Knowledge Base Category -

Resource Spotlight: COVID-19 Public Health Emergency (PHE) Extended

On January 7, 2021, Alex M. Azar II, Secretary of Health and Human Services renewed the Public Health Emergency (PHE) due to COVID-19 effective January 21, 2021. PHE declarations last for the duration of the PHE or 90 days and may then be extended.

January 4, 2021: FDA Communication - Risk of False COVID-19 Results with Curative SARS-CoV-2 Test

The FDA sent an Alert to patients and health care providers regarding the risk of false results, particularly false negative COVID-19 results with the Curative SARS-CoV-2 test. This communication goes on to provide important recommendations for health care providers, patients, and caregivers.

January 5, 2021: COVID-19 Updates in the January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

MLN Matters Article MM12120 was published January 5, 2021 and provides highlights from the January 2021 updates of the Hospitals OPPS outlined in Change Request (CR) 12120. Several highlights in this article are related to COVID-19 and includes the following:

• COVID-19 Laboratory Tests and Services Coding Update,
• CPT Proprietary Laboratory Analyses (PLA) Coding Changes Effective October 6, 2020 and January 1, 2021,
• Monoclonal Antibody Therapy Product and Administration Codes for drugs granted emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 positive cases at high risk for progressing to severe COVID-19 and/or hospitalization,
• New COVID-19 CPT Vaccines and Administration Codes, and
• Comprehensive APC (C-APC) Exclusion for COVID-19 Treatments. Specifically, this article reminds providers that “in the interim final with request for comments (IFC) entitled, ‘‘Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency”, published on November 6, 2020, we stated that effective for services furnished on or after the effective date of the IFC and until the end of the PHE for COVID-19, there’s an exception to the OPPS C-APC policy to ensure separate payment for new COVID–19 treatments that meet certain criteria (85 FR 71158 through 71160). Under this exception, any new COVID-19 treatment that meets the two following criteria will, for the remainder of the PHE for COVID-19, will always be separately paid and won’t be packaged into a C-APC when it’s provided on the same claim as the primary CAPC service. MLN Matters: MM12120 Related CR 12120 Page 9 of 17

1. The treatment must be a drug or biological product (which could include a blood product) authorized to treat COVID-19, as indicated in Section I, “Criteria for Issuance of Authorization,” of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating COVID-19.

2. Second, the EUA for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat COVID-19 disease and not limit its use to the inpatient setting.

For further information regarding the exception to the C-APC policy for COVID–19 treatments, please refer to the IFC (85 FR 71158 through 71160) at https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-andregulatory-revisions-in-response-to-the-covid-19-public-health-emergency.”

January 7, 2021: COVID-19 Vaccine and Long-Term Care Facilities

CMS information related to the COVID-19 vaccine in their weekly MLN Connects e-newsletter. Specifically, they indicated that the CDC has recommended early vaccination for health care personnel and residents in long-term care facilities and has developed a Long-Term Care Facility toolkit to assist in preparing for and building confidence in the vaccine.

January 7, 2021: Preventing Chronic Disease (PCD) Essay: Chronic Disease and COVID-19

The CDC announced the release of a new PCD essay on COVID-19 and Chronic Disease. Specifically, senior leadership of the CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), NCCDPHP Director Karen A. Hacker, MD, MPH, and Peter A. Briss, MD, MPH, Medical Director of NCCDPHP’s Office of Medicine and Science, discuss the importance of prevention and care during the COVID-19 pandemic.

January 7, 2020: AHA, COVID-19 and Hospital Price Transparency Rule

The American Hospital Association (AHA) submitted a January 7, 2021 letter to Secretary Azar urging that CMS “exercise enforcement discretion with respect to the hospital price transparency rule.” The letter goes on to indicate that “Hospitals ability to comply with the rule at this time is particularly challenged by an increase in the volume of COVID-19 patients and the need to distribute multiple vaccines.”

January 8, 2021: FDA Alert Regarding SARS-CoV-2 Viral Mutation

The FDA notes in this Alert that they are “monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.”

January 8, 2021: FDA’s COVID-19 Update - Moderna COVID-19 Vaccine FAQs

In their January 8, 2021 COVID-19 Update, the FDA announced the post of a new webpage, Moderna COVID-19 Vaccine FAQs. Questions range from how well does the Moderna COVID-19 vaccine prevent COVID-19? To, is it possible to obtain an 11th dose from the multi-dose vial of the Moderna COVID-19 vaccine?

January 11, 2021: What to Expect After Getting a COVID-19 Vaccine

The CDC has a What to Expect after Getting a COVID-19 Vaccine webpage which includes information on the following:

• Common side effects,
• Helpful tips,
• When to call the doctor,
• Scheduling your second shot,
• About your second shot,
• Things to remember, and
• A printable handout for a vaccine recipient.

CDC COVID Data Tracker – United States COVID-19 Cases

Monthly, MMP provides a summary of Medicare Transmittals, related MLN Articles, Coverage Updates, CMS education resources and any other Medicare updates we believe to be pertinent to our readers. With the holiday season, December’s updates were released in last week’s Wednesday@One article. Since then, CMS has released additional MLN articles with updates effective early in January. For this reason, following is a list of pertinent updates that providers need to know before the end of January when our usual monthly article is published.

MEDICARE TRANSMITTALS – RECURRING UPDATES

January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: January 5, 2021
• What You Need to Know: The following major changes made in Change Request (CR) 12120 are highlighted in this MLN article:
• COVID-19 Laboratory Tests and Services Coding Update,
• CPT Proprietary Laboratory Analyses (PLA) coding changes effective October 6, 2020,
• Monoclonal antibody therapy product and administration codes for drugs granted emergency use authorizations (EUAs) to treat mild to moderate cases of COVID-19,
• New COVID-19 CPT vaccines and administration codes,
• New device pass-through categories, device offset from payment, transitional pass-through payments for designated devices, and alternative pathway for devices that have a Food and Drug Administration (FDA) Breakthrough Device designation,
• New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
• New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
• New HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
• Comprehensive APCs (C-APCs) updates,
• Changes to the Inpatient-Only List (IPO) for CY 2021,
• Removals of selected National Coverage Determinations (NCDs) Effective January 1, 2021,
• Changes to some Opioid Treatment Program (OTP) – related codes,
• Change to the Status Indicator for HCPCS code P9099 (blood component or product not otherwise classified) from SI “ER” to SI “R,”
• Drugs, Biologicals, and Radiopharmaceuticals updates,
• Skin Substitutes,
• Reporting for certain Outpatient Department services (that are similar to Therapy Services)(“Non-therapy outpatient department services”) and are Adjunctive to Comprehensive APC Procedures,
• Payment Adjustment for Certain Cancer Hospitals Beginning CY 2021,
• Method to control for unnecessary increased in utilization of outpatient services /G0463 with Modifier PO,
• Changes to OPPS Pricer Logic,
• Updates to the Outpatient Provider Specific File (OPSF),
• Wage Index Policies in the CY 2021 OPPS,
• Coverage Determinations reminder, and
• General Supervision of Outpatient Hospital Therapeutic Services currently assigned to the Non-Surgical Extended Duration Therapy Services (NSEDTS) level of supervision.
• MLN Article MM12120: https://www.cms.gov/files/document/mm12120.pdf

January 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: January 5, 2021
• What You Need to Know: This article details changes and billing instructions for policies implemented in the January 2021 Ambulatory Surgical Center (ASC) update. Following are key points from the related Change Request (CR) 12129 included in this MLN article are:
• Three new device pass through categories,
• Device offset from Payment,
• Device Pass-Through Payments,
• New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
• New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
• Four new HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
• Removal of five National Coverage Determinations (NCDs) effective January 1, 2021 as stated in the CY 2021 Physician Fee Schedule (PFS) final rule.
• The one existing and fifteen new HCPCS codes for certain drugs and biologicals in the ASC setting that will start to receive separate payment beginning January 1, 2021.
• Retroactive payment for HCPCS J1097 (Phenylep ketorolac opth soln), brand name Omidria. This code became separately payable October 1, 2020. However, there was no available payment rate for MACs. “Consequently, ASCs that may have submitted claims for this drug, may not have been paid correctly…suppliers who think they may have previously received an incorrect payment or incorrect disposition associated with this correction for J1097, for claims beginning October 1, 2020, may request their MAC adjust the previously processed claims.”
• Drugs and Biologicals with payments based on Average Sales Price (ASP),
• Drugs and Biologicals based on ASP methodology with restated payment rates, and
• Skin substitute procedure edits.

