Dorsey Health Law

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed regulations as part of the Regulatory Sprint on areas that have historically been viewed as barriers to innovative care coordination arrangements—namely, healthcare fraud and abuse and health information privacy. On November 20, 2020, the HHS Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) each issued a sweeping set of final regulations that introduced significant new value-based terminology, safe harbors and exceptions, as well as clarifications of existing requirements, under the federal anti-kickback statute (“AKS”) and federal physician self-referral law (“Stark Law”), respectively. Additionally, the OIG issued final regulations related to modernizing the civil monetary penalty law governing inducements provided to Medicare and Medicaid beneficiaries (the “CMPL”).  The final OIG and CMS rules are effective on January 19, 2021, with the exception of changes to the Stark “group practice” definition, which do not go into effect until January 1, 2022.  There are hundreds of pages of preamble guidance and revised regulation text setting forth these sweeping changes to the Stark Law, AKS and CMPL regulations from CMS and OIG.  To help you digest these materials, a team of attorneys from Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group has published two white papers, which are available at the links below.  In addition, we have posted at a link below the playback of a webinar we hosted about the final rules on January 6, 2021.  The white papers and webinar playback provide an in-depth summary of the changes to these regulations, including key provisions from CMS and OIG preamble guidance.  Finally, we have posted below redlines comparing the existing Stark Law, AKS and CMPL regulations to the revised version of each of these regulations in the final rules. With respect to health information privacy, the HHS Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) on December 10, 2020 which proposes changes to the Health Insurance Portability and Accountability Act (“HIPAA”) and to the Health Information Technology for Economic and Clinical Health Act (“HITECH”) Privacy Rule.  Additionally, the HHS Substance Abuse and Mental Health Services Administration (“SAMHSA”) published final rules to revise regulations related to the privacy of substance use disorder treatment records in July 2020. These changes in federal regulations are anticipated to make a significant impact on healthcare providers and other stakeholders that may have been reticent to initiate certain care coordination arrangements because of perceived regulatory barriers and lack of regulatory clarity.  In addition, clarifications to existing regulations impact stakeholders beyond their involvement in care coordination arrangements. The team of attorneys in Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group will continue to closely monitor these changes, and post updates and analysis below as new information becomes available.   Stark Regulatory Changes Effective January 1, 2022 Require Modifying Certain Group Practice Compensation Methodologies | News & Resources Webinar Playback: Final Stark and Anti-Kickback Statute Rules: What You Need to Know White Paper: Understanding the Final Rules to Revise the Stark Law Regulations White Paper: Understanding the Final Rules to Revise the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations The Regulatory Sprint Catches up to HIPAA: New Proposed HIPAA Rules Redline of Final AKS Regulatory Text Redline of Final CMP Regulatory Text Redline of Final Stark Regulatory Text effective 1.1.2022 - 411.352(i) only Redline of Final Stark Regulatory Text effective 1.19.2021 Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care” CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates Sweeping Proposals Issued by CMS to Revise Stark Law Regulations  Sweeping Proposals Issued By OIG To Make Changes To The Anti-Kickback Statute Safe Harbors And Add An Exception To The Civil Monetary Penalty Law Governing Beneficiary Inducements A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process CMS "Actively Working" on Stark Law Reforms to be Issued Later this Year; "Regulatory Sprint to Coordinated Care" Continues OIG Seeks Public Input on Anti-Kickback Statute and Beneficiary Inducements CMP as part of the “Regulatory Sprint to Coordinated Care” Calls for Modernizing the Stark Law Continue; CMS Seeks Public Input on Stark Law Reforms

On January 18, 2021, a lawsuit was filed against the U.S. Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) challenging a CMS policy change dating back to 2017.  The plaintiffs, the National Consumer Voice for Quality Long-Term Care and the California Advocates for Nursing Home Reform, are non-profit consumer advocacy groups for long-term care.  The policy at the heart of the lawsuit concerns a change CMS made as to how civil monetary penalties (“CMP”) are imposed against nursing facilities. As a bit of background, under the Nursing Home Reform Act of 1987 (NHRA), Congress created a scheme whereby CMS and the states shared responsibility for ensuring states meet federal quality and safety standards of resident care for residents in nursing facilities.  Under this scheme, state agencies regularly evaluate a nursing facility’s compliance with the requirements by conducting periodic surveys, often unannounced. The survey findings would then be reported to the CMS regional offices (“RO”) with recommended enforcement actions.  Acting on the survey results and the recommendation from the state agency, the ROs would then impose per-day CMPs on facilities for past noncompliance with federal standards. The 2017 change, however, made clear that ROs, regardless of findings and recommendations from state survey agencies, are to impose a CMP for past noncompliance based only on each instance of noncompliance that occurred but was corrected before the state survey is conducted.  “Past noncompliance” is a statutorily defined term which means those situations in which a state finds that a nursing facility meets all of the federal requirements “but, as of a previous period, did not meet such requirements.”  With this 2017 policy change, if a facility has corrected that noncompliance just before the survey team shows up at the facility, even if the noncompliance had lasted months, then the facility would not be penalized for each day of noncompliance but rather, would receive a “per instance” CMP. The plaintiffs in the recently filed litigation argue that, by announcing to the state survey agencies that its ROs will assess CMPs only for each instance of past noncompliance and not for each day of past noncompliance, CMS’ policy change effectively contravenes Congress’ express intent to give the states the direction to recommend (and CMS the discretion to impose) a per-day CMP for past noncompliance. The complaint alleges that the plaintiffs have been adversely impacted by this change. Per instance CMPs currently range in amount, as adjusted for inflation, from a minimum of $2,233 to a maximum of $22,320 for each instance of noncompliance. 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3. Taking the example of a non-immediate jeopardy deficiency, the maximum per-instance CMP that a nursing facility faces for this type of deficiency is $22,320, regardless of whether the facility has allowed the deficiency to remain uncorrected for one day, one week, or one month. By contrast, the maximum per day CMP for this type of deficiency begins to exceed, and quickly dwarfs, the maximum per instance CMP whenever the facility has allowed the deficiency to remain uncorrected for four or more days (4 x $6,695 = $26,780). The plaintiffs argue that the imposition of only per instance CMPs for past noncompliance will thus encourage nursing facilities to knowingly allow deficiencies to linger for days, weeks, or even months, until the next state survey, because the penalty will be the same regardless of whether the deficiency persisted for a day or a month.  As long the facility remedies the deficiency before the next survey (usually 12-15 months apart), the facility can only be fined the per instance maximum of $22,320. The human impact of this, as argued in the lawsuit, is that for each day a facility permits a deficiency to persist, whether it be for one week or a number of months, the residents at that facility may be endangered by the deficiency. As a result, the plaintiffs assert that if facilities do not fear the monetary penalties, they will be less inclined to make their facilities safe for residents. Certainly, nursing facilities across the country will see it very differently from the plaintiffs in the litigation.  Because surveys are unannounced, facilities do not “let down their guard” and intentionally allow the facilities to become less safe simply because they know they will be assessed a per instance penalty instead of a per day penalty.  Rather, the possibility of getting a per instance CMP (as opposed to a per day penalty) would be an incentive for nursing facilities to identify and correct issues immediately so that such issues will be identified as past noncompliance when the state survey agency does come knocking.  While there may be some bad actors out there, most nursing facilities are doing all that they can to avoid noncompliance. In other words, facilities’ actions and decisions are not based upon whether they would rather have a per day versus a per instance penalty. It is also notable that, while the litigation mentions the COVID-19 pandemic, it does not mention the enhanced CMPs that are now available for infection control violations.  CMS has been aggressively using these enhanced CMPs to impose large per instance and large per day CMPs for relatively low-level transgressions. For example, having one employee make an error on his/her mask wearing or daily documentation regarding COVID-19 symptoms (even if it does not lead to any adverse consequences) can result in a $15,000 CMP if the facility had any infection control deficiency in the last two years.  A surveyor may see a staff member not following the requirements every time (e.g. not wiping down the face shield after they sit it down for a few seconds, letting their mask fall below their nose, etc.) and may assess severe penalties as a result.  While most facilities would agree that infection control is important, these penalties are excessive, especially taking into account they are assessed for some of the more minor and isolated events that may occur. Facilities should be cognizant of this litigation and the views expressed by the organizations seeking to change the CMP landscape to be harsher than it is now.  CMS has already shown its willingness to increase the CMP levels for infection control purposes, and they may seek to expand such penalties on a more permanent basis. If you have any questions about any of the topics addressed in this post, please contact the authors or any member of the Dorsey & Whitney Health Transactions & Regulations Practice Group.

In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect.  These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes to the Stark Law and AKS in a decade.  There are hundreds of pages of preamble guidance and revised regulation text setting forth these sweeping changes from the Centers for Medicare & Medicaid Services (“CMS”) and HHS Office of Inspector General (“OIG”). To help you digest these materials, a team of attorneys from Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group has published two white papers, which are available at the following links: White Paper: Understanding the Final Rules to Revise the Stark Law Regulations White Paper: Understanding the Final Rules to Revise the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations These white papers provide an in-depth summary of the changes to these regulations, including key provisions from CMS and OIG preamble guidance.  Please contact the authors or your regular Dorsey attorney if you would like assistance with understanding how the final rules impact your organization.

