-5 (Mandatory Testing for Nursing Home Staff), requiring all staff, paid and unpaid with direct or indirect patient contact, to submit to COVID-19 testing every two weeks, with resources provided by the state.  Click here to view Emergency Rule 59AER20-4.  Click here to view Emergency Rule 59AER20-5.
  • Florida Medicaid Prior Authorization Reinstatement:  On June 12, 2020, the Agency for Health Care Administration announced the reinstatement of prior authorization requirements for certain Medicaid covered services.  The Agency for Health Care Administration is reinstating prior authorization requirements for the following Florida Medicaid services that were waived in response to COVID-19: (1) hospital services (including long-term care hospitals); (2) nursing facility services; (3) physician services; (4) advanced practice registered nursing services; (5) physician assistant services; (6) home health services; (7) ambulance transportation; and (8) durable medical equipment and supplies.  This change is effective for dates of service on or after June 19, 2020 when prior authorization is required for the service, and applies in both the fee-for-service and the managed care delivery systems.  Click here to view the Florida Medicaid Health Care Alert.
  • Medicaid Coverage of Coronavirus Antibody Testing:  On June 12, 2020, the Agency for Health Care Administration provided additional guidance related to Florida Medicaid coverage requirements for the Coronavirus antibody test.  Click here to view this guidance.
  • Mandatory Facility Access for Infection Prevention and Control: On May 10, 2020, the Florida Agency for Health Care Administration issued Emergency Rule 59AER20-2 and Emergency Rule 59AER20-3, requiring nursing homes and assisted living facilities to grant access to the Florida Department of Health or its authorized representatives for purposes of infection prevention and control, and mandating COVID-19 testing of both on-duty and off-duty staff, as directed by the Florida Department of Health. To view Emergency Rule 59AER20-2 please click here. To view Emergency Rule 59AER20-3, please click here
  • Behavior Analysis Continuation of Authorization: On May 6, 2020, the Florida Agency for Health Care Administration posted a Florida Medicaid Health Care Alert announcing that, to reduce the need for providers to conduct reassessments for recipients currently receiving behavior analysis services, the Agency for Health Care Administration will provide administrative approval to extend current authorizations. To view this Florida Medicaid Health Care Alert, please click here
  • Testing Prior to Discharge: On May 5, 2020, the Florida Agency for Health Care Administration issued Emergency Rule 59AER20-1, requiring every hospital to test patients for COVID-19 prior to their discharge to a long-term care facility. To view Emergency Rule 59AER20-1, please click here
  • Additional Flexibilities Related to Behavioral Health Services: On May 5, 2020, the Florida Agency for Health Care Administration posted a Florida Medicaid Health Care Alert announcing that Governor DeSantis is requiring Medicaid to waive prior authorization requirements and services limits (frequency and duration) for behavioral health services, including targeted case management services, covered under the Medicaid program. To view this Florida Medicaid Health Care Alert, please click here
  • Interim Rate Request Threshold Change: On May 5, 2020, the Florida Agency for Health Care Administration posted a Florida Medicaid Health Care Alert announcing that the Agency for Health Care Administration is allowing Intermediate Care Facility for Individuals with Intellectual Disabilities providers to request a change to their current reimbursement rates based on increased costs related to COVID-19. Requests for interim rate changes reflecting increased costs occurring as a result of resident care, administration changes or capital replacement will be considered if the change in cost to the provider is at least $5,000 and would cause a change of 1 percent or more in the provider’s current total per diem rate. To view this Florida Medicaid Health Care Alert, please see https://ahca.myflorida.com/Medicaid/pdffiles/provider_alerts/2020_05/COVID-19_Interim_Rate_Request_Threshold_Change_050520.pdf.
  • Executive Order 20-112: On April 29, 2020, Governor DeSantis issued Executive Order 20-112, providing that, effective May 4, 2020, elective procedures prohibited by Executive Order 20-72 may resume if: (1) the facility has the capacity to immediately convert additional surgical and intensive care beds for treatment of COVID-19 patients in a surge capacity situation; (2) the facility has adequate personal protective equipment (PPE) to complete all medical procedures and respond to COVID-19 treatment needs, without the facility seeking any additional federal or state assistance regarding PPE supplies; (3) the facility has not sought any additional federal, state or local government assistance regarding PPE supplies since resuming elective procedures; and (4) the facility has not refused to provide support to and proactively engage with skilled nursing facilities, assisted living facilities and other long-term care residential providers. Click here to view Executive Order 20-112.
  • Additional Prior Authorization and Claims Payment Requirements: On April 29, 2020, the Florida Agency for Health Care Administration posted a Florida Medicaid Health Care Alert, announcing that Statewide Medicaid Managed Care plans must waive prior authorization for all services for enrollees diagnosed with COVID-19. Click here to view this Florida Medicaid Health Care Alert.
  • Medicaid Coverage of Coronavirus Laboratory Testing Update:  On April 27, 2020, the Florida Agency for Health Care Administration posted a Florida Medicaid Health Care Alert, announcing that Florida Medicaid currently covers, and will continue to cover, all medically necessary services required to facilitate testing and treatment of COVID-19, and providing Florida Medicaid coverage updates regarding laboratory testing for COVID-19.  Click here to view this Florida Medicaid Health Care Alert. Click here to view the related Health Plan Policy Transmittal.
  • COVID-19 Medicaid Information:  The Florida Agency for Health Care Administration has created a comprehensive website to track Medicaid Alerts related to, among others, prior authorization requirements, co-payment requirements, telemedicine coverage, provider enrollment flexibilities, provider site visit requirements, Long-Term Care and other Home and Community-Based Waiver Flexibilities, and Medicaid eligibility requirements.  Click here to view this webpage.
  • Telemedicine Flexibilities for Behavioral Health Providers:  On April 16, 2020, the Florida Agency for Health Care Administration announced that, during the state of emergency, it is further expanding coverage of behavioral health services provided via telehealth.  To view this Florida Medicaid Health Care Alert and learn more about new telehealth flexibilities, please click here.
  • Ambulance Transportation:  On April 16, 2020, the Florida Agency for Health Care Administration announced that, during the state of emergency, ambulance providers may seek reimbursement at the advanced life support (ALS) rate when providing ground transportation for individuals requiring the use of isolation procedures related to a suspected or confirmed diagnosis of COVID-19. This flexibility applies in both the fee-for-service and managed care delivery systems.  To view this Florida Medicaid Health Care Alert, please click here.
  • Quality Assessment Fees:  On April 15, 2020, the Florida Agency for Health Care Administration announced that it has extended the deadline for March 2020 Quality Assessment payments due from nursing homes and Intermediate Care Facilities until May 20, 2020.  To view this Florida Medicaid Health Care Alert, please click here.
  • Medicaid Provider Revalidation Extension:  On April 15, 2020, the Florida Agency for Health Care Administration announced that Florida Medicaid providers who have a revalidation date of March 19, 2020, through September 30, 2020, will automatically have their revalidation date extended 6 months from the current revalidation date. This systematic update will occur with no action required by the provider. To view this Florida Medicaid Health Care Alert, please click here.
  • COVID-19 Florida Medicaid Frequently Asked Questions:  On April 10, 2020, the Florida Agency for Health Care Administration posted COVID-19: Florida Medicaid Frequently Asked Questions.  To view these FAQs, please click here.
  • Re-employment of Essential Personnel: On March 30, 2020, Governor DeSantis issued Executive Order 20-88, declaring that certain employees who have retired since October 1, 2019, or who may retire prior to or on August 1, 2020, under a state-administered retirement system may have certain limitations relating to re-employment or continued employment waived if such re-employment or continued employment assists the COVID-19 emergency response. The Executive Order allows Florida Retirement System (FRS)-participating employers to utilize recent retirees for emergency work without incurring liability or voiding the recent retirees’ retirement. The Executive Order applies to law enforcement officers, first responders, emergency management and public safety personnel, health and medical professionals and other critical COVID-19 response personnel as identified and determined by a state agency head. To view the Executive Order, please click here.
  • Telehealth and Immunizations for State Group Insurance: On March 26, 2020, Governor DeSantis issued Executive Order 20-51, directing the Department of Management Services to amend the state employee health benefits plan to include telehealth services at no additional cost to employees; amend the state employee pharmacy benefits plan to include telehealth services, as appropriate, to employees participating in the State Group Insurance Program (SGI); and ensure that all state employees have access without cost sharing to telehealth services through the state’s contracted HMO plans and PPO organization plan. The Executive Order also lessens restrictions related to immunizations for state employees and waives cost sharing for influenza vaccinations for state employees. To view a copy of the Executive Order, please click here.
  • Telehealth and EMTs/Paramedics:  On March 21, 2020, Dr. Rivkees, the Surgeon General of the State of Florida, issued Emergency Order 20-003, providing that clinical social workers, marriage and family therapists, mental health counselors and psychologists holding a valid, unrestricted license in another state or territory may provide telehealth services in Florida.  The Emergency Order also allows any emergency medical technician or paramedic possessing a clear and active Florida license or certification to provide basic or advanced life support in an acute care setting at a hospital.  View a copy of Emergency Order 20-003.
  • Non-Essential Elective Medical Procedures:  On March 20, 2020, Governor DeSantis issued Executive Order 20-72, providing that all hospitals, ambulatory surgical centers, office surgery centers, dental, orthodontic and endodontic offices, and other health care practitioners' offices in Florida may no longer provide “any medically unnecessary, non-urgent or non-emergency procedure or surgery which, if delayed, does not place a patient's immediate health, safety, or wellbeing at risk, or will, if delayed, not contribute to the worsening of a serious or life-threatening medical condition.”  As a result, all health care practitioners licensed in Florida, including dentists, are prohibited from performing such elective services.  View a copy of Executive Order 20-72.
  • Section 1135 Waiver: On March 16, 2020, the Centers for Medicare and Medicaid Services approved Florida’s March 13, 2020 request for a waiver under Section 1135 of the Social Security Act of certain federal Medicare, Medicaid and CHIP requirements. A copy of the CMS waiver approval may be found here.
  • Health Professionals:  On March 16, 2020, Dr. Rivkees, the Surgeon General of the State of Florida, issued Emergency Order 20-002, providing that certain health care professionals, advanced life support professionals and basic life support professionals holding a valid, unrestricted license in any state, territory and/or district may provide such services in Florida, subject to certain restrictions.  The Emergency Order also loosens restrictions relating to the provision of telehealth services by such professionals.  View a copy of Emergency Order 20-002.
  • Federal Funds: On March 16, 2020, the Florida Department of Health received a notice of award for nearly $28 million in federal funding from the US Department of Health and Human Services and Centers for Disease Control and Prevention to address the COVID-19 response in Florida. 
  • Florida Medicaid: On March 16, 2020, the Agency for Health Care Administration published a Florida Medicaid Health Care Alert, providing that Florida Medicaid is taking the following steps in response to COVID-19: (1) waiving prior authorization requirements for medically necessary hospital services, physician services, advanced practice registered nursing services, physician assistant services, home health services, and durable medical equipment and supplies, among others; (2) lifting limits on certain services and prescription refills; (3) waiving copayment requirements; (4) paying for medically necessary services to recipients diagnosed with COVID-19, even if a provider is located out of state; (5) providing a process for provisional provider enrollment; and (6) postponing face-to-face provider-site visit requirements.  These steps were authorized as a result of CMS’s approval of the Agency for Health Care Administration’s 1135 Medicaid Waiver request
  • State of Emergency: On March 9, 2020, Governor DeSantis issued Executive Order 20-52, declaring a state of emergency due to COVID-19 and providing that “[m]edical professionals and workers, social workers, and counselors with good and valid professional licenses issued by states other than the State of Florida may render such services in Florida during this emergency for persons affected by this emergency with the condition that such services be rendered to such persons free of charge, and with the further condition that such services be rendered under the auspices of the American Red Cross or the Florida Department of Health.” 
  • Public Health Emergency: On March 1, 2020, Governor DeSantis issued Executive Order 20-51, directing Surgeon General Rivkees to declare a public health emergency due to COVID-19. 

