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CMS Interim Final Rule – Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (PHE)

Craneware® Insights Regulatory Updates – CWI1234 (12 May 2020)


Topic

CMS Interim Final Rule – Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (PHE)

On April 30, 2020, Medicare issued a second interim final rule in response to the COVID-19 pandemic entitled “Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (42 CFR Parts 409, 410, 412, 414, 415, 424, 425, 440, 483, 484 and 600) [CMS-5531-IFC]. This interim final rule contains additional information on changes Medicare has made to existing regulations to provide flexibilities for Medicare beneficiaries and providers to respond effectively to the 2019 Novel Coronavirus (COVID-19) public health emergency (PHE).

Provider Types Affected

Critical Access Hospitals
Comprehensive Outpatient Rehabilitation Facility
OPPS Hospitals
Provider-Based FQHC
Provider-Based Rural Health Clinics
Physicians

Departments/Areas Affected

AntiCoagulation Clinic
Business Office
Chemotherapy
Compliance / Revenue Integrity
OP Diabetes Education
Finance
Infusion Therapy
Laboratory – General
HIM/Medical Records
Medical Nutrition Therapy
Occupational Therapy
Outpatient Psychiatric
OP Clinics
Partial Hospitalization Program Pharmacy
Physical Therapy
Speech Therapy
Telemedicine
Wound/Ostomy Clinic

What You Need to Know

The provisions in this interim final rule (CMS-5531-IFC) are effective May 8, 2020, with applicability dates of January 27, 2020 or March 1, 2020, except where otherwise noted. The final provisions included in this IFC are only for the duration of the COVID-19 PHE, unless otherwise indicated (85 FR 27553).

CMS is providing a 60-day public comment period for this IFC for which comments must be received by CMS no later than 5 p.m. on July 7, 2020. Instructions for comment(s) submission can be found on the first page of the interim final rule.

This second interim final rule revises regulations that were published in the first IFC, which was posted in the Federal Register on April 6, 2020. It also implements regulations in response to recent legislation in the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020), the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020), and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020).

Key Dates Concerning the COVID-19 Pandemic:

  • January 30, 2020: The International Health Regulations Emergency Committee of the World Health Organization (WHO) declared a “Public Health Emergency of international concern”;
  • January 31, 2020: Health and Human Services Secretary, Alex M. Azar II, determined that a Public Health Emergency (PHE) exists for the United States;
  • March 11, 2020: WHO publicly declared COVID-19 a pandemic;
  • March 13, 2020: The President of the United States declared the COVID-19 pandemic a national emergency; and
  • April 21, 2020: Secretary Azar renewed the determination that a PHE exists, effective April 26, 2020.

As with the first interim final rule, the information in the second interim final rule pertains to many types of providers and suppliers. This Craneware Insights article provides a summary of information applicable to the types of providers/supplies for whom we normally provide regulatory updates. A list of topics for which we did not provide a summarization are posted at end of this article.

The following information presents the regulatory changes CMS has made subsequent to the first interim final rule in response to the COVID-19 pandemic.

Supervision of Diagnostic Tests by Certain Nonphysician Practitioners

Under current regulation(s) nurse practitioners (NPs), physician assistants (PAs), clinical nurse specialists (CNSs) and certified nurse midwives (CNMs) may order and furnish directly (“incident to” their own professional services) diagnostic tests paid under the Physician Fee Schedule (PFS), to the extent authorized under their state scope of practice. Diagnostic tests furnished by PAs must be under the appropriate level of physician supervision. Regulations under § 410.32 do not address whether NPs, CNNs, PAs, and CNMs may supervise others when furnishing diagnostic tests.

CMS is implementing changes to allow NPs, CNs, PAs, and CNMs to order, furnish directly, and supervise the performance of COVID-19-related and other diagnostic tests payable under the PFS, subject to applicable state law. CMS is also implementing interim changes to allow diagnostic tests to be performed by a PA without supervision and to allow NPs, CNs, PAs, and CNMs to supervise COVID-19 related diagnostic psychological and neuropsychological testing, in addition to physicians and clinical psychologists (85 FR 27555-27556).

Therapy Assistants Furnishing Maintenance Therapy

Currently, maintenance therapy for medically necessary services that are provided to maintain, prevent or slow the deterioration of a patient’s condition requires the skills of a physical therapist (PT) or occupational therapist (OT), to carry out a therapist-established maintenance program. Therapists and providers are required to use the “CO” and “CQ” modifiers on claims for services furnished by physical therapy assistants (PTAs) or occupational therapists (OTAs) to indicate that a supervised therapy assistant performed the rehabilitative or maintenance therapy services.