The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements.  The final rule also modifies various aspects of Medicare reimbursement methodologies for health plans, physicians, and other providers.  This post summarizes each of these regulatory changes, which are effective as of September 2, 2020. New Enforcement Requirements for COVID-19 Related Data Reporting To assist public health officials in detecting and tracking COVID-19 outbreaks and save lives, CMS is adding new reporting requirements for healthcare facilities along with expanded CMS enforcement authority to ensure compliance with such reporting requirements. The Interim Final Rule addresses reporting and related enforcement for three general categories of healthcare entities: long term care (LTC) facilities, hospitals and critical access hospitals (CAHs), and laboratories. A. LTC Facilities Under CMS regulations issued in May, LTC facilities are required to electronically report COVID-related data to the Centers for Disease Control and Prevention (CDC) on a weekly basis. Facilities must report a variety of information, including suspected and confirmed COVID-19 infections among residents and staff, the number of COVID-19 resident and staff deaths, the personal protective equipment and hand hygiene supplies in the facility, and more. The Interim Final Rule allows CMS to impose civil money penalties (“CMPs”) if a LTC facility fails to submit its weekly report.  CMS may impose a minimum of $1,000 for an initial violation. For every subsequent time the facility fails to report the required data, the CMP imposed will increase by $500, up to a maximum of $6,500.  For example, a facility that fails to report for two consecutive weeks will be subject to a minimum CMP of $2,500: $1,000 for the first week and $1,500 for the second week. CMS waived the normal notice-and-comment process due to the urgent need to track and contain COVID-19 infection outbreaks. LTCs are subject to these new penalties for reporting failures effective September 2, 2020, and the penalties will continue to be in effect for up to one year beyond the end of the COVID-19 public health emergency (“PHE”). B. Hospitals and CAHs The Interim Final Rule also makes daily reporting of COVID-related data a Condition of Participation in the Medicare and Medicaid programs for hospitals and CAHs. To support broader surveillance of the spread of COVID-19, CMS will require hospitals and CAHs to report certain COVID-related information to the Department of Health and Human Services (“HHS”) daily, through a standardized format specified by HHS, set forth here. CMS does not have authority to impose CMPs on hospitals or CAHs who fail to provide this reporting. However, should a hospital or CAH fail to consistently report test results throughout the duration of the PHE, it will be non-compliant with the hospital and the CAH Conditions of Participation set forth at 42 CFR §§ 482.42(e) and 485.640(d), respectively, and consequently subject to CMS termination of its Medicare provider agreement. C. Laboratories Additionally, the Interim Final Rule modifies the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) to require all laboratories to report SARS-CoV-2 test results within 24 hours of a positive test result. Reports must be made throughout the PHE, as specified here.  If a laboratory fails to submit SARS-CoV-2 test results as required under the CLIA modifications, the Department of Health and Human Services may impose CMPs or other penalties on the laboratory. CMS states that CMPs for reporting violations will be $1000 for the first day of noncompliance, and $500 for each subsequent day the laboratory fails to report SARS-CoV-2 test results. The applicable statute allows for the imposition of CMPs of up to $10,000 for each violation. LTCs Must Test Residents and Staff for COVID-19 In addition to reporting COVID-related data, LTCs are required under the new rule to test their facility residents and staff for COVID-19.   Testing includes not only staff employees, but volunteers and those providing services under arrangements at the facility.  Testing must be conducted in a manner consistent with current professional standards of practice for COVID testing.   Documentation of testing and resulting must be provided in staff personnel records, and in resident medical records. CMS has published additional guidance here that addresses testing frequency, types of testing that should be conducted, and guidance on handling staff who refuse testing, among other topics. Limitation on Medicare Coverage of COVID-19 Testing Without an Order In a prior Interim Final Rule with Comment Period, CMS expanded coverage for COVID-19 testing for Medicare beneficiaries by eliminating the need for an order from a treating physician or other practitioner. CMS has now revised this policy, citing fraud and abuse concerns and clinical concerns that beneficiaries are receiving too many COVID-19 tests without medical attention and oversight.  Consequently, beginning September 2 and continuing for the duration of the PHE, Medicare will cover only one (1) COVID-19 diagnostic test without the order of a physician or other practitioner.   A single otherwise covered laboratory test each for influenza or a similar respiratory condition needed to obtain a final COVID-19 diagnosis, when performed in conjunction with a COVID-19 test, will also be covered.  Medicare will cover additional COVID-19 tests only with the order of a physician or other practitioner. Any COVID-19 test(s) that a beneficiary received prior to September 2, 2020 is disregarded for purposes of this new single COVID-19 test coverage rule. CMS points out that this coverage rule applies to the Medicare program only; COVID-19 testing coverage policies for group health plans, health insurance issuers, and other public programs must comply with applicable law. CMS is also allowing pharmacists and other practitioners allowed to order laboratory tests in accordance with state scope of practice and other laws to fulfill the requirements related to orders for covered COVID-19 tests for Medicare patients. Quality Reporting: Updates to the Extraordinary Circumstances Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in Response to the PHE for COVID-19, and Update to the Performance Period for the FY 2022 SNF VBP Program Early in the PHE, CMS granted several “Extraordinary Circumstances Exceptions” (“ECEs”) which relieved facilities of certain data collection and reporting obligations so that more time and resources could be directed to patient care. CMS used such data reporting to score certain program performance, resulting in adjustments of Medicare payments pursuant to certain value-based and quality-related features of Medicare reimbursement methodologies.  CMS states that, although it was gathering data on these programs, it has concerns about the national comparability of data due to the geographic differences of COVID-19 incidence rates and hospitalizations and the impacts of varying state and local laws and policy changes implemented in response to COVID-19. Therefore, the Department proposes updating the ECEs it granted for the following value-based purchasing programs: The End-Stage Renal Disease Quality Incentive Program (ESRD QIP); The Hospital-Acquired Condition (HAC) Reduction Program; The Hospital Readmissions Reduction Program (HRRP); and The Hospital Value-Based Purchasing (HVBP) Program. Under the updated ECEs, CMS will only score data that was voluntarily reported for the fourth quarter of calendar year 2019. Further, CMS will exclude all data reported for the first or second quarter of calendar year 2020, due to the significant and variable impacts COVID-19 had on facilities during this period. In addition, the Interim Final Rule updates the performance period for the fiscal year 2022 SNF VBP Program, because CMS believes that the current measurement periods would not produce reliable results for measuring SNF quality of care as determined by hospital readmission rates.  The measurement periods are changing from October 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020 to April 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020. NCD Procedural Volumes for Facilities and Practitioners to Maintain Medicare Coverage The Interim Final Rule acknowledges that, because of the PHE, far fewer non-essential procedures have been performed over the past several months. As a result, hospitals and practitioners may not be able to meet certain procedural volume requirements that are set forth in certain national coverage determinations (“NCDs”), including: NCD 20.34 Percutaneous Left Atrial Appendage Closure (LAAC). NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR). NCD 20.33 Transcatheter Mitral Valve Repair (TMVR). NCD 20.9.1 Ventricular Assist Devices (VADs). Typically, failure to meet the procedural volume requirements would prevent Medicare payment for those categories of procedures.  However, CMS will not enforce the procedural volume requirements contained in the four above-noted NCDs because of disruptions caused by the PHE. This waiver of enforcement only applies to facilities and practitioners that had met the volume requirements prior to the PHE for COVID-19. All other non-volume based coverage requirements under these NCDs remain in effect. Merit-Based Incentive Payment System (MIPS) Updates CMS is making changes to the Merit-Based Incentive Payment System (“MIPS”) for physicians and other clinicians, to reflect the manner in which Medicare beneficiaries are receiving primary care services during the PHE.  For the 2020 MIPS performance year and any subsequent performance year that starts during the PHE, CPT and HCPCS codes for communications technology-based services and telephone evaluation and management services are to be included in the definition of primary care services under MIPS.  This will allow those remote services to be included in CMS determinations of where Medicare beneficiaries receive a plurality of their primary care services for purposes of MIPS beneficiary assignment to physicians and other clinicians. CMS is also modifying one of the Improvement Activities in MIPS relating to COVID-19 clinical trial participation, so that clinicians can receive credit under this Improvement Activity not only for participating in a COVID-19 clinical trial, but also for participating in the care of patients diagnosed with COVID-19 and simultaneously submitting relevant clinical data to a clinical data registry for ongoing or future COVID-19 research. Recognizing Temporary Premium Credits as Premium Reductions CMS previously adopted policies allowing health insurance issuers offering health insurance coverage in the individual and small group markets on the American Health Benefit Exchanges established under The Patient Protection and Affordable Care Act (Pub. L. 111-148) to grant temporary premium credits for individuals and small businesses that may be struggling to pay premium during the PHE.  In this Interim Final Rule, CMS makes a number of technical changes and clarifications to ensure that health plan premium reporting takes into account any premium credits granted, including for purposes of medical loss ratio (MLR) reporting and rebates. Part C and Part D Health Plan Star Ratings Finally, CMS made changes to the Star Rating system for Medicare Part C and Part D health plans.  The Star Rating system allows CMS to publish comparative information to beneficiaries about Medicare Advantage and Medicare Part D health plans, and is the basis for determining quality bonus payments to Medicare Advantage plan, as well as beneficiary rebates. CMS currently excludes certain scores within the Stark Rating system if a plan has 60 percent or more of its enrollees living in a Federal Emergency Management Agency (FEMA)-designated Individual Assistance area.  Because of the PHE, the maintenance of this rule would remove almost all plans from those scoring metrics.  Consequently, CMS is removing that 60 percent rules for the 2022 Star Ratings (for which 2020 is the measurement year) to avoid having to exclude the vast majority of plans from the methodology. This recent Interim Final Rule clearly indicates that CMS wants to ensure consistent reporting of COVID-19 related data from laboratories, hospitals and long term care facilities.  It also illustrates the profound and widespread degree to which the PHE continues to impact Medicare reimbursement methodologies and systems. If you have any questions about the Interim Final Rule or any of the topics addressed in this post, please contact the authors or any member of the Dorsey & Whitney Health Transactions & Regulations Practice Group.

As we described in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published multiple COVID-19 Blanket Waivers for Health Care Providers. CMS announced another round of Blanket Waivers on April 30, which are available here. These waivers provide additional flexibility to health care providers responding to the COVID-19 pandemic by expanding access to telehealth services and giving providers and facilities relief from many reporting and audit requirements so they can focus on patient care. The following is a summary of the new Blanket Waivers available to providers. These Blanket Waivers are retroactively effective back to March 1, 2020 and will continue through the end of the emergency declaration. Flexibility for Medicare Telehealth Services Eligible Practitioners CMS is expanding the types of health care practitioners who may be reimbursed for providing Medicare telehealth services to all practitioners who are eligible to bill Medicare for non-telehealth services. Thus, physical therapists, occupational therapists, speech language pathologists, and others may now furnish and receive reimbursement for Medicare telehealth services. Audio-Only Telehealth for Certain Services CMS is now permitting more services to be provided by audio-only technology. Several evaluation and management services, behavioral health counseling, and educational services no longer require a two-way, real-time interactive communication between the patient and practitioner. For a list of billing codes for these audio-only services, please review the CMS list of Medicare telehealth services, available here. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Certain Staffing Requirements In an effort to address potential staffing shortages, CMS is waiving the requirement that certain practitioners (NP, PA, or certified nurse-midwife) be available to furnish patient care services at least 50 percent of the time a Rural Health Clinic operates. However, a physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical psychologist must still be available to furnish patient care services at all times the Rural Health Clinic operates. Long-Term Care Facilities and Skilled Nursing Facilities (SNFs) and/or Nursing Facilities (NFs) Quality Assurance and Performance Improvement (QAPI) CMS is modifying QAPI program requirements to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This will help ensure facilities focus on aspects of care delivery most closely associated with COVID-19 during the PHE. In-Service Training Nursing assistants will now have more time to complete their required 12 hours of in-service training. CMS has extended the deadline for completing this training until the end of the first full quarter after the declaration of the PHE concludes. Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities In order to help long-term care facilities expedite the discharge and movement of residents among care settings, CMS is waiving the discharge planning requirement that facilities must assist residents and their representatives in selecting a post-acute care provider using data such as standardized patient assessment data, quality measures, and resource use. All other discharge planning requirements remain in place. Clinical Records Long-term care facilities may now take ten working days to provide a resident a copy of their records after requested. Previously, facilities were required to provide a copy within two working ways when requested by the resident. Home Health Agencies (HHAs) Training Requirement for Home Health Aides Medicare conditions of participation for HHAs state that each Home Health Aide must receive 12 hours of in-service training every 12 months. To give both aides and the nurses that provide the training more time to perform patient care, this training requirement is postponed, and the new deadline for aide in-service training is the end of the first full quarter after the declaration of the PHE concludes. Detailed Information for Discharge Planning The requirement to provide patients with detailed information regarding discharge planning in selecting a post-acute care provider (such as quality and resource use measures of potential providers) is temporarily waived during the PHE. All other discharge planning requirements remain applicable. Clinical Records HHAs may take ten business days to provide a patient with copies of their medical records, instead of four business days. Hospice Training Requirement for Home Health Aides Hospice conditions of participation requiring the annual assessment and in-service training and education of all individuals furnishing care is postponed until the end of the first full quarter after the declaration of the PHE concludes. HHAs and Hospice Onsite Supervisory Visits For both HHAs and Hospices, the condition of Medicare participation that requires a registered nurse (or for HHA any other appropriate skilled professional) to make an annual onsite supervisory visit for each aide is postponed. Postponed onsite assessments must be completed no later than 60 days after the expiration of the PHE. Quality Assurance and Performance Improvement (QAPI) To allow HHAs and Hospices to focus on COVID-19 effort, the requirement that HHAs and Hospices maintain an effective, ongoing, data-driven QAPI program is modified to narrow the scope of the mandated QAPI program to infection control issues. Remaining QAPI activities should focus on adverse events. Ambulatory Surgical Centers (ASCs) Medical Staff During the PHE, CMS is waiving the ASC conditions of coverage requiring ASCs to periodically reappraise medical staff privileges. This will allow physicians whose privileges will expire to continue practicing at the ASC without the need for reappraisal. Community Mental Health Centers (CMHCs) Quality Assurance and Performance Improvement (QAPI) While maintaining the general requirement that CMHCs maintain an effective, ongoing, data-driven QAPI program, CMS is waiving the specific detailed requirements for QAPI program organization and content to provide flexibility for CMHCs to focus QAPI resources on circumstances that arise during the PHE. CMHC modifications to QAPI programs must be consistent with a state’s emergency preparedness or pandemic plan. Home Services CMS is waiving the prohibition on CMHCs providing partial hospitalization services and other CMHC services in an individual’s home. This will allow clients to safely shelter in place during the PHE while receiving needed care and services from the CMHC. CMHCs must still assess client needs, implement and update each client’s individualized active treatment plan, and promote client rights, including a client’s right to file a complaint. 40% Rule To promote access to services, the requirement that CMHCs provide at least 40% of their items and services to individuals who are ineligible for Medicare benefits is waived. Physical Environment for Multiple Providers/Suppliers Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS is waiving the following physical environment requirements for Hospitals, CAHs, inpatient hospices, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. Requirements to maintain facilities and equipment to ensure an acceptable level of safety and quality are temporarily modified as necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment. These facilities may adjust scheduled ITM frequencies and activities required by the applicable Life Safety Codes and Health Care Facilities Codes. The following are not included in this waiver:  Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing. Portable fire extinguisher monthly inspection. Elevators with firefighters’ emergency operations monthly testing. Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing. Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency. Requirements to have an outside window or outside door in every sleeping room are waived to permit these providers to utilize space not normally used for patient care for temporary care or quarantine. If you have any questions about the CMS Blanket Waivers, please contact the authors or your regular Dorsey & Whitney attorney. We continue to closely monitor the rapidly evolving legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog related to health law updates, available here. You can also access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here.