 

Massachusetts Actions

  • Prohibition on billing the uninsured for COVID-19 testing:  On July 22, 2020, the Massachusetts Commissioner of Public Health issued an emergency order prohibiting healthcare facilities, providers and other entities performing COVID-19 testing from billing any uninsured individual for COVID-19 testing or from assessing any cost or fee associated with such testing.  A copy of the order may be found here.
  • Updates on the Performance of Non-Essential Elective Invasive Procedures: On June 24, 2020, the Massachusetts Commissioner of Public Health issued a new order relating to non-essential elective invasive procedures.  The new order, a copy of which may be found here, replaces two prior orders issued on May 18, 2020 and June 6, 2020.  It requires health care providers seeking to resume the provision of non-essential elective invasive procedures, including elective cosmetic procedures, to complete an attestation certifying that they meet clinical, capacity, safety standards, and governance requirements and to implement procedures published by the Department of Public Health regarding the scheduling and performance of such procedures, including adhering to timelines for airborne contaminant removal.  A copy of the new associated guidance document, which replaced prior guidance of May 18, 2020 and June 6, 2020, may be found here.
  • Requirements to Resume Non-Essential Elective Invasive Procedures: On June 6, 2020, the Massachusetts Commissioner of Public Health issued an updated order relating to non-essential elective invasive procedures.   The new order, which went into effect June 8, 2020 and is to remain in place until the earlier of the Governor of Massachusetts’ termination of the State of Emergency or the Commissioner’s rescindment of the order, requires health care providers seeking to resume the provision of non-essential elective invasive procedures, excluding elective cosmetic procedures, to complete an attestation certifying that they meet clinical, capacity, safety standards, and governance requirements and to implement procedures published by the Department of Public Health regarding the scheduling and performance of such procedures, including adhering to timelines for airborne contaminant removal.  A copy of the order, which replaces a previous May 18, 2020 order, may be found here and a copy of the associated guidance document, which replaces a previous May 18, 2020 guidance document, may be found here.
  • Waiver of Timeframe Requirements for Nurse Aides: On May 12, 2020, the Commissioner of the Massachusetts Department of Public Health issued an order suspending certain statutory and regulatory requirements, consistent with CMS 1135 waivers, to remove the requirement that a nurse aide must complete nurse aide training within 90 days of employment, provided the long term care facility ensures the individual working as a nurse aide is competent to provide nursing and nursing-related services and demonstrates competency in skills and techniques necessary to care for residents’ needs.  A copy of the order may be found here.
  • Staffing of Out-of-Hospital Dialysis Units: On April 28, 2020, the Commissioner of the Department of Public Health issued an order regarding staffing of out-of-hospital dialysis units. The order, a copy of which may be found here, suspends certain specified statutory and regulatory requirements mandating that out-of-hospital dialysis units maintain at least one direct patient care staff member to every three patients undergoing dialysis. The order instead expresses an expectation that out-of-hospital dialysis units “make every reasonable effort to meet the 1:3 ratio” and requires all dialysis units to ensure that they have sufficient direct care staff trained in dialysis care available to meet the needs of patients undergoing dialysis. The order is to remain in effect until the earlier of the Governor of Massachusetts’s termination of the State of Emergency or the Commissioner of the Department of Public Health’s termination of the order.
  • Clinical Laboratory Referrals for COVID-19 Testing: On April 28, 2020, the Commissioner of the Department of Public Health issued an order suspending certain statutory provisions to facilitate the referral of patients or specimens for COVID-19 testing to clinical laboratories in which there is a direct or indirect ownership interest.  The permissibility of the referrals are subject to the following conditions:  (i) the referral may only  be made for the purpose of conducting COVID-19 testing; (ii) the person or company making the referral is restricted to charging a per diem rate and may not receive any profit from the referrals; and (iii) all specimen collection must be undertaken in accordance with standard infection control procedures for individuals who are suspected or confirmed to be infected with COVID-19.  A copy of the order may be found here.
  • Crisis Standards of Care:  On April 20, 2020, the Massachusetts Commissioner of Public Health issued an order, contemporaneous with the Department of Public Health’s publication of revised Crisis Standards of Care Planning Guidance for the COVID-19 Pandemic, ordering any healthcare facility implementing crisis standards of care (whether the Department’s Crisis Standards of Care Planning Guidance or other critical care allocation framework) to provide prior notification to the Department and to provide information and timely access to records as necessary for the Department to monitory quality control and equitable implementation.  A copy of the Commissioner’s order may be found here and a copy of the revised Crisis Standards of Care Planning Guidance may be found here.
  • Expedited Licensure for Physician Graduates of International Medical Schools: On April 9, 2020, Governor Baker issued an emergency order to provide for accelerated licensing of physicians educated in foreign medical schools.  The emergency order requires the Massachusetts Board of Registration in Medicine to adopt a policy, set forth in the order, for expedited licensure of physicians educated in international medical schools and currently practicing in a United States jurisdiction under a limited license.  Pursuant to the policy set forth in the order, all such graduates who have satisfactorily completed at least two years of post-graduate medical training in a program approved by the American Council for Graduate Medical Education (ACGME) or the American Osteopathic Association or in an accredited Canadian program are eligible for licensure, and the Board is required to review and approve pursuant to an expedited process applications that meet the foregoing requirements.  The Governor’s emergency order further requires the Board to issue guidance to implement the terms of the order.  The order is to remain in effect until rescinded or until the termination of Massachusetts’ state of emergency, whichever occurs first.  A copy of the emergency order may be found here.
  • Nursing Practice Licensure:  On April 9, 2020, Governor Baker issued an emergency order, to remain in effect for the duration of Massachusetts’ state of emergency, authorizing students who have graduated from registered nursing or practical nursing programs approved by the Massachusetts Board of Registration in Nursing and senior nursing students in their last semester of such a program to practice nursing, exempting them from the prohibition on the unlicensed practice nursing, provided certain requirements specified in the order are met.  First, the individuals must be employed by or providing services at the direction of a licensed health care facility or licensed health care provider, under direct supervision while providing services, and providing services in response to the COVID-19 outbreak.  Second, the employing licensed health care facility or licensed health care provider must verify that the individual has met the educational requirements of the order.  The emergency order further requires the Board to publish guidance to implement the order, including guidance regarding appropriate supervision of nursing students.  A copy of the emergency order may be found here.
  • Mandated COVID-19 Emergency Department and Inpatient Coverage:  On April 9, 2020, Governor Baker issued an emergency order requiring insurers to cover all medically necessary emergency department and inpatient services, including all professional, diagnostic and laboratory services, related to COVID-19 at both in-network and out-of-network providers without an cost-sharing obligations, whether in the form of co-payments, deductibles, co-insurance or similar charges.  Insurers covered by the emergency order are required to reimburse acute care hospitals with whom they contract, but do not participate in a member’s plan, at the contracted rate for the applicable medically necessary services.  Unless otherwise directed by the Division of Insurance, such insurers are further required to reimburse acute care hospitals with whom they do not contract at a rate equal to 135% of the rate paid by Medicare in the provider’s geographic region  for the applicable medically necessary services.  Payments made in accordance with the foregoing are considered payment in full, and the emergency order expressly prohibits balance billing by health care providers.  The order further requires the Massachusetts Commissioner of Insurance to issue guidance to implement the order.  A copy of the emergency order, which is to remain in effect until rescinded or until termination of Massachusetts’ state of emergency, whichever occurs first, may be found here.
  • Maximizing Available Health Care Providers: On April 3, 2020, the Commissioner of the Massachusetts Department of Public Health issued an emergency order, rescinding and replacing a previous March 29, 2020 order, expanding availability of certain health care providers.  Like the prior order, the April 3rd order permits healthcare providers licensed and in good standing in one state to be issued a corresponding license by the appropriate licensing authority in Massachusetts, which license is to remain valid during Massachusetts’ state of emergency and permits the healthcare provider to provide services within the scope of authority issued under the license, both in-person in Massachusetts and across state line using telemedicine, where appropriate.  In addition, like the prior order, the April 3rd order allows any healthcare provider who, within the last ten (10) years, has held a license issued by a Massachusetts licensing authority to practice as a healthcare provider in Massachusetts to have their license immediately renewed or reactivated upon request, notwithstanding any continuing education or reactivation requirements and provided the prior license expired, lapsed or was retired and was not revoked, suspended, surrendered or subject to any non-disciplinary restriction.  Licenses renewed or reactivated pursuant to the order are to remain valid for ninety (90) days following termination of Massachusetts’ state of emergency.   The term “healthcare provider” is defined to include the types of healthcare providers covered by the prior order (i.e., registered nurses, licensed practical nurses, advanced practice registered nurses, dentist, dental hygienists, dental assistants, pharmacists, pharmacy technicians, nursing home administrators, physician assistants, respiratory therapists, perfusionists, genetic counselors, community health workers, and emergency medical technicians) and newly adds social workers, psychologists, marriage and family therapists, licensed mental health counselors, rehabilitation counselors, applied behavior analysts, assistant behavior analysts, licensed school psychologists, licensed alcohol and drug counselors, radiologic technologists, radiologist assistants, and nuclear medicine advanced associates.  A copy of the order may be found here and a copy of the associated guidance document may be found here.
  • Skilled Nursing Care and Staffing in Assisted Living Facilities: On April 2, 2020, the commissioner of the Massachusetts Department of Public Health issued an order permitting a nurse employed by an assisted living residence certified by the Executive Office of Elder Affairs to provide skilled nursing care in accordance with valid medical orders, provided the nurse holds a valid license to provide such care. The order also suspends the prohibition on retaining residents who require skilled nursing care for more than 90 days and, in addition, waives certain staffing and training requirements for purposes of ensuring assisted living residences are positioned to have adequate staffing to care for residents, in each instance as set forth in guidance issued by the Executive Office of Elder Affairs. A copy of the order may be found here and a copy of the guidance may be found here.
  • Maximizing Healthcare Providers in Massachusetts: The Commissioner of Public Health on March 29, 2019 issued an order authorizing healthcare providers licensed and in good standing in one state to be issued a corresponding license by the appropriate licensing authority in Massachusetts to remain valid during Massachusetts’ state of emergency. Health care providers issued licenses pursuant to the order may provide services within the scope of authority issued under the license, both in person in Massachusetts and across state lines using telemedicine, where appropriate. The order further allows any healthcare provider who, within the last ten (10) years, has held a license issued by a Massachusetts licensing authority to practice as a healthcare provider in Massachusetts to have their license immediately renewed or reactivated upon request, notwithstanding any continuing education or reactivation requirements and provided the prior license expired, lapsed or was retired and was not revoked, suspended, surrendered or subject to any nondisciplinary restriction. Licenses renewed or reactivated pursuant to the order are to remain valid for ninety (90) days following termination of Massachusetts’ state of emergency. The term “healthcare provider” is defined by the order to include registered nurses, licensed practical nurses, advanced practice registered nurses, dentists, dental hygienists, dental assistants, pharmacists, pharmacy technicians, nursing home administrators, physician assistants, respiratory therapists, perfusionists, genetic counselors, community health workers and emergency medical technicians. A copy of the order may be found here.
  • Section 1135 Waiver: On March 26, 2020, the Centers for Medicare and Medicaid Services approved Massachusetts’ March 20, 2020, request for a waiver under Section 1135 of the Social Security Act of certain federal Medicaid and CHIP requirements. A copy of the CMS waiver approval may be found here.
  • Waiver of Certain Determination of Need Requirements: The Commissioner of the Massachusetts Department of Public Health on March 24, 2020, issued an emergency order temporarily waiving Notice of Determination of Need requirements for persons seeking approval for a Substantial Capital Expenditure, Substantial Change in Service or Transfer of Site necessary to address COVID-19, provided the person seeking the approval complies with guidance issued by the Department of Public Health. A copy of the Commissioner’s order may be found here and a copy of the guidance document may be found here.
  • Nurse Staffing Requirements: The Commissioner of the Massachusetts Department of Public Health on March 24, 2020 issued an emergency order temporarily exempting hospitals licensed or operated by the Department of Public Health from acuity-assessed staffing and nurse-to-patient requirements under G.L. c. 111, s. 231 to facilitate care to all patients and to facilitate best practices for addressing the COVID-19 public health emergency. A copy of the Commissioner’s order may be found here.
  • Physician Assistants:  The Massachusetts Commissioner of Public Health on March 18, 2020, issued an order providing for flexible reassignment of physician assistants.  A copy of the order may be found here.
  • Professional Registrations:  Governor Baker, on March 17, 2020, issued an order requiring registrations held in good standing by registered nurses, licensed practical nurses, pharmacists and physician assistants that expired or are set to expire during Massachusetts’ state of emergency be extended by a period of at least 90 days following termination of the state of emergency.  The same order, among other actions, prohibits any state board of registration from prohibiting any licensed nurse, social worker, psychologist or medical doctor in good standing from providing telemedicine services across state lines to their established patients who, during the 2019-2020 academic year, have been enrolled at a college or university in the state.   A copy of the order may be found here.  On March 18, 2020, Governor Baker issued an additional order requiring the extension of occupational and professional licenses, certificates and registrations that expired or are set to expire and were not covered by a prior order.  A copy of the March 18 order may be found here.
  • Expanding Access to Physician Services:  Governor Baker, on March 17, 2020, issued an order requiring the Board of Registration in Medicine to adopt policies and procedures and to issue guidance providing for: (i) all physicians who have retired in the past year without any outstanding claims or investigations to have their licenses immediately reactivated upon request, (ii) certain license renewal extensions for physician licensed in good standing, (iii) physicians who are licensed in good standing in another state to secure emergency licensure in Massachusetts, enabling physicians so licensed to provide professional medical services in-person or via telemedicine where appropriate, and (iv) individuals holding limited licenses to engage in patient care activities outside the scope of their specialty training program (i.e., internal moonlighting) under certain conditions.  A copy of the order may be found here.  Information published by the Board of Registration in Medicine in response to the order may be found here.
  • Emergency Credentialing and Licensed Staff Transfer Procedures: On March 17, 2020, the Massachusetts Commissioner of Public Health issued an order for emergency credentialing and licensed staff transfer procedures for medical facilities located in Massachusetts. Pursuant to the order, all hospitals and facilities licensed or operated by the Massachusetts Department of Public Health are directed immediately to implement expedited credentialing procedures to process applications from licensed independent practitioners to practice at the hospital during the period of the public health emergency. The order further requires all hospitals and facilities licensed or operated by the Department of Public Health to permit all licensed clinical staff including but not limited to registered nurses, licensed practical nurses, respiratory technicians and licensed independent practitioners who are employed by or work at one such hospital or facility to work at another such hospital or facility. All such hospitals and facilities are further required to accommodate the expedited exchange of licensed clinical staff between the staff member’s regular place of employment and the facility to which the staff member is transferred consistent with Department of Public Health guidance. 
  • Telehealth: On March 15, 2020, the Massachusetts Department of Public Health published guidance, pursuant to an order issued by Governor Baker, that in part requires commercial insurers and the Group Insurance Commission to cover medically necessary telehealth services in the same manner they cover in-person services. Insurers are also required to cover COVID-19 testing and treatment without requiring cost sharing of any kind. 
  • State of Emergency Declaration: Governor Charlie Baker on March 10, 2020, declared a state of emergency in Massachusetts to respond to COVID-19. A copy of the executive order declaring the state of emergency may be found here.
  • Other Steps: Additional steps Massachusetts has taken to facilitate the provision of health care during the COVID-19 state of emergency may be found here

