HHS/CMS to Suspend Out-of-State MD Licensure Restrictions; Elective Surgeries Recommended Postponed

At the now-daily White House press briefing around the COVID-19 pandemic that began at about 12 noon eastern time on Wednesday, Vice President Mike Pence announced that the Department of Health and Human Services had approved the temporary suspension of restrictions on physicians practicing out of state, per licensure rules and regulations, in the wake of the emergence of the COVID-19 pandemic.

Here is the entire text of the action, as signed by Alex Azar, Secretary of Health and Human Services:

“Waiver or Modification of Requirements Under Section 1135 of the Social Security Act

March 13, 2020

Pursuant to Section 1135(b) of the Social Security Act (the Act) (42 U.S.C. § 1320b-5), I, Alex M. Azar II, Secretary of Health and Human Services, hereby waive or modify the following requirements of titles XVIII, XIX, and XXI of the Act and regulations thereunder, and the following requirements of Title XI of the Act, and regulations thereunder, insofar as they relate to Titles XVIII, XIX, and XXI of the Act, but in each case, only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services, to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid and CHIP programs and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of these requirements as a result of the consequences of the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse:

Certain conditions of participation, certification requirements, program participation or similar requirements for individual health care providers or types of health care providers, including as applicable, a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services, and pre-approval requirements.

Requirements that physicians or other health care professionals hold licenses in the State in which they provide services, if they have an equivalent license from another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area).

Sanctions under section 1867 of the Act (the Emergency Medical Treatment and Labor Act, or EMTALA) for the direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency for the COVID-19 pandemic.

Sanctions under section 1877(g) (relating to limitations on physician referral) under such conditions and in such circumstances as the Centers for Medicare & Medicaid Services determines appropriate.

Limitations on payments under section 1851(i) of the Act for health care items and services furnished to individuals enrolled in a Medicare Advantage plan by health care professionals or facilities not included in the plan’s network.

Pursuant to Section 1135(b)(7) of the Act, I hereby waive sanctions and penalties arising from noncompliance with the following provisions of the HIPAA privacy regulations: (a) the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510); (b) the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and (c) the patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522); but in each case, only with respect to hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect.

Pursuant to Section 1135(b)(5), I also hereby modify deadlines and timetables and for the performance of required activities, but only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services, to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid and CHIP programs and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of these requirements as a result of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse.

These waivers and modifications will become effective at 6:00 P.M. Eastern Standard Time on March 15, 2020, but will have retroactive effect to March 1, 2020, nationwide, and continue through the period described in Section 1135(e). Notwithstanding the foregoing, the waivers described in paragraph 2 above are in effect for a period of time not to exceed 72 hours from implementation of a hospital disaster protocol but not beyond the period described in Section 1135(e). The waivers described in paragraphs 1(c) and 2 above are not effective with respect to any action taken thereunder that discriminates among individuals on the basis of their source of payment or their ability to pay.

The waivers and modifications described herein apply in the geographic area covered by the President’s proclamation, pursuant to the National Emergencies Act, on March 13, 2020, that the COVID-19 outbreak in the United States constitutes a national emergency; and my January 31, 2020, determination, pursuant to section 319 of the Public Health Service Act, that a public health emergency as a result confirmed cases of 2019 Novel Coronavirus, exists and has existed since January 27, 2020, nationwide.”

As contained in the above text, the Secretary’s action also relieves hospitals from penalties under the HIPAA regulations around such requirements as ensuring that patients receive HIPAA-related privacy notifications, as hospitals move forward under emergency conditions.

After Vice President Pence had referenced the HHS regulatory relaxation, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services (CMS) stated that HHS and CMS were recommending that all non-urgent elective surgeries in the United States be postponed for the moment. “Yesterday, the President made a very important announcement about telehealth,” Verma said. “We’re also making sure the healthcare system is prepared” to manage the COVID-19 pandemic. The reality is, the stakes are high, and we need to preserve PPE”—stocks of personal protective equipment, including masks and gowns. “We’ve put out guidelines over the last two weeks [designed to help us ]save those N-95s”—the N-95 respirators and surgical masks—"for the most important situations.”

And, related to that, Verma said, “We are going to be sharing detailed recommendations to promote this needed conservation, specifically by eliminating non-essential elective medical and surgical procedures, including dental procedures. We believe this will allow providers to prioritize” which procedures must go forward to care for those with the coronavirus and the other patients with the most urgent conditions and situations. “We urge providers and clinicians and patients to seriously consider these recommendations,” Verma said. “It will not only preserve equipment… but it will also protect patients from potential infection.”

And, Verma said, “I want to thank the medical societies such as the American College of Surgeons and American Dental Association, that have taken proactive approach, by putting these recommendations on their websites.”

In that regard, as Verma referenced, yesterday, the Chicago-based American College of Surgeons (ACS) posted new “COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures” on its website.

The ACS wrote, “In response to the rapidly evolving challenges faced by hospitals related to the Coronavirus Disease 2019 (COVID-19) outbreak, and broad calls to curtail “elective” surgical procedures, the American College of Surgeons (ACS) provides the following guidance on the management of non-emergent operations. It is not possible to define the medical urgency of a case solely on whether a case is on an elective surgery schedule.”

Further, the society noted, “While some cases can be postponed indefinitely, the vast majority of the cases performed are associated with progressive disease (such has cancer, vascular disease and organ failure) that will continue to progress at variable, disease-specific rates. As these conditions persist, and in many cases, advance in the absence of surgical intervention, it is important to recognize that the decision to cancel or perform a surgical procedure must be made in the context of numerous considerations, both medical and logistical. Indeed, given the uncertainty regarding the impact of COVID-19 over the next many months, delaying some cases risks having them reappear as more severe emergencies at a time when they will be less easily handled.”

The entire text of the ACS’s guidance can be found here.

Meanwhile, on its website, the Chicago-based American Dental Association (ADA) posted a similar kind of guidance on its website, under the heading, “ADA Calls Upon Dentists to Postpone Elective Procedures.” The ADA wrote that “The American Dental Association (ADA) recognizes the unprecedented and extraordinary circumstances dentists and all health care professionals face related to growing concern about COVID-19. The ADA is deeply concerned for the health and well-being of the public and the dental team. In order for dentistry to do its part to mitigate the spread of COVID-19, the ADA recommends dentists nationwide postpone elective procedures for the next three weeks,” the ADA wrote. “Concentrating on emergency dental care will allow us to care for our emergency patients and alleviate the burden that dental emergencies would place on hospital emergency departments.”

The statement added that, “As health care professionals, it is up to dentists to make well-informed decisions about their patients and practices. The ADA is committed to providing the latest information to the profession in a useful and timely manner. The ADA is continually evaluating and will update its recommendation on an ongoing basis as new information becomes available. Please visit ADA.org/virus for the latest information.”