CMS ends this MLN article with the following statement about Coverage Determinations:

“Assignment of an HCPCS code and payment rate under the ASC payment system to a drug, device, procedure, or service doesn’t imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. MACs determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary’s condition and whether it’s excluded from payment.”

• MLN Article MM12129: https://www.cms.gov/files/document/mm12129.pdf

January 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.0

• Article Release Date: January 5, 2021
• What You Need to Know: This article details changes to the January 2021 version of the Integrated Outpatient Code Editor (I/OCE) instructions and specifications for the Integrated OCE that Medicare uses:
• Under the OPPS and Non-OPPS for hospital outpatient departments, community mental health centers and all non-OPPS providers,
• For limited services when provided in a Home Health Agency (HHA) not under the Home Health Prospective Payment System, and
• For a hospice patient for the treatment of a non-terminal illness.
• MLN Article MM12114: https://www.cms.gov/files/document/mm12114.pdf

REVISED MEDICARE TRANSMITTALS

Billing for Home Infusion Therapy Services on or After January 1, 2021

• Article Release Date: August 7, 2020 – Revised December 31, 2020
• What You Need to Know: A revised Change Request (CR) 11880 was issued on December 31, 2020. This MLN Article was revised to reflect the CR where two codes (J1559 JB and J7799 JB) were added in Table 3.2 on page 7 of this article.
• MLN MM11880: https://www.cms.gov/files/document/MM11880.pdf

MEDICARE EDUCATIONAL RESOURCES

Hospital Price Transparency Webcast: Audio Recording & Transcript

CMS provided the following information in their Thursday, January 7, 2021 edition of MLN Connects: “An audit recording, transcript, and clarification are available for the December 8 Medicare Learning Network webcast on Hospital Price Transparency. Effective January 1, each hospital operating in the United States is required to provide clear, accessible pricing information online. Learn about resources to help you prepare for compliance.”

In mid-November 2020, CMS published a CMS.gov Fact Sheet detailing the estimated improper payment rates for CMS Programs for Fiscal Year (FY) 2020.

Audit findings are used to calculate a Medicare Fee-for-Service (FFS) program improper payment rate. “The CERT program considers any claim that was paid when it should have been denied or paid at another amount (including both overpayments and underpayments) to be an improper payment.”

CMS reminds the reader in the Fact Sheet that improper payment rates are not necessarily indicative of or are measures of fraud. Instead, improper payments are payments that did not meet statutory, regulatory, administrative, or other legally applicable requirements and may be overpayments or underpayments.”

The following tables compares the improper payment rate for FY 2018, FY 2019, and FY 2020.

Fiscal Year 2020 Supplemental Improper Payment Data

On December 21, 2020, CMS released the Supplemental Improper Payment Data Report that delves into the details behind the final Improper Payment Rate and Improper Payments. This report includes a review of claims submitted from July 1, 2018 through June 30, 2019.

“0 or 1 Day” LOS Claims Continued Outlier

Since the Two-Midnight Rule was implemented, the annual data has included a table comparing improper payment rates for Part A hospital claims by Length of stay. At 19.9% for 2020, the Improper Payment Rate for “0 or 1 day” LOS claims is at an all-time high since the CERT began reporting improper payments by LOS.    

Compliance with Short Stays

Short stay reviews have been under scrutiny for several years. With the consistent increase in the improper payment rate for this patient population it is not surprising that the OIG is once again targeting short stays for review. You can read more about this in a related MMP article.

MEDICARE TRANSMITTALS – RECURRING UPDATES

Update to the Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) for Calendar Year (CY) 2021 – Recurring File Update

• Article Release Date: December 4, 2020
• What You Need to Know: Since 2017 CMS has updated the FQHC PPS rate annually. Based on historical data through the second quarter of 2020, the FQHC market basket for CY 2021 is 1.7 percent increasing the FQHC PPS base payment of $173.50 in 2020 to $176.45 for 2021.
• MLN MM12046: https://www.cms.gov/files/document/mm12046.pdf

Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit for Calendar Year (CY) 2021

• Article Release Date: December 4, 2020
• What You Need to Know: This article provides the CY 2021 payment limit for RHCs. The CY 2021 amount has increased from $86.31 in 2020 to $87.52 effective January 1, 2021. The related Change Request (CR) 12035 was released on October 29, 2020.
• MLN MM12035: https://www.cms.gov/files/document/mm12035.pdf

Summary of Policies in the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction list, and Preventive Services List

• Article Release Date: December 4, 2020
• What You Need to Know: CR 12071 provides a summary of policies in the CY 2021 MPFS Final Rule and makes other policy changes that apply to Medicare Part B. This MLN article is a supplement to the CR.
• MLN MM12071: https://www.cms.gov/files/document/mm12071.pdf

2021 Annual Update of Per-Beneficiary Threshold Amounts

• Article Release Date: December 7, 2020
• What You Need to Know: The related Change Request (CR) 12014 updates the annual per-beneficiary incurred expenses amounts now called the KX modifier thresholds and related policy for CY 2021.
• MLN MM12014: https://www.cms.gov/files/document/mm12014.pdf

CY 2021 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: December 7, 2020
• What You Need to Know: Information on the data files, update factors, and other information related to the CY 2021 update to the fee schedule can be found in this article.
• MLN MM12063: https://www.cms.gov/files/document/mm12063.pdf

Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: December 18, 2020
• What You Need to Know: Information provided in this article is related to CR 12080 and intended for clinical diagnostic laboratories. CR 12080 provided instructions for CY 2021 CLFS, mapping for new codes for clinical laboratory tests, and an update for laboratory costs subject to reasonable charge payment.
• MLN MM12080: https://www.cms.gov/files/document/MM12080.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.1, Effective April 1, 2021

• Article Release Date: December 23, 2020
• What You Need to Know: This article provides a background on NCCI Edits and refers to CR 12110, which provides quarterly updates to the NCCI PTP edits.
• MLN MM12110: https://www.cms.gov/files/document/mm12110.pdf

Updating Calendar Year (CY) 2021 Medicare Diabetes Prevention Program (MDPP) Payment Rates

• Article Release Date: December 23, 2020
• What You Need to Know: For organizations enrolled as MDDP suppliers, this article includes a link to the accompanying CR 12030, which contained instructions for MACs and the Railroad Specialty MAC to update the MDPP Expanded Model payment rates for CY 2021.
• MLN MM12030: https://www.cms.gov/files/document/mm12030.pdf

Quarterly Update to Home Health (HH) Grouper

• Article Release Date: December 30, 2020
• What You Need to Know: This article provides information regarding the January 2021 update to the HH Grouper software to reflect new COVID-19-related diagnosis code changes.
• MLN MM12047: https://www.cms.gov/files/document/MM12047.pdf

2021 Annual Update to the Therapy Code List

• Article Release Date: December 31, 2020
• What You Need to Know: This article provides updates to the list of codes that sometimes or always describe therapy services.
• MLN MM12126: https://www.cms.gov/files/document/MM12126.pdf

OTHER MEDICARE TRANSMITTALS

Review of Hospital Compliance with Medicare’s Transfer Policy with the Resumption of Home Health Services and the Use of Condition Codes (A-04-18-04067)

• Article Release Date: December 1, 2020
• What You Need to Know: An OIG audit report released August 2020 (report No. A-04-18-04067) identified Medicare overpayments to hospitals that did not comply with Medicare’s post-acute-care transfer policy. This MLN Special Edition article was published to remind hospitals of proper coding of the patient discharge status code and the use of condition codes 42 and 43.
• MLN SE20025: https://www.cms.gov/files/document/SE20025.pdf

FAQs on the 3-Day Payment Window for Services Provided to Outpatients Who Later Are Admitted as Inpatients

• Article Release Date: December 3, 2020
• What You Need to Know: This Special Edition MLN article is informational in nature. CMS notes that In May of this year, the OIG released the report, Medicare Made $11.7 Million in Overpayments for Nonphysician Outpatient Services Provided Shortly Before or During Inpatient Stays. This article includes FAQs to help providers avoid incorrect billing for outpatient services within 3 days before date of admission and on the date of admission.
• MLN SE20024: https://www.cms.gov/files/document/SE20024.pdf

REVISED MEDICARE TRANSMITTALS

Changed to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020

• Article Release Date: July 31, 2020 – Revised November 30, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11889 issued on August 14th. CR 11889 was revised to update the codes for NCD 190.15.
• MLN MM11889: https://www.cms.gov/files/document/MM11889.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