 

New York Actions

  • COVID-19 and Influenza Testing and Reporting Protocols:  On August 28, 2020, Governor Cuomo issued an executive order in part directing the Commissioner of Health to develop emergency regulations establishing comprehensive statewide protocols for COVID-19 and influenza testing and reporting, the purpose of which is to ensure accurate case numbers and timely contact tracing in all regions throughout the state.   
  • Pharmacist COVID-19 Testing; Skilled Nursing and Adult Care Facilities; Patients Giving Birth; General Hospital’s Performance of Elective Procedures: On June 21, 2020, Governor Cuomo issued an executive order suspending or temporarily modifying until July 21, 2020 certain specified provisions of law and regulation, among other things, (i) to allow licensed pharmacists to order and administer COVID tests or antibody tests; (ii) to allow licensed pharmacists to be designated as qualified healthcare professional so they can direct a limited service laboratory to test for COVID or its antibodies; (iii) to allow clinical labs to accept and examine specimens for COVID-19 testing from nursing home and adult care facilities personnel without a prescription or order and to report tests to the appropriate facility staff, and to require the facilities to report positives to the local department of health for treatment and isolation orders; and (iv) to the extent necessary, to allow physicians to order COVID-19 tests for self-collection without having a physician-patient relationship.  The same executive order includes several directives to remain in effect through July 21, 2020, including directives (i) authorizing the Commissioner of Health to suspend or revoke the operating certificate of any skilled nursing facility or adult care facility that is determined not to have adhered to any regulations or directives issued by the Commissioner of Health, and authorizing the Commissioner of Health to appoint a receiver to continue the operations on 24 hours’ notice to the current operator, in order to preserve life, health and safety; (ii) modifying prior to directives to require any article twenty-eight facility, as a condition of licensure, to allow any patient giving birth to have present a support person and/or doula, who does not have symptoms of COVID-19, for the labor, delivery and also the remaining duration of the patient’s stay; and (iii) extending for a period of thirty days any prior suspension or modification of law undertaken in Executive Order 202, or any amended or modified Executive Order issued thereafter, which allowed for the practice of a profession in the state of New York without a current New York State licensure, or registration, including but not limited to those individuals validly licensed in another state or Canada, to allow those professionals the ability to continue to provide services necessary for the State’s COVID-19 response.  Importantly, the executive order also includes an additional directive authorizing general hospitals to resume performing elective surgeries and procedures under certain specified conditions.  
  • Continuation and Amendment to Prior Modifications of Law Regarding Nursing Home and Adult Care Facility COVID-19 Testing:  On June 10, 2020, Governor Cuomo issued an executive order in part extending through July 9, 2020 the suspensions and modifications of law as well directives made by previous Executive Order 202.30.  The order specifically provides that certain prior modifications of law and regulation effected by Executive Order 202.30 are continued “provided that such modification is amended only to the extent that the operator and administrator of all nursing homes and all adult care facilities, which are located in regions that have reached Phase Two of reopening, must test or make arrangements for the testing of all personnel, including all employees, contract staff, medical staff, operators and administrators, for COVID-19, once per week.”  
  • Easing of Requirements to Establish Practitioner-Patient Relationship for Purposes of Ordering Clinical Laboratory Tests: On June 2, 2020, Governor Cuomo issued an executive order in part modifying or suspending certain statutory provisions “to the extent necessary to allow a questionnaire administered through an asynchronous electronic interface or electronic mail that is approved by a physician licensed in the State of New York to be sufficient to establish a practitioner-patient relationship for purposes of ordering a clinical laboratory test.”  
  • Requirements for COVID-19 Testing: On May 21, 2020, Governor Cuomo issued an executive order temporarily suspending or modifying certain specified statutory and regulatory requirements to allow clinical laboratories to accept and examine specimens for COVID-19 testing from personnel of nursing homes and adult care facilities, without a prescription or order from an authorized ordering source, and to report the test results to the appropriate operators and administrators of the nursing home or adult care facility; provided that, to ensure appropriate follow-up with patients who test positive for COVID-19, the facility administrator is required to contact the local health department to ensure all facility personnel who test positive are provided appropriate clinical guidance as well as appropriate isolation orders.  The same executive order temporarily suspends or modifies certain other statutory an regulatory requirements to allow physicians to order COVID-19 tests, authorized by the U.S. Food and Drug Administration (FDA) for self-collection, without otherwise having an initial physician-patient relationship with the patient. 
  • Mandatory COVID-19 Testing of Nursing Home and Adult Care Facility Personnel; Article 28 General Hospital Discharges to Nursing Homes: On May 10, 2020, Governor Cuomo issued an executive order requiring the operators and administrators of all nursing homes and all adult care facilities, including adult homes, enriched housing programs and assisted living residences, to perform (or arrange for the performance of) twice-weekly COVID-19 testing on all personnel. The testing is to be performed pursuant to a plan developed by the facility administrator that is required to be filed with the Department of Health no later than 5:00 p.m. on Wednesday, May 13, 2020, and all positive test results are required to be reported to the Department by 5:00 p.m. the day following receipt of the test result in a manner determined by the Commissioner of Health. The executive order also contains specific directives (i) requiring operators and administrators to submit to the Department certifications of compliance with the executive order and directives of the Commissioner of Health, as well as all other applicable executive orders and directives of the Commissioner of Health, no later than May 15, 2020; (ii) authorizing the Commissioner of Health to suspend or revoke the license of a nursing home or adult care facility that fails to comply with the executive order or any regulations or directives issued by the Commissioner of Health, and to appoint a receiver to continue to operate the facility; (iii) providing for penalties of $2,000 per violation per day for failure to comply with the executive order and $10,000 per violation per day for subsequent violations; and (iv) prohibiting any personnel who refuse the required testing from providing services to the nursing home or adult care home. The executive order also prohibits any article 28 general hospital from discharging a patient to a nursing home unless the nursing home has first certified its ability to care for the patient and until such time as the hospital has performed COVID-19 testing on the patient and obtained a negative result.  
  • Extension of Authorization for Out-of-State Professionals: On May 5, 2020, Governor Cuomo issued an executive order containing a directive extending for a period of 30 days suspensions or modifications of existing law effected by prior executive order to allow “for the practice of a profession in the state of New York without a current New York State licensure, or registration, including but not limited to those individuals who are validly licensed in another state or Canada … to allow those professionals the ability to continue to provide services necessary for the State’s COVID-19 response.”
  • Executive Order Addressing Birthing Sites, Performance of Elective Surgeries and Procedures by General Hospitals: On April 29, 2020, Governor Cuomo issued an executive order, effective through May 29, 2020, suspending or modifying certain New York regulatory provisions “to the extent necessary to allow for the approval and certification by the Commissioner of Health of temporary dedicated birthing sites operated by currently-licensed birthing hospitals and currently-licensed birthing centers.” The order also modifies directives contained in prior executive orders in two respects. First, the order modifies prior directives to require facilities subject to the order, as a condition of licensure, to “allow any patient giving birth to have present with them: a support person, who does not have symptoms of COVID-19, for the labor, delivery and also the remaining duration of the patient’s stay; and/or a doula, who does not have symptoms of COVID-19 for the labor, delivery, and the remaining duration of the patient’s stay. The presence of a support person and/or doula will be subject to exceptions for medical necessity determined by the Commissioner.” Second, the order modifies a prior directive relating to the cancellation of elective surgeries and procedures for the limited purpose of permitting general hospitals to perform elective surgeries and procedures under certain specified criteria set forth in the directive and for which the Commissioner of Health is expressly authorized to issue implementation guidance. General hospitals that meet the specified criteria are required to report the number and types of surgeries and procedures performed to the Department of Health, in a manner prescribed by the Commissioner. General hospitals that do not meet the specified criteria to perform elective surgeries and procedures may seek a waiver from the prohibition, “by submitting a plan that includes, at a minimum, their facility capacity, physical configuration, infectious disease protocols, and staffing capacity, including any applicable employment hardship information that includes any reductions in workforce, including furloughs, that have occurred due to the inability of such facility to perform elective surgeries or procedures, or any reductions in workforce, including furloughs, that may imminently occur due to the inability of such facility to perform elective surgeries or procedures, to the Department of Health, in a manner prescribed by the Commissioner.” The order further includes a directive prohibiting general hospitals from performing any elective surgery or procedure on a patient until “the patient has tested negative for COVID-19 through an approved diagnostic test, and the hospital and patient have complied with the pre-operative and pre-procedure guidelines in a manner prescribed by the Commissioner.” 
  • Pharmacists and COVID-19 Testing: On April 25, 2020, Governor Cuomo issued an executive order temporarily suspending or modifying through May 25, 2020, certain provisions of (i) the Education Law to the extent necessary to authorize licensed pharmacists to order FDA-approved COVID-19 tests to detect SARS-CoV-2 or its antibodies, and to administer COVID-19 tests subject to certificate of waiver requirements pursuant to the federal Clinical Laboratory Improvement Act of 1986, in patients suspected of a COVID-19 infection, or suspected of having recovered from COVID-19 infection, subject to completion of appropriate training developed by the Department of Health; and (ii) the Public Health Law to the extent necessary to permit licensed pharmacists to be designated as a qualified healthcare professional for the purpose of directing a limited service laboratory, pursuant to subdivision 579(3) of the Public Health Law, to test patients suspected of a COVID-19 infection or its antibodies provided that such test is FDA-approved and waived for use in a limited service laboratory. 
