COVID-19 Regulatory Update – 4/6/2020April 6, 2020 Report on Medicare Compliance Vol. 29, Num 13 COVID-19 Waivers, New Rule Clear Regulatory, Audit Decks; Reviews Will Come in Time By Nina Youngstrom Attorney Ann McCullough has clients who are turning medical office buildings into COVID-19 screening sites and enrolling ambulatory surgery centers in Medicare as hospitals, all with CMS's blessing, which was unthinkable a few weeks ago within the existing regulatory framework. But a slew of blanket waivers[1] announced March 30 under Sec. 1135 of the Social Security Act[2] -the second round of waivers since the coronavirus took hold-will clear the regulatory brush that slows patient testing and treatment until the pandemic ends. "CMS issued very sweeping blanket waivers. For hospitals specifically, the waivers provide very temporary flexibility for space, for the workforce and for paperwork," said McCullough, with Polsinelli in Denver, Colorado. CMS also issued an interim final regulation[3] to suspend regulatory requirements that overlap with the waivers but require activation by regulation because they're payment related, said attorney Andy Ruskin, with Morgan Lewis in Washington, D.C. The waivers and related activity cover an astounding amount of ground, including aspects of the patient discharge regulations, documentation, the Emergency Medical Treatment and Labor Act (EMTALA), enrollment and licensure, and the Stark Law (see story, p. 1),[4] to name a few. In addition to the waivers, CMS informally freed hospitals from distractions in their battle against the pandemic. For example, CMS suspended most fee- for-service audits and additional documental requests, according to answers to frequently asked questions about COVID-19 provider burden relief.[5] Notwithstanding the reprieve, hospitals must keep their eyes on compliance, attorneys said. "I don't think you can throw normal compliance procedures to the winds," said attorney Jim Boswell, with King & Spalding in Atlanta, Georgia. Some Sec. 1135 waivers must be viewed side by side with state requirements, including waivers that apply to personnel, what locations are eligible to provide services and what services can be provided where consistent with state pandemic plans, he said. "One difficult and somewhat intricate part of this is figuring out the relationship between federal and state regulations of facility licensure and the licensure of personnel," Boswell said. "It requires checking two boxes." And hospitals and other providers don't have a pass on compliance with billing, coding and medical necessity requirements during the public health emergency. "Because there are no audits doesn't mean the care being provided is not subject to audits at a future date," said Ron Hirsch, M.D., vice president of R1 RCM. CMS Allows Hospitals Without Walls After HHS declared a public health emergency in January and President Trump declared a national emergency March 13, CMS started issuing blanket waivers. They apply to all providers and suppliers, who don't have to ask permission to use them. CMS gave hospitals a lot of latitude to use nonhospital space to screen and treat hospital patients during the coronavirus pandemic, McCullough said. The blanket waivers allow "hospitals without walls," for one thing. "CMS is providing additional flexibilities for hospitals to create surge capacity by allowing them to provide room and board, nursing, and other hospital services at remote locations or sites not considered part of a healthcare facility such as hotels or community facilities," the waiver document states. "This flexibility will allow hospitals to separate COVID-19 positive patients from other non-COVID-19 patients to help efforts around infection control and preservation of personal protective equipment (PPE)." CMS also relaxed certain conditions of participation to allow ambulatory surgery centers to temporarily enroll as hospitals. The March 30 interim final rule clears the way for hospitals to provide routine services to patients outside hospitals, Ruskin said. While waivers only set aside the conditions of participation, the regulation was necessary to create an avenue for hospitals to get paid for providing services in alternate sites, such as hotels, "under arrangements," he explained. "What hospitals are trying to do now is team up with anyone to find beds in the community," he said. "They still have to provide oversight over the care they provide to patients outside the hospital." Hospitals should be prudent with the license they have. "The guardrails are so vague and broad at this point," Ruskin said. "Because not every town will have a surge, they need to document everything." Otherwise, CMS may question whether the waiver applies to a hospital. For example, the hospital would document it had a 20% surge of patients and is already at 90% capacity before services are provided under arrangements outside the hospital. Don't Worry About Condition Code 44 CMS also has waived the utilization review (UR) condition of participation, which requires hospitals to have a UR plan and committee, which reviews hospital admissions and length of stay. "People may think this is carte blanche to admit every patient as an inpatient, but that's not the case," Hirsch said. "You still have to follow the two-midnight rule." What the waiver accomplishes, however, is freeing physicians to focus on the pandemic by making admission decisions without worrying about UR committee oversight until much later, as long as they have a