During the COVID-19 PHE, CMS will permit PTs and OTs who establish maintenance programs to delegate the performance of maintenance therapy to a PTA or OTA (85 FR 27556).

Medical Record Documentation

In the CY 2020 Physician Fee Schedule (PFS) final rule, CMS changed the medical record documentation requirements to allow the physician, PA, NP, CNS, CNM and CRNA who furnishes and bills for their professional services to review and verify, rather than re-document information included in the medical record by physicians, residents, nurses, students or other members of the medical team. This principle applies across the spectrum of all Medicare-covered services paid under the PFS.

During the PHE, CMS is allowing for any individual who may furnish and bill for their professional services under Medicare to review and verify (sign and date) notes in the medical record made by physicians, residents, nurses, and students, or other members of the medical team. This policy ensures that therapists may also review and verify notes in the medical record rather than spend time re-documenting information (85 FR 27556).

Pharmacists Providing Services Incident to a Physicians’ Service

CMS is clarifying that pharmacists may provide services, particularly medication management services, incident to the services, and under the appropriate level of supervision of the billing physician or non-physician practitioner (NPP) in accordance with the pharmacist’s state scope of practice and applicable state law. if payment for the service is not made under the Medicare Part D benefit. This clarification does not alter current payment policy for pharmacist services furnished incident to the professional services of a physician or NPP. The clarification is intended to encourage pharmacists to work with physicians and NPPs in new ways that expand the availability of health care services during the COVID-19 PHE and to increase access to medication management of individuals with substance/opioid use disorder (85 FR 27557).

Modified Requirements for Ordering COVID-19 Diagnostic Laboratory Tests

For the duration of the COVID-19 PHE,CMS is allowing laboratory tests for influenza virus and respiratory syncytial virus, in addition to COVID-19 laboratory testing, to be ordered by any healthcare professional authorized to do so under state law. CMS is removing the treating physician or NPP ordering requirement for these additional diagnostic laboratory tests only when they are furnished in conjunction with a COVID-19 diagnostic laboratory test as medically necessary in the course of establishing or ruling out a COVID-19 diagnosis or for identifying patients with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection.

For the duration of the COVID-19 PHE, Medicare will not require an order from a treating physician or NPP as a condition of Medicare coverage of COVID-19 testing or any other diagnostic laboratory test that is necessary to establish or rule out a COVID-19 diagnosis. When an order is written for the laboratory test(s), the entity submitting the claim for the test(s) is required to include the ordering or referring NPI information on the claim form. When the COVID-19 tests are furnished without a physician’s or NPP’s order, the laboratory conducting the tests is required to directly notify the patient of the test results (85 FR 27558).

Opioid Treatment Programs (OTPs) – Furnishing Periodic Assessments via Communication Technology

In the March 31, 2020 COVID-19 IFC, CMS allowed the therapy and counseling portions of the OTP weekly bundle of services to be furnished using audio-only telephone calls rather than two-way interactive audio-video communication technology during the PHE. In the April 30, 2020 COVID-19 IFC, CMS is also allowing the periodic assessments to be furnished via two-way interactive audio-video communication technology or audio-only telephone calls for the duration of the COVID-19 PHE (85 FR 27558).

The April 30, 2020 IFC includes multiple links to the Substance Abuse and Mental Health Services Administration (SAMHSA) for resources on OTP guidance during the PHE (see pages 27558-27559).

Treatment of Certain Relocating Provider-Based Departments (PBDs) During the COVID-19 PHE

CMS is adopting an expanded version of the extraordinary circumstance relocation policy for the duration of the PHE. In addition to applying the extraordinary circumstances policy for excepted off-campus departments that relocate to a different off-campus location due to circumstances outside of the hospital’s control, on-campus departments that relocate on or after March 1, 2020, during the COVID-19 PHE, may also seek an extraordinary circumstance relocation exception so that they may continue to bill at the OPPS rate, as long as their relocation is not inconsistent with the state’s emergency preparedness or pandemic plan.

Hospitals that choose to permanently relocate these PBDs off-campus, after the end of the PHE, will be considered new off-campus PBDs, and therefore, will be considered a non-excepted off-campus department for purposes of Medicare Part B payment. The on-campus and excepted off-campus PBDs that permanently relocate will be required to use the “PN” modifier and will be reimbursed at the PFS-equivalent payment rate.

