July 6, 2020

Volume X, Number 188

July 06, 2020

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CMS Updates Waivers, Provides More Flexibility for Providers Responding to COVID-19

As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of the regulatory challenges currently facing providers responding to COVID-19, and providers must be careful to continue to track the scope of CMS’ flexibilities, they will be very helpful to many providers in their ongoing COVID-19 response efforts.  In particular, and among other things, CMS’ new guidance expands flexibility for telehealth services, provides additional support for COVID-19 testing, relaxes additional regulatory requirements applicable to certain payors, provides other key regulatory flexibilities, and offers guidance to MSSP ACOs on payment calculations for periods affected by the public health emergency.

We will be providing in-depth analysis of many of these new flexibilities over the coming week.  Below, we highlight key aspects and themes for immediate consideration.

  1. CMS Continues to Emphasize and Expand Telehealth Flexibilities

Telehealth has played a critical role in COVID-19 response efforts, allowing providers to more safely and efficiently treat many patients during the crisis.  In recognition of this role, CMS has dramatically expanded Medicare coverage of telehealth services, including by eliminating restrictive originating site requirements to allow physicians to furnish telehealth services to patients anywhere, by allowing physicians to furnish telehealth services via video-enabled smart phones, and by expanding the list of services covered when provided via telehealth.  Despite this expansion, challenges have remained for providers seeking to rapidly ramp up telehealth capacity during the public health emergency.  CMS’ new flexibilities address, at least in part, several of those challenges, in particular through the following changes:

  • Expansion of Eligible Practitioners. CMS is waiving statutory requirements limiting the types of practitioners that can furnish and bill Medicare for telehealth services  This waiver will allow a broader range of professionals, including physical therapists, occupational therapists, speech language pathologists, and others, to furnish and bill Medicare for telehealth services.

  • Audio-Only Telehealth Services. CMS will allow providers to furnish and be reimbursed for certain audio-only telephone evaluation and management services, and behavioral health counseling and educational services.  CMS is also increasing payments for audio-only telephone visits from a range of about $14-$41 to about $46-$110, retroactive to March 1, 2020.  Other services included on the telehealth services list will continue to require the use of a video component.

  • Hospital Billing. In response to numerous hospital concerns about telehealth billing, CMS will allow hospitals to bill for services furnished remotely by hospital-based practitioners to registered hospital outpatients, including when the patient is at home and the home is serving as a temporary provider-based department of the hospital.  CMS will also allow hospitals to bill when serving as originating sites for telehealth services furnished by hospital-based practitioners to registered hospital outpatients.

  1. CMS Offers Additional Support for COVID-19 Testing

Effectively responding to the COVID-19 crisis depends heavily on increasing access to testing, which will identify patients who have the virus – enabling efforts to minimize its spread – and potentially individuals who may have developed some immunity to the virus.  CMS seeks to provide additional support for this testing through several new flexibilities.  First, Medicare will allow diagnostic tests, including COVID-19 testing, to be supervised by a nurse practitioner, clinical nurse specialist, physician assistant, or certified nurse midwife during the public health emergency. Medicare will also no longer require a practitioner’s order for a beneficiary to receive a COVID-19 test, or tests required as part of COVID-19 diagnosis.  Tests will be covered so long as they are requested by any authorized professional, and a written order will not be required.  When a COVID-19 test is furnished without an order, the laboratory must directly notify the patient of the test results, and meet other test reporting requirements.

Additionally, Medicare will pay separately for patient assessment and specimen collection for COVID-19 testing by hospitals and practitioners when those are the only services the patient receives.  Medicare and Medicaid will also cover serology tests that may help to determine whether an individual has developed an immune response to COVID-19.

  1. CMS Continues to Clarify the Broad Scope of Its Hospital Without Walls Initiative

CMS has provided substantial flexibility for hospitals to furnish and bill for hospital services provided at alternate expansion sites during the public health emergency.  In furtherance of that initiative, CMS is offering additional clarity as to the impact of expansion on payment for certain facility types, as well as the scope of its Hospital Without Walls flexibility.  For instance, CMS states explicitly in the IFC that it will allow “payment for outpatient hospital services – such as wound care, drug administration, and behavioral health services – that are delivered in temporary expansion locations, including parking lot tents, converted hotels, or patients’ homes (when they’re temporarily designated as part of a hospital).”