On March 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a memorandum describing hospitals’ continuing obligations with respect to the Emergency Medical Treatment and Labor Act (“EMTALA”) during the COVID-19 public health emergency (“PHE”). Check out our previous blog post on this topic here. Last week, in response to a growing number of questions from hospitals and critical access hospitals (“CAHs”), CMS released additional guidance in the form of frequently asked questions (“FAQs”) concerning the implications of COVID-19 on EMTALA compliance. The FAQs address questions CMS has received on a variety of topics, including patient presentation to the emergency department (“ED”), the applicability of EMTALA in different facilities, determining who is a qualified medical professional, as well as information on medical screening exams, patient stabilization, transfers, and other EMTALA-related topics. Below, we set forth a sampling of some of those questions and answers. A full list of the FAQs, covering all of the EMTALA topics CMS addressed in its FAQs, including topics not covered in this blog, can be found here. Patients Presenting to the Emergency Department Q. May hospitals place a sign outside an ED stating “COVID-19 testing is not being offered to asymptomatic patients”? A. Yes. In general, signage may be used to inform individuals about the availability of COVID-19 testing or to provide direction to alternative sites on the hospital’s campus where medical screening examinations (“MSE”) are available; for example, directing the patient to a parking lot test site for COVID-19. CMS emphasized, however, that it is a violation of EMTALA for hospitals to use signage that presents a barrier to individuals, including potential COVID-19 patients, from coming to the ED or for hospitals to otherwise refuse to provide a MSE to anyone who comes to the ED for examination or treatment. Hospitals may encourage the public to go to off-campus sites to be screened for COVID-19 instead of to the hospital. Normally, a hospital may not tell individuals who have already entered an ED to go to the off-site location for the MSE—such a redirection usually may only be to an on-campus alternative site. However, CMS has approved via a section 1135 waiver for the COVID-19 public health emergency (“PHE”) the ability to re-direct patients to an offsite location for screening, in accordance with a state emergency preparedness or pandemic plan. Q. Is a hospital’s ability to refer an individual to an alternative off-campus screening site limited strictly to those individuals with COVID-19 symptoms? A. No. CMS clarified that any patients may be redirected to an off-campus screening location to receive an MSE under the section 1135 waivers regardless of the presence of COVID-19 symptoms. For example, ambulance patients may be referred off-campus (i.e., without any off-loading or any evaluation before the referral). Public health officials, emergency medical services (“EMS”) systems, and hospitals may develop protocols, including COVID-19 protocols, governing where EMS should transport individuals for emergency care. As a reminder, for a hospital owned-and-operated ambulance operating in accordance with community-wide EMS protocols that directs the transport of individuals to a hospital other than the hospital that owns the ambulance (for example, to the closest appropriate hospital), the presenting individual is considered to have come to the ED of the hospital to which the individual is transported. The receiving hospital is subject to EMTALA at the time the individual is brought onto hospital property. Where Does EMTALA Apply? Q. Can EMTALA be relaxed to allow hospitals to refer patients to urgent care facilities? A. Hospitals may encourage the public to go to off-campus sites for COVID-19 screening instead of the hospital so long as those sites are operating in accordance with the state or local pandemic plan, are identified specifically by the hospital as the place to receive an MSE, and have the capability to provide that MSE. Additionally, CMS has approved a section 1135 waiver for the duration of the public health emergency granting hospitals the ability to re-direct patients to an off-site location. Q. What is the definition of “on campus”? A. The definition of campus can be found at 42 C.F.R. § 413.65(a)(2) and means the physical area immediately adjacent to the provider’s main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings and any other areas determined on a case-by-case basis. Per 42 C.F.R. § 489.24(b), “Hospital property” means the entire main hospital campus, including the parking lot, sidewalk, and driveway, but excluding other areas or structures of the hospital’s main building that are not part of the hospital, such as physician offices, rural health centers, skilled nursing facilities, or other entities that participate separately under Medicare, or restaurants, shops, or other nonmedical facilities. During the COVID-19 PHE, non-hospital properties, such as hotels, dormitories, and field hospitals at places like parks, are becoming extensions of hospitals, otherwise known as temporary expansion sites. This is permissible under the section 1135 waiver of the provider-based regulations at 42 C.F.R. § 413.65 and certain requirements under the Medicare conditions of participation at 42 C.F.R. § 482.41 and § 485.623. For the duration of the COVID-19 PHE, these waivers allow a hospital to establish and operate as part of the hospital any location meeting the Conditions of Participation (CoPs) for hospitals that continue to apply during the PHE. These waivers also allow a hospital to change the status of its current provider-based department locations to the extent necessary to address the needs of hospital patients as part of the state or local pandemic plan. As such, it is acceptable to triage and treat patients in these temporary expansion sites. Q: Can multiple hospitals with different Medicare provider numbers join together to establish the off-site location in accordance with the state emergency plan? If so, what EMTALA implications would result for each hospital involved? A: Yes. Temporary expansion sites may serve multiple hospitals if it is consistent with their state emergency plan. Unless the off-campus site is already a dedicated emergency department (“DED”) of a hospital, as defined under EMTALA regulations at 42 C.F.R. § 489.24(b), EMTALA requirements do not apply. If an individual being treated at a temporary expansion site needs additional medical attention on an emergent basis, the site is required, under the Medicare CoPs, to arrange referral/transfer. When multiple hospitals join to establish an off-site location, the hospitals should operate in distinct clinical spaces within the location or designate one facility that will assume responsibility for ensuring compliance with the CoPs including EMTALA requirements (if applicable). If the space is shared across multiple hospitals, CMS notes that noncompliance problems at a temporary expansion sites may implicate associated certified hospitals depending upon the type of noncompliance. Q: How does EMTALA apply if a community has exhausted its supply of beds and/or ventilators and a patient presents with an emergent condition that needs these resources for stabilization? A: Hospitals are required to provide stabilizing treatment to individuals determined to have an emergency medical condition within the hospital’s capability prior to arranging an appropriate transfer. In situations where facilities may not have the necessary services or equipment, they should provide stabilizing interventions within their capability until the individual can be transferred. For example, in cases where the hospital does not have available ventilators, establishing an advanced airway and providing manual ventilation can assist in stabilizing the individual until an appropriate transfer can be arranged. Q: If a hospital sets up an alternative off-campus testing site, is that site regulated by the hospital conditions of participation? A: Yes. Alternative care sites and temporary extension sites that are established by the hospital are still required to follow the applicable hospital CoPs to the extent not waived under the blanket waivers issued by CMS. Community testing centers established by the state would be under the state emergency and pandemic plan and are not required to meet the hospital CoPs. Qualified Medical Professionals (QMPs) Q: Has CMS removed the requirement to have a QMP, approved by the governing body, perform the MSE? A: No. QMPs responsible for performing MSEs must still be approved by the hospital’s governing body. Hospitals may request a case-by-case section 1135 waiver to allow MSEs to be performed by qualified medical staff authorized by the hospital, who are acting within their scope of practice and licensure, but are not designated in the hospital bylaws to perform the MSEs. Medical Screening Exams CMS has received a number of questions from providers regarding how MSEs may be performed in light of the COVID-19 pandemic. Q: Can emergency physicians and other health care practitioners conduct medical screening exams (MSEs) under EMTALA via telehealth? A: Yes. QMPs, including emergency physicians, can perform MSEs using telehealth equipment. The QMP may be on-campus and using technology to self-contain or offsite due to staffing shortages. The MSE may be performed solely via telehealth if clinically appropriate. If the patient is seen by a QMP located on campus via electronic two-way technology, the service would not be considered a telehealth visit. Regardless of location, the QMP must be performing within the scope of his/her state practice act and approved by the hospital’s governing body to perform MSEs. Q: Can CMS waive certain elements of EMTALA to allow for more flexibility in meeting the current medical screening exam (MSE)? A: CMS has temporarily waived some EMTALA requirements to allow screening for 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. Under the waiver, hospital EDs may redirect incoming patients to alternative screening sites staffed by QMPs, to ensure symptomatic or COVID-19-positive patients are directed to appropriate settings of care. Q: Can emergency physicians perform medical screening exams outside of the ED, such as in tents in the parking lot, under EMTALA? A: Yes. A hospital may set up alternative sites on its campus to perform MSEs. Individuals may be redirected to these sites. Whether the individual is seen at the alternate on-campus site or in the 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. This is a triage function, and the person providing the redirection from the ED should be qualified to recognize individuals who are obviously in need of immediate treatment in the ED. Hospital non-clinical staff stationed at other entrances to the hospital may provide redirection to the on-campus alternative screening location for individuals seeking COVID-19 testing. Q: Can the MSE be conducted by a Registered Nurse (RN)? A: Yes. MSEs must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician’s assistants, or RNs trained to perform MSEs, acting within the scope of their state licensure law, and as approved by the hospital’s governing body. Hospitals may request a waiver to allow MSEs to be performed by other personnel, including trained RNs not previously approved by the governing body to perform MSEs. Q: If there is an on-site COVID-19 testing location (e.g., tent outside main ED), would EMTALA apply if individuals are only requesting COVID-19 testing? Would a MSE be required? A: EMTALA would apply if a patient who was solely seeking COVID-19 testing made a request for medical treatment while on the hospital campus or demonstrated a medical condition that a prudent layperson would believe, based on the individual’s appearance or behavior, indicated that the individual needed examination or treatment of a medical condition. However, patients who present solely for the purpose of COVID-19 testing and are not making a request for treatment of a medical condition, do not necessarily require a MSE. If the person complains of or exhibits any symptoms of a medical condition, then that person should receive an appropriate MSE to determine whether an emergency medical condition (“EMC”) exists. The EMTALA obligation is satisfied if the MSE determines no EMC exists. Q: Can a hospital conduct an MSE if the patient remains in an automobile and meet its EMTALA obligations? A: It depends. The MSE does not have to take place in the ED to satisfy EMTALA. The content of the MSE varies according to the individual’s presenting signs and symptoms, and it can be as simple or as complex, as needed, to determine if an emergency medical condition exists. MSEs must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician’s assistants, or RNs trained to perform MSEs and acting within the scope of their state practice act. If a clinically-appropriate MSE can be performed in an automobile to determine whether or not an emergency medical condition exists, that MSE would be permissible under EMTALA. Q: For off-campus, hospital-controlled sites, can a person first presenting to the ED be redirected from the ED to the off-campus site where the MSE will be completed? A: Yes. Hospitals may redirect patients presenting to the ED to an off-campus site where an MSE will be completed. Normally, a hospital may not tell individuals who have already entered an ED to go to the off-site location for the MSE, such a redirection usually only occurs to an on-campus alternative site. However, CMS has issued a blanket section 1135 waiver for the duration of the COVID-19 PHE the ability to re-direct patients to an offsite location for screening, in accordance with a state emergency preparedness or pandemic plan. Hospitals are generally able to manage the separation and flow of potentially infectious patients through alternate screening locations on the hospital campus during the COVID-19 PHE. Q: Is there a specific time frame in which the MSE has to take place if a patient is referred to an off-campus site? Would it have to happen that same day? A: There is no specified time frame in which the MSE has to occur after the referral from the hospital to an off-campus site. However, triage entails the clinical assessment of the individual’s presenting signs and symptoms at the time of arrival at the hospital, in order to prioritize when the individual will be seen by a physician or other QMP. Individuals presenting must be provided an MSE appropriate to the individuals’ presenting signs and symptoms, as well as the capability and capacity of the hospital. The MSE must be the same MSE that the hospital would perform on any individual coming to the hospital’s dedicated emergency department with those signs and symptoms, regardless of the individual’s ability to pay for medical care. If a hospital applies a nondiscriminatory screening process that is reasonably calculated to determine whether an EMC exists, it has met its obligations under EMTALA. The required MSE and stabilizing treatment should not be delayed. If the MSE is appropriate and does not reveal an EMC, the hospital has no further obligation. Q: If a hospital set up a COVID-19 testing location offsite, and patients only present to the hospital for testing without requesting additional services, do those patients need an MSE before we refer them offsite? A: Those patients would not be subject to an MSE in this case unless they are requesting examination or treatment for a medical condition or demonstrate a medical condition for which a MSE is necessary. EMTALA requires that all persons who present to the hospital or ED for a medical condition be provided an MSE to determine whether they have an EMC. Transfer and Stabilization of Patients Q: Has CMS waived elements of EMTALA to allow for more flexibility in the transfer and stabilization requirements? A: No. CMS has not waived EMTALA transfer or stabilization requirements. Hospitals are expected to provide stabilizing treatment within their capabilities and capacity prior to the initiation of a transfer to another hospital. However, when a section 1135 waiver has been issued, sanctions for an inappropriate transfer of a patient or for the direction or relocation of a patient to receive a MSE at an alternate location do not apply if certain conditions are met, as enumerated at 42 C.F.R. §489.24(a)(2)(i)(A)-(E). Q: Is transfer to a designated facility permissible regardless of COVID-19 status, as long as positives go to designated positive facilities and negatives go to designated negative facilities? A: Yes. A patient transfer under the state emergency and pandemic plan would apply to all patients regardless of COVID-19 status following an appropriate MSE and determination that patient is stable for an appropriate transfer. Q: When could a hospital refer a patient who comes to the ED for medical treatment to an urgent care center? A: Hospitals must provide a MSE to all patients who come to the ED requesting treatment for a medical condition or where the individual is demonstrating presence of a medical condition to determine if an EMC exists. The content of the MSE varies according to the individual’s presenting signs and symptoms, but should be provided within the capabilities of the hospital’s ED, including ancillary services routinely available to the hospital. Once the MSE is complete and if the patient is determined not to have an EMC, the hospital’s EMTALA obligation ends and the patient may be referred to an urgent care center for continued care of non-emergency illnesses or injuries. However, a section 1135 waiver gives the ability for hospitals to re-direct patients that have presented to the ED to an offsite location for the MSE in accordance with a state emergency preparedness or pandemic plan. Under the section 1135 waiver, hospital EDs may redirect incoming patients to alternative screening sites staffed by qualified medical personnel, to ensure that symptomatic or COVID-19-positive patients are directed to appropriate settings of care. Waivers Under Section 1135 of the Social Security Act Q: Has EMTALA been broadly waived? A: No. CMS has approved a section 1135 waiver for the COVID-19 PHE, which temporarily includes the ability to re-direct patients to an offsite location for screening in accordance with a state emergency preparedness or pandemic plan. Hospitals are still expected to provide an MSE to any individual who comes to the emergency department and requests examination or treatment, or has a request for examination or treatment made on their behalf. The purpose of the MSE is to determine if an emergency medical condition exists. If an EMC is determined to exist, the hospital must provide stabilizing treatment within the hospital capabilities or an appropriate transfer per 42 C.F.R. § 489.24. While certain aspects of EMTALA may be waived under the section 1135 waiver, federal civil rights laws have not been waived. Hospitals that receive federal financial assistance are still obligated to comply with federal civil rights laws, including Section 504 of the Rehabilitation Act, Title VI of the Civil Rights Act of 1964, Section 1557 of the Affordable Care Act and the Hill-Burton Act. Hospitals do not have to initiate a disaster plan before the section 1135 waiver becomes effective and hospitals are not required to provide notification to CMS upon initiation of the disaster plan. The flexibilities and blanket waivers released by CMS are retroactive to March 1, 2020. The waivers will end no later than the termination of the COVID-19 PHE, or 60 days from the date the waiver or modification is first published, unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. Any additional formal guidance, revisions to existing guidance, or additional clarifications will be released via a QSO memorandum or other CMS approved communication. We at Dorsey are continuing to monitor the developments related to COVID-19. If you have any questions about the issues addressed in this blog, please contact the authors or your regular Dorsey attorney. You can access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here. You can also access Dorsey’s health law blog related to health law updates, available here.