Following the end of the COVID-19 PHE, hospitals may seek an extraordinary circumstances relocation exception for excepted off-campus locations that have permanently relocated, but these hospitals would need to follow the standard extraordinary circumstances application process that was adopted in CY 2017 and file an updated CMS-855A enrollment form to reflect the new address(es) of the PBD(s). The standard relocation policy only applies to excepted off-campus PBDs that relocate. On-campus PBDs that wish to permanently relocate are not eligible to receive an extraordinary circumstances relocation exception (CMS-85 FR 27560).

New Exception Process for Extraordinary Circumstances Relocation of Existing On-Campus and Excepted Off-Campus PBDs

Hospitals that relocate on-campus or excepted off-campus PBDs to off-campus locations in response to the COVID-19 PHE should notify their CMS Regional Office (RO) by email of the relocation. The email should include the following information:

  • Hospital’s CCN;
  • Address of current PBD;
  • Address of relocated PBD;
  • Date which they began furnishing services at the new PBD;
  • A brief justification for the relocation and the role of the relocation in the hospital’s response to COVID-19; and
  • Attestation that the relocation is not inconsistent with their state’s emergency preparedness or pandemic plan.

CMS states that they expect hospitals to include in their justification for the relocation why the new PBD location (including instances where the relocation is to the patient’s home) is appropriate for furnishing covered outpatient items and services. CMS also states that to the extent a hospital may relocate to an off-campus PBD that is the patient’s home, only one relocation request per location is necessary during the COVID-19 PHE. CMS has stated in various question and answer sessions that a notification email may include multiple off-campus PBD addresses and needs to be made only once for each address. Hospitals must send the email to the CMS Regional Office within 120 days of beginning to furnish and bill for services at the relocated on-or-off-campus PBD(s).

For purposes of the COVID-19 PHE, hospitals may relocate part of their excepted PBD to a new off-campus location(s) while maintaining the original PBD location and continue to bill under the OPPS under the revised extraordinary circumstances policy during the COVID-19 PHE.

CMS reiterates that the relocation or partial relocation of an on-campus or excepted off-campus PBD may relocate to a patient’s home (for purposes of furnishing a covered OPD service) which under the Hospitals without Walls initiative, can be provider-based to the hospital during the COVID-19 PHE. The patient’s home would be considered a PBD of the hospital when the patient is registered as a hospital outpatient and is receiving covered OPD services from the hospital.

If the hospital considers the beneficiary’s home a relocated PBD, and follows the temporary extraordinary circumstances exception policy, the hospital would bill the applicable HCPCS code along with the “PO” modifier to continue to receive payment under the OPPS. If the hospital does not seek an extraordinary circumstances relocation exception for their PBD, the hospital will be paid under the PFS.

CMS expects that the number of relocations will be limited and that the services would be consistent with the on-campus or excepted off-campus PBD. For example, if the PBD is an oncology clinic, CMS would expect the hospital would provide oncologic services in the relocated PBD (85 FR 27561-27562).

Furnishing Outpatient Services in Temporary Expansion Locations of a Hospital or a Community Mental Health Center (CMHC) (including the Patient’s Home)

During the COVID-19 PHE, the section 1135 waivers of the provider-based rules allow temporary expansion locations to become provider-based to the hospital to bill for medically necessary hospital outpatient therapeutic services furnished at those locations assuming all other applicable requirements are met, effective March 1, 2020.

For clarification purposes, CMS considered hospital outpatient therapeutic services in three categories:

  1. Hospital outpatient therapy, education, and training services, including partial hospitalization program services that can be furnished other than in-person, and are furnished in a temporary expansion location (which may be the patient’s home) that is a PBD of the hospital or an expanded CMHC
  2. Hospital outpatient clinical staff services furnished in-person to the beneficiary in a temporary expansion location; and
  3. Hospital services associated with a professional service delivered by telehealth.

Hospital Outpatient and CMHC Therapy, Education, and Training Services

In the discussion concerning hospital/CMHC therapy services, CMS is including behavioral health, education, and training services furnished by hospital-employed counselors or other licensed professionals. Examples of the services include psychoanalysis, psychotherapy, diabetes self-management training, and medical nutrition therapy. In many cases, these services are billable by hospitals under the OPPS.