CMS also explains that it will allow certain on-campus provider-based hospital outpatient departments to relocate off-campus, on or after March 1, 2020, and continue to be paid under OPPS through expansion of its extraordinary circumstances relocation exception.  CMS explains that relocating departments will need to notify their CMS Regional Offices of the relocation via email, but CMS will also allow such departments to begin furnishing and billing for services under OPPS in the new location prior to submitting documentation to the Regional Office.  CMS notes that hospitals may also relocate outpatient departments to more than one off-campus location, or partially locate off-campus while still furnishing care at the original site.  This flexibility will allow hospitals to temporarily relocate their on-campus or excepted off-campus departments to alternate locations, including patient homes, and to bill for services furnished in these locations with the -PO modifier. CMS also notes that “[i]f Medicare-certified hospitals will be rendering services in relocated excepted provider-based departments (PBDs), but intend to bill Medicare for the services under the main hospital, no additional provider enrollment actions are required.”

  1. CMS Continues to Ease Regulatory Burdens on Providers

A major focus of CMS’ IFC and its new waivers is decreasing regulatory and administrative burden on providers to enable a greater focus on patient care, as well as using regulatory flexibility to enable access to care.  This focus manifests in many aspects of the IFC.

            Waiver of Physical Environment Requirements

As health care facilities have expanded and reorganized to facilitate patient care during the COVID-19 emergency, many have experienced challenges in immediately and consistently meeting all CMS requirements for physical environment.  Moreover, many inspectors, agencies, and accreditation organizations are not willing or not able to make onsite visits to facilities consistent with various stay-at-home orders and social distancing recommendations.  In view of these challenges, CMS is offering additional flexibility with respect to physical environment requirements for hospitals, critical access hospitals, inpatient hospices, ICD/IIDs, and SNFs/NFs during the public health emergency.  In particular, CMS is waiving requirements for these facilities to maintain equipment as is necessary to permit these facilities to adjust scheduled inspection, testing, and maintenance (ITM) frequencies and activities for the equipment, and requirements for these facilities to comply with most of the Life Safety Code (LSC) and Health Care Facilities Code (HCFC) to permit these facilities to adjust scheduled ITM frequencies and activities.  CMS is also waiving requirements for these facilities to have an outside window or outside door in every sleeping room, to permit these providers to use facility and non-facility space not normally used for patient care as needed for temporary patient care or quarantine.

            Home Health Agency and Hospice Flexibilities

Home health agencies have experienced unique challenges during the COVID-19 crisis.  Home health services may provide an important avenue to care for beneficiaries at increased risk of contracting COVID-19 at medical facilities or of spreading the disease.  At the same time, face-to-face contact between home health care providers and patients may also need to be limited to effectively control infection risk.  In view of these challenges, and as mandated by the CARES Act, CMS will now – and retroactively to March 1, 2020 – allow nurse practitioners, clinical nurse specialists, and physician assistants to: (1) order home health services, (2) establish and periodically review plans of care, and (3) certify and re-certify patients’ eligibility for home health services.  CMS is also waiving several regulatory requirements for HHAs and hospices, including postponing training deadlines and deadlines for completion of supervisory visits, waiving requirements related to certain discharge planning information, modifying QAPI requirements, and providing additional time to provide patients with copies of their records.

            Rural Health Clinic (RHC) Flexibilities

A critical source of treatment for many patients, RHCs operate pursuant to different regulatory frameworks and different payment structures than other providers.  As such, many of CMS’ initial waivers, targeted at traditional hospitals, did not apply to RHCs.  Recognizing RHCs’ key treatment role and their need for additional flexibility, CMS provides in the IFC that hospital bed expansion in response to COVID-19 will not impact RCH payment.  CMS is also waiving the requirement that a nurse practitioner, physician assistant, or certified nurse-midwife be available to furnish patient care services at least 50% of the time the RHC operates, offering RHCs additional staffing flexibility during the public health emergency.

            Teaching Hospital Flexibilities

In the IFC, CMS provides that teaching hospitals may increase their temporary beds without facing reduced payments for indirect medical education and that CMS will not reduce Medicare payments for teaching hospitals that shift their residents to other hospitals to meet COVID-related needs, or penalize hospitals that accept these residents.  CMS is also expanding on the flexibility it provided in the interim final rule that was effective March 31 to allow teaching physicians to review services provided with the resident during or immediately after the visit using telecommunications technology, and is also expanding the list of services for which Medicare will pay the teaching physician when furnished by a resident under the primary care exception.

            Long-Term Care Facility and Nursing Facility Flexibilities

To allow long-term care and nursing facilities to focus their efforts on patient care during the public health emergency, CMS is waiving several regulatory requirements, including postponing training deadlines, waiving requirements related to certain discharge planning information, modifying QAPI requirements, and providing additional time to provide patients with copies of their PBD.