  • Suspension and Revocations of Skilled Nursing and Adult Care Facility Operating Certificates: On April 24, 2020, Governor Cuomo issued an executive order containing a directive which authorizes the Commissioner of Health “to suspend or revoke the operating certificate of any skilled nursing facility or adult care facility if it is determined that such facility has not adhered to any regulations or directives issued by the Commissioner of Health, and if determined to not be in compliance notwithstanding any law to the contrary the Commissioner may appoint a receiver to continue the operations on 24 hours’ notice to the current operator, in order to preserve the life, health and safety of the people of the State of New York.”  The directive contained in the order is to remain in effect through May 24, 2020. 
  • Statewide Coordinated Process for COVID-19 Testing: On April 17, 2020, Governor Cuomo issued an executive order in part directing the New York Department of Health to establish a single, statewide coordinated testing prioritization process for all public and private laboratories in New York State that conduct COVID-19 testing.  All such laboratories are required to prioritize COVID-19 testing in accordance with the statewide process and are prohibited, absent an exemption from the Department of Health, from entering into an agreement that would reserve testing capabilities for any private or public entity and therefore impede New York State’s ability to prioritize and coordinate COVID-19 testing.  Violations of the directive are subject to civil penalties of up to $10,000 or three times the value of the testing provided in violation of the directive, and the Commissioner of the Department of Health is further authorized to revoke the operating certificate or license of any laboratory violating the directive.  
  • Canadian Healthcare Providers: On April 16, 2020, Governor Cuomo issued an executive order that modifies or suspends specific statutory and regulatory provisions to the extent necessary to allow certain categories of healthcare providers licensed and in good standing in any province or territory of Canada, including, among others, physicians, physician assistants, registered nurses, licensed practical nurses, nurse practitioners, radiologic technologists, clinical nurse specialists, and specialist assistants, to practice in New York State without civil or criminal penalty due to the lack of licensure, certification or registration, as applicable.  
  • Expanded Antibody Testing: On April 12, 2020, Governor Cuomo issue an executive order to expand eligibility of individuals to conduct antibody testing for COVID-19.    Executive Order 202.16, a copy of which may be found here, in part temporarily waives or modifies through May 12, 2020, certain specified statutes and regulations  “to the extent necessary to permit individuals to perform testing for the detection of SARS-CoV-2, or its antibodies, in specimens collected from individuals suspected of suffering from a COVID-19 infection; individuals performing testing must meet the federal requirements for testing personnel appropriate to the assay or device authorized by the FDA or the New York State Department of Health.”
  • Executive Order Addressing Prescription Drug or Device Delivery, Pharmacy Receipt of Drugs and Supplies, and 2020 Medical School Graduates: On April 9, 2020, Governor Cuomo issued Executive Order No. 202.15.  Among other actions, the executive order temporarily suspends or modifies certain statutory and regulatory requirements to the extent necessary  to permit a manufacturer, repacker, or wholesaler of prescription drugs or devices, physically located outside of New York and not registered in New York, but licensed and/or registered in any other state, to deliver prescription drugs or devices into New York.  It also temporarily suspends or modifies certain other statutory and regulatory requirements to allow, subject to certain conditions set forth in the order, a New York-licensed pharmacy to receive drugs and medical supplies or devices from an unlicensed pharmacy, wholesaler, or third-party logistics provider located in another state to alleviate a temporary shortage of a drug or device that could result in the denial of health care.  In addition, the order temporarily suspends or modifies specific statutory and regulatory requirements “to the extent necessary to allow individuals, who graduated from registered or accredited medical programs located in New York State in 2020, to practice medicine in New York State, without the need to obtain a license and without civil or criminal penalty related to lack of licensure, provided that the practice of medicine by such graduates shall in all cases be supervised by a physician licensed and registered to practice medicine in the State of New York.”  
  • Executive Order Addressing 2020 Medical School Graduates and Inventorying and Redistribution of Certain Medical Equipment: On April 7, 2020, Governor Cuomo issued Executive Order No. 202.14.  Among other actions, the executive order temporarily suspends or modifies certain statutory and regulatory requirements “to the extent necessary to allow any physician who will graduate in 2020 from an academic medical program accredited by a medical education accrediting agency for medical education by the Liaison Committee on Medical Education or the American Osteopathic Association, and has been accepted by an Accreditation Council for Graduate Medical Education accredited residency program within or outside of New York State to practice at any institution under the supervision of a licensed physician.”  The executive order in relevant part further directs entities in New York holding in inventory or otherwise locating in New York “any medical equipment (personal protective equipment (PPE), ventilators, respirators, bi-pap, anesthesia, or other necessary equipment or supplies as determined by the Commissioner of Health)” to report such inventory to the Department of Health (DOH), and permits DOH to “shift any such items not currently needed, or needed in the short term future by a health care facility, to be transferred to a facility in urgent need of such inventory, for purposes of ensuring New York hospitals, facilities and health care workers have the resources necessary to respond to the COVID-19 pandemic, and distribute them where there is an immediate need.”  DOH is further directed to “either return the inventory as soon as no longer urgently needed and/or, in consultation with the Division of the Budget, ensure compensation is paid for any goods or materials acquired at the rates prevailing in the market at the time of acquisition, and shall promulgate guidance for businesses and individuals seeking payment.” 
  • Jacob K. Javitz Center Temporary Hospital: On April 2, 2020, Governor Cuomo announced that President Trump had authorized his request for the temporary hospital run by the US Army at the Javitz Center to treat COVID patients. The temporary hospital, which has 2,500 beds, originally was planned as a 1,000-bed facility to care for non-COVID patients.
  • Conversion of BiPAP Machines to Ventilators: On April 2, 2020, Governor Cuomo announced the New York State Department of Health had approved Northwell’s protocol for conversion of BiPAP machines to ventilators. New York has 250 BiPAP machines in stock and has purchased an additional 3,000 for distribution to hospitals across the state. Governor Cuomo also announced that the state has begun surveying hospitals on a nightly basis to take inventory on supplies and has requested that hospitals contribute unneeded inventory to a central stockpile for redistribution to hospitals with the greatest need. 
  • Personal Care Service Assessments: On March 31, 2020, NC Medicaid issued a bulletin announcing that it is taking certain precautions regarding independent assessments conducted to determine eligibility for Personal Care Services (PCS). For example, NC Medicaid will extend prior approvals for current beneficiaries approaching their annual due date. Click here to view the bulletin.
  • Public-Private Hospital Partnership: On March 30, 2020, Governor Cuomo announced a statewide public-private hospital partnership to combat COVID-19. Details regarding the partnership may be found here.
  • Section 1135 Waiver: On March 26, 2020, the Centers for Medicare and Medicaid Services approved New York’s March 23, 2020, request for a waiver under Section 1135 of the Social Security Act of certain federal Medicaid and CHIP requirements. A copy of the CMS waiver approval may be found here.
  • Mandated Increases in Hospital Bed Capacity: Governor Cuomo, on March 23, 2020, issued an executive order temporarily modifying or suspending numerous provisions of law to enable healthcare providers greater flexibility to respond to the COVID-19 crisis.  Importantly, the executive order also sets forth a series of directives, including a directive mandating the New York Commissioner of Health to direct “all general hospitals, ambulatory surgery centers, office-based surgery practices and diagnostic and treatment centers to increase the number of beds available to patients, including by canceling all elective surgeries and procedures, as the Commissioner of Health shall define. General hospitals shall comply with such order by submitting COVID-19 Plans to the New York State Department of Health (NYSDOH), on a schedule to be determined by NYSDOH, to accomplish this purpose.”  The same executive order also authorizes the Commissioner of Health to suspend or revoke the operating certificate of any general hospital in the event it is unable to meet the requirements of the necessary capacity directives and to appoint a receiver to continue the operations on 24 hours’ notice to the current operator, in order to preserve the life, health and safety of the people of the State of New York.  
  • Javitz Center Temporary Hospital: Governor Cuomo, on March 23, 2020, announced the delivery of initial supplies to the Jacob K. Javitz Center, where the Federal Emergency Management Agency (FEMA) is creating a 1,000-bed temporary hospital to assist New York in addressing the need for additional hospital bed capacity to combat COVID-19.  The hospital is scheduled to open next week.  The temporary hospital at the Javitz Center is in addition to other sites within the state identified by the Army Corps of Engineers for temporary hospitals.  
  • Out-of-State Health Care Professionals: On March 18, 2020, Governor Cuomo issued an executive order which, in part, modifies or suspends certain existing law to allow physicians, nurse practitioners, registered nurses, licensed practical nurses and physician assistants licensed and in good standing in any state in the United States to practice in New York without civil or criminal penalty due to their lack of licensure in New York. The same executive order modifies or suspends existing law to enable physicians licensed and in good standing in New York but not registered in New York to practice in New York without civil or criminal penalty due to their lack of registration in New York. 
  • USNS Comfort: On March 18, 2020, Governor Cuomo announced the USNS Comfort will be deployed to New York harbor to provide additional surge capacity to help the state address capacity constraints associated with an influx of COVID-19 patients requiring hospital care. The Comfort is a 1,000-bed hospital ship with 12 operating rooms. It is expected to arrive in New York harbor in early April. 
  • Waiver of Cost-Sharing Obligations for Telehealth Services: On March 17, 2020, the State Department of Financial Services (DFS) issued an emergency regulation requiring New York State insurance companies to waive cost-sharing obligations for in-network telehealth visits, regardless of whether the telehealth visit is related to COVID-19, to encourage New Yorkers to seek medical care from their homes rather than at a doctor’s office or hospital. Following issuance of DFS’s emergency regulation, several state agencies published guidance letters for telehealth services. A summary of DFS’s emergency regulation and links to the relevant state agencies’ guidance documents may be found here
  • Disaster Emergency Declaration: Governor Cuomo declared a state disaster emergency for the State of New York due to COVID-19 on March 7, 2020. A copy of the executive order declaring the emergency may be found here. The emergency declaration allows, among other things, the expedited procurement of cleaning supplies, hand sanitizer and other essential resources; allowing qualified professionals other than doctors and nurses to conduct testing; expedited procurement of testing supplies and equipment; expedited personnel onboarding; expedited leasing of lab space; EMS personnel to transport patients to quarantine locations other than just hospitals. 