With the section 1135 blanket waivers that allow the hospital to consider the beneficiary’s home or any other temporary expansion location operated by the hospital to be a PBD of the hospital, the hospital’s clinical staff may provide outpatient therapy, education, and training service to a patient in the hospital (which can include the patient’s home) and the patient is registered as an outpatient of the hospital.

CMS reminds us that physician supervision for most of the hospital outpatient therapeutic services must still be furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the service. CMS has provided a list of the outpatient therapy, counseling, and educational services that hospital clinical staff can furnish incident to a physician’s or qualified NPP’s service during the COVID-19 PHE, which can be accessed via the following link:

https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

Services furnished by the hospital still require an order by the physician or qualified NPP and must be supervised by a physician or other NPP appropriate for supervising the service given their hospital admitting privileges, state licensing, and scope of practice, consistent with the requirements in § 410.27. The hospital should bill for these services as if they were furnished in the hospital (85 FR 27563).

Partial Hospitalization Program (PHP)

For the duration of the COVID-19 PHE, providers can furnish certain partial hospital services remotely to patients in a temporary expansion location of the hospital or CMHC, which may include the patient’s home. The following services may be furnished to beneficiaries by facility staff using telecommunications technology during the COVID-19 PHE:

  • Individual psychotherapy
  • Patient education
  • Group psychotherapy

CMS expects that the telecommunications technology will consist of audio and video capabilities except for those instances where the beneficiary might not have access to video communication technology. CMS has provided a list of individual psychotherapy, patient education, and group psychotherapy services that hospital or CMHC staff can furnish during the COVID-19 PHE to a beneficiary in their home or other temporary expansion location that functions as a PBD of the hospital or expanded CMHC, when the beneficiary is registered as an outpatient, which can be accessed via the following link:https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers (click on “List of Hospital Outpatient Services and List of Partial Hospitalization Program Services Accompanying the 4/30/2020 IFC”).

All other PHP requirements are unchanged and still in effect, including that all PHP services still require an order by a physician, must be supervised and certified by a physician, and must be furnished in accordance with coding requirements by a clinical staff member working within his or her scope of practice (85 FR 27564).

Community Mental Health Centers

For the duration of the COVID-19 PHE, CMS will consider temporary expansion locations where the beneficiary may be located (including the patient’s home) to be a part of the CMHC once a patient is registered as an outpatient of the CMHC, while PHP services are being furnished by CMHC staff in accordance with the supervising practitioner’s scope of practice. The CMHC should bill for these services as if they were furnished in the CMHC (85 FR 27564).

Hospital In-Person Clinical Staff Services in a Temporary Expansion Location

Several outpatient hospital services are furnished by clinical staff under a physician’s or qualified NPP’s order that do not require professional work by the physician or qualified NPP, which are billed under the OPPS. These types of services would include wound care, chemotherapy administration, and other drug administration and require the hospital’s clinical staff presence to furnish the service.

For the duration of the COVID-19 PHE, hospitals may furnish and bill for these clinical staff services in the patient’s home as an outpatient PBD when the patient is registered as a hospital outpatient. These services cannot be furnished via telecommunication technology by the hospital. During the time period the patient is receiving services from the hospital as a registered outpatient, the patient’s home cannot be considered a home for purposes of HHA services. The hospital should be aware if the patient is under a home health plan of care, it must not furnish services to the patient that could be furnished by the HHA while the plan of care is active.

These services still require an order by the physician or qualified NPP and the physician supervision level must still be met, which is usually a “general” level of supervision.

Hospitals should bill for these services as they would ordinarily along with any specific billing requirements for relocating PBDs during the COVID-19 PHE (85 FR 27565).

Hospital Services Accompanying a Professional Service Furnished Via Telehealth

For the duration of the COVID-19 PHE, practitioners who are furnishing telehealth services to a patient who is located at home (or in other location that is not considered a telehealth originating site ) who ordinarily practice in a HOPD, should submit their claims with the place of service code indicating the service was furnished in the HOPD and use the “95” modifier (telehealth). CMS will then pay the practitioner’s claim at the “facility” rate.

HCPCS Description APC SI National Unadjusted Payment Rate
C9803 Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), any specimen source 5731 Q1 $23.46

Additionally, when a registered outpatient of the hospital is receiving a telehealth service, the hospital may bill the originating site facility fee (Q3014) to support such telehealth services furnished by a physician or practitioner who ordinarily practices there. This includes services furnished by a physician or practitioner located at a distant site to a patient who is located in the home after the patient’s home has been made provider-based to the hospital. The home would be considered a PBD of the hospital (originating site for the telehealth service) (85 FR 27566).