            Flexibility for Ambulatory Surgery Centers (ASCs)

Like hospitals, ASCs have been subject to new and challenging demands during the COVID-19 crisis, which have created staffing challenges for many.  In recognition of these challenges, CMS is waiving the requirement that medical staff privileges be periodically reappraised and that the scope of procedures performed in an ASC be periodically reviewed.

            Flexibility for Mental Health Services

The COVID-19 emergency has ushered in not only a physical but also a mental health crisis, as many have limited access to mental health services while complying with social distancing recommendations or stay-at-home orders, and as rates of depression, anxiety and other mental health issues rise with increased isolation combined with worry about the pandemic and its effects.  Community mental health centers (CMHCs) are an important source of the mental health care required to address this crisis.  In view of this key role, CMS is offering new flexibilities designed to reduce administrative burdens on CMHCs.  CMS’ changes include permitting CMHCs to provide partial hospitalization services and other CMHC services in an individual’s home, including through telecommunication technology, to allow patients to safely shelter in place during the public health emergency.  Additionally, CMS is more generally providing that certain partial hospitalization services – that is, individual psychotherapy, patient education, and group psychotherapy – furnished by CMHCs or by hospitals may be covered when delivered in temporary expansion locations, including patients’ homes and when delivered by telecommunications technology.

            Additional Key Flexibilities

Largely in response to stakeholder comments and questions over the past several weeks, CMS is also providing the following additional flexibilities to help improve health care access and ease regulatory burden during the public health emergency.

  • Therapy Assistant Services. CMS will allow physical and occupational therapists to delegate outpatient maintenance therapy services to physical and occupational therapy assistants.

  • RPM Services. CMS is adding to its flexibilities to “eliminate as many unnecessary obstacles as possible to delivering” remote patient monitoring (RPM) services to allow RPM services to be reported to Medicare for periods fewer than 16 of the 30 days, but not less than two days.

  • Clinical Indications for CGM. CMS will exercise discretion not to enforce the clinical indications for therapeutic continuous glucose monitors in LCDs; for instance, it will not enforce clinical indications restricting the type of diabetes that a beneficiary must have or relating to demonstrated need for frequent glucose testing.

  • Hospital Value-Based Program Reporting. CMS is granting an extraordinary circumstance exception with respect to all hospitals participating in the Hospital Value-Based Program for specified reporting requirements.

  1. CMS Addresses Challenges Particular to the Medicare Shared Savings Program

CMS is forgoing the annual MSSP application cycle for 2021 and giving ACOs whose participation is set to expire this year an option to extend their participation for another year.  Additionally, ACOs that are required to increase their financial risk over their agreement periods will be allowed to maintain their current risk level for next year if they so choose.

CMS is also making adjustments to the financial methodology used to calculate ACO payments to account for COVID-19 costs, in particular by excluding from Shared Savings Program calculations all Parts A and B FFS payment amounts for an episode of care for the treatment of COVID-19, triggered by an inpatient service, and as specified on Parts A and B claims with dates of service during the episode.  CMS is applying its extreme and uncontrollable circumstances policy beginning in January 2020, consistent with the beginning of the public health emergency (not March 2020, as stated in CMS’ previous interim final rule) through the end of the public health emergency.

CMS is also expanding the list of codes used in beneficiary assignment to include codes for virtual check-ins, e-visits, and telephone E/M services, to reflect the importance of these services during the COVID-19 pandemic.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 122

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About this Author

Partner

Mr. Paddock's practice primarily involves healthcare fraud and abuse matters, particularly those relating to civil False Claims Act, physician self-referral (Stark Law), and anti-kickback issues. He often advises clients on compliance and transactional matters, the conduct of internal investigations related to potential fraud and abuse issues, and responding to and defending against government anti-fraud and abuse enforcement efforts and regulatory inquiries, including qui tam and government allegations of False Claims Act violations. He is an active member of...

202-747-1954
Associate

Ms. Kraus focuses her practice on representing healthcare entities in regulatory compliance matters.  Ms. Kraus advises clients on compliance with federal and state fraud and abuse laws, assists clients in responding to government investigations, and represents clients in False Claims Act litigation.  Ms. Kraus also assists clients with regulatory due diligence in transactional matters, and through advocacy with federal and state regulators, and leverages her background in health policy to help clients maximize opportunities in the changing healthcare landscape.  Representative matters include:

  • Drafting and submitting self-disclosures through CMS’ Self-Referral Disclosure Protocol
  • Assisting in internal investigations of reported potential regulatory non-compliance
  • Responding to government Civil Investigative Demands
  • Representing defendants in False Claims Act litigation
  • Advising clients on compliance with the Civil Monetary Penalties Law and Anti-Kickback Statute
  • Preparing filings with the Provider Reimbursement Review Board
  • Advising clients on the potential impact of MACRA implementatio
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