 

North Carolina Actions

  • Section 1915(c) Home and Community-Based Services (HCBS) Waivers:  On October 29, 2020, the Centers for Medicare & Medicaid Services (CMS) approved North Carolina’s request to amend certain Section 1915(c) HCBS Waivers, Community Alternatives Program for Children and Community Alternatives Program for Disabled Adults, with the Emergency Preparedness and Response Appendix K.  The amendments are effective until March 12, 2021.
  • Approval of Section 1135 Flexibilities:  On August 28, 2020, the Centers for Medicare & Medicaid Services announced its approval of certain Section 1135 waivers as requested by the North Carolina Department of Health and Human Services.  CMS approved, among others, the following flexibilities: (1) waiver or modification of pre-approval requirements to permit services approved on or after March 1, 2020, to continue being provided without a new or renewed prior authorization; (2) modification of the deadline for initial and annual level of care determinations required for the 1915(c) HCBS waiver; and (3) modification of the deadline for the face-to-face encounter required for Home Health services.
  • Medicaid Disaster State Plan Amendment Round 4 Approval:  On August 20, 2020, the Centers for Medicare & Medicaid Services (CMS) approved North Carolina’s State Plan Amendment 20-0013, effective June 1, 2020.  Under the State Plan Amendment, NC Medicaid will cover the new optional testing group as defined in Section 1902(a)(10)(A)(ii)(XXIII) of the Social Security Act, which includes families whose income is less than 250 percent of the income official poverty line.
  • Medicaid Disaster State Plan Amendment Round 2 Approval:  On August 18, 2020, the Centers for Medicare & Medicaid Services (CMS) approved North Carolina’s State Plan Amendment 20-0009, effective March 1, 2020.  The State Plan Amendment includes, among others, numerous changes to benefits currently covered in the State Plan, a fee increase for prescriptions that are mailed or delivered to Medicaid beneficiaries and a temporary ten percent rate increase for Skilled Nursing Facilities, Personal Care Service Providers (Adult Care Homes and In-Home), Home Health Providers, Veteran Home Nursing Facilities and Tsali Tribal Skilled Nursing Facilities.    
  • Executive Order No. 156:  On August 11, 2020, Governor Cooper issued Executive Order No. 156, directing North Carolina Department of Health and Human Services (NCDHHS) to provide additional time for families, students and children to complete required immunizations by implementing the Immunization Extension from the State Health Director.  The Executive Order also directs NCDHHS to align immunization report deadlines with the Immunization Extension from the State Health Director.
  • Federal Approval of Additional Medicaid Flexibilities:  On July 8, 2020, NC Medicaid announced that it has received federal approval of additional flexibilities during the COVID-19 pandemic for the NC Innovations Waiver, for individuals with intellectual and developmental disabilities, and the NC Traumatic Brain Injury (TBI) Waiver, for individuals who have a TBI diagnosis after age 21.  These flexibilities were approved effective April 30, 2020, to March 13, 2021.  Click here to view more information. 
  • Rate Increase:  On June 15, 2020, NC Medicaid announced that NC Medicaid is implementing a 5% rate increase for all Fee-For-Service Medicaid providers who have not yet received a 5% increase during the COVID-19 public health emergency.  Click here to view a list of such providers.
  • COVID-19 Knowledge Center:  NC Medicaid and NC Health Choice providers have created a resource to find answers to questions about COVID-19.  The COVID-19 Knowledge Center is an online resource collection of Medicaid and behavioral health COVID-19 information, including answers to questions submitted to the COVID-19 mailbox.  The COVID-19 Knowledge Center also includes resource documents such as COVID-19 Special Medicaid Bulletins. Click here to view instructions on how to access the COVID-19 Knowledge Center.
  • State Plan Amendment Request:  On May 27, 2020, North Carolina submitted to the Centers for Medicare and Medicaid Services a request to amend Section 7.4 of its Medicaid State Plan (“Medicaid Disaster Relief for the COVID-19 National Emergency”).  The request proposes certain adjustments to benefits currently covered by the Medicaid State Plan and temporary payment rate increases for select fee for service providers.  Click here to view the request letter.
  • State Plan Amendment:  On May 18, 2020, the Centers for Medicare and Medicaid Services approved North Carolina’s proposed amendment to add Section 7.4 Medicaid Disaster Relief for the COVID-19 National Emergency to its Medicaid State Plan.  North Carolina’s State Plan Amendment includes, among other changes, the following: (1) waiver of cost-sharing requirements for testing services, testing-related services and treatments for COVID-19; (2) suspension of enrollment fees and monthly premiums for the Health Care for Workers with Disabilities program; and (3) increase in payment rates for skilled nursing facilities, local health departments and home health providers, among others.  Click here to view the approved State Plan Amendment.
  • Expedited Hardship Advances and Retroactive Targeted Rate Increases: On May 6, 2020, NC Medicaid released a bulletin announcing that it is directing increased financial assistance to North Carolina skilled nursing facilities and adult care homes to address the increased costs of caring for COVID-19 positive residents in a congregate care setting. This targeted assistance is retroactive to April 1, 2020, and replaces Special Bulletin COVID-19 #68 in its entirety. To view this bulletin, please click here.
  • COVID-19 Relief Package: On May 4, 2020, Governor Cooper signed into law a COVID-19 relief package, which includes almost $1.6 billion in relief measures for critical expenditures related to public health and safety, educational needs, small business assistance and continuity of state government operations. Of this amount, $1.4 billion has been appropriated and $150 million is set aside in a reserve fund for future local government needs. The relief package also includes provisions shielding health care providers from civil liability during the health care crisis. Click here to view the press release. Click here to view a copy of Senate Bill 704.  Click here to view a copy of House Bill 1043.
  • Primary and Specialty Care Providers: On May 1, 2020, NC Medicaid released a bulletin announcing that NC Medicaid is temporarily adding telemedicine and telepsychiatry clinical coverage codes for specialty providers and increasing reimbursement rates for telephonic visits and primary care medical home per member per month fees. Click here to view this bulletin. 
  • Telehealth and Virtual Patient Communications: NC Medicaid continues to update certain clinical coverage policies related to telehealth and virtual patient communications to better enable the delivery of remote care to Medicaid and NC Health Choice beneficiaries. Click here to view these updates and additional guidance materials.
  • Appendix K Requests: On April 30, 2020, North Carolina submitted to the Centers for Medicare and Medicaid Services requests for additional Medicaid 1915(c) Appendix K Waiver Flexibilities for the NC Innovations Waiver and the NC Traumatic Brain Injury (TBI) Waiver. The requested flexibilities would have an anticipated end date of March 12, 2021. Click here to view the request for the NC Innovations Waiver. Click here to view the request for the NC TBI Waiver.
  • Increased Rates for Federally Qualified Health Centers and Rural Health Clinics: On April 30, 2020, NC Medicaid released a bulletin announcing that NC Medicaid is temporarily increasing financial assistance to Federally Qualified Health Centers and Rural Health Clinics to support them in maintaining critical access to care for Medicaid beneficiaries. Click here to view this bulletin.
  • Expedited Hardship Advances and Retroactive Targeted Rate Increases: On April 27, 2020, NC Medicaid released a bulletin announcing that it is directing increased financial assistance to North Carolina skilled nursing facilities and adult care homes to address the increased costs of caring for COVID-positive residents in a congregate care setting. This targeted assistance is retroactive to April 1, 2020. Click here to view this bulletin.
  • Special Bulletin COVID-19 Clarifications: On April 27, 2020, NC Medicaid released a bulletin providing clarifications to Special Bulletin COVID-19 #15 (Medicaid and NC Health Choice Temporary Flexibilities - 1135 Waiver Provisions) and replacing the effective dates set forth in Special Bulletins COVID-19 #2 (General Guidance and Policy Modifications), #10 (Durable Medical Equipment: Temporary Flexibilities Effective March 23, 2020) and #11 (Outpatient Specialized Therapies Temporary Flexibilities). Click here to view this bulletin.
  • Suspending Copays on COVID-19-related Services:  On April 23, 2020, NC Medicaid released a bulletin announcing that North Carolina Department of Health and Human Services is directing providers to stop collecting copayments from Medicaid and NC Health Choice beneficiaries on all COVID-19 related testing, services and treatments.  This change is effective retroactive to January 1, 2020 through the end of the calendar quarter of the federally-declared public health emergency period.  NC Medicaid will reimburse providers for lost copay revenue through claims adjustment or through a lump-sum payment. Details, including timing of the reimbursement, will be announced by NC Medicaid at a future date.  Click here to view this bulletin.
  • Telemedicine and Telepsychiatry Clinical Coverage Policy:  NC Medicaid continues to update its Telemedicine and Telepsychiatry Clinical Coverage Policy to better enable the delivery of remote care to Medicaid and NC Health Choice beneficiaries.  Click here to view these updates and additional guidance materials.
  • Telehealth Provisions – Clinical Policy Modifications:  NC Medicaid continues to release updates and revisions to its Telemedicine and Telepsychiatry Clinical Coverage Policy.  On April 17, 2020, NC Medicaid released a bulletin announcing that it is temporarily adding coverage for providers to help their patients engage in Remote Physiologic Monitoring.  Click here to view this bulletin.  On April 17, 2020, NC Medicaid also released a bulletin replacing, in its entirety, SPECIAL BULLETIN COVID-19 #42 regarding perinatal care.  To view the new bulletin, please click here.
  • Behavioral Health and Intellectual and Developmental Disability Clinical Coverage Policies:  On April 16, 2020, NC Medicaid released a bulletin announcing that NC Medicaid, in partnership with the Division of Mental Health, Developmental Disabilities and Substance Abuse Services, is temporarily modifying its Behavioral Health and Intellectual and Developmental Disability Clinical Coverage Policies to better enable the delivery of care to NC Medicaid, NC Health Choice and State-funded individuals.  These changes are retroactive to March 10, 2020. and will end the earlier of the cancellation of the North Carolina state of emergency declaration or when the policy modification is rescinded.  Click here to view the bulletin. 
  • Emergency Demonstration Project:  On April 13, 2020, NC Medicaid published the North Carolina Department of Health and Human Services’ Request for Emergency Demonstration Project Under Section 1115 of the Social Security Act, which was submitted to CMS on March 27, 2020.  The request seeks CMS approval under Section 1115 to accomplish the following: (1) expand coverage for uninsured individuals; (2) establish a COVID-19 Disaster Relief Fund; (3) provide temporary shelter for certain homeless populations; (4) offer nutrition support to allow Medicaid beneficiaries to comply with social distancing and home orders; (5) provide more flexibility for beneficiaries receiving home care; (6) ensure appropriate behavioral health care; and (7) streamline eligibility determinations and enrollment.  Click here to view this request. 
  • Executive Order No. 131:  On April 9, 2020, Governor Cooper issued Executive Order No. 131, placing mandatory risk mitigation requirements on skilled nursing facilities, and encouraging such measures be adopted, to the extent possible, by other types of long term care facilities, such as family care homes and adult care homes, among others.  Click here to view this executive order.