As we explained in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. On April 21, 2020, CMS issued explanatory guidance, available here, on the scope and application of the Stark Blanket Waivers to certain financial relationships (the “Explanatory Guidance”). In addition to answering a variety of questions raised by the initial announcement of the Stark Blanket Waivers, the Explanatory Guidance provides an important reassurance to stakeholders. CMS states: “The Secretary will work with the Department of Justice to address False Claims Act relator suits where parties using the blanket waivers have a good faith belief that their remuneration or referrals are covered by a blanket waiver.” Despite this reassurance, however, it is crucial that parties seeking to rely on a Stark Blanket Waiver ensure that their arrangement, in fact, relates to “COVID-19 Purposes” (as defined in the Stark Blanket Waivers document), falls within the parameters of a specifically enumerated waiver within the Stark Blanket Waivers document, and that all non-waived requirements of an applicable Stark Law exception are met. We also note that, as CMS reminds parties in the Explanatory Guidance, relying on a Stark Blanket Waiver may not be necessary for certain arrangements related to COVID-19 Purposes, if these arrangements satisfy the requirements of an existing Stark Law exception. The following information summarizes the Explanatory Guidance. A. Compliance with Non-Waived Requirements of an Applicable Exception Many of the Stark Blanket Waivers eliminate or alter some, but not all, of the existing requirements of particular Stark Law exceptions. CMS warns that financial relationships or referrals must satisfy all non-waived requirements of an applicable exception in order to avoid implicating the Stark Law’s referral and billing prohibitions. We note that this includes, for example, meeting the “set in advance” requirement of applicable compensation exceptions, as this requirement is not waived by any of the Stark Blanket Waivers. B. Amendment of Compensation Arrangements The Explanatory Guidance clarifies when parties may modify the remuneration terms of an existing arrangement during the COVID-19 emergency period, and whether such terms can be amended during the emergency period and again at the conclusion of the emergency period to return to the original terms. This guidance applies when parties are relying on a compensation exception that has both a one-year term requirement and a “set in advance” requirement (such as the personal services arrangements exception). CMS points to the preamble guidance in the Fiscal Year 2009 Inpatient Prospective Payment System final rule (“FY 2009 IPPS Rule”), which CMS interprets as allowing for a second or subsequent amendment of the compensation terms of an arrangement, even within the first year of an initial amendment of those terms, as long as each time those terms are amended, “all requirements of an applicable exception are satisfied, the amended remuneration is determined before the amendment is implemented, the formula for the amended remuneration does not take into account the volume or value [of] referrals or other business generated by the referring physician, and the overall arrangement remains in place for at least 1 year following the amendment.” CMS reiterates that if parties amend a compensation arrangement during the emergency period, all non-waived requirements of an applicable exception must be met. The compensation terms of the arrangement may again be amended after the public health emergency is over. This further amendment may restore the original terms of the arrangement or make additional changes, as long as each of the criteria from the FY 2009 IPPS Rule (described above) are met. Finally, CMS points out that a modification of an existing arrangement could instead be analyzed as an additional compensation arrangement, for which the parties could use the Stark Blanket Waivers (if all applicable requirements are met). C. Applicability of Blanket Waivers to Indirect Compensation Arrangements The Explanatory Guidance states that the Stark Blanket Waivers do not apply to indirect compensation arrangements, and only apply to direct compensation arrangements. Parties can, however, seek an individual waiver of sanctions related to indirect compensation arrangements. The Explanatory Guidance goes on to note that many compensation arrangements that may appear to be indirect may be analyzed as direct compensation arrangements under the “stand in the shoes” provisions of the Stark Law. D. Repayment Options for Loans between a DHS Entity and a Physician (or the Immediate Family Member of a Physician) Two Stark Blanket Waivers (waivers #10 and #11) involve remuneration in the form of a loan with an interest rate below fair market value or on terms that are unavailable from a lender that is not in a position to make referrals to or generate business for the party making the loan. CMS states that these waivers do not require cash payments to the lender to satisfy a borrower’s debt. Loans may be repaid through in-kind payments, as long as the aggregate value of the in-kind payments is consistent with the amount of the loan and the arrangement is commercially reasonable. CMS provides that an example in-kind payment could be the maintenance of a medical practice and continuing to serve patients in the community where the entity is located. E. Repayment of Loans, Rent Abatement, or Other Amounts Due Following the End of the Emergency Period CMS clarified that, if parties use the Stark Blanket Waivers such as the loan arrangements described above, repayment obligations do not need to be completed prior to the termination of the Stark Blanket Waivers (which will be at the end of the public health emergency that was declared related to the COVID-19 outbreak). Many parties expressed concern that, after the termination of the Stark Blanket Waivers, the compensation arrangements entered into would no longer satisfy the requirements of an applicable exception because the interest charges or other charged amounts would not be consistent with the fair market value of the remuneration provided. The Explanatory Guidance provides that appropriate repayment terms agreed to before the termination of the Stark Blanket Waivers may continue beyond the termination of the waivers. However, disbursement of loan proceeds or additional remuneration after the termination of the Stark Blanket Waivers must satisfy all requirements of the applicable Stark exception. F. Restructuring of Existing Recruitment Arrangements with Income Guarantees CMS also responded to inquiries about the extension or restructuring of existing physician recruitment arrangements, such as whether a hospital could extend an income guarantee to address a recruited physician’s medical practice interruption due to the COVID-19 pandemic. The Explanatory Guidance states that CMS maintains its position that, under the Stark Law exception for physician recruitment, the terms of a recruitment arrangement cannot be altered once the physician has relocated their practice. Some Stark Blanket Waivers, however, may be available for remuneration from a hospital (or other entity) to assist a relocated physician whose medical practice is disrupted due to the pandemic in order to maintain the availability of medical care and related services for patients and the community. * * * For help determining whether an existing or proposed arrangement complies with a Stark Blanket Waiver and/or for inquiries regarding individual waiver requests, please contact the authors of this post or your regular Dorsey attorney. We continue to closely monitor the legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog providing health law updates, available here. You can also access Dorsey’s coronavirus resource center, containing a wide variety of legal resources related to the coronavirus outbreak, available here.