• Article Release Date: November 9, 2020 – Revised December 2, 2020
• What You Need to Know: This is the second time that CMS has updated this MLN article. The December 2nd revisions added information for reporting the use of cinacalcet by ESRD facilities. “Beginning January 1, 2021, cinacalcet is an oral drug eligible for consideration as an ESRD outlier service. ESRD facilities should report revenue code 250 with the drug’s NDC.
• MLN MM12011: https://www.cms.gov/files/document/mm12011.pdf

New & Expanded Flexibilities for RHCs & FQHCs during the COVID-19 PHE

• Article Releases Date: April 17, 2020 – Revised December 3, 2020
• What You Need to Know: Revisions to this article includes additional guidance on telehealth services that have cost-sharing and cost-sharing waived and language changes for clarity that did not alter the substance of the article.
• MLN MMSE20016: https://www.cms.gov/files/document/se20016.pdf

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – April 2021

• Article Release Date: November 4, 2020 – Revised December 10, 2020
• What You Need to Know: This article was revised due to a revised CR 12027. Revisions made did not impact the substance of this article.
• MLN MM12027: https://www.cms.gov/files/document/MM12027.pdf

Medicare Claims Processing Transmittal 10521: New Medicare Uniform Billing Committee (NUBC) Type of Bill (TOB), Condition Code and implementing Billing Codes for Opioid Treatment Programs

• Transmittal 10266 Release Date: August 6, 2020
• Transmittal 10521 Release Date: December 16, 2020
• What You Need to Know: Transmittal 10266 was rescinded and replaced by Transmittal 10266 to add the Provider Type "34", note that CAH's are paid via the OTP fee schedule, and clarification on the 2020 OTP fee schedule file (attachment 1) versus the 2021 OTP fee schedule file (new attachment 3). This correction revises business requirement 1856-4.1 and only impacts publication 100-04. All other information remains the same.
• Transmittal 10521: https://www.cms.gov/files/document/r10521cp.pdf
• Effective Date: January 1, 2021 for claims received on or after 1/1/2021

Note, a related Medicare Financial Management Transmittal 10521 revises business requirement 1856-4.1 and only impacts publication 100-04. (https://www.cms.gov/files/document/r10521fm.pdf)

Transmittal 10525: Implementation of the New Ambulatory Surgical Center (ASC) Payment Indicator “K5”

• Transmittal 10245 Release Date: July 30, 2020
• Transmittal 10525 Release Date: December 17, 2020
• What You Need to Know: Transmittal 10245 was rescinded and replaced by Transmittal 10525 to remove the word “DRAFT” from Attachment A. CMS created “a new ASC payment indicator, specifically, “K5” to identify codes that describe items, procedures, and services for which pricing information and claims data are not available, and consequently, no ASC payment will be made. This new payment indicator, effective January 1, 2021, provides the assignment, definition, and detail needed for this subset of HCPCS codes.”
• Transmittal 10525: https://www.cms.gov/files/document/r10525otn.pdf

Telehealth Expansion Benefit Enhancement Under the Pennsylvania Rural Health Model (PARHM) – Implementation

• Article Release Date: August 10, 2020 – Revised December 22, 2020
• What You Need to Know: Revisions were made due to a revised CR 11870 with updates to some denial edits.
• MLN MM11870: https://www.cms.gov/files/document/MM11870.pdf

MEDICARE COVERAGE UPDATES

December 1, 2020: CMS Updates Coverage Policies for Artificial Hearts and Ventricular Access Devices (VADs)

CMS released Decision Memo CAG-00453N on December 1st updating coverage requirements for artificial hearts and VADs. Specifically,

• Artificial Hearts: “CMS is removing the NCD at § 20.9, ending coverage with evidence development for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act.”
• VADs: CMS notes in a related Press Release that “The final national coverage determination, which is effective today, also provides updated coverage criteria for VADs that better aligns with current medical practice and that we believe will expand coverage to a greater number of candidates who are likely to benefit from this technology. Specifically, the updated patient criteria in the NCD aligns with the inclusion criteria derived from recent large randomized controlled trials, which demonstrated improved patient outcomes.”

December 21, 2020: Proposed Updates to Coverage Policy for Autologous Blood-Derived Products from Chronic Non-Healing Wounds

CMS proposed to “update coverage of Platelet Rich Plasma (PRP) for the treatment of chronic non-healing diabetic, venous, and pressure wounds. PRP is a blood-derived product prepared from the patient’s own blood to be used as a wound covering in the management of chronic wounds. PRP is currently covered under the Coverage with Evidence Development (CED) pathway for the treatment of chronic, non-healing diabetic, venous, and pressure wounds when beneficiaries are enrolled in a clinical study. This proposed National Coverage Determination would eliminate the CED requirement and nationally cover PRP for the treatment of chronic non-healing diabetic wounds. The proposal also would provide for coverage determinations for PRP for all other chronic non-healing wounds to be made by local Medicare Administrative Contractors.”

CMS is seeking comments on the proposed national coverage determination.

MEDICARE EDUCATIONAL RESOURCES

December 10, 2020: MLN Call – Physician Fee Schedule Final Rule: Understanding 4 Key Concepts

CMS hosted a Medicare Learning Event to provide information about the following four key concepts in the 2021 PFS Final Rule:

• Extending Telehealth & Licensing Flexibilities,
• Evaluation and Management (E/M) Visits and Analogous Services,
• Quality Payment Program Updates, and
• Opioid Use Disorder/Substance Use Disorder Provisions.

You can access the Presentation on the 2020-12-10 Physician Fee Schedule webpage. 

KEPRO Case Review Connections: Acute Care Edition Winter 2020

KEPRO has released their Winter 2020 Edition of their Case Review Connections e-newsletter for Acute Care. Examples of what’s in this newsletter are the Medical Director’s Corner, a notice about them now accepting Medical Records electronically and an immediate advocacy success story.

MLN Educational Tool Medicare Preventive Services Updated in December

CMS has revised this Medicare Learning Network educational too. The tool provides information about coding, coverage and the beneficiary’s copayment/coinsurance and deductible.

• ICN: MLN006559: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319?DLPage=1&DLEntries=10&DLFilter=preventive%20ser&DLSort=0&DLSortDir=ascending

OTHER MEDICARE UPDATES

December 1, 2020: CMS Releases 2021 Medicare Physician Fee Schedule (PFS) Final Rule

The following list highlights several of the changes found in the PFS Final Rule for 2021:

• Within the Final Rule, CMS issued two interim final rules with comment period.
• The first interim final rule is “to establish coding and payment for virtual check-in services to support the continued need for coding and payment to reflect the provisions of lengthier audio-only services outside of the PHE for COVID,19, if not as substitutes for in-person services.”
• The second interim final rule is “to establish coding and payments for PPE as a bundled service and certain supply pricing increases in recognition of the increased market-based costs for certain types of PPE.”
• Payments have been Increased to physicians and other practitioners for additional time spent with patients providing chronic disease management,
• Sixty additional services have been added to the telehealth list that will continue to be covered beyond the COVID-19 public health emergency (PHE),
• CMS established on an interim final basis a new HCPCS G-code describing 11-20 minutes of medical discussion to determine the necessity of an inpatient visit.”
• CMS commissioned a study of its telehealth flexibilities during the COVID-19 PHE,
• The increase in payment rates for office/outpatient face-to-face evaluation and management (E/M) visits finalized in 2020 goes into effect in 2021. According to a related CMS Press Release, the payment increases “support clinicians who provide crucial care for patients with dementia or manage transitions between the hospital, nursing facilities, and home,”
• Simplified coding and documentation changes for Medicare billing for E/M office visits goes into effect January 1, 2021 modernizing guidelines developed in the 1990’s,
• CMS Finalized the following workforce flexibilities that have been provided during the COVID-19 PHE:

• “Certain non-physician practitioners such as nurse practitioners and physician assistants can supervise the performance of diagnostic tests within their scope of practice and state law, as they maintain required statutory relationships with supervising or collaborating physicians.
• Physical and occupational therapists will be able to delegate “maintenance therapy” – the ongoing care after a therapy program is established – to a therapy assistant.
• Physical and occupational therapists, speech-language pathologists, and other clinicians who directly bill Medicare can review and verify, rather than re-document, information already entered by other members of the clinical team into a patient’s medical record. As a result, practitioners have the flexibility to delegate certain types of care, reduce duplicative documentation, and supervise certain services they could not before, increasing access to care for Medicare beneficiaries.”