  • Telehealth Provisions – Clinical Policy Modifications:  NC Medicaid continues to release updates and revisions to its Telemedicine and Telepsychiatry Clinical Coverage Policy. On April 7, 2020, NC Medicaid released bulletins that replace, in their entirety, certain bulletins previously published by NC Medicaid that address, among others, enhanced behavioral services, outpatient specialized therapies and dental services.  On April 9, 2020, NC Medicaid released bulletins regarding related modifications to optometry services, postpartum care, and self-measured blood pressure monitoring.  Click here to view NC Medicaid bulletins addressing modifications to its Telemedicine and Telepsychiatry Clinical Coverage Policy.
  • Optical and Hearing Services:  On April 9, 2020, NC Medicaid released a bulletin announcing that it has temporarily modified its policies regarding delivery of specific optical and hearing aid services to reduce in-person visits for Medicaid and NC Health Choice beneficiaries.  These temporary changes are retroactive to March 10, 2020, and will end the earlier of the cancellation of the North Carolina state of emergency declaration or when these modifications are rescinded.  Click here to view this bulletin.
  • Executive Order No. 130:  On April 8, 2020, Governor Cooper issued Executive Order No. 130, a comprehensive order that addresses numerous topics related to the delivery of health care services.  The Executive Order delegates to the Secretary of Health and Human Services authority to waive or modify enforcement of any legal or regulatory constraints that would prevent or impair, among others, increasing health facilities’ licensed bed capacity, relocating beds, adding or relocating dialysis stations, and allowing an ambulatory surgical facility to operate as a temporary hospital, subject to certain restrictions.  The Executive Order sets forth the process for requesting such temporary increases and relocations, and addresses the relationship between these actions and North Carolina’s Certificate of Need requirements.  The Executive Order also delegates to each professional health care licensure board the authority to waive or modify enforcement of any legal or regulatory constraints that would prevent or impair, among others, allowing persons to provide care if they are licensed in other states (but not licensed in North Carolina), allowing persons to provide care if they are retired or if their licenses are inactive, allowing unlicensed yet skilled volunteers to provide care, and allowing certain students to provide care.  The Executive Order also discusses limitation of liability for emergency management workers under N.C. Gen. Stat. 166A-19.60.  Click here to view the Executive Order.
  • Provider Site Visits and Enrollment:  On April 8, 2020, NC Medicaid released a bulletin replacing, in its entirety, SPECIAL BULLETIN COVID #8, regarding face-to-face provider site visits and fingerprinting requirements for NC Medicaid provider enrollment.  Click here to view the new bulletin.
  • Section 1915(c) Home- and Community-Based Services (HCBS) Waivers:  On April 6, 2020, CMS approved North Carolina’s request to amend the following Section 1915(c) HCBS waivers with the Emergency Preparedness and Response Appendix K: (1) NC Innovations, (2) Community Alternatives Program for Disabled Adults, (3) Community Alternatives Program for Children, and (4) NC Traumatic Brain Injury Waiver.  Click here to view a copy of CMS’s approval letter.  Click here to view Appendix K for NC Innovations.  Click here to view Appendix K for Community Alternatives Program for Disabled Adults. Click here to view Appendix K for Community Alternatives Program for Children.  Click here to view Appendix K for NC Traumatic Brain Injury Waiver.
  • Rate Increase and Claims Reprocessing:  On April 3, 2020, NC Medicaid issued a bulletin announcing that the Division of Health Benefits has implemented a 5% rate increase for certain Medicaid provider groups, including skilled nursing facilities, hospice facilities, and local health departments, among others.  The Division of Health Benefits will systematically reprocess claims submitted with dates of service beginning March 10, 2020, through the implementation date of the rate increase.  Click here to view a copy of the bulletin.
  • Telehealth Provisions – Clinical Policy Modification: On March 30, 2020, NC Medicaid issued a bulletin addressing additional changes to its Telemedicine and Telepsychiatry Clinical Coverage Policy. The changes set forth in this bulletin supersede Special Bulletin COVID-19 #9, which was published on March 20, 2020. To view the most recent bulletin, please  click here.
  • Update to Telehealth Provisions: Clinical Policy Modifications: On March 27, 2020, NC Medicaid issued a bulletin announcing that, effective March 30, 2020, through the conclusion of the declared North Carolina State of Emergency related to COVID-19, the Division of Health Benefits and the Division of Mental Health, Developmental Disabilities and Substance Abuse Services are temporarily modifying the Telemedicine and Telepsychiatry Clinical Coverage Policies to better enable the delivery of remote care to beneficiaries. This bulletin is specific to telepsychiatry. To view the bulletin, please click here. To view the Telemedicine and Telepsychiatry Clinical Coverage Policies, please click here.
  • Telehealth Provisions for Enhanced Behavioral Health Services: On March 27, 2020, NC Medicaid issued a bulletin announcing that, effective March 30, 2020, through the conclusion of the declared North Carolina State of Emergency related to COVID-19, the Division of Health Benefits and the Division of Mental Health, Developmental Disabilities and Substance Abuse Services are temporarily modifying certain Enhanced Behavioral Health policies to better enable the delivery of remote care to beneficiaries. These changes are retroactive to March 10, 2020. To view the bulletin, please click here.
  • Telehealth Provisions – Outpatient Specialized Therapies and Dental Services: On March 27, 2020, NC Medicaid issued a bulletin announcing that, effective March 30, 2020, NC Medicaid is temporarily modifying its Telemedicine and Telepsychiatry Clinical Coverage Policy to allow for certain outpatient specialized therapies, such as physical therapy, occupational therapy, speech language therapy and audiology, as well as certain dental services to be delivered via telehealth. To view the bulletin, please click here.
  • Durable Medical Equipment: On March 24, 2020, NC Medicaid issued a bulletin announcing that, effective March 23, 2020, certain respiratory equipment, nursing equipment and supplies that typically require prior authorization may be provided to beneficiaries without seeking prior authorization, as long as such equipment and supplies are medically necessary. To view the bulletin, please click here. NC Medicaid issued an additional bulletin, announcing that, effective March 23, 2020, outpatient respiratory therapy services provided through the Independent Practitioner Provider program, which typically require prior authorization, may be provided to NC Medicaid and NC Health Choice beneficiaries without prior authorization. To view the second bulletin, please click here.
  • 1135 Waiver Policy Flexibilities: On March 24, 2020, NC Medicaid issued a bulletin announcing that the Centers for Medicare & Medicaid Services (CMS) granted NC Medicaid the authority to temporarily modify several NC Medicaid and NC Health Choice policies retroactive to March 1, 2020, and through the end of the federal emergency declaration or when the flexibility is ended by North Carolina or CMS, whichever is first. The bulletin describes the following 1135 waiver policy flexibilities: Reimbursement for Medically Necessary Services without Prior Authorization, Skilled Nursing Facilities, Critical Access Hospitals, Durable Medicaid Equipment, Hospital Acute Care Units, Supporting Care for Patients in Long-term Care Acute Hospitals, Home Health Agencies, Services Provided in Alternative Settings and Temporary Preadmission Screening and Resident Review (PASRR) Procedures. To view this bulletin, please click here.
  • Section 1135 Waiver: On March 23, 2020, the Centers for Medicare and Medicaid Services approved North Carolina’s March 17, 2020 request for a waiver under Section 1135 of the Social Security Act of certain federal Medicaid and CHIP requirements. A copy of the CMS waiver approval may be found here.
  • Enrollment as NC Medicaid Provider:  On March 20, 2020, NC Medicaid issued a bulletin announcing that North Carolina Department of Health and Human Services (NC DHHS) received authority from CMS under Section 1135 of the Social Security Act to waive certain federal Medicare, Medicaid, CHIP and HIPAA requirements.  As a result, NC DHHS has implemented a temporary, expedited enrollment process to allow non-Medicaid enrolled health care professionals rendering services to Medicaid beneficiaries due to the COVID-19 outbreak to quickly enroll as a NC Medicaid provider.  
  • Provider Site Visits:  On March 20, 2020, NC Medicaid issued a bulletin announcing that North Carolina Department of Health and Human Services (NC DHHS) will temporarily discontinue visiting providers at their service locations to satisfy the site visit requirement.   North Carolina’s vendor, Public Consulting Group will conduct visits virtually or by phone. 
  • Telemedicine:  On March 20, 2020, NC Medicaid issued a bulletin announcing that, effective March 23, 2020, NC Medicaid is temporarily modifying its Telemedicine and Telepsychiatry Clinical Coverage Policy.  The bulletin addresses payment parity for telehealth, expanding eligible telehealth technologies, expanding eligible provider types, expanding the list of eligible originating and distant sites, and eliminating the need for prior authorization and referrals, subject to certain limitations.   Click here to view the Telemedicine and Telepsychiatry Clinical Coverage Policy
  • NC Medicaid - Section 1915(c) Home- and Community-Based Services (HCBS) Waivers:  On March 19, 2020, NC Medicaid issued a bulletin announcing that CMS has granted NC Medicaid the authority to move forward with HCBS waiver flexibilities requested March 13, 2020.  The bulletin describes the waiver policy flexibilities for Community Alternative Program for Children (CAP/C) and Community Alternative Program for Disabled Adults (CAP/DA) Waivers, Innovations Waiver and Traumatic Brain Injury Waiver.  
  • Letter of Concurrence:  On March 17, 2020, Dave Richard, the Deputy Secretary for NC Medicaid, submitted a Letter of Concurrence to CMS to invoke existing federal authorities to allow displaced beneficiaries to maintain enrollment; delay application and renewal processing timeframes; delay acting on certain changes affecting eligibility; accept self-attestation for eligibility criteria; suspend adverse actions, delay scheduling fair hearings and decisions; and reinstate services or eligibility if discontinued due to displacement. 
  • NC Health Choice (CHIP) State Plan Amendment:  On March 17, 2020, North Carolina notified CMS that it intends to provide temporary adjustments to CHIP enrollment, application and redetermination policies, prior authorization requirements and certain payment policies.  View the NC Health Choice (CHIP) State Plan Amendment.   
  • North Carolina - Section 1135 Waivers: On March 17, 2020, North Carolina requested waivers of certain federal Medicare, Medicaid, CHIP and HIPAA requirements. In the letter to CMS, Dave Richard, the Deputy Secretary for North Carolina Medicaid, stated that North Carolina is seeking to avail itself of already-approved 1135 Waivers as authorized under March 13, 2020 CMS Guidance and Secretary Azar’s March 13, 2020 Declaration. The letter also stated that North Carolina is seeking 1135 Waiver approval for certain requirements as described in the August 20, 2018, CMS Disaster Relief Inventory and as authorized under March 13, 2020 CMS Guidance. The letter requested 1135 authority for additional flexibilities to ensure ongoing access to health care items and services. 
  • North Carolina Medicaid - Section 1915(c) Home- and Community-Based Services (HCBS) Waivers: On March 13, 2020, North Carolina requested that CMS grant certain temporary modifications to home- and community-based services provided through Medicaid state plan waivers, including the Innovations, Community Alternatives for Disabled Adults, Community Alternatives for Children and Traumatic Brain Injury waivers. Click here for a description of each requested modification
  • State of Emergency: On March 10, 2020, Governor Cooper issued Executive Order No. 116 declaring a state of emergency due to COVID-19. The declaration activates the Emergency Operations Center to help agencies coordinate from one location and makes it easier to purchase needed medical supplies, protect consumers from price gouging and increase county health departments’ access to state funds. The declaration also waives licensure requirements for health care and behavioral health care personnel who are licensed in another state, territory or the District of Columbia so such personnel may provide health care services in North Carolina. Executive Order No. 116 (link removed). 