On Monday, April 6th the Centers for Medicare and Medicaid Services (“CMS”) adopted an interim final rule to change a wide range of Medicare payment policies during the COVID-19 public health emergency so that Medicare providers and suppliers have flexibility to furnish services to beneficiaries using remote communications technology. As healthcare providers implement infection prevention and control procedures throughout their operations, CMS recognizes that immediately and temporarily increasing the availability of services using telecommunications technology is necessary and appropriate to maintain Medicare beneficiary access to medically necessary services without jeopardizing their health or the health of the healthcare workers furnishing those services. The interim final rule with comment period is applicable to services provided beginning March 1, 2020, and will be effective for the period of the COVID-19 public health emergency. The rule addresses a variety of Medicare payment policies (including coverage, supervision, and “home bound” requirements) applicable to physicians and other clinicians, hospitals, home health agencies, hospice agencies, independent laboratories, ambulance service providers, rural health clinics, federally qualified health centers, inpatient rehabilitation facilities, and Medicare Part C and D health plans. The following summarizes the Medicare payment policy changes. 1. Place of Service Coding for Medicare Telehealth Services Medicare pays for a discrete set of services under Social Security Act § 1834(m) that are reported using codes that describe ‘‘face-to-face’’ services but are furnished using audio/video, real-time communication technology, instead of in-person. Clinicians bill for these Medicare telehealth services using a unique place of service code “02,” which identifies them as Medicare telehealth services. CMS pays the physician or practitioner for Medicate telehealth services at the lower Medicare Physician Fee Schedule “facility rate” because facility expenses (e.g., staff, supplies, and equipment) associated with the services are generally incurred by the site where the patient is located, and not by the remotely-located practitioner. On an interim basis CMS will pay for Medicare telehealth services at the rate that ordinarily would be paid under the Medicare physician fee schedule if the services were furnished in-person. Physicians and other practitioners billing for Medicare telehealth services should report the place of Service code that would have been reported had the service been furnished in person instead of place of service code “02.” Because Medicare identifies claims for telehealth services through the place of service code “02,” CMS has finalized use on an interim basis of CPT telehealth modifier 95, which applies to claim lines that describe services furnished via telehealth. 2. Additions to Medicare Telehealth Services As noted above, Medicare pays for a defined set of Medicare telehealth services. For telehealth services with dates of service beginning March 1, 2020 through the end of the declared COVID-19 public health emergency (including any renewals), CMS is adding the following services to the list of covered Medicare telehealth services. Together with CMS’ waivers the originating site requirements applicable to Medicare telehealth services and the OIG’s policy statement addressing waiver of beneficiary copayments for telehealth services, this expansion in covered telehealth services can facilitate the meaningful and quick expansion in deployment of telehealth services. A. Emergency Department Visits  99281 99282 99283 99284 99285 B. Initial and Subsequent Observation, and Observation Discharge Day Management 99217 99218 99219 99220 99224 99225 99226 99234 99235 99236 C. Initial Hospital Care and Hospital Discharge Day Management 99221 99222 99223 99238 99239 D. Initial Nursing Facility Visits and Nursing Facility Discharge Day Management 99304 99305 99306 99315 99316 E. Critical Care Services 99291 99292 F. Domiciliary, Rest Home, or Custodial Care Services 99327 99328 99334 99335 99336 99337 G. Home Visits 99341 99342 99343 99344 99345 99347 99348 99349 99350 H. Inpatient Neonatal and Pediatric Critical Care 99468 99469 99471 99472 99473 99475 99476 I. Initial and Continuing Intensive Care Services 99477 99478 99479 99480 J. Care Planning for Patients With Cognitive Impairment 99483 K. Group Psychotherapy 90853 (Group psychotherapy (other than of a multiple-family group)) L. End-Stage Renal Disease (ESRD) Services 90952 90953 90959 90962 M. Psychological and Neuropsychological Testing 96130 96131 96132 96133 96136 96137 96138 96139 N. Therapy Services: For these services, CMS states that because Social Security Act § 1834(m) does not provide for payment for these services as Medicare telehealth services when furnished by physical therapists, occupational therapists, or speech language pathologists. 97161 97162 97163 97164 97165 97166 97167 97168 97110 97112 97116 97535 97750 97755 97760 97761 92521 92522 92523 92524 92507 O. Radiation Treatment Management Services 77427 77427 3. Frequency Limitations on Subsequent Care Services in Inpatient and Nursing Facility Settings, and Critical Care Consultations CMS is removing the frequency restrictions for each of the following codes for subsequent inpatient visits and subsequent nursing facility visits furnished via Medicare telehealth for the duration of the PHE for the COVID–19 pandemic. A. Subsequent Inpatient Visits 99231 99232 99233 B. Subsequent Nursing Facility Visits 99307 99308 99309 99310 C. Critical Care Consultation Services G0508 G0509 4. Required ‘‘Hands-On’’ Visits for ESRD Monthly Capitation Payments Current Medicare rules state that for End Stage Renal Disease (“ESRD”) related services that are on the Medicare telehealth list, a required clinical examination of the vascular access site must be furnished face-to-face ‘‘hands on’’ (without the use of an interactive telecommunications system) by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant (PA). CMS is permitting on an interim basis the required clinical examination to be furnished as a Medicare telehealth service during the COVID–19 pandemic. In addition, Medicare rules typically require that a beneficiary receive a face-to-face visit, without the use of telehealth, at least monthly in the case of the initial 3 months of home dialysis and at least once every 3 consecutive months after the initial 3. CMS states that they will exercise enforcement discretion on an interim basis to relax enforcement in connection with the requirements under Social Security Act § 1881(b)(3)(B) that certain visits be furnished without the use of telehealth. Specifically, CMS will not conduct review to consider whether those visits were conducted face-to-face, without the use of telehealth. This applies to the following codes: 90951 90952 90953 90954 90955 90957 90958 90959 90960 90961 90962 90963 90964 90965 90966 90967 90968 90969 90970 5. Communication Technology-Based Services Certain services are performed using remote communications technology and are paid for by the Medicare program, but are not considered Medicare telehealth services because these services are by their nature performed using communications technology and are not ordinarily performed in person. These services include certain remote patient monitoring services (e.g., CPT codes 99453, 99454, 99457, and 99458, virtual check-in services). CMS payment rules for these services have limited their use to established patients only, and advance beneficiary consent has been required. The interim final rule states that all of these services can be furnished to both new and established patients. CMS also states that beneficiary consent to receive these services can be obtained annually, can be obtained at the time that a service is furnished, and may be documented by auxiliary staff under general supervision. To mitigate exposure risks, CMS is also broadening the types of clinicians that can perform remote evaluation of patient images and virtual check-ins (HCPCS codes G2010 and G2012) to include licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech-language pathologists. 6. Direct Supervision Many services paid under the Medicare physician fee schedules, such as services performed incident to a physician’s professional service (see 42 C.F.R. § 410.26), must be provided under the direct supervision of the billing physician or nonphysician practitioner, meaning that the physician or nonphysician practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. CMS is temporarily modifying the definition of direct supervision at 42 C.F.R. § 410.32(b)(3)(ii) to state that direct supervision includes virtual presence through audio/video real-time communications technology. Similarly, the definitions of direct supervision applicable to hospital outpatient services at 42 C.F.R. § 410.28(e)(1) and hospital rehabilitation and intensive cardiac rehabilitation services described at 42 C.F.R. §§ 410.47 and 410.49 are modified in the same manner to permit physician supervision of these hospital services via virtual presence through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider. Additionally, the minimum default level of physician supervision for the initiation of outpatient non-surgical extended duration therapeutic services will now be changed from direct supervision to general supervision. 7. Definition of Homebound for Purposes of Home Health Benefits The interim final rule addresses whether beneficiaries instructed to remain in their homes or are under ‘‘self-quarantine’’ are considered ‘‘confined to the home’’ or ‘‘homebound’’ for purposes of the Medicare home health benefit. CMS states that the current definition of ‘‘confined to the home’’ (that is, ‘‘homebound’’) would apply to patients: (a) Where a physician has determined that it is medically contraindicated for a beneficiary to leave the home because he or she has a confirmed or suspected diagnosis of COVID–19; or (b) where a physician determines that it is medically contraindicated for a beneficiary to leave the home because the patient has a condition that may make the patient more susceptible to contracting COVID–19. Beneficiaries must meet all other eligibility requirements to receive Medicare home health services. The beneficiary must be under the care of a physician; receiving services under a plan of care established and periodically reviewed by a physician; be in need of skilled nursing care on an intermittent basis or physical therapy or speech-language pathology; or have a continuing need for occupational therapy. 8. Home Health Benefits and Remote Technology CMS is also amending home health plan of care requirements at 42 C.F.R. § 409.43(a) to allow the integration of technology and remote communication into the home health plan of care, so long the use of technology is related to the skilled services being furnished by the nurse/therapist/therapy assistant to optimize the services furnished during the home visit, and that the use of technology is included on the home health plan of care along with a description of how the use of such technology will help to achieve the goals outlined on the plan of care without substituting for an in person visit as ordered on the plan of care. On an interim basis home health agencies can report the costs of telecommunications technology as allowable administrative and general costs on their cost reports. 9. Telecommunications and Hospice For hospices, regulations at 42 C.F.R. § 418.204 are modified to state that when a patient is receiving routine home care, hospices may provide services via a telecommunications system if it is feasible and appropriate to do so to ensure that Medicare patients can continue receiving reasonable and necessary services for the palliation and management of a patients’ terminal illness and related conditions without jeopardizing the patients’ health or the health of those who are providing such services. The use of such technology must be included on the plan of care. The inclusion of technology on the plan of care must continue to meet the requirements at 42 C.F.R. § 418.56, and must be tied to the patient-specific needs as identified in the comprehensive assessment and the measurable outcomes that the hospice anticipates will occur as a result of implementing the plan of care. Telecommunication technology can also be used by a hospice physicians or nurse practitioner for a face-to-face visit used solely for the purpose of recertifying a patient for hospice services. Telecommunications technology for this purposes means multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site hospice physician or nurse practitioner. Hospices can also report hospices can report the costs of telecommunications technology used to furnish services under the routine home care level of care during the public health emergency as ‘‘other patient care services’’ on their cost report. 10. Inpatient Rehabilitation Facilities In order to be considered medically necessary, inpatient rehabilitation facility services must be expected to require medical supervision involving a rehabilitation physician conducting face-to-face visits with the patient at least 3 days per week throughout the patient’s stay. CMS is modifying these rules to permit such visits to be conducted using remote telecommunication technology. In addition, CMS is temporarily eliminating the requirement that at the time of admission a patient’s medical record at the facility must contain a postadmission physician evaluation. 11. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) For RHCs and FQHCs, CMS is expanding the services that can be included in the payment for HCPCS code G0071, and is updating the payment rate for this code to include the national non-facility payment rates for three new codes (CPT Codes 99421, 99422, and 99423) to reflect the addition of these services. In addition, to address the impact of the COVID–19 pandemic on underserved rural and urban communities, CMS is implementing changes to the requirements for visiting nursing services furnished in the home by RHCs and FQHCs. For the duration of the public health emergency, any area typically served by the RHC, and any area that is included in the FQHCs service area plan, is determined to have a shortage of home health agencies, and there is no need for the RHC or FQHC to request a determination that there is a shortage of home health agencies in the area in order for visiting nurse services to be covered by Medicare. 12. Clinical Laboratory Fee Schedule and Merit-based Incentive Payment System Updates In order to expand the testing available to Medicare beneficiaries who need it, payments will now be provided to independent laboratories for specimen collection for COVID-19 testing under certain circumstances. A travel allowance will also be provided for a lab technician to collect a specimen for testing from non-hospital inpatients or homebound patients. Clinician participation in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection will now be credited as an improvement activity for the Merit-based Incentive Payment System (MIPS) 2020 performance period. Additionally, the MIPS automatic extreme and uncontrollable circumstances policy will be applied to MIPS eligible clinicians for the 2019 MPS performance period as data submission for 2019 will be impacted. 13. Opioid Treatment Programs Audio-only telephone calls will be permitted for the therapy and counseling portions of the weekly bundle of services furnished by Opioid Treatment Programs if the beneficiaries do not have access to two-way audio/video communications technology. 14. Teaching Physicians, Residents and Moonlighting Regulations The teaching physician regulations are amended to allow the teaching physician to provide supervision either with physical presence or be present through interactive telecommunications technology during the key portion of residents’ service. Residents may also provide services from quarantine, such as reading the results of tests and other imaging studies under the supervision of the teaching physician by interactive telecommunications technology. This change does not apply in the case of surgical, high risk, interventional, or other complex procedures, services performed through an endoscope, and anesthesia services. CMS clarified that Medicare may make payment under the PFS for teaching physician services, including under the primary care exception, when a resident furnishes telehealth services to beneficiaries under direct supervision of the teaching physician which is provided by interactive telecommunications technology. CMS is also permitting the hospital that is paying the resident’s salary and fringe benefits for the time that the resident is at home or in the home of a patient that is already a patient of the physician or hospital, but performing patient care duties within the scope of the approved residency program, to claim that resident for indirect medical education and direct graduate medical education purposes. During the emergency, “moonlighting,” or services of residents that are not related to their approved GME programs and are performed in the inpatient setting of a hospital in which they have their training program, are separately billable physicians’ services for which payment can be made. 15. Psychiatric Hospitals CMS has deleted several references to 42 C.F.R. § 482.12(c) in 42 C.F.R. § 492.61(d) to clarify that the latter’s provisions apply to all patients, not only Medicare beneficiaries. 16. Innovation Center Models CMS is now permitting certain beneficiaries to obtain the set of Medicare Diabetes Prevention Program (MDPP) services more than once per lifetime, increase the number of virtual make-up sessions, and allow certain MDPP suppliers to deliver virtual MDPP sessions on a temporary basis. CMS is also implementing a 3-month extension to the Comprehensive Care for Joint Replacement model performance year 5 and amending the CJR extreme and uncontrollable circumstances policy to be applicable to episodes impacted by the COVID-19 pandemic. 17. Remote Physiologic Monitoring Remote physiologic monitoring services can temporarily be furnished to new patients, as well as to established patients. Further, consent to receive RPM services can be obtained once annually, including at the time services are furnished, during the duration of the COVID-19 public health emergency. RPM codes can also be used for physiologic monitoring of patients with acute and/or chronic conditions. 18. Evaluation and Management (E/M) Services CMS is finalizing, on an interim basis, separate payment for CPT codes 98966-98968 and CPT codes 00441-99443. For these codes, work RVUs as recommended by certain AMA Committees are finalized: 0.25 for CPT code 98966 0.50 for CPT code 98967 0.75 for CPT code 98968 0.25 for CPT code 99441 0.50 for CPT code 99442 0.75 for CPT code 99443. Additionally, CMS is finalizing the recommended direct PE inputs which consist of 3 minutes of post-service RN/LPN/MTA clinical labor for each time code. CMS will also not conduct reviews to consider whether those services were furnished to established patients, and the services may be furnished to new patients as well. To facilitate billing of CPT codes 98966-98968, CMS is designating these codes as “sometimes therapy” services that would require the private practice occupational therapist, physical therapist, and speech-language pathologist to include the corresponding GO, GP, or GN therapy modifier on those claims. CMS is also permitting the office/outpatient E/M level selection for office/outpatient services when furnished via telehealth to be based on MDM or time, with time defined as all of the time associated with the E/M on the day of the encounter. Any requirements regarding documentation of history and/or physical exam in the medical record are removed for office/outpatient services via telehealth, though E/M visits should continue to be documented as necessary to ensure quality and continuity of care. 19. National Coverage Determination and Local Coverage Determination Requirements Certain National Coverage Determinations and Local Coverage Determinations of covered items or services will not apply during the COVID-19 Pandemic, including: face-to-face and in person requirements; clinical indications for certain respiratory, home anticoagulation management and infusion pump policies; and requirements for consultations or services furnished by or with the supervision of a particular medical practitioner or specialist. 20. Part C and Part D Quality Star Ratings CMS is modifying the calculation of the 2021 and 2022 Medicare Part C and D Star Ratings in several ways to address the expected disruption to data collection. The interim final rule: A. replaces the 2021 Star Ratings measures calculated based on HEDIS and Medicare CAHPS data collections with earlier values from the 2020 Star Ratings (which are not affected by the public health threats posed by COVID-19); B. establishes how CMS will calculate or assign Star Ratings for 2021 in the event that CMS’ functions become focused on only continued performance of essential agency functions and CMS and/or its contractors do not have the ability to calculate the 2021 Star Ratings; C. modifies the current rules for the 2021 Star Ratings to replace any measure that has a data quality issue for all plans due to the COVID-19 outbreak with the measure-level Star Ratings and scores form the 2020 Star Ratings; D. in the event that CMS is unable to complete HOS data collection in 2020 (for the 2022 Star Ratings), replaces the measures calculated based on HOS data collections with earlier values that are not affected by the public health threats posed by COVID-19 for the 2022 Star Ratings; E. removes guardrails for the 2022 Star Ratings; and F. expands the existing hold harmless provision for the Part C and D Improvement measures to include all contracts for the 2022 Star Ratings. 21. Ordering Medicaid Home Health Services In addition to physicians, licensed practitioners such as NPs and PAs may order Medicaid home health services during the existence of the PHE for the COVID-19 pandemic. These services include part-time or intermittent nursing, home health aide services, medical supplies, equipment, and appliances, and may include therapeutic services. This change applies to who can order home health services covered under 42 C.F.R. § 440.70(b)(1)–(4). It does not expand the benefit categories where these items can be covered. 22. Origin and Destination Requirements Under the Ambulance Fee Schedule The list of destinations for covered ambulance transportation is expanded to include all destinations, from any point of origin, that are equipped to treat the condition of the patient consistent with EMS protocols established by state and/or local laws where the services will be furnished. 23. Inpatient Hospital Services Furnished Under Arrangements Outside the Hospital The “under arrangements” policy is changed to allow hospitals broader flexibilities to furnish inpatient services, including routine services, outside the hospital. For services provided for discharges for patients admitted to the hospital during the PHE for COVID-19 beginning March 1, 2020, if routine services are provided under arrangements outside the hospital to its inpatients, these services are considered as being provided by the hospital. 24. Advance Payments to Suppliers Furnishing Items and Services under Part B Under Medicare Part B, the definition of advance payments to suppliers furnishing items and services will change from a payment made by the carrier to a payment made by the contractor, and payments under emergency exceptions will be permitted. CMS is also increasing the advance payment limit from 80 percent of the anticipated payment to 100 percent.