• CMS notes in a related Fact Sheet that “direct supervision may be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021.”
• CMS finalized the elimination of six older National Coverage Determinations (NCDs) and noted in the final rule “that if the previous NCD barred coverage for an item or service under title XVIII (that is, national noncoverage NCD), a MAC would now be able to cover the item or service if the MAC determined that such action was appropriate under the statue…proactively removing obsolete broad non-coverage NCDs removes barriers to innovation and reduces burden for stakeholders and CMS.” The effective date for removal of the following six NCDs is on the date of the final rule:
• NCD 20.5 – Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 30.4 – Electrosleep Therapy,
• NCD 100.9 – Implantation of Gastrointestinal Devices,
• NCD 110.19 – Abarelix for the Treatment of Prostate Cancer
• NCD 220.2.1 – Magnetic Resonance Spectroscopy, and
• NCD 220.6.16 - FDG PET for Inflammation and Infection.

December 2, 2020: OIG Fall 2020 Semiannual Report to Congress

The OIG Semiannual Report reflects work performed from April 1, 2020 through September 30, 2020. Following are some of the high-level findings from the report by the numbers:

• 97 – the number of audit reports completed
• 27 – the number of evaluation reports completed
• $337 million – the amount identified in expected recoveries,
• $446 million – costs questions by the OIG because of an alleged violations, costs not supported by adequate documentation, or the expenditure of funds where the intended purpose is unnecessary or unreasonable,
• $2 billion – potential savings identified for HHS; and
• 416 – The number of new audit and evaluation recommendations made by the OIG.

December 7, 2020: 2021 IPPS Final Rule Correction Notice Published in Federal Register

This document corrects technical and typographical errors in the September 18, 2020 issue of the FY 2021 IPPS Final Rule.

December 10, 2020: CMS Proposed Modifications to the HIPAA Privacy Rule

HHS notes in their announcement the proposed changes will “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.” The Summary statement in the Proposed Rule indicates that “these modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information.”

December 10, 2020: CMS Proposes New Rules to Address Prior Authorization and Reduce Burden on Patients and Providers

CMS released the following information in a December 12, 2020 Special Edition of MLNConnects:

On December 10, under President Trump’s leadership, CMS issued a proposed rule that would improve the electronic exchange of health care data among payers, providers, and patients and streamline processes related to prior authorization to reduce burden on providers and patients. By both increasing data flow and reducing burden, this proposed rule would give providers more time to focus on their patients and provide better quality care. For More Information:

• Proposed Rule (PDF): Comment period closes January 4
• Full press release
• Fact sheet
• Blog
• CMS Interoperability and Patient Access Final Rule”

December 16, 2020: CMS Report – National Healthcare Spending in 2019

“The National Health Expenditure Accounts (NHEA) are the official estimates of total health care spending in the United States. Dating back to 1960, the NHEA measures annual U.S. expenditures for health care goods and services, public health activities, government administration, the net cost of health insurance, and investment related to health care. The data are presented by type of service, sources of funding, and type of sponsor.

U.S. health care spending grew 4.6 percent in 2019, reaching $3.8 trillion or $11,582 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent.”

You can download the entire report on the CMS National Health Expenditure Data Historical webpage.

December 18, 2020: Special Edition MLNConnects: Monitoring for Hospital Price Transparency

CMS indicated in this Special Edition MLNConnects that they plan “to audit a sample of hospitals for compliance starting in January, in addition to investigating complaints that are submitted to CMS and reviewing analyses of non-compliance, and hospitals may face civil monetary penalties for noncompliance.” CMS also reminds providers of their Hospital Price Transparency website where they have provided several resources for hospitals as they work towards compliance with Hospital Price Transparency. 

December 31, 2020: Palmetto GBA offers Introduction to 2021 E&M Changes

Palmetto GBA included the following information in their December 31st Daily Newsletter:

“Effective January 1, 2021, the Centers for Medicare and Medicaid Services (CMS) implemented a new coding, prefatory language, and interpretive guidance framework that the American Medical Association Current Procedural Terminology Editorial Panel issued for office and outpatient E/M visits. Please review the information in this job aid and share it with your staff.” You can access this introduction education material at: https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20B~BWSU772836?opendocument.

January 1, 2021: CMS Releases MLN Guide Titled Evaluation and Management (E/M) Services

CMS has released publication ICN: 006764 that serves as a guide to learning the principles of documentation, common sets of codes used to bill for services, and other considerations.

In this New Year, I hope all of our readers found some joy during the holiday season while socially distancing, wearing your masks and washing your hands. Having taken a couple of weeks off from our full newsletter, we are getting back to business. MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 15th, 2020 through January 4, 2021.

Resource Spotlight: Avoid COVID-19 Vaccine Scams

With the roll-out of COVID-19 vaccines, reminders abound to protect yourself against vaccine scams. Do you know the signs of potential scams? On December 21, 2020, Federal Agencies warned of emerging fraud schemes related to COVID-19 vaccines. This two page document includes:

• Potential indicators of fraudulent activity,
• Tips to avoid COVID-19 vaccine-related fraud, and
• General online/cyber fraud prevention techniques.

They Federal Agencies have also released a pdf document titled Protect Yourself Avoid COVID-19 Vaccine Scams.

December 13, 2020: 8 Things to Know about the U.S. COVID-19 Vaccination Program

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html?ACSTrackingID=USCDC_2067-DM44618&ACSTrackingLabel=Vaccines%20%7C%20COVID-19&deliveryName=USCDC_2067-DM44618

December 15, 2020: FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

The FDA announced a EUA for the Ellume COVID-19 Home Test. This is the first over-the-counter (OTC) fully at home diagnostic test granted EUA. FDA Commissioner Stephen M. Hahn, M.D. noted in this announcement that “today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can but it, swab their nose, run the test and find out their results in as little as 20 minutes.”

December 14 & December 18 2020: Special Edition MLNConnects - COVID-19 Vaccine Codes for Pfizer-BioNTech and Moderna

Late in the afternoon, CMS issued the following information regarding the Pfizer-BioNTech Vaccine:

“On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage”

On December 22, 2020, CMS issued another Special Edition MLNconnects announcing that the FDA had issued a EUA for Moderna’s COVID-19 vaccine on December 18, 2020. Similar to the Pfizer-BioNTech announcement, this announcement includes links to the EUA and a Fact Sheet for Healthcare Providers Administering the Vaccine regarding the limitations of authorized use.  

December 16, 2020: FDA Issues EUA for BinaxNOW COVID-19 Ag Card Home Test

The FDA issued a new EUA for this at home test authorized for use by patients at home with a prescription. This test is authorized for individuals 15 years or older “who are suspected of COVID-19 by their healthcare provider within the first seven days of symptoms onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

December 17, 2020: CMS Memo – COVID-19 Infection Control for Psychiatric and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

In this Memorandum (Ref: QSO-21-07-Psych Hospital, PRTF & ICF/IID) to State Survey Agency Directors, CMS indicated the following in the Memorandum Summary:

• CMS is committed to taking critical steps to protect all Americans including those with intellectual and developmental disabilities to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).
• CMS is providing guidance to psychiatric hospitals, Psychiatric Residential Treatment Facilities (PRTFs) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to improve their infection control and prevention practices, in part, to prevent or lessen the need for use of seclusion and restraint as an infection control intervention.
• All Psychiatric hospitals, PRTFs and ICF/IIDs should monitor the CDC website for information and resources, and contact the local health department, when necessary.

December 17, 2020: AMA Announces Additional CPT codes for COVID-19 Vaccines

The AMA announced new CPT codes for the AstraZeneca vaccine noting that the codes will be effective for use “on the condition that the AstraZeneca vaccine receives approval or emergency use authorization from the Food and Drug Administration (FDA).”

December 17, 2020: New FDA webpage: Pfizer-BioNTech COVID-19 Vaccine FAQs

The FDA announced they have posted a new FAQs webpage covering specifics related to the Pfizer-BioNTech COVID-19 Vaccine. Questions range from very specific to this vaccine to more general questions, “such as how does a vaccine go from emergency use authorization to licensure.”

December 18, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines

The CDC hosted this call on December 18, 2020. In an overview statement, this call provided clinicians with an overview of the Pfizer-BioNTech and Moderna COVID-19 vaccines. Specific information included vaccine characteristics and administration, vaccinating special populations, and contraindications. In case you missed this COCA webinar hosted by the CDC on December 18th, you can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

December 18, 2020: Special Edition 2 MLNConnects: COVID-19 Add-On Payments for New Treatments

On December 18, 2020, in a second Special Edition MLNConnects, CMS provided the following information:

“CMS issued an Interim Final Rule with Comment Period, which established the New COVID-19 Treatments Add-on Payment (NCTAP) under the Medicare Inpatient Prospective Payment System (IPPS), effective from November 2, 2020, until the end of the Public Health Emergency (PHE) for COVID-19. To mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products with current Food and Drug Administration approval or emergency use authorization to treat COVID-19. Visit the NCTAP webpage for more information.”