  

Texas Actions

  • Executive Order Increasing Hospital Capacity: On April 17, 2020, Governor Abbott issued an Executive Order loosening the restrictions on elective surgeries that were put in place in March to address hospital capacity and personal protective equipment (PPE) needed to cope with the COVID-19 disaster.  The Executive Order indicates that from April 22 through May 8 all licensed health care professionals and all licensed health care facilities must continue to postpone all surgeries and procedures that are not immediately medically necessary, but creates exceptions for (A) any procedure that, if performed in accordance with the commonly accepted standard of clinical practice, would not deplete the hospital capacity or the PPE needed to cope with COVID-19, or (B) any surgery or procedure performed in a licensed health care facility that has certified in writing to Texas Health and Human Services Commission both (1) that it will reserve at least 25% of its hospital capacity for treatment of COVID-19 patients, accounting for the range of clinical severity of COVID-19 patients, and (2) that it will not request any PPE from any public source — whether federal, state, or local — for the duration of the COVID-19.  A copy of the Executive Order is available here
  • Waiver of Regulations on Physicians in Training: On April 11, 2020, Governor Abbott temporarily waived certain regulations on physicians-in-training (PIT) permit holders in order to allow Texas hospitals and facilities associated with Graduate Medical Education (GME) training programs to utilize PIT permit holders, with proper physician oversight, in areas outside of their GME training program.
  • Waiver of Additional Regulations to Expand Telehealth Options:  On April 9, 2020, Governor Abbott temporarily waived a series of additional regulations to lift certain telehealth restrictions. These waivers allow a smart phone or any audio-visual, real-time, or two-way interactive communication system to qualify as a telecommunications technology that can be used to provide certain telehealth services by speech-language pathologists and audiologists, behavior analysts, hearing instrument fitters and dispensers, and dyslexia therapists and practitioners. More information about the specific waivers can be found here.
  • Emergency Rule to Allow Off-Site ESRD Facilities: On April 7, 2020, Governor Abbott announced that the Texas Health and Human Services Commission (HHSC) adopted an emergency rule for end stage renal disease (ESRD) facilities to facilitate treatment of dialysis patients that have tested positive for COVID-19 at a location separate from other dialysis patients.  The emergency rule will allow currently licensed ESRD facilities to operate off-site outpatient facilities without obtaining a new license at (i) an ESRD facility that closed within the past 36 months; a mobile, transportable, or relocatable medical unit; a physician’s office; or an ambulatory surgical center or freestanding emergency medical care facility that closed within the past 36 months. 
  • Waiver of Licensure Regulations to Expand Health Care Workforce: On April 5, 2020, Governor Abbott temporarily waived certain regulations to allow Physician Assistants, Medical Physicists, Perfusionists, and Respiratory Care candidates for licensure who have completed all other requirements to enter the workforce under a​n emergency license working under supervision prior to taking the final licensure examination. Additional information on COVID-19 Disaster Licensing for Pending Physician Assistants, Respiratory Care Practitioners, Perfusionists, and Medical Physicists Applicants is available here
  • Section 1135 Waiver: On March 30, 2020, Governor Abbott announced that the Centers for Medicare and Medicaid Services (CMS) has approved the Section 1135 Medicaid waiver submitted by the Texas Health and Human Services Commission (HHSC) on March 26, 2020. The 1135 waiver grants Texas flexibility in administering Medicaid in responding to COVID-19, including flexibilities around extension of prior authorizations, fair hearing and appeals, provider enrollment, reimbursement of out-of-state providers and temporary cessation of provider revalidations. To view the press release, please click here. A copy of the CMS waiver approval may be found here.
  • Waiver of Pharmacist Licensure Renewal Regulations: On March 28, 2020, Governor Abbott waived certain licensure renewal regulations from the Texas Board of Pharmacy to temporarily extend expiration dates for licenses of pharmacists and pharmacy technicians. To view the press release, please click here.
  • Waiver of Advanced Practice Registered Nurse Licensure Regulations: On March 28, 2020, Governor Abbott waived certain licensure renewal regulations to allow for an expedited licensing reactivation process for advanced practice registered nurses (APRN) such that an APRN with a license that has been inactive for more than two but less than four years will not have to pay a reactivation fee or complete continuing education credits or current practice requirements. To view the press release, please click here.
  • Emergency Rule Allowing Expansion of ASC Services: On March 27, 2020, the Texas Health and Human Services Commission (HHSC) adopted an emergency rule allowing for ambulatory surgical centers (ASCs) to expand their services beyond surgical services and keep patients for longer periods of time in response to the COVID-19 pandemic. The emergency rule also requires ASCs to report to the Department of State Health Services the number of functioning ventilators and other respiratory support equipment at the ASC. To view the letter, please click here.
  • Emergency Rule Waiving Certain Hospital Licensure Regulations: On March 25, 2020, Governor Greg Abbott announced the temporary waiver of certain hospital licensing rules and the Texas Health and Human Services Commission (HHSC) adopted an emergency rule to provide for additional hospital capacity in response to COVID-19. To view the press release, please click here. The emergency rule and waivers allow for licensed hospitals to provide inpatient care at certain types of off-site facilities under the hospital’s existing license, including hospitals, ambulatory surgical centers, freestanding emergency medical care facilities and certain other facilities that have current or pending licenses or that have been closed for no more than 36 months, and also remove certain mileage restrictions, which will allow hospitals to operate additional facilities that are more than 30 miles away from the main licensed hospital. To view the letter, please click here.
  • Waiver of Nursing Licensure Renewal Regulations: On March 25, 2020, Governor Abbott waived certain licensure renewal regulations from the Texas Board of Nursing to allow for a six-month grace period for nurses with expired licenses. To view the press release, please click here.
  • Executive Order on Hospital and Lab Reporting: On March 24, 2020, Governor Abbott issued an executive order requiring all state-licensed hospitals, except for psychiatric hospitals, to submit daily reports on hospital bed capacity to the Texas Department of State Health Services (TDSHS). The executive order also requires all entities utilizing FDA-approved testing for COVID-19 to submit daily reports on test results to TDSHS. To view the order, please click here.
  • TMB Emergency Rules on Postponing Surgeries and Medical Procedures Not Immediately Medically Necessary: On March 24, 2020, the Texas Medical Board (TMB) published emergency rules to enforce Governor Abbott’s Executive Order GA-09 on postponing surgeries and medical procedures that are not immediately medically necessary through April 21, 2020. The emergency rules allow for the TMB to temporarily suspend or restrict the license of a physician performing non-urgent elective procedures in violation of Executive Order GA-09 and also require hospitals, peer review committees and licensees to immediately report to the TMB any physician scheduling to perform or performing a non-urgent elective surgery or procedure while Executive Order GA-09 is in effect.
  • Executive Order Increasing Hospital Capacity: On March 22, 2020, Governor Abbott issued an Executive Order directing all licensed healthcare facilities to postpone all surgeries and procedures that are not immediately medically necessary unless the procedure would not deplete the hospital capacity or the personal protective equipment needed to cope with the COVID-19 disaster. The Executive Order also suspended certain licensing regulations to allow for increased occupancy of hospital rooms in the event of surge needs for hospital capacity due to COVID-19.  
  • Waiver of Certain Nursing Licensure Regulations: On March 21, 2020, Governor Abbott waived several regulations to help meet the growing need for nurses as the state responds to the COVID-19 virus and has allowed for temporary permit extensions to practice for graduate nurses who have yet to take the licensing exam, students in their final year of nursing school to meet their clinical objectives by exceeding the 50% limit on simulated experiences and nurses with inactive licenses or retired nurses to reactivate their licenses. 
  • Waiver of Certain Pharmacy Regulations: On March 20, 2020, Governor Abbott announced that he is temporarily suspending certain regulations to allow pharmacists to conduct telephonic consultations and remove regulatory barriers to continued access to pharmacy services. The Texas Board of Pharmacy has posted a listing of specific regulatory waivers as well as certain emergency rules regarding emergency dispensing of prescription medications and limitations on prescriptions for chloroquine, hydroxychloroquine, mefloquine or azithromycin. 
  • Emergency Rule on Reimbursement for Telemedicine Visits: On March 17, 2020, Governor Abbott announced a temporary waiver of certain hospital licensing regulations so that facilities may use unlicensed patient beds in patient treatment areas to address any potential surge capacity without submitting an application or associated fees.
  • Emergency Rule on Reimbursement for Telemedicine Visits: On March 17, 2020, Governor Abbott waived certain regulations relating to telemedicine care for patients with state-regulated insurance plans and directed that the Texas Department of Insurance (TDI) issue an emergency rule to allow telemedicine visits for patients with state-regulated plans to be paid the same as in-office visits for insurance purposes. The TDI emergency rule is available here.
  • Disaster Proclamation: Governor Abbott on March 13, 2020, declared a state of disaster in Texas due to COVID-19 and issued a proclamation that any regulatory statute prescribing the procedures for conduct of state business or any order or rule of a state agency that would in any way prevent, hinder or delay necessary action in coping with the disaster shall be suspended upon written approval of the Office of the Governor.
  • Suspension of Restrictions on the Use of Telemedicine: To facilitate access to medical care and contain the spread of the coronavirus, the Texas Medical Board is temporarily suspending certain provisions of the Texas Occupations Code and Texas Administrative Code that restrict the ability of health care practitioners to use telemedicine in the treatment of patients. 
  • Fast-Tracking of Licensing for Out-of-State Medical Professionals: Governor Abbott directed the Texas Medical Board and the Texas Board of Nursing to fast track the temporary licensing of out-of-state physicians, physician assistants, certain retired physicians, nurses and other license types to assist in the response to COVID-19.  The Texas Medical Board is utilizing its disaster emergency licensure rule to allow out-of-state physicians and certain other health care professionals to obtain a Texas limited emergency license or hospital-to-hospital credentialing through the time period that encompasses the Governor’s Disaster Declaration.  Any out-of-state nurse may practice in Texas for the purpose of rendering aid in a disaster relief setting, provided the nurse holds a current license in good standing in their home state. 