On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a compilation of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (each, a “Blanket Waiver”). Section 1135 of the Social Security Act gives CMS the authority to issue waivers that ease requirements for providers affected by an emergency if: (1) the President makes an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”); and (2) the Secretary of the Department of Health and Human Services declares a Public Health Emergency (“PHE”), both of which have now occurred in light of COVID-19. CMS is permitted to issue both blanket waivers and provider/supplier requested waivers on a case-by-case basis. Blanket waivers apply to all applicable providers and suppliers, while individual waivers apply only to the requesting provider or supplier. A provider or supplier need not request a provider/supplier-specific waiver of a requirement if CMS has issued a blanket waiver addressing the same requirement. It is important to note that 1135 waivers apply solely to federal requirements and do not apply to state licensure or other requirements. Any applicable state requirements (e.g., licensure) must also be addressed with the relevant state agency. Another important note of caution is that these 1135 waivers often include specific details and requirements. It is critical for health care providers to review the waivers carefully before taking action under them. To that end, providers should visit the CMS Coronavirus Waivers & Flexibilities website, here, to locate the specific guidance and requirements from CMS about the type of program waiver(s) being sought. CMS has provided numerous Frequently Asked Questions (“FAQ”) documents and provider-specific fact sheets that detail the details about and limits of the available waivers and flexibilities for each type of provider (hospital, skilled nursing facility, physicians, laboratories, home health providers, etc.). Additionally, this website contains links to all of the waivers provided in each state. The following is a summary of the Blanket Waivers CMS has made available to providers and suppliers on March 30, 2020. These Blanket Waivers are retroactively effective back to March 1, 2020 and will continue through the end of the emergency declaration. I. Hospital Waivers The Blanket Waivers include significant regulatory relief for hospitals. The following is a summary of the hospital-specific Blanket Waivers, and here is a CMS Fact Sheet that was published for hospitals to further explain these specific Blanket Waivers: a. Temporary Expansion Sites (a.k.a. Hospitals Without Walls) Under this Blanket Waiver, hospitals are permitted to offer health care services in locations that are not currently part of the hospital. Previously, hospitals would have been required to meet Life Safety Code and other regulatory provisions and obtain approvals to provide services in a new location. This waiver will help hospitals set up temporary expansion sites to offer inpatient services (e.g., nursing, room and board) in locations such as shell space in a hospital, parking structures, dormitories and the like – as long as the hospital exercises control and oversees the services provided at the location, and as long as the location is approved by the state (to ensure safety and comfort for patients and staff). CMS is also allowing currently enrolled ambulatory surgery centers (“ASCs”) to temporarily enroll as hospitals by calling the COVID-19 Provider Enrollment Hotline to complete and sign an attestation form in order to enroll and provide services during the PHE as a hospital. CMS also encourages other entities (e.g., freestanding emergency departments which are not currently allowed to enroll in Medicare) to call the COVID-19 Provider Enrollment Hotline to complete and sign an attestation form in order to enroll and provide services during the PHE. Further, CMS is allowing hospitals to change their provider-based locations to address patient needs, as well as allowing additional flexibilities related to inpatient services furnished under arrangements. Moreover, hospitals are permitted to screen patients at locations off of a provider’s campus, in order to avoid the spread of COVID-19. Further, for surge facilities in off campus departments, CMS is waiving the requirements to have policies and procedures for evaluating emergencies so these facilities do not need to focus time on drafting policies and procedures but rather can focus on patient care needs. b. Relaxed Paperwork, Policies, Cost Reporting, Filing Deadlines and Enrollment Requirements For hospitals that are impacted by a widespread outbreak of COVID-19, the timeframes for providing patients a copy of their medical records are waived, as are the requirements related to visitation and seclusion. Additionally, CMS is granting a 30-day post-discharge requirement to complete medical records, CMS is waiving medical records department staffing requirements, and also waiving specific requirements for the form and content of the medical record and the medical record completion requirements. Further, verbal orders can be authenticated more than 48 hours after the fact (although read-back verification is still required). CMS is also waiving requirements to provide information about advanced directives to patients. Further, To ensure that hospitals and critical access hospitals focus on patient care and ensuring patients are discharged in an appropriate setting, as opposed to focusing on the paperwork and other regulatory obligations, CMS is waiving the detailed regulatory paperwork and other requirements related to discharge planning. For example, CMS recognizes that during the PHE, hospitals may not be able to use specific quality metrics and other data, or a comprehensive list of nursing homes in the area, to select a nursing home or home health agency. However, hospitals are still required to work with families to ensure that the discharge meets patients’ care needs. Further, CMS is waiving the entire condition of participation related to utilization review plans and committees, nursing care plans, having available a current therapeutic diet manual, developing and implementing emergency preparedness policies and procedures and communication plans, as well as waiving the detailed provisions governing a hospital’s quality assessment and performance improvement program (although hospitals must still have such a program in place). CMS has established a toll-free hotline for all providers as well as significant flexibilities in provider enrollment. See here for additional information from CMS on provider enrollment relief, as well as our previous blog post on this topic, available here. Further, CMS is waiving the signature and proof of delivery requirements for Part B drugs and durable medical equipment (although the delivery and the fact that a signature could not be obtained due to COVID-19 should be documented in the record). Additionally, CMS is delaying the cost-report filing deadlines until June and July, and CMS is extending the data submission deadlines for hospitals on the reporting of occupational mix of employees until August 3, 2020. Further, Medicare Administrative Contractors (“MACs”), Qualified Independent Contractors (“QICs”), and Independent Review Entities (“IREs”) are allowed to grant extensions to providers on appeals and are permitted to offer other flexibilities on filings and deadlines. c. Critical Access Hospitals (“CAHs”) Without Walls CAHs are now permitted to exceed their 25 bed limit and the 96 hour length of stay limit. CMS is also permitting CAHs to treat patients in urban areas (they typically must be located in a rural area) as needed in order to establish surge locations. Further, CMS is waiving the restrictions on CAHs’ ability to establish off campus provider based locations, and to establish the normally restricted co-location arrangements with other providers. CMS is waiving the minimum personnel qualification requirements at CAHs for clinical nurse specialists, nurse practitioners and physician assistants, and CMS is deferring to the state for the requirements of staff licensure, certification or registration, which will allow more flexibility to CAHs in states where federal requirements are more stringent. d. Distinct Part Units CMS is also now allowing hospitals to house acute care patients in excluded distinct part units (as long as the unit’s beds are appropriate for acute inpatients). Hospitals are permitted to bill for the care provided in the distinct part unit under the Inpatient Prospective Payment System. Providers should annotate in the medical record to explain that the care was provided in the distinct part unit due to capacity issues related to the PHE. Hospitals are also now permitted to provide care in acute care beds and units for patients who would normally be treated in distinct part psychiatric units or distinct part rehabilitation units, as long as the acute beds and units are appropriate for such patients. Hospitals should continue to bill under the Inpatient Psychiatric or Inpatient Rehabilitation Prospective Payment System for those patients, and annotate in the medical record to explain that the care was provided in the acute care unit due to capacity issues or other exigent circumstances related to the PHE. e. Telemedicine CMS is waiving telemedicine restrictions on hospitals and CAHs to make it easier for these providers to provide telemedicine for their patients through agreements with off-site hospitals, in order to improve access to specialty care. f. Workforce CMS is waiving the sterile compounding requirements to allow the re-use of face masks. CMS is also waiving the 2-year reappointment period for medical staff re-credentialing, the requirement that patients in a hospital be under the care of a physician (to allow other practitioners like physician assistants and APRNs to be used to the fullest extent possible), and CMS is waiving the requirement for CRNAs to work under the supervision of a physician. Further, CMS has stated that Hospitals do not have to designate in writing the personnel qualified to perform specific respiratory care procedures or the amount of supervision required for personnel to carry out those procedures. II. Long-Term Care, Skilled Nursing Facilities, and Nursing Facility Waivers The Blanket Waivers provide a number of flexibilities related to nursing services. See here for the CMS fact sheet published specifically for long term care facilities. CMS is waiving the 3-day prior hospitalization requirement for coverage of a skilled nursing facility (“SNF”) stay, waiving the timeframe requirements for certain data submission for SNFs and long-term care (“LTC”) facilities, and allowing nursing homes to suspend pre-admission screening and annual resident review assessments. Certain physical environment requirements are now waived, allowing for expanded use of non-SNF buildings or non-resident rooms in a LTC facility for patients in certain emergency circumstances. To promote social distancing: requirements that residents participate in-person in resident groups are waived; requirements related to room-sharing and moving a resident’s room are waived for the purpose of grouping or separating residents with respiratory illness symptoms and/or residents with a confirmed COVID-19 diagnosis from residents without these symptoms or diagnosis; and physicians and non-physician practitioners may conduct visits through telehealth options when previously the visits were required to be in-person. CMS is also partially waiving training and certification requirements required for nurse aids employed for longer than four months at a facility in order to assist with potential staffing shortages. CMS has waived certain resident transfer and discharge requirements in particular circumstances, though advance notification and receiving facility agreements are generally still required, and related care planning requirements are also waived in certain circumstances. Additionally, CMS is delaying the cost-report filing deadlines until June and July, and CMS is extending the data submission deadlines for hospitals on the reporting of occupational mix of employees until August 3, 2020. Further, Medicare Administrative Contractors (“MACs”), Qualified Independent Contractors (“QICs”), and Independent Review Entities (“IREs”) are allowed to grant extensions to providers on appeals and are permitted to offer other flexibilities on filings and deadlines. III. Home Health, Hospice, ESRD, and DMEPOS Waivers CMS has provided FAQ documents on these waivers for home health, here; for hospice, here; for ESRD Facilities, here; and for DME Suppliers, here. Under the Blanket Waivers, CMS provided extensions for home health, hospice, and ESRD providers to complete certain assessment required for Medicare reimbursement. CMS also waived certain home health, hospice and ESRD in-person assessment, visit, and supervision requirements to reduce the need for ordinary course check-ins and to allow for greater use of telehealth. In addition, hospices are relieved of the requirement to provide non-core hospice services, such as physical therapy, occupational therapy, and speech-language pathology. In providing additional flexibility in timing and in-person visits, CMS’s goal is to support containment efforts for at-risk populations and to free up professional resources to focus on treatment of those infected with coronavirus and to focus on operations related to the pandemic. In addition, CMS is waiving certain routine audits, maintenance, and certification requirements for ESRD Facilities and ESRD Facility staff. Again, CMS is attempting to free up resources and provide flexibility to support providers’ focus on pandemic-related efforts. CMS authorized the establishment of Special Purpose Renal Dialysis Facilities (“SPRDF”) to mitigate transmission among the at-risk population. Such facilities do not require a federal survey to be completed before providing services. CMS is allowing physicians that are appropriately credentialed at a certified dialysis facility to provide care at a “designated isolation location” such as a SPRDF without separate credentialing. Dialysis services may now also be provided in nursing homes and SNFs, so long as the services and necessary equipment and supplies are provided by personnel of the resident’s usual Medicare-certified dialysis facility. In an effort to expedite supply of and reimbursement for DMEPOS, CMS is waiving the replacement requirements (such as the face-to-face requirement, a new physician’s order, and new medical necessity documentation) for DMEPOS that are lost, destroyed, irreparably damaged, or otherwise rendered unusable. DMEPOS suppliers must still provide a narrative description about why the equipment must be replaced. IV. Practitioner Licensure, Provider Enrollment, Appeals, and Medicaid/CHIP Waivers CMS has provided a specific fact sheet describing the waivers and flexibilities available for physicians and other clinicians, available here. The Blanket Waivers are intended to ease the burden on the health system in order to allow providers to focus on patient care. To that end, CMS is temporarily waiving the Medicare reimbursement requirements that out-of-state practitioners be licensed in the state in which they are providing services when they are licensed in another state when the following four conditions are met: The practitioner must be enrolled in Medicare; The practitioner must have a valid license to practice in the state which relates to his or her Medicare enrollment; The services must be furnished, whether in-person or remote via telehealth, in a state in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity; and The practitioner must not be excluded in any state that is part of the PHE. Please note that the foregoing Medicare reimbursement waiver for licensure does not waive state or local licensure requirements. As a result, providers must review the state licensure requirements in each jurisdiction prior to delivering telehealth to patients in that location. Please see the blog post we published on this topic of telehealth opportunities here. Additionally, CMS has taken a number of steps to ease the provider enrollment requirements. See here for additional information from CMS on provider enrollment relief, as well as our previous blog post on this topic, available here. CMS has set up a hotline for physicians and non-physician practitioners to enroll and receive temporary Medicare billing privileges. Additionally, CMS has taken the following steps to facilitate the enrollment of providers in the wake of the COVID-19 outbreak, including: Waiver of certain screening requirements, including application fees, background checks, and site visits; Postponement of revalidation actions; Allowing licensed providers to render services outside their state of enrollment;  Expediting pending or new applications;  Easing telehealth restrictions; and Allowing physicians and non-physician practitioners to terminate opt-out status early and enroll in Medicare. Regarding appeals, the new waivers grant broad powers to MACs, QICs, and IREs to relax the requirements of federal regulations regarding the appeals process in FFS, and Parts C and D. MACs, QIEs, and IREs are instructed to allow extensions to file an appeal and to permit the waiver of requests for timeliness requirements for additional information to adjudicate appeals. MACs, QICs, and IREs are now allowed to process an appeal even with incomplete Appointment of Representation forms as outlined in federal regulations. Additionally, MACs, QICs, and IREs can now process appeals that do not meet the required elements of those same federal regulations. MACs, QICs, and IREs are given broad flexibility with respect to other parts of the appeals process so long as good cause requirements are satisfied. Finally, regarding Medicaid and CHIP, the new waivers permit states to request approval that certain statutes and implementing regulations be waived under section 1135. To request such an approval, states may submit an 1135 waiver request directly to their Center for Medicaid and CHIP Services (CMCS) state lead or Jackie Glaze, Acting Director, Medicaid and CHIP Operations Group, Center for Medicaid and CHIP Services at CMS by e-mail (Jackie.Glaze@cms.hhs.gov) or by letter. CMS sets forth a number of examples of the kinds of requests that states can make under this waiver, including: Waiver of prior authorization requirements for FFS programs; Waiver of out-of-state requirements for providers to provide care to another state’s Medicaid enrollees impacted by COVID-19; Temporary suspension of provider enrollment and revalidation requirements to increase access to care; Temporary waiver of state licensure requirements; Temporary suspension of requirements for pre-admission and annual screening requirements for nursing home residents. CMS encourages states to assess their needs and take advantage of these waivers. To assist states with the waiver request process and provide additional guidance, CMS released the Medicaid and CHIP Disaster Response Toolkit, which can be found here. Further, the CMS Coronavirus Waivers & Flexibilities website, here, contains a link to each state’s request for waivers and the responses from CMS. V. Stark Waivers On the same date, CMS also issued much-anticipated Blanket Waivers of sanctions under the federal physician self-referral law, or “Stark Law,” for “COVID-19 Purposes.” These Blanket Waivers are set forth here. Please see our separate post, available here, with detailed information about these Stark Law Blanket Waivers. * * * If you have questions about the new CMS waivers, please contact the authors or your regular Dorsey & Whitney LLP attorney. Dorsey is closely monitoring the rapidly evolving legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog related to health law updates, available here. You can also access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here.