December 18, 2020: Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Payment Charge

MLN Article MM12080 provides instructions for clinical diagnostic laboratories for the CY 2021 CLFS, mapping new codes for clinical laboratory tests (including several new codes related to COVID-19 testing), and updates laboratory costs subject to the reasonable charge payment.

December 18, 2020: OCR Issues Guidance on HIPAA, Health Information Exchanges (HIE), and Disclosures of Protected Health Information (PHI) for Public Health Purposes

The OCR issued guidance providing “examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associated to disclose PHI to an HIE for reporting to a Public Health Authority (PHA) that is engaged in public health activities.”

December 21, 2020: U.S. Surgeon General Calls for COVID-19 Survivors to Donate Plasma

Surgeon General VADM Jerome Adams urges individuals who have recovered from COVID-19 to consider donating COVID-19 Convalescent Plasma (CCP). He notes that “just like wearing a mask, donating CCP is a way for individuals to help in our nation’s fight against COVID-19.  Donating CCP is safe, and may spare others from lengthy hospitalizations, and from suffering the most severe effects of COVID-19.” This HHS announcement includes a link to a YouTube recorded by the Surgeon General.

December 23, 2020: MLN Article – Instructions to Medicare Administrative Contractors (MACs) on COVID-19 Emergency Declaration Blanket Waivers for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals

MLN Article MM12070 is for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals (SCHs). The article provides information about the actions CMS is taking to help health care providers contain the spread of COVID-19 with the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers and includes a link to all of the current blanket waivers.

December 23, 2020: MLN Article – Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 87811 and 87428

MLN Matters article MM12093 informs providers of the addition of the QW modifier to the following CMS HCPCS Codes:

• 87811 [Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])] and code
• 87428 [Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B].

December 23, 2020: HHS Announcement – HHS & the Department of Defense (DOD) Purchases 100 Million Additional Doses of COVID-19 Vaccine from Pfizer

HHS indicated in this announcement that Pfizer will deliver at least 70 million doses by June 30, 2021, with the remaining 30 million to be delivered no later than July 31, 2021. Per HHS Secretary Alex Azar,

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio…This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”

December 28, 2020: New CDC webpage – New Variant of Virus that Causes COVID-19 Detected

The CDC indicated that the United Kingdom (UK) has seen a rapid increase in COVID-19 cases in London and southeast England since November 2020. A new variant of the virus causing COVID-19 has been linked to the rapid increase in cases. This CDC web page provides current information on:

• What we know,
• What we do not know.
• What it means, and
• What the CDC is doing.

December 28, 2020: Special Edition MLN Connects – 2% Sequestration Suspended Through March

CMS released the following information in a Special MLN Connects edition:

“The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the payment adjustment percentage of 2% applied to all Medicare Fee-For-Service (FFS) claims from May 1 through December 31.  The Consolidated Appropriations Act, 2021, signed into law on December 27, extends the suspension period to March 31, 2021.”

December 30, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions

This call provided clinicians an overview of recommendations for use of COVID-19 vaccines in certain populations. Information provided included recent reports of anaphylaxis following vaccination, and CDC’s update clinical considerations around contraindications and precautions to vaccination. You can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

December 30, 2020: FDA Hand Sanitizer Safety and Use Communication Toolkit

The FDA released this new toolkit for consumers, patients, and health care professionals to help increase hand sanitizer safety. Information available in the toolkit includes:

• Infographic,
• Social media images and messages,
• Drop-in newsletter article for clinicians,
• Responses for health care professionals to commonly asked questions,
• Fact Sheet,
• Online quiz,
• Consumer articles (in 6 languages), and
• A hand sanitizer safety video.

December 30, 2020: Flexibility for Exceeding the 24-hour Time Frame for Patients in ASC Setting During COVID-19 PHE

CMS has released a December 30, 2020 memorandum indicating that “as COVID-19 cases continue to surge, CMS will temporarily exercise survey enforcement discretion regarding the 24-hour time frame to allow patients to remain in the ASC longer, if needed, during the COVID-19 PHE. This applies to ASCs that have not converted to a hospital during the PHE.”

December 30, 2020: Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care

CMS notes in this memorandum that they are “making revisions to the non-long term care (NLTC) focused infection control survey tool for acute and continuing care providers to reflect COVID-19 guidance updates, provide clarifications to existing information, and update the appropriate CMS regulatory tag considerations if a citation is warranted.”

December 31, 2020: List of Approved Hospitals for Acute Hospital Care at Home Program

CMS posted an updated pdf document listing the 24 systems and 51 hospitals that are currently included in this program. As a reminder, “the Acute Hospital Care at Home program is an expansion of the CMS Hospital Without Walls initiative launched in March 2020 as a part of a comprehensive effort to increase hospital capacity, maximize resources, and combat COVID-19 to keep Americans safe. This program creates additional flexibility that allows for certain health care services to be provided outside of a traditional hospital setting and within a patient’s home.” You can find a link to this document on the CMS Coronavirus Disease 2019 Current emergencies web page.

January 1, 2021: Mandatory Deadline for Renewed Advanced Beneficiary Notice (ABN) Form

Reminder, the ABN form was renewed by the Office of Management and Budget (OMG) in 2020. Due to COVID-19 concerns, CMS expanded the deadline for using the renewed from CMS-R_131 (exp. 6/30/2023). The renewed ABN was mandatory for use on 1/1/2021.

CDC COVID Data Tracker – United States COVID-19 Cases

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020 and is scheduled to be published in the Federal Register on December 29th. A Wednesday@One article released earlier this month highlighted changes to the Inpatient Only Procedure List and the Hospital Outpatient Department Prior Authorization Program.

This week’s article details finalized changes for supervision of outpatient therapeutic services and the Ambulatory Surgical Center (ASC) Covered Procedures List.

Changes in the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.

This policy became effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

In the 2021 OPPS Proposed Rule, CMS noted that a March 31, 2020 interim final rule with comment period (IFC) was issued with the intent to give providers “needed flexibilities to respond effectively to the serious public health threats posed by the spread of the COVID-19.”

Specific to the level of supervision the following policies were adopted in the IFC to be effective for the duration of the Public Health Emergency (PHE) due to COVID-19:

• A policy to reduce the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS previously required direct supervision on initiation of the service.
• A policy indicating that the requirement for direct supervision of pulmonary, cardiac and intensive cardiac rehabilitation services includes virtual presence of the physician 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.

CMS decided that these policies are appropriate outside of the PHE and proposed to adopt them for CY 2021 and beyond.

NSEDTS Level of Supervision

In the final rule, CMS finalized their proposal without modification to reduce the minimum default level of supervision for NSEDTS to general supervision. They do “note that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services, including NSEDTS, may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

In response to a comment from Med PAC, CMS intends to “monitor NSEDTS for safety or service quality issues that may arise from the change to general supervision as the minimum default level of supervision for the initiation period of these services.”

Direct Supervision of Pulmonary, Cardiac, and Intensive Cardiac Rehabilitation Services Using Interactive Telecommunication Technology

Several commenters expressed concerns regarding the proposed change to direct supervision for these three rehabilitation services.

Ultimately, CMS finalized their “proposed policy to permit direct supervision of these services using virtual presence only until the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising practitioner, as discussed in IFC-1 (85 FR 19246).

When the policy to permit direct supervision through virtual presence ends, we will resume our current policy to require direct physician supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, and that the supervising practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the supervising practitioner must be present in the room when the procedure is performed.”

CMS also clarified “that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology during the PHE, the requirement could be met by the supervising practitioner being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.”

Proposed Additions to the Ambulatory Surgical Center (ASC) Covered Procedures

In general procedures on the ASC covered procedure list (ASC-CPL) are those procedures that are not “expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.”

CMS proposed to continue to apply the revised definition of “surgery” adopted in the CY 2019 OPPS/ASC Final Rule that includes procedures that are “surgery-like” procedures that are assigned outside the CPT surgical range, for CY 2021 and subsequent years.