Medical Education

Teaching hospitals, inpatient rehabilitation facilities (IRFs) and inpatient psychiatric facilities (IPFs) receive adjusted payment amounts to account for the higher indirect patient care costs of teaching hospitals relative to non-teaching hospitals. CMS is changing current policies for calculating IME payments and teaching status payment adjustments so that these facilities do not experience undue reductions in payment amounts for the duration of the COVID-19 PHE. For details on the changes to the policies for each facility type, please refer to 85 FR 27567-27568.

Rural Health Clinics

CMS is changing policies that apply to provider-based rural health care centers (RHCs). Provider-based RHCs that were exempt from the national per-visit payment limit in the period prior to the effective date of the PHE (January 27, 2020) will continue to be exempt for the duration of the COVID-19 PHE (85 FR 27569).

Additional Flexibility under the Teaching Physician Regulations

In the primary care setting, regulations under Section 415.174(a)(30) require teaching physicians to be immediately available to direct the care furnished by a resident to a patient (direct supervision) and to review the beneficiary’s medical history, physical examination, diagnosis, and record of tests and therapies during or immediately after each visit.

In the March 31 COVID-19 IFC, CMS revised regulations to allow teaching physicians to meet the direct supervision requirement by audio/video real-time communications technology due to the teaching physician’s ability to be physically present in light of the COVID-19 pandemic (85 FR 19245). In this interim final rule, CMS is permitting physicians to review the services provided by a resident, during or immediately after the visit furnished remotely through audio/video real time communication technology for the duration of the COVID-19 PHE (85 FR 27587).

Medicare makes PFS payment in primary care settings for certain services of lower and mid-level complexity furnished by a resident without the physical presence of a teaching physician, referred to as the “primary care exception”. Under the March 31 COVID-19 IFC, CMS expanded the levels of E/M services provided by residents in a primary care center that had to be furnished under the direct supervision of a teaching physician from low and mid-level E/M services to all levels of E/M services, which may be satisfied with physical presence or via interactive telecommunications technology (85 FR 19259).

In this interim final rule, CMS is also adding the following services to the primary care exception:

  • CPT® code 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion);
  • CPT® code 99442 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion);
  • CPT® code 99443 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion);
  • CPT® code 99495 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge);
  • CPT® code 99496 (Transitional Care Management services with the following required elements: communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge);
  • CPT® code 99421 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5–10 minutes);
  • CPT® code 99422 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 11–20 minutes);
  • CPT® code 99423 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes);
  • CPT® code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes);
  • HCPCS code G2012 (Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5–10 minutes of medical discussion); and
  • HCPCS code G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment).

The E/M visit levels may be based on MDM or time. Time is defined as all time associated with the E/M on the day of the encounter and the requirements regarding documentation of history and/or physical exam in the medical record do not apply. The typical times for level selection are listed in the CPT® code description (85 FR 27588-27589).

Audio-Only Telephone Evaluation and Management Services

CMS has a new understanding of the time practitioners spend furnishing audio-only services that serve as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enable telecommunications technology. Given CMS’s new understanding, they are adjusting the RVU amounts for audio-only telephone E/M services that were established in the March 31, 2020 COVID-19 IFC, as follows (85 FR 27590):

CPT OLD RVU NEW RVU
99441 .25 .48
99442 .50 .97
99443 .75 1.50

Application of Certain National Coverage Determination and Local Coverage Determination Requirements during the PHE for the COVID-19 Pandemic

In the March 31, 2020 COVID-19 IFC, CMS finalized a revision for National Coverage Determinations ( NCDs), Local Coverage Determinations (LCDs), and articles to remove the requirements of a face-to-face or in-person encounter during the COVID-19 PHE. CMS also finalized not to enforce the clinical indications for coverage across respiratory, home anticoagulation management, and infusion pump NCDs and LCDs (including articles).

In this interim final rule, CMS is finalizing the action to not enforce clinical indications for therapeutic continuous glucose monitors in LCDs on an interim basis. This action will allow patients to more closely monitor their glucose levels and proactively treat their diabetes and prevent the need for hospital-based diabetic care.

CMS reminds providers that items and services paid under Part A or Part B must be reasonable and necessary for the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body member and medical record documentation must support the services billed (85 FR 27595).