The COVID-19 pandemic has led to rapid and drastic changes to health care delivery in the United States, including as it relates to arrangements between health care providers and physicians that may implicate the federal physician self-referral law, or “Stark Law.” On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued much-anticipated nationwide blanket waivers of sanctions under the Stark Law for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. The Stark Blanket Waivers have a retroactive effective date of March 1, 2020 and will continue through the end of the Public Health Emergency (“PHE”) that was declared related to the COVID-19 outbreak. The Stark Blanket Waivers, which were issued under Section 1135 of the Social Security Act, permit numerous flexibilities to ensure that: “(1) sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and CHIP programs; and (2) health care providers . . . that furnish such items and services in good faith, but are unable to comply with one or more of the specified requirements of [Stark] as a result of the consequences of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent the government’s determination of fraud or abuse.” These flexibilities provide welcome relief for health care providers that are facing much uncertainty and overwhelm in this time of rapid and drastic change. Stark is a strict liability law with very significant civil penalties and prohibitions on billing the Medicare program associated with its violation. However, during the PHE, CMS will reimburse for services provided pursuant to referrals that would otherwise violate Stark, and will not impose penalties, as long as the Stark Blanket Waivers are followed. It is important to keep in mind that each Stark Blanket Waiver is limited to the specific circumstances described in the waiver. Health care providers are required to satisfy every condition of the Stark Blanket Waiver in order to take advantage of it, so special attention should be paid to the requirements. CMS cautioned that any remuneration described in the Stark Blanket Waivers must be directly between the entity and: (1) the physician or the physician organization in whose shoes the physician stands under 42 C.F.R. § 411.354(c); or (2) the immediate family member of the physician. Further, CMS cautioned that the remuneration and referrals described in the Stark Blanket Waivers must be solely related to “COVID-19 Purposes.” CMS specifies that “COVID-19 Purposes” means, for purposes of the Stark Blanket Waivers: Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19; Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States; Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;  Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States; Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community. There are eighteen Stark Blanket Waivers. It is critical to know that each waiver is specific in its requirements and application, so health care providers should not rely on this summary in order to use a Stark Blanket Waiver. Instead, providers should carefully review the details of each waiver prior to making a decision to proceed with an arrangement in reliance on a waiver. A few of the Stark Blanket Waivers are briefly summarized as follows: Remuneration to a physician that is above or below fair market value for services personally performed by the physician. Rental charges paid to a physician that are below fair market value. Remuneration to a physician in the form of medical staff incidental benefits or non-monetary compensation that exceeds the limits set forth in applicable Stark regulations. Loans to a physician with below fair market value interest rates or on terms that are not available from a traditional lender. Referrals by a physician owner of a hospital that temporarily expands its facility capacity above its baseline number without prior application and approval of the facility expansion as required under Stark. Referrals by physicians in a group practice in a location that does not qualify as the “same building” or “centralized building” as typically required under Stark. Referrals by a physician to an entity with which the physician has a compensation arrangement that does not satisfy the writing or signature requirements of the applicable Stark exception, as long as all of the other requirements of the exception are met (unless the other requirements have been waived under one or more of the Stark Blanket Waivers). While no data or notification is required to be submitted to CMS in order to use the Stark Blanket Waivers, parties seeking to utilize the Stark Blanket Waivers should develop and retain records related to the use of the waivers in order to support the fact that the decision to use the waivers was for COVID-19 Purposes, and to document that each requirement of the waiver was satisfied. These records must be made available to the Secretary of the Department of Health and Human Services upon request. At the end of the document setting forth the Stark Blanket Waivers, CMS provided two pages of examples of the application of the Stark Blanket Waivers. CMS clarified that unless a Stark Blanket Waiver expressly applies only to a specific type of entity (e.g., a home health provider), then the examples that CMS provided which reference a hospital would apply to any entity that furnishes designated health services. Finally, CMS provided the email address for individuals to use to submit inquiries about the blanket waivers, available here: 1877CallCenter@cms.hhs.gov. We note that individual waivers of sanctions under the Stark Law are still available and may be granted upon request submitted to the email address noted above. Such individual waiver requests are a good option for a party to consider if an existing or proposed arrangement does not appear to qualify for a Stark Blanket Waiver (or an existing Stark exception). * * * For assistance in determining whether an existing or proposed arrangement complies with a Stark Blanket Waiver and/or for inquiries regarding individual waiver requests, please contact the authors or your regular Dorsey & Whitney LLP attorney. Dorsey is closely monitoring the rapidly evolving legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog related to health law updates, available here. You can also access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here.

On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting deadlines for Medicare quality reporting programs.  The exceptions and extensions are intended to reduce data collection and reporting burdens for entities that are responding to COVID-19 so that they can continue to focus on caring for patients.  CMS states that this is “unprecedented relief for the clinicians, providers, and facilities participating in Medicare quality reporting programs including the 1.2 million clinicians in the Quality Payment Program and on the front lines of America’s fight against the 2019 Novel Coronavirus (COVID-19).” The CMS programs impacted by this “extreme and uncontrollable circumstances” policy exceptions and extensions include, among others, the Quality Payment Program–Merit-based Incentive Payment System (MIPS), Medicare Shared Savings Program Accountable Care Organizations (ACOs), and various hospital quality reporting programs (e.g., Hospital-Acquired Condition Reduction Program).  CMS provided a table in the press release indicating how both 2019 and 2020 data submissions are impacted. For programs that have data submission deadlines in April and May 2020, this submission will be optional.  In addition, no data reflecting services provided from January 1 through June 30, 2020 will be used in CMS’s calculations for value-based purchasing programs and Medicare quality reporting.  CMS stated as follows: “CMS recognizes that quality measure data collection and reporting for services furnished during this time period may not be reflective of their true level of performance on measures such as cost, readmissions and patient experience during this time of emergency and seeks to hold organizations harmless for not submitting data during this period.” For other Dorsey publications on Medicare’s Quality Payment Program, see here and here.

On March 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) Quality, Safety and Oversight Group (“QSO”) issued a memorandum, QSO-20-15, providing guidance to health care providers related to the Emergency Medical Treatment and Labor Act (“EMTALA”) implications regarding the COVID-19 pandemic. EMTALA is a Federal law that requires all Medicare-participating hospitals (including critical access hospitals (“CAHs”)) with dedicated emergency departments (“EDs”) to perform an appropriate medical screening exam (“MSE”) for all individuals who come to their EDs to determine if the individual has an emergency medical condition (“EMC”), regardless of their ability to pay.  If there is no EMC, the hospital’s EMTALA obligations end.  If there is an EMC, the hospital must treat and stabilize the EMC within its capability or transfer the individual to a hospital that has the capability and capacity to stabilize the EMC. Hospitals with specialized capabilities may not refuse an appropriate transfer under EMTALA if they have the capacity to treat the transferred individual. In the wake of the COVID-19 pandemic, many hospital EDs are under increased strain due to an influx of patients with suspected or confirmed cases of COVID-19.  Hospitals are concerned not only about their ability to handle this unprecedented increase in ED patients but also about their ability to minimize the risk of exposure of COVID-19 to other ED patients as well as healthcare workers.  CMS released their guidance to address these concerns and to remind hospitals of their EMTALA obligations during the COVID-19 pandemic. On March 13, 2020, the Secretary of the U.S. Department of Health And Human Services (“HHS”) waived certain EMTALA requirements following President Trump’s declaration that the COVID-19 pandemic constitutes a national emergency. The HHS waiver specially waives sanctions 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.” Below is a FAQ of the guidance for Medicare-participating hospitals (including CAHs) issued by CMS as well as a summary of the EMTALA waivers issued by HHS. What do the screening, stabilization, and transfer requirements for hospitals under EMTALA look like in light of the implications of COVID-19? Generally speaking, Medicare-participating hospitals must, at a minimum, (1) provide a MSE to every individual who comes to the ED for examination or treatment for a medical condition to determine if they have an EMC (an EMC is present when there are acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in serious impairment or dysfunction); (2) provide necessary stabilizing treatment for individuals with an EMC within the hospital’s capability and capacity; and (3) provide for transfers of individuals with EMCs, when appropriate. Every hospital with a dedicated ED is required to conduct an appropriate MSE for all individuals who come to the ED, including individuals who are suspected of having COVID-19, regardless of whether they arrive by ambulance or are walk-ins, unless an EMTALA waiver applies (see FAQ #7 below). Every ED is expected to have the capability to apply appropriate COVID-19 screening criteria when applicable, to immediately identify and isolate individuals who meet the screening criteria to be a potential COVID-19 patient, and to contact their state or local public health officials to determine next steps. Is my hospital required to accept transfers of patients with suspected or confirmed cases of COVID-19 from small or rural hospitals that do not have appropriate or sufficient isolation facilities or equipment? Yes.  If your hospital has the capacity and the specialized capabilities needed for stabilizing treatment, then you are required to accept appropriate transfers from hospitals without such capacity and capabilities.  Hospitals should continue to coordinate with state and local public health officials regarding placement of individuals who meet COVID-19 assessment criteria and the most current standards of practice for treating COVID-19 as this situation continues to develop. The situation continues to change on a near-hourly basis. How will CMS determine whether an EMTALA violation has occurred? CMS has stated they will evaluate the capabilities and capacity of both the referring and recipient hospitals to determine whether a violation has occurred.  Because of the dynamic situation, this evaluation would include the recommendations of the Centers for Disease Control and Prevention (“CDC”) at the time the suspected violation occurred.  At the time of this writing, the CDC’s recommendations focus on factors such as the individual’s recent travel, exposure history, and presenting signs and symptoms in differentiating the types of capabilities hospitals should have to screen and treat individuals who have or may have COVID-19.  See the CDC website for the most current infection prevention and control recommendations for hospital patients with suspected or known cases of COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html). All hospitals are required to accept appropriate transfers of individuals with EMCs if the hospital has the specialized capabilities an individual requires for stabilization and the capacity to treat these individuals. This obligation applies regardless of whether the hospital has a dedicated ED. What are the requirements for alternative screening sites our hospital sets up on campus? Hospitals may set up alternative screening sites on campus.  CMS highlights that the MSE does not have to take place in the ED. A hospital may set up alternative sites on its campus to perform MSEs.  Individuals may be redirected to these sites after being logged in. The redirection and logging in can even take place outside the entrance to the ED.  The person doing the directing should be qualified (e.g., an RN) to recognize individuals who are in need of immediate treatment in the ED.  The content of the MSE varies according to the individual’s presenting signs and symptoms. It can be as simple or as complex, as needed, to determine if an EMC exists.  MSEs must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician’s assistants, or RNs trained to perform MSEs and acting within the scope of their State Practice Act. Finally, the hospital must provide stabilizing treatment (or appropriate transfer) to individuals found to have an EMC, including moving them as needed from the alternative site to another on-campus department. What are the requirements for alternative screening sites our hospital sets up off campus? Hospitals may set up screening at off-campus, hospital-controlled sites.  CMS guidance states that hospitals and community officials may encourage the public to go to these sites instead of the hospital for screening for influenza-like illness (“ILI”).  However, a hospital may not tell individuals who have already come to its ED to go to the off-site location for the MSE unless it is done pursuant to a state emergency preparedness plan. Unless the off-campus site is already a dedicated ED (“DED”) of the hospital, as defined under EMTALA regulations, EMTALA requirements do not apply. The hospital should not hold the site out to the public as a place that provides care for EMCs in general on an urgent, unscheduled basis. They can, however, hold it out as an ILI screening center.  The off-campus site should be staffed with medical personnel appropriately trained to evaluate individuals with ILIs. If an individual needs additional medical attention on an emergent basis, the hospital is required, under the Medicare Conditions of Participation, to arrange referral/transfer. Prior coordination with local emergency medical services is advised to develop transport arrangements. What if a screening suggests possible COVID-19? If an individual “comes to the emergency department” (as defined at 42 C.F.R. § 489.24(b)), the hospital must provide that individual with an appropriate MSE.  It is a violation of EMTALA for hospitals with EDs to use signage that presents barriers to individuals suspected of having COVID-19 from coming to the ED.  However, use of signage to direct individuals to alternative screening locations on campus would be acceptable. If, consistent with applicable standards for COVID-19 screening, a hospital determines an individual who has come to the ED may have COVID-19, the hospital is expected to isolate the patient immediately and coordinate with their state or local public health officials.  CMS expects all hospitals to, within their capability, provide MSEs and initiate stabilizing treatment while maintaining isolation in accordance with COVID-19 standards of practice. How do the EMTALA waivers relating to the COVID-19 outbreak change my hospital’s obligations under EMTALA? On March 13, 2020, the Secretary of HHS waived certain EMTALA requirements following the President’s declaration that the COVID-19 pandemic constitutes a national emergency. The HHS waiver specially waives sanctions 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.” The new EMTALA waiver permits a hospital to (1) redirect an individual to another location — including another hospital — to receive an MSE without first performing an MSE at the hospital if it is done pursuant to a state emergency preparedness plan, or (2) transfer an individual who has not yet been stabilized to another location if such actions are necessary and the result of circumstances due to the COVID-19 pandemic. HHS makes clear that the EMTALA waivers do not apply to any actions taken by a hospital that discriminate against individuals on the basis of their source of payment or ability to pay. The EMTALA waiver under Section 1135 does not appear to be a blanket waiver, so providers wishing to use the waiver may require “case-by-case” requests and approvals from your CMS Regional Office. “ The waiver is retroactively effective back to March 1, 2020 and will remain in effect for the duration of the national emergency period, unless terminated sooner.

The Centers for Medicare & Medicaid Services (“CMS”) recently posted two annual updates related to the physician self-referral law (“Stark Law” or “Stark”) on its Stark website: (1) CPI-U updates related to the nonmonetary compensation exception and medical staff incidental benefits exception; and (2) CPT/HCPCS codes used to identify certain categories of Stark designated health services (or “DHS”).  These updates are important for stakeholders to be aware of as they seek to ensure continued compliance with Stark Law requirements. CPI-U Updates As per usual, the CPI-U Updates page of the CMS Stark website, found here, was updated before the end of the year to reflect the new compensation limits (based on inflation) for the nonmonetary compensation exception (at 42 C.F.R. § 411.357(k)) and medical staff incidental benefits exception (at 42 C.F.R. § 411.357(m)).  For calendar year 2020, the non-monetary compensation limit is $423 (up from $416 for calendar year 2019) and medical staff incidental benefits must be less than $36 per occurrence (up from $35 in calendar year 2019). DHS Code List Updates As we explained in our blog post here, in the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), CMS finalized changes to the advisory opinion process under the Stark Law, and also included the annual update to the list of CPT/HCPCS codes used to identify certain categories of DHS (the “Code List”).  As we also explained, the Stark Law regulations at 42 C.F.R. § 411.351 specify that the following four categories of DHS are defined by reference to the Code List: (1) clinical laboratory services; (2) physical therapy, occupational therapy, and outpatient speech-language pathology services; (3) radiology and certain other imaging services; and (4) radiation therapy services and supplies.  The Code List is updated annually to reflect changes in the most recent CPT and HCPCS Level II publications. Further, items and services that may qualify for either of two Stark Law exceptions—the exception for preventive screening tests, immunizations and vaccines at 42 C.F.R. § 411.355(h) and the exception for EPO and other dialysis-related drugs at 42 C.F.R. § 411.355(g)—are identified by reference to the Code List.  The Code List included the annual updates to the codes eligible for the preventive screening tests, immunizations and vaccines exception.  However, as in previous years, the Code List does not include any codes eligible for the EPO and other dialysis-related drugs exception (for reasons explained by CMS in the rule).  The PFS rule includes tables showing the additions and deletions to the Code List. As per usual, the complete Code List was posted before the end of the year to the CMS Stark website dedicated to the Code List, found here.  The new list is effective January 1, 2020.