CMS Outlook for the Future of the ASC-CPL

CMS reiterated many thoughts/beliefs about the future of ASCs included in the proposed rule. Following are some of the statements found in the final rule:

• CMS believes “that significant advancements in medical practice, surgical techniques, medical technology, and other factors have allowed certain ASCs to safely perform procedures that were once too complex, including those involving major blood vessels and other general exclusion criteria.”
• CMS acknowledges “that ASCs and hospitals have different health and safety requirements. Despite this fact, ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals as well as meet Medicare conditions for coverage (see 42 CFR 416.40 through 416.54).”
• CMS reminds the reader that “in recent years, we have added procedures to the ASC-CPL that were largely considered hospital inpatient procedures in the past, such as total knee arthroplasty (TKA) and certain coronary intervention procedures.”
• “Many procedures that are currently only payable as hospital outpatient services under Medicare fee-for-service are safely performed in the ASC setting for other payors.”
• CMS recognizes “that non-Medicare patients tend to be younger and have fewer comorbidities than the Medicare population.” However, “careful patient selection can identify Medicare beneficiaries who are suitable candidates for these services in the ASC setting.”
• “Medicare Advantage plans are not obligated to adopt the ASC-CPL as it exists in Medicare fee-for-service and…many MA enrollees have had services performed in the ASC setting that are not currently payable under Medicare fee-for-service.”
• “The COVID-19 pandemic has highlighted the need for more healthcare access points throughout the country…Looking ahead to after the pandemic, it will be more important than ever to ensure that the health care system has as many access points and patient choices for all Medicare beneficiaries as possible. Because the pandemic has forced many ASCs to close, thereby decreasing Medicare beneficiary access to care in that setting, we believe allowing greater flexibility for physicians and patients to choose ASCs as the site of care, particularly during the pandemic, would help to alleviate both access to care concerns for elective procedures as well as access to emergency care concerns for hospital outpatient departments.”
• “In the CY 2021 OPPS/ASC proposed rule, we sought to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expand the ASC CPL to include as many procedures that can be performed in the HOPD as reasonably possible to advance that goal.”

CMS finalized without modification the addition of the eleven proposed procedures to the ASC-CPL. These procedures are listed in Table 59 of the final rule.

Table 59: Final Additions to the List of ASC Covered Surgical Procedures for CY 2021

Specific to the addition of total hip arthroplasty (THA) to the ASC-CPL, CMS notes in the final rule that they “are aware that beneficiaries may incur greater cost-sharing for THA procedures in an ASC setting under our proposal, but note that this is not an occurrence that is unique to THA.” Section 4011 of the 21st Century Cures Act added the requirement that the Secretary make a searchable website available to the public, “with respect to an appropriate number of items and services, the estimated payment amount for the item or service under the OPPS and the ASC payment system and the estimated beneficiary liability applicable to the item or service.” CMS implemented this provision by providing an Outpatient Procedure Price Lookup tool available at https://www.medicare.gov/procedure-price-lookup. “This web page allows beneficiaries to compare their potential cost-sharing liability for procedures performed in the hospital outpatient setting versus the ASC setting.” CMS that this tool will include cost-sharing liability for THA in the outpatient hospital and ASC settings in the future.

At the end of the day, whether a procedure is performed in the Inpatient, Outpatient or ASC setting, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 8th through the 14th.

Resource Spotlight: CDC December 14 Call – What Every Clinician Should Know about COVID-19 Vaccine Safety

For those that missed it, the CDC held a call about COVID-19 vaccine safety on Monday December 14th. Information shared with the clinicians during this call included:

• How to educate patients about what to expect after COVID-19 vaccination,
• The important role clinicians play in monitoring the safety of COVID-19 vaccines, and
• How to report adverse events (possible side effects) to the Vaccine Adverse Event Reporting System (VAERS).

You can access the call materials on the CDC’s webpage.

December 3, 2020: Alabama Medicaid COVID-19 Emergency Expiration Date Extended

Alabama Medicaid published an ALERT to All Providers letting them know that the new expiration date for the COVID-19 emergency is the earlier of January 31, 2021, the conclusion of the COVID-19 national emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.

December 7, 2020: FDA Safety Communication: Wear Face Masks with No Metal During MRI Exams

In this FDA Safety Communication the FDA notes that they have “recently received a report that a patient’s face was burned from the metal in a face mask worn during an MRI. The FDA reminds patients and providers that patients should not wear any metal during an MRI.”

December 7, 2020: Hospital Facility-Level COVID-19 Data Published by HHS

HHS announced the release of new hospital COVID-19 capacity data at the facility level. “Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture to protect patient privacy, while providing a view of how COVID-19 is impacting hospitals and local communities across the country.”

December 9, 2020: Alabama Governor, Kay Ivey, Extends Safer at Home Order

Alabama Governor, Kay Ivey, issued her twentieth supplemental emergency proclamation extending the Safer at Home Order until Friday, January 22, 2021 at 5:00 pm. This includes a statewide mask requirement when in public and in close contact with other people.

December 9, 2020: MLN Connects Special Edition – In Case You Missed It – Medicare Coverage of COVID-19 Antibody Treatment

CMS published a December 3rd Special Edition MLNConnects which included information about monoclonal antibody infusions. Just six days later, on December 9th, CMS published another Special Edition MLNConnects titled In Case You Missed It: CMS Announces Guidance for Medicare Coverage of COVID-19 Antibody Treatment. The following information was included in the December 9th newsletter:

“On December 9, CMS posted updates to FAQs and an infographic about coverage and payment for monoclonal antibodies to treat COVID-19. The FAQs include general payment and billing guidance for these products, including questions on different setting types. The infographic has key facts about expected Medicare payment to providers and information about how Medicare beneficiaries can receive these innovative COVID-19 treatments with no cost-sharing during the public health emergency (PHE). CMS’ November 10, 2020 announcement about coverage of monoclonal antibody therapies allows a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the Food & Drug Administration’s Emergency Use Authorization (EUA), and bill Medicare to administer these infusions. Currently, two monoclonal antibody therapies have received EUA’s for treatment of COVID-19.

For More Information:

• Therapeutics Coverage Infographic

• Section BB of the FAQs: billing and payment for COVID-19 monoclonal antibody treatments
• Monoclonal toolkit and program guidance”

December 9, 2020: CDC COCA Now Newsletter: Similarities in Symptoms of COVID-19 and Carbon Monoxide Poisoning

In this newsletter, the CDC notes that COVID-19 cases, hospitalizations and deaths and carbon monoxide poisoning incidence are on the rise and the symptoms may overlap. They go on to note that “The purpose of this COCA Now is to remind emergency department, urgent care, and other clinical professionals who are assessing patients for SARS-CoV-2 infection to consider the possibility of CO poisoning.” You can find additional CDC Clinician Outreach and Community Activity (COCA) Now messages related to COVID-19 on the CDC website at https://emergency.cdc.gov/coca/cocanow/index.asp.

December 9, 2020: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

LabCorp’s Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer test system and does not require a prescription. Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health notes in this announcement that “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription…While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

December 11, 2020: FDA Issues Emergency Use Authorization (EUA) to Pfizer for COVID-19 Vaccine

Pfizer has been granted the first EUA for a COVID-19 vaccine in the United States. Acting Secretary of Defense, Christopher C. Miller, indicates in the HHS Announcement that “The massive logistical planning our military has contributed to Operation Warp Speed gives me even more pride in the talent and dedication of our service members. They have been crucial in bringing a safe and effective vaccine to the American people and in restoring the health of our country.”

December 11, 2020: FDA’s Vaccine and Related Biological Products Advisory Committee to Meet December 17th to discuss Moderna’s COVID-19 Vaccine EUA Request

Moderna’s Phase 3 clinical trial began July 27th and “was the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the U.S. and enrolled approximately 30,000 adult volunteers who did not have COVID-19. An independent data safety monitoring board overseeing the Phase 3 clinical trial reviewed the trial data and concluded that the vaccine was safe, prevented disease in 94 percent of the volunteers who received the vaccine and was generally well tolerated. The clinical studies are ongoing.”

HHS announced plans to purchase 100 million doses of the COVID-19 vaccine called mRNA-1273 from Moderna. This purchase brings the total doses of mRNA-1273 owned by the Federal Government to 200 million.

December 14, 2020: Special Edition MLNConnects - COVID-19 Vaccine Codes

Late in the afternoon, CMS issued the following information regarding the Pfizer-BioNTech Vaccine:

“On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage”

CDC COVID Data Tracker – United States COVID-19 Cases

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020. This article focuses on changes to the Medicare Inpatient Only Procedure (IPO) List including medical reviews of procedures being removed from the list and additions to the Hospital Outpatient Prior Authorization Program that went into effect July 1, 2020.