Update to the Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) Policy

CMS finalized a disaster/extraordinary circumstance exception (ECE) policy for the Hospital Value-Based Purchasing (VBP) Program in the FY 2014 IPPS/LTCH final rule. This policy is intended to mitigate any adverse impact of quality performance as a result of unforeseen extraordinary circumstances outside of the hospital’s control with resulting impact on their value-based incentive payment amounts. Hospitals must submit the Hospital VBP Program ECE request form with evidence of the impact of the extraordinary circumstances on the hospital’s quality performance, within 90 days of the date on which the extraordinary circumstance occurred (78 FR 50704-50707).

CMS is modifying the Hospital VBP Program to grant ECE exceptions to hospitals which have not requested them when they determine that an extraordinary circumstance is out of the control of hospitals and it affects an entire region or locale. If CMS grants an ECE to hospitals located in an entire region or locale and one or more hospitals located in the region or locale does not report the minimum number of cases and measures required to calculate a total performance score for the applicable program year, the hospital will be excluded from the Hospital VBP Program for the applicable program year. A hospital that does not report the minimum number of cases or measures for a program year will not receive a 2 percent reduction to its base operating DRG payment and will not be eligible to receive any value-based incentive payments for the applicable program year (85 FR 27597).

In accordance with the updated policy, CMS is granting an ECE with respect to the COVID-19 PHE to all hospitals participating in the Hospital VBP Program for the following reporting requirements:

  • Hospitals will not be required to report National Healthcare Safety Network (NHSN) HAI measures and HCAHPS survey data for the following quarters: October 1, 2019 – December 31, 2019 (Q4 2019), January 1, 2020 – March 31, 2020 (Q1 2020), and April 1, 2020 – June 30, 2020 (Q2 2020).
  • CMS will exclude all claims data from the mortality, complications, and Medicare Spending per Beneficiary measures for the following quarters: January 1, 2020 – March 31, 2020 (Q1 2020) and April 1, 2020 – June 30, 2020 (Q2 2020) (85 FR 27597-27598).

COVID-19 Serology Testing

A blood-based serology test can be used to detect whether a patient may have previously been infected with the virus that causes COVID-19 by identifying whether the patient has antibodies specific to the SARS-CoV-2 virus. Patients with these antibodies may have developed an immune response to SARS-CoV-2. An FDA-authorized serology test that detects the antibodies that cause COVID-19 may potentially aid in identifying patients who have had an immune response to current or prior SARS-CoV-2 infection.

On an interim basis, CMS will cover these tests as the test results may be useful to patients, their practitioners, and their communities in future decision-making and practitioner management of the beneficiaries’ medical treatment. Specifically, CMS will cover FDA-authorized COVID-19 serology tests as reasonable and necessary for beneficiaries with known current or known prior COVID-19 infection or suspected current or past COVID-19 infection (85 FR 27598).

Time Used for Level Selection for Office/Outpatient Evaluation and Management Services Furnished Via Medicare Telehealth

In the March 31, 2020 COVID-19 IFC, CMS revised their policy on office/outpatient E/M level selection for E/M services when furnished via telehealth to allow for the level selection to be based on MDM or time. CMS states that typical times associated with E/M visits were available as a public use file at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F.

CMS has received feedback from the provider community indicating that the typical times posted in the public use file did not align with the times included in the office/outpatient E/M code descriptors. To that end, CMS is finalizing on an interim basis that the typical times for purposes of level selection of an office/outpatient E/M visits are the times posted in the CPT® code descriptor (85 FR 27602).

Updating the Medicare Telehealth List

For the duration of the COVID-19 PHE CMS will use a subregulatory process to modify the services included on the Medicare telehealth list by posting new services to the web listing of telehealth services when the agency receives a request to add a service that can be furnished in full, as described by the code, by a distant site practitioner to a beneficiary in a manner similar to the in-person service. Additional services using the revised process will remain on the list only during the COVID-19 PHE (85 FR 27602).

Payment for COVID-19 Specimen Collection to Physicians, Nonphysician Practitioners and Hospitals

In the March 31, 2020 COVID-19 IFC, CMS revised payment polices for independent laboratories for specimen collection related to COVID-19 testing under certain circumstances. The revision allows payment of a nominal specimen collection fee and associated travel allowance to independent laboratories for the collection of COVID-19 specimens from beneficiaries who are homebound or inpatients not in a hospital. The applicable HCPCS codes are G2023 (specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source) and HCPCS code G2024 (specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID19]), from an individual in a SNF or by a laboratory on behalf of a HHA, any specimen source).