physician order to change patient status to observation. "There's no need for condition code 44 temporarily," Hirsch said. "You don't need to find a UR physician or notify the patient in writing. You just need to get the status changed." One caveat: Hirsch noted that changing status is a patient rights issue, and the ground has shifted overnight because of a March 24 federal court decision[6] giving Medicare patients the right to appeal a change in status from inpatient to observation. Also, when status is changed, hospitals still must give patients the Medicare Outpatient Observation Notice (MOON) if more than 24 hours of observation services elapse. Although CMS said hospitals can be creative in the ways they deliver the MOON and other Medicare notices to patients with suspected or confirmed cases of COVID-19, there is no waiver for delivering the forms. CMS also waived the patient choice part of the discharge planning regulation. While the public health emergency is in effect, hospitals don't have to give patients a list of post-acute care (PAC) providers, including home health agencies and skilled nursing facilities (SNFs), or provide quality data and resource use about them. "This is especially crucial now when we are seeing so many SNFs severely limiting who they will take into their facilities,"[7] Hirsch said. Although it's a blanket waiver, he thinks hospitals should give patients a list of PAC providers until they are affected by COVID-19. Giving Patients Over Paperwork Whole New Meaning There also are waivers of certain documentation requirements. For example, during the public health emergency, CMS waived the requirement for authentication of verbal orders within 48 hours and completion of medical records within 30 days of the patient's discharge. There are also waivers related to "the organization and staffing of the medical records department, requirements for the form and content of the medical record, and record retention requirements, and these flexibilities may be implemented so long as they are not inconsistent with a state's emergency preparedness or pandemic plan." CMS has been reducing documentation and other burdens in the past three years with its Patients over Paperwork initiative, but this is in another league. "They have really stepped up to the plate," said Kathy Reep, senior manager of PYA and former vice president of financial services at the Florida Hospital Association. "It doesn't mean we don't have to go back and do them when this is all over, but at least they're waived for now." Waivers Clear Licensing, Privileging Hurdles The blanket waivers pave the way for hospitals to expand their workforce to deal with the surge of COVID-19 patients. For one thing, CMS swept away its requirement for Medicare patients to be under the care of a physician so hospitals can make the most of other practitioners. "That struck me as particularly significant to say that, temporarily, Medicare patients don't necessarily have to be under the care of a physician," Boswell said. CMS also waived requirements to let physicians "whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval to address workforce concerns related to COVID-19." Certain details of the credentialing and privileging process also were waived. There's also a broad waiver for critical access hospitals (CAHs). "CMS is deferring to staff licensure, certification, or registration to state law by waiving 42 C.F.R. § 485.608(d) regarding the requirement that staff of the CAH be licensed, certified, or registered in accordance with applicable federal, state, and local laws and regulations," the waiver said. Some workforce waivers have been tailored to teaching hospitals, said Reep. There's a waiver that allows teaching physicians to perform services with medical residents through audio/video real-time communications technology,[8] although it doesn't apply for surgical, high-risk, interventional or other complex procedures; services performed through an endoscope; and anesthesia services. Updated EMTALA Memo Sheds Light on Waiver Although the list of blanket waivers includes enforcement of EMTALA, "it's not a complete waiver of EMTALA," McCullough said. "There are still guidelines hospitals have to follow." CMS is waiving enforcement to "allow hospitals, psychiatric hospitals, and CAHs to screen patients at a location offsite from the hospital's campus to prevent the spread of COVID-19, so long as it is not inconsistent with a state's emergency preparedness or pandemic plan." To better understand exactly what's waived, McCullough points hospitals to CMS's memo on EMTALA to state surveyors,[9] which was updated March 30. For example, hospitals are permitted to set up alternative screening sites on campus, and whether patients are seen there or in the emergency department (ED), "they should be logged in where they are seen. Individuals do not need to present to the ED, first, and if they do present to the ED, they may still be redirected to the on- campus alternative screening location for logging and subsequent screening." Some hospitals are using drive- through sites to test patients for the coronavirus, and the waiver protects them from EMTALA sanctions, McCullough said. But patients who have an emergency medical condition must be returned to the main hospital for stabilization. Contact Ruskin at [email protected], Hirsch at [email protected], Boswell at [email protected], McCullough at [email protected] and Reep at [email protected].
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