Inpatient Only Procedure List

Currently, there are approximately 1,740 services on the IPO List. In the proposed rule, CMS proposed the following changes for CY 2021: 

• Eliminate the IPO list over a three-year transitional period with the list completely phased out by CY 2024, and
• Begin with the removal of nearly 300 musculoskeletal-related services.

They also requested comments on “whether three years is an appropriate time frame for transitioning to eliminate the IPO list; other services that are candidates for removal from the IPO list for CY 2021; and the sequence in which to remove additional clinical families and/or specific services from the IPO list in future rulemaking.”

Not surprisingly, CMS has finalized their proposal to phase out the IPO list by CY 2024. For CY 2021, 298 services are being removed from the IPO list and can be found in Table 48 of the final rule. This list includes:

• 266 musculoskeletal related services,
• 16 anesthesia codes related to the musculoskeletal procedures being removed, and
• 16 additional procedures that were recommended for removal by the Hospital Outpatient Panel (HOP).

“All 298 services that are being removed from the IPO list beginning in CY 2021 are assigned status indicator “J1” and will receive payment through C-APCs, except for 34 services that are assigned status indicator “N”, which indicates that payment for the service is packaged into payment for other services and there is no separate APC payment, and two services assigned status indicator “Q1) which indicates conditionally packaged payment. CPT code 44314 (Revision of ileostomy; complicated (reconstruction in-depth) (separate procedure)), is the only code to be removed from the IPO list that is assigned status indicator “T”, indicating that it is a separately paid procedure. The vast majority of the procedures being removed from the IPO list for CY 2021 are assigned to C-APCs or packaged into payment for other services, which will result in beneficiaries paying one copayment amount.”

“Commenters urged CMS to develop national guidelines outlining beneficiaries who are appropriate candidates for the inpatient vs outpatient setting, particularly for services that generally have a short length of stay (i.e. do not meet 2-midnight benchmark).”

In response, CMS again stated that this decision is a complex medical judgment and should be based on a “beneficiary’s individual clinical needs.” However, they did note that they “agree with the commenters that, in the near term, in light of the elimination of the IPO list over a three-year period, physicians and providers could benefit from having access to general considerations for physicians regarding the types of services that may continue to be more appropriately performed in the inpatient setting for Medicare beneficiaries. Therefore, in the future, we plan to provide information on appropriate site of service selection to support physicians’ decision-making. We note that these considerations will be for informational or educational purposes only and will not supersede physicians’ medical judgment about whether a procedure should be performed in the inpatient or outpatient hospital setting.”

‍Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule)

The Two-Midnight Rule, as finalized in the FY 2014 IPPS Final Rule, clarified when an inpatient admission is to be considered reasonable and necessary for purposes of Medicare Part A payment. Per CMS “when a beneficiary enters a hospital for a surgical procedure not designated as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n), a diagnostic test, or any other treatment, and the physician expects to keep the beneficiary in the hospital for only a limited period of time that does not cross 2 midnights, the services would be generally inappropriate under Medicare Part A.”

Additionally, CMS has consistently indicated that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the generally appropriate setting.”

So, what exactly does this mean? It means that when a surgical procedure has been removed from the IPO List, if you admit a patient as an inpatient for a surgical procedure not on the IPO list, documentation in the record must support the need for the inpatient admission.

In the CY 2020 OPPS Final Rule, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

For CY 2021, CMS proposed to continue the two-year exemption for procedures removed from the IPO list beginning on January 1, 2021. They also requested comments on whether this continues to be the appropriate time frame, or if a longer or shorter period may be warranted.

Ultimately, CMS finalized a policy where procedures removed from the IPO list beginning January 1, 2021 “will be indefinitely exempted from site-of-service claim denials under Medicare Part A, eligibility for Beneficiary and Family-Centered Care-Quality Improvement Organization (BFCC-QIO) referrals to Recovery Audit Contractors (RACs) for noncompliance with the 2-midnight rule, and RAC reviews for “patient status.”

CMS plans to maintain this exemption until they “have Medicare claims data indicating that the procedure is more commonly performed in the outpatient setting than the inpatient setting.”

As a provider, it is important to be mindful that this exemption is specific to site-of-service claim denials. This exemption does not include medical necessity based on a National or Local Coverage Determinations (NCDs and LCDs). Ultimately, irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the surgical procedure.

Hospital Outpatient Department Prior Authorization Program: Proposed New Service Categories

With the CY 2020 OPPS/ASC Final Rule (CMS-17-17-FC), CMS established the nationwide prior authorization process and requirements for certain hospital outpatient department (OPD) services.  Effective July 1, 2020 blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation all required a prior authorization.  

CMS indicates in the CY 2021 OPPS final rule that they received over 100 comments to their proposal to add cervical fusion with disc removal and implanted spinal neurostimulators to this program effective for services provided on or after July 1, 2021.

Several commenters expressed the concern “that the MACs have not demonstrated the ability to handle the volume of prior authorization requests since the OPD process began July 1, 2020. These commenters stated that MACs have taken longer than the 10 days specified for communicating the results of prior authorization requests.” CMS responded by acknowledging “there have been occasions when a few of the MACs were not able to issue decisions within this timeframe, as they adjusted to this new workload.” They went on to indicate they have worked with the MACs to ensure outstanding requests were resolved as soon as possible and “as this program continues, we will continue tracking MAC timeliness metrics and are confident that the MACs will be able to meet the required review and decisions timeframes so as not to cause additional burden for OPD providers or delay medically necessary services.” Only time will tell.

Ultimately, CMS finalized their proposal without modifications. Table 74 of the final rule includes the overall list of outpatient department services that will require a prior authorization. Following are the new procedure codes effective July 1, 2021.

Cervical Fusion with Disc Removal

• 22551: Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex, initial, and
• 22552: Fusion of spine bones with removal of disc in upper spinal column below second vertebra of neck, anterior approach, each additional interspace

Implanted Spinal Neurostimulators

• 63650: Implantation of spinal neurostimulator electrodes, accessed through the skin,
• 63685: Insertion or replacement of spinal neurostimulator pulse generator or receiver, and
• 63688: Revision or removal of implanted spinal neurostimulator pulse generator or receiver

Timely to the concerns raised about this Medicare Fee-for-Service prior authorization program, on December 2nd, the American Hospital Association (AHA) published the document Addressing Commercial Health Plan Abuses to Ensure Fair Coverage for Patients and Providers.  The AHA notes that “Inappropriate use of prior authorization can negatively impact the quality of care. A survey of more than 1,000 physicians found that more than 90 percent of respondents said prior authorization “had a significant or somewhat negative clinical impact, with 28 percent reporting that prior authorization had led to a serious adverse event such as a death, hospitalization, disability or permanent bodily damage, or other life-threatening event for a patient in their care.”

Resources:

December 2, 2020 CMS Press Release: https://www.cms.gov/newsroom/press-releases/trump-administration-finalizes-policies-give-medicare-beneficiaries-more-choices-around-surgery

December 2, 2020 CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0

CMS Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webpage: https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services‍

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 1st through the 7th

Resource Spotlight: Starbucks Offering Free Coffee to Front-Line Responders

Starbucks is expressing thanks and providing a little holiday cheer to front-line responders by offering free coffee starting December 1 through December 31.

Offer Details:

• “Starting December 1 through December 31, any customer who identifies as a front-line responder to the COVID-19 outbreak will receive a tall brewed coffee (hot or iced) at no charge (see full eligibility list below).

• The offer can be redeemed at Starbucks U.S. company-operated locations and select licensed stores.”

Who is Eligible?

“Those eligible for the offer include front-line health care providers and first responders, including: doctors, nurses, public health workers, pharmacists, dispatchers, fire fighters, paramedics, EMTs, law enforcement officers, dentists and dental hygienists, mental health workers (therapist, psychologist, social worker, counselor, etc.), hospital staff such as janitor/housekeeping/security, military on active duty, contact tracers, vaccine and pharmaceutical researchers, pilots, flight attendants, TSA, and medical researchers.”

November 30, 2020: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans

This new CDC webpage notes “the possibility of one or more COVID-19 vaccines becoming available before the end of the year,” and provides 10 things healthcare professionals need to know about current plans, for example one thing is the critical role healthcare providers will play in building confidence in a COVID-19 vaccination.

December 1, 2020: Letter to the American Public on COVID-19 Vaccines

The American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association (ANA) released an open letter to the American public in support of COVID-19 Vaccines. Collectively, they remind readers that as “partners in health” they are committed to the following:

• “Following the science. We are committed to supporting the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be authorized and recommended for use in the population.