In this IFC, CMS is providing additional payment for assessment and COVID-19 specimen collection to support testing by HOPDs, and physicians and other practitioners, to recognize the resources involved to safely collect specimens.

For the duration of the PHE, CMS will recognize physician and NPP use of CPT® code 99211 for established and new patients to bill for a COVID-19 symptom and exposure assessment and specimen collection provided by clinical staff incident to their services. CMS notes that they previously adopted a policy to permit the direct supervision requirement to be met through virtual presence of the supervising physician or practitioner using interactive audio and video technology for the duration of the PHE (85 FR 27604).

Additionally, CMS now understands that HOPDs are engaging in significant specimen collection and testing for COVID-19 at locations of the hospital and at temporary expansion locations. To that end, CMS has created the following new HCPCS code to support COVID-19 testing by HOPDs, for the duration of the COVID-19 PHE:

There is no beneficiary cost sharing when a physician or other practitioner uses CPT® code 99211 or a HOPD uses HCPCS code C9803 for testing related visits that result in an order for or administration of a COVID-19 test (85 FR 27604).

Payment for Remote Physiologic Monitoring (RPM) Services Furnished During the COVID-19 Public Health Emergency

In the March 31, 2020 COVID-19 interim final rule CMS finalized the use of RPM services to be furnished to new patients in addition to established patients; with beneficiary consent to be obtained at the time services are furnished by auxiliary personnel for patients with acute and/or chronic conditions, under general supervision. Current RPM CPT® codes (99453 and 99454) cannot be reported for monitoring of less than 16 days during a 30-day period. Stakeholders alerted CMS that many patients with COVID-19 who need monitoring do not need to be monitored for as many as 16 days. To address this concern CMS will allow RPM services to be reported for periods of time that are less than 16 days within a 30 day period, but no less than 2 days for patients who have a suspected or confirmed diagnosis of COVID-19 (85 FR 27606).

Miscellaneous

The interim final rule contains information for which Craneware does not typically provide summarizations in the Craneware Insights articles. We are providing the following list of items that fall in this category for your convenience:

  • DME Competitive Bidding Program (85 FR 27569-27571);
  • Medicare Home Health Services (85 FR 27571-27572);
  • IRF Hospitals (85 FR 27572-27573);
  • Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) (85 FR 27573-27587);
  • Flexibility for Medicaid Laboratory Services (85 FR 27590-27591);
  • Improving Care Planning for Medicaid Home Health Services (85 FR 27591-27593);
  • Basic Health Program Blueprint Revisions (85 FR 27593-27594);
  • Merit-based Incentive Payment System (MIPS) Qualified Clinical Data Registry (QCDR) Measure Approval Criteria (85 FR 27594-27595);
  • Delay in the Compliance Date of Certain Reporting Requirements Adopted for IRFs, LTCHs, HHAs and SNFs (85 FR 27595-27597);
  • Modification to Medicare Provider Enrollment Provision Concerning Certification of Home Health Services (85 FR 27598-27599);
  • Health Insurance Issuer Standards under the Affordable Care Act, Including Standards Related to Exchanges: Separate Billing and Segregation of Funds for Abortion Services (85 FR 27599-27601); and
  • Requirement for Facilities to Report Nursing Home Residents and Staff Infections, Potential Infections, and Deaths Related to COVID-19 (85 FR 27601-27602);

Action Needed

This interim final rule covers a wide-range of providers and suppliers. The portions of the interim final rule that are applicable to the type of service(s) furnished in your entity should be read in their entirety. There are multiple COVID-19 resources available via the CMS website at https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit and https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit and https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page, as well as through Craneware at https://public.craneware.com/news/covid-19-coding-and-billing.

Effective Date

27 January 2020

Background

Coronavirus Preparedness and Response Supplemental Appropriations Act: https://www.congress.gov/bill/116th-congress/house-bill/6074

Families First Coronavirus Response Act: https://www.congress.gov/bill/116th-congress/house-bill/6201/text

Coronavirus Aid, Relief, and Economic Security Act (CARES Act): https://www.congress.gov/bill/116th-congress/senate-bill/3548/text?q=product+actualizaci%C3%B3n

April 6, 2020 COVID-19 Interim Final Bill: https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf

Reference

https://www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf

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