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”).  CMS also published its annual update to CPT/HCPCS codes used to identify certain categories of Stark designated health services (or “DHS”).  These regulatory changes and annual code update both go into effect on January 1, 2020. Finalized Changes to Stark Advisory Opinion Regulations Under the CMS advisory opinion process, the regulations for which are found at 42 C.F.R. §§ 411.370–389, parties can seek an advisory opinion from CMS as to whether a referral for DHS (other than clinical laboratory services) is prohibited under the Stark Law.  CMS determines in the opinion whether an arrangement constitutes a “financial relationship” that would implicate the Stark Law’s referral prohibition and whether the arrangement or the referred service qualifies for a Stark Law exception.  CMS issued a Request for Information (“RFI”) in June 2018 as part of the “Regulatory Sprint to Coordinated Care” about ways CMS could modify the Stark Law regulations in order to reduce barriers to patient care coordination and value-based arrangements and to reduce the regulatory burden of complying with the Stark Law generally, which we wrote about here.  CMS did not specifically solicit comments regarding the Stark advisory opinion process in the RFI, but CMS received a number of comments about ways that the Stark advisory opinion process could be improved.  CMS explains in preamble to the PFS that it “undertook a fresh review” of the advisory opinion process in light of the comments it received to “identify limitations and restrictions that may be unnecessarily serving as an obstacle to a more robust advisory opinion process.” CMS also recently issued sweeping proposed Stark Law regulatory changes as part of the Regulatory Sprint to Coordinated Care on topics related to the RFI, which we wrote about in a white paper available here.  While the changes to the advisory opinion regulations do not directly relate to the shift to a value-based health care delivery system, CMS acknowledges in preamble to the PFS that “a faster and more robust advisory opinion process facilitates the shift to value-based care arrangements by providing more guidance for parties trying to understand how the physician self-referral law applies in an evolving and innovative marketplace. This will help to reduce provider burden by providing insight into what does and does not comply with the law, which encourages innovation.” Since the initial advisory opinion regulations were issued in 1998, CMS has only issued 16 advisory opinions, which are available here.  (CMS also issued 15 advisory opinions from 2004-2005 during the 18-month moratorium on physician ownership and investment interests in specialty hospitals that was in effect at that time, which are available here.)  In contrast, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”), which has a separate advisory opinion process for the federal anti-kickback statute (“AKS”) and certain other laws, issued 14 advisory opinions in calendar year 2018 alone (available here).  In preamble to the PFS, CMS recognizes the importance of an accessible advisory opinion process and acknowledges that the current advisory opinion process has not been widely used.  An accessible advisory opinion process is particularly important in the context of the Stark Law, since it is a strict liability statute, and there is a great need for certainty because, as CMS acknowledges, “parties that act in good faith may nonetheless face significant financial exposure if they misunderstand or misapply the law’s exceptions.” We anticipate that the changes to the advisory opinion process may indeed help to make the process more meaningful and accessible to entities that are seeking to understand if their arrangement complies with the Stark Law, particularly due to CMS’s broadening of how advisory opinions can be relied upon (as described below).  If you are interested in submitting an advisory opinion request, or for advice on whether and how you can rely on a published advisory opinion in assessing an arrangement for compliance with the Stark Law, please contact the authors or your regular Dorsey attorney. The most notable changes to the advisory opinion regulations in the PFS are the following: Reliance on an Advisory Opinion: Under existing Stark regulations, only the individual or entity that requested the advisory opinion may rely on the opinion. In the PFS, CMS finalizes revisions to regulations to specify the following: An advisory opinion is binding on the Secretary of HHS, and a favorable advisory opinion means that sanctions will not be imposed under the Stark Law with respect to individuals/entities that are parties to the arrangement upon which the opinion was issued (as well as the individuals/entities that requested the opinion). The Secretary of HHS will not pursue sanctions under the Stark Law “against any party to an arrangement that CMS determines is indistinguishable in all its material aspects from an arrangement with respect to which CMS issued a favorable advisory opinion.” Parties can submit an advisory opinion request to determine whether CMS would view their arrangement as “indistinguishable in all material aspects” from another arrangement that has received a favorable opinion, which will be issued by CMS on an expedited basis (as explained below). Individuals/entities can rely on advisory opinions “as non-binding guidance that illustrates the application of the physician self-referral law and regulations to the specific facts and circumstances described in the advisory opinion.” CMS acknowledges that stakeholders already use advisory opinions to inform their decision-making, and this change is intended to make clear that “such reliance is permissible and reasonable.” Timeline for Issuing an Advisory Opinion: Under existing regulations, CMS currently has a 90-day timeframe to issue an advisory opinion. CMS finalizes its proposed changes to the regulatory text to shorten this to 60 “working days” (where “working day” excludes weekends and holidays) after the request has been formally accepted.  CMS maintains the discretion it has in existing regulations to extend this time period when a request involves “complex legal issues of first impression or highly complicated fact patterns” and to suspend the time period in certain circumstances. CMS finalizes revisions to regulations to provide for expedited review of advisory opinion requests that relate to whether an arrangement is “indistinguishable in all material aspects” from an arrangement that was the subject of a favorable advisory opinion. The expedited review period will be 30 working days. Fees for the Cost of Advisory Opinions: CMS finalizes revisions to regulations to revise the fee structure for advisory opinions. Specifically, the $250 initial fee is removed and a $220 hourly rate is implemented. In the PFS, CMS also finalizes its proposed changes to the advisory opinion regulations in the following areas (among others): Matters Subject to Advisory Opinions: CMS finalizes revisions to regulations to allow CMS to consider advisory opinion requests that “relate to” existing or planned arrangements, rather than requests that “involve” them, which is intended to capture the scope of appropriate advisory opinion requests. CMS explains that it remains its position that advisory opinion requests cannot be regarding only “hypothetical facts or general questions of interpretation,” but must be about a specific referral, physician, financial relationship and facts/circumstances. CMS does acknowledge, however, that there is some confusion over what is a planned arrangement versus a hypothetical arrangement, so is removing this language from the advisory opinion regulations.  It also revised the regulatory text to reflect its view that a request for an advisory opinion would not be accepted if the claim could not be billed to Medicare for some reason unrelated to the Stark Law. CMS finalizes revisions to regulations to allow CMS more flexibility related to advisory opinion requests that involve conduct that is “substantially similar to conduct that is under investigation or is the subject of a law enforcement proceeding.” Certification Requirement: CMS finalizes revisions to regulations to allow for any authorized officer of the corporation to sign the certification statement, in addition to the Chief Executive Officer. Rescission: CMS finalizes revisions to regulations related to when CMS may rescind an advisory opinion, which is when CMS determines that there is good cause to do so. “Good cause” exists when “(i) there is a material change in the law that affects the conclusions reached in an opinion; or (ii) a party that has received a negative advisory opinion seeks reconsideration based on new facts or law.”  CMS declines to adopt a minimum wind-down period in regulatory text for arrangements that are the subject of a rescinded advisory opinion, and states that it will work with parties affected by a rescinded opinion to determine a reasonable wind down period.  CMS also finalizes regulatory changes to provide for an advance notice to the requestor and the public of a rescinded opinion. 2020 DHS Code List and CPI-U Updates The PFS also includes the annual update to the list of CPT/HCPCS codes used to identify certain categories of DHS (the “Code List”).  As we explained in prior posts (such as this one), the Stark Law regulations at 42 C.F.R. § 411.351 specify that the following four categories of DHS are defined by reference to the Code List: (1) clinical laboratory services; (2) physical therapy, occupational therapy, and outpatient speech-language pathology services; (3) radiology and certain other imaging services; and (4) radiation therapy services and supplies.  The Code List is updated annually to reflect changes in the most recent CPT and HCPCS Level II publications. Further, items and services that may qualify for either of two Stark Law exceptions—the exception for preventive screening tests, immunizations and vaccines at 42 C.F.R. § 411.355(h) and the exception for EPO and other dialysis-related drugs at 42 C.F.R. § 411.355(g)—are identified by reference to the Code List.  The Code List included the annual updates to the codes eligible for the preventive screening tests, immunizations and vaccines exception.  However, as in previous years, the Code List does not include any codes eligible for the EPO and other dialysis-related drugs exception (for reasons explained by CMS in the rule).  The PFS rule includes tables showing the additions and deletions to the Code List.  We expect that, as per usual, the complete list will be posted before the end of the year to the CMS Stark website dedicated to the Code List, found here. We also expect that the CPI-U Updates page of the CMS Stark website, found here, will be updated before the end of the year to reflect the new compensation limits for the nonmonetary compensation exception (at 42 C.F.R. § 411.357(k)) and medical staff incidental benefits exception (at 42 C.F.R. § 411.357(m)), which are both updated annually for inflation.

The Centers for Medicare and Medicaid Services (CMS) has issued a final rule to require every hospital licensed in the United State to make public a robust set of standard charges for every item or service that the hospital bills.  In addition, CMS and other agencies have issued a proposed rule to require group health plans and health insurance issuers to: (1) disclose in-network negotiated rates and out-of-network allowed amounts for every health care item or service; and (2) offer a real-time tool to provide a plan enrollee with an estimate of cost-sharing and out-of-pocket expenses associated with plan covered items and services. The hospital price disclosure rule is effective January 1, 2021.  Hospitals and hospital trade associations have stated that they will bring a legal challenge against the final rule as exceeding CMS’ legal authority. The rule will require every licensed hospital to provide two separate sets of standard charge lists: (1) a list of standard charges for at least 300 “shoppable” hospitals services that a consumer can schedule in advance; and (2) a comprehensive list of standard charges for all items and services for which the hospital establishes a charge.  Both lists must be updated at least annually and placed on a publicly-accessible website.  Only hospitals are regulated under the final rule; ambulatory surgery centers or other clinics or facilities that may provide items and services that are also performed in hospitals are not required to report pricing. For the comprehensive charge list the hospital must report seven data elements for each item or service: (1) description; (2) code used to bill the item or service; (3) hospital’s gross charge; (4) negotiated rate with every third party payer (linked by name to the third party payer and plan); (5) highest charge the hospital has negotiated with any third party payer; (6) lowest charge the hospital has negotiated with any third party payer; and (7) charge applicable to an individual who pays cash.  The “shoppable” charge list must include similar data elements, with the addition of the hospital location(s) at which the “shoppable” service is provided.   The resulting report will be an exceedingly dense data set of hundreds of thousands of line items for a typical hospital. The biggest change the final rule would effect is that payment rates that a hospital negotiates with third party payers would no longer be confidential or proprietary, and would in fact be public information under the final rule. CMS made clear that a hospital must report data on all items or services the hospital provides and charges, including the professional services of its employed physicians or other clinicians.  This appears to apply only to the hospital itself (presumably identified by NPIs associated with the hospital) and not to separate corporate entities, formed for the purpose of operating physician group, that do not operate the hospital but may be owned by the same entity (or corporate affiliate) that operates the hospital. The health plan proposed rule would require every group health plan or health insurance issuers to make available on a website a negotiated rate file that lists: (1) the name and Employer Identification Number (EIN) or Health Insurance Oversight System (HIOS) identifier for each plan option or coverage offered; (2) codes and plan language description for each item or service; and (3) negotiated rate for each item or service furnished by every in-network provider (linked by National Provider Identifier (NPI) to each in-network provider) along with the last date of contract term for that rate.  A separate file that lists out-of-network allowed amounts for each items or service furnished by out-of-network providers must also be posted.  These lists must be updated monthly under the proposed rule. In addition, health plans must offer a tool to allow plan enrollees to obtain real-time information about cost-sharing information with regard to specific items or services. Unless halted by courts, hospitals will need to begin the considerable work of compiling and formatting the data files required under the final rule.  And, although it is unclear how the hospital pricing data will be analyzed and used (and by whom), hospitals should analyze their own pricing data and begin anticipating and preparing for the questions and critiques that will arise.

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP) for beneficiary inducements.  The proposed rules are part of HHS’s “Regulatory Sprint to Coordinated Care,” which seeks to remove regulatory obstacles to care coordination and a value-based healthcare delivery system. The HHS press release regarding the proposed rules is available here,  and includes links to each of the CMS and OIG proposed rules.  For our prior posts on the Regulatory Sprint to Coordinated Care, see here and here. Relatedly, the Substance Abuse and Mental Health Services Administration (SAMHSA) published proposed rules to revise privacy rules for substance use disorder records on August 26, and CMS published proposed rules to revise the Stark Law advisory opinion regulations on August 14 (as part of the Medicare Physician Fee Schedule proposed rule). We are reviewing the proposed rules and will post an in-depth analysis shortly.