 

Virginia Actions

  • Liability Protections for Healthcare Workers:  On April 28, 2020, Governor Northam issued Executive Order 60 to clarify aspects of the Governor’s prior executive actions and existing statutes (Va. Code §§ 8.01-225.01 and 8.01-225.02) and reinforce the applicability of certain liability protections for Virginia healthcare workers during the pandemic.  Neither the statutes nor the Order prevents liability in the case of gross negligence or willful misconduct. 
  • Medicaid Provider Flexibility: On April 23, 2020 Governor Northam issued Executive Order 58, providing flexibility to Medicaid providers in certain areas.  The Order eliminates copayments for individuals receiving coverage through the Family Access to Medical Insurance Security (FAMIS) program; permits Medicaid members to obtain replacements for durable medical equipment and supplies that are lost or damaged without requiring in-person verifications or paperwork; suspends the preadmission screening requirements for nursing facility admissions; and allows personal care, respite, and companion providers to work for up to 60 days, rather than the current 30 days, while background checks are conducted. 
  • Amendment of Executive Order 57:  On April 23, 2020, Governor Northam amended Executive Order 57 to permit licensed physician’s assistants with two or more years of clinical experience to practice without a collaborative agreement. 
  • Extension of Order Prohibiting Most Outpatient Procedures:  On April 23, 2020, Governor Northam amended Order of Public Health Emergency Two, extending until May 1, 2020 the prohibition on inpatient and outpatient surgical hospitals, endoscopy centers, physicians’ offices, and dental, orthodontic and endodontic offices from providing procedures and surgeries that require personal protective equipment (PPE), to the extent delay would not be anticipated to cause harm to the patient. The Order does not apply to outpatient visits delivered in hospital-based clinics or to the “full suite of family planning services and procedures nor to treatment for patients with emergency or urgent needs.”  
  • Executive Order Relaxing Licensing Requirements: On April 17, 2020, Governor Northam issued Executive Order 57, which authorizes certain out-of-state licensed professionals, residents, interns and senior students to practice in Virginia to help meet increased demands on the Commonwealth’s health professional workforce due to COVID-19.  During the state of emergency declared in Executive Order 51, a license in good standing issued to a health care practitioner by another state is deemed to be an active license issued by Virginia for the same types of services, provided that the individual is engaged by a hospital or hospital affiliate, nursing facility, dialysis facility, physicians’ office or other health care facility in Virginia to assist that facility or office with public health and medical disaster response operations; temporary licenses by endorsement can be issued to licensed out-of-state clinical psychologists, professional counselors, marriage and family therapists and clinical social workers; certain nurse practitioners licensed in Virginia with two or more years of clinical experience may practice and prescribe without a written practice agreement; interns, residents and fellows with active temporary training licenses may practice in a hospital without supervision of a licensed physician at all times; and senior fourth year medical students may practice in a hospital without direct tutorial supervision or a licensed physician member of the hospital staff.  
  • On March 25, 2020, Governor Northam and State Health Commissioner Oliver issued Order of Public Health Emergency Two, prohibiting inpatient and outpatient surgical hospitals, endoscopy centers, physicians’ offices, and dental, orthodontic and endodontic offices in Virginia from providing procedures and surgeries that require personal protective equipment (PPE), to the extent delay would not be anticipated to cause harm to the patient. The Order does not apply to the “full suite of family planning services and procedures nor to treatment for patients with emergency or urgent needs.” 
  • The Virginia Department of Health, Division of Certificate of Public Need (COPN) announced on March 24, 2020, an extension of the deadline for charity care reporting by COPN holders to the date that is 30 days after the expiration of the Governor’s declaration of a state of emergency due to COVID-19.
  • On March 23, 2020, the Centers for Medicare and Medicaid Services approved the request submitted by the Virginia Department of Medical Assistance Services for a waiver under Section 1135 of the Social Security Act of certain federal Medicaid and CHIP requirements. A copy of the CMS waiver approval is available here.
  • Governor Northam issued an Executive Order on March 20, 2020, directing the State Health Commissioner, at the Commissioner’s discretion, to “authorize any general hospital or nursing home to increase licensed bed capacity as determined necessary by the Commissioner to respond to increased demand for beds resulting from COVID-19.” The Executive Order deems such beds to be licensed beds not requiring further approval.  Any bed expansion authorized by the Commissioner will expire 30 days after the expiration or recession of the Governor’s declaration of a state of emergency due to COVID-19. 
    • On March 24, 2020, the State Health Commissioner released a letter announcing the process and criteria that would be used to evaluate requests for temporary bed expansions
  • The Virginia Board of Medicine announced that “a license issued to a health care practitioner by another state, and in good standing with such state, shall be deemed to be an active license issued by the Commonwealth to provide health care or professional services as a health care practitioner of the same type for which such license is issued in another state, provided such health care practitioner is engaged by a hospital, licensed nursing facility, or dialysis facility in the Commonwealth for the purpose of assisting that facility with public health and medical disaster response operations. Hospitals, licensed nursing facilities, and dialysis facilities must submit to the applicable licensing authority each out-of-state health care practitioner’s name, license type, state of license, and license identification number within a reasonable time of such healthcare practitioner arriving at the applicable health care facility in the Commonwealth.” The Board of Medicine further announced that the Board is streamlining its licensing process for physicians (medical and osteopathic), physician assistants, podiatrists and respiratory therapists and eliminating the need for transcripts of professional education, certain employment verifications and state verifications of licensure from the Virginia license application   Further information is available here.
  • Disaster Declaration: Governor Northam declared a state of emergency in Virginia due to novel coronavirus (COVID-19) on March 12, 2020. Among other things, such proclamation authorized the heads of the executive branch agencies of Virginia, with the concurrence of their Cabinet Secretary, to waive any state requirement or regulation, and enter into contracts without regard to normal procedures or formalities, and without regard to application or permit fees or royalties. 
  • Guidance for Health Professionals: The Virginia Department of Health has issued a variety of guidance and recommendations for Virginia’s health care community, including health care providers, emergency medical services, lab and long-term care providers. Materials can be accessed here.