• Your health and safety. We commit to establishing safe and effective processes for administering vaccine to all who are eligible and choose to get vaccinated.
• Being transparent. We will make critical information about vaccines available as it is released, working together to share plans for vaccinating communities across this country. We will share the benefits and risks of a vaccine so that you can make an informed decision for yourself and your loved ones.”

December 1, 2020: COVID-19 FAQs on Medicare Fee-for-Service Billing Updated

CMS has updated this now 159 page document twice in the past week.

• December 1st Update:
• Section QQ. Indian Health Service (IHS) Hospitals was added at the end of the document.
• December 3rd Updates:
• Section F. Hospital Inpatient Prospective Payment Systems (IPPS) Payments two new FAQs were added answering questions about the new COVID-19 treatments add-on payment (NCTAP) under the IPPS.
• Section BB. Drugs & Vaccines under Part B 12 new FAQs were added related to monoclonal antibody treatment for COVID-19.

December 1, 2020: Alabama Public Health Announces COVID-19 Vaccination Plan

State Health Officer Dr. Scott Harris is quoted as saying that “We want to assure the public that there will be equitable distribution of vaccine to all Alabamians, especially to vulnerable populations in rural and urban areas. Many external partners will have input in vaccine allocations.” A link to the complete plan is included in this announcement.

December 1, 2020: FDA Reissues Emergency Use Authorization for use of COVID-19 Convalescent Plasma

The FDA announced in their December 1st COVID-19 bulletin that they have reissued of “the August 23, 2020 Emergency Use Authorization (EUA) for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.”

December 2, 2020: FDA Updates Fact Sheet: Combating COVID-19 with Therapeutics

This FDA Fact Sheet includes a table of the drugs and biological products to date that have been granted Emergency Use Authorization (EUA) to treat COVID-19 and serious conditions caused by COVID-19. 

December 2, 2020: CDC Updates Quarantine Guidance

The CDC has provided updated guidance related to options to reduce quarantine from 14 to 10 days. Specifically, “CDC now recommends two additional options for how long quarantine should last. Based on local availability of viral testing, for people without symptoms quarantine can end:

• On day 10 without testing

• On day 7 after receiving a negative test result

After stopping quarantine, people should

• Watch for symptoms until 14 days after exposure.

• If they have symptoms, immediately self-isolate and contact their local public health authority or healthcare provider.
• Wear a mask, stay at least 6 feet from others, wash their hands, avoid crowds, and take other steps to prevent the spread of COVID-19.

CDC continues to endorse quarantine for 14 days and recognizes that any quarantine shorter than 14 days balances reduced burden against a small possibility of spreading the virus. CDC will continue to evaluate new information and update recommendations as needed. See Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing for guidance on options to reduce quarantine.”

December 2, 2020: CY 2021 OPPS/ASC Final Rule COVID-19 Revised and New Reporting Requirements

CMS notes in the CY 2021 OPPS final rule (CMS-1736-FC) that “Infection prevention and control is a primary goal of hospitals and CAHs in their normal day-to-day operations, and these programs have been at the center of initiatives in hospitals and CAHs during the PHE for COVID-19.”

The current COVID-19 PHE hospital and Critical Access Hospital (CAH) Conditions of participation (CoP) reporting requirements, have been revised “to now require hospitals and CAH’s to report data elements that must include, but not be limited to the following: 1) the hospital’s (or the CAH’s) current inventory supplies of any COVID-19-related therapeutics that have been distributed and delivered to the hospital (or CAH) under the authority and direction of the Secretary; and (2) the hospital’s (or the CAH’s) current usage rate for any COVID-19-related therapeutics that have been distributed and delivered to the CAH under the authority and direction of the Secretary.”

In addition, CMS is also now requiring hospitals and CAHs “to report information with a frequency, and in such standardized format as specified by the Secretary during the COVID-19 PHE, on Acute Respiratory Illness (including, but not limited to, Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection).”

“The new rules make reporting a requirement of participation in the Medicare and Medicaid programs and the required reporting is needed to support broad surveillance of COVID-19 in conjunction with other acute respiratory illnesses that may further burden and strain hospital and CAH resources.”

December 3, 2020: Special Edition MLN Connects – Steps to Widen Access to COVID-19 Antibody Treatment and Vaccine & Monoclonal Antibody Infusions – Enforcement Discretion

Bamlanivimab was the first investigational monoclonal antibody therapy granted Emergency Use Authorization (EUA) by the FDA on November 9th. Similar to Bamlanvimab, the monoclonal antibody therapy of casirivimab and Imdevimab, administered together has been granted EUA “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization.

CMS’ December 3rd Special Edition MLNConnects reminds providers that this drug combination “may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary.” The following coding information is excerpted directly from the MLNConnects article:

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) (ZIP), EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Also included in this MLNmatters article is CMS action taken “To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance.”

December 3, 2020: FDA Issues Emergency Use Authorization (EUA) for Ultraviolet Light

The FDA announced in their December 4, 2020 Daily Update an EUA for the Lumin LM3000 Bioburden Reduction UV System, “the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.”

December 3, 2020: HHS Amends Public Readiness and Emergency Preparedness Act (PREP Act) to Expand Access to Countermeasures against COVID-19

HHS announced their fourth amendment to the PREP Act “to increase access to critical countermeasures against COVID-19.” One example provided in the announcement is authorizing the provision of COVID-19 covered countermeasures via telehealth across state lines noting that “many states have already authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of COVID-19; this action will ensure that COVID-19 Covered Countermeasures can be provided via telehealth across state lines.” 

December 4, 2020: FDA Approves Home Test to Detect COVID-19 and Influenza A and B (Flu)

The FDA announced they have authorized the first diagnostic test for at home collection of patient samples to detect COVID-19 and influenza A and B. The test was developed by Quest Diagnostics and is the RC COVID-19 + Flu RT-PCR test.

December 4, 2020: CDC Morbidity and Mortality Weekly Report (MMWR): Guidance to Address the High Level of COVID-19 Cases

The CDC indicates in this MMWR Report that “with colder weather, more time spent indoors, the ongoing U.S. holiday season, and silent spread of disease, with approximately 50% of transmission from asymptomatic persons (2), the United States has entered a phase of high-level transmission where a multipronged approach to implementing all evidence-based public health strategies at both the individual and community levels is essential.” Specific strategies outlined in this article includes:

• Universal face mask use,
• Maintaining physical distance from other persons and limiting in-person contacts,
• Avoiding nonessential indoor spaces and crowded outdoor spaces,
• Increasing testing to rapidly identify and isolate infected persons,
• Promptly identifying, quarantining, and testing close contacts of persons with known COVID-19,
• Safeguarding persons most at risk for severe illness or death from infection,
• Protecting essential workers with provisions of adequate personal protective equipment (PPS) and safe work practices,
• Postponing travel,
• Increasing room air ventilation and enhancing hand hygiene and environmental disinfection, and
• Achieving widespread availability and high community coverage with effective COVID-19 vaccines.

CDC COVID Data Tracker – United States COVID-19 Cases

NEW RISK AREA - TOTAL KNEE REPLACEMENT

Last Wednesday December 2nd, the Program for Evaluating Payment Patterns Electronic Report (PEPPER) Team sent out a notice to list serve recipients informing them that the Q3 Fiscal Year 2020 PEPPER Report for Short-Term Acute Care Hospitals was recently completed. It is important to note that your hospital specific report will only be available for download until December 14, 2020 as the QualityNet file transfer service will be decommissioned on December 15th. If you do not download the report before the deadline, the report will not be available until the next release scheduled for March 8, 2021.

This article focuses on the Short-Term Acute Care Hospitals PEPPER. Specifically, the changes in the recently released Fiscal Year (FY) 2020 Q3 Short-Term Acute Care PEPPER and an analysis of Palmetto JJ Total Knee claims. But first, for those not familiar with the PEPPER, let’s take a look at what it is and why it is a valuable resource for hospitals.  

Background

What is PEPPER?

The PEPPER contains statistics for specific “Target Areas” that have been identified as being “at risk for improper payment due to billing, coding and/or admission necessity issues.” The Centers for Medicare & Medicaid Services (CMS) approves the Short Term PEPPER target areas.

The PEPPER compares you to other hospitals in your state, Medicare Administrative Contractor (MAC) Jurisdiction and to the nation. “Comparisons enable a hospital to determine if it is an outlier, differing from other short-term acute care hospitals.” Reports are delivered to a hospital electronically, are hospital specific, and provide the most recent twelve federal fiscal quarters for each target area.

In addition to your hospital specific report, the PEPPER Resources National-level Data Reports webpage includes a Target Area Analysis that provides claims volume, average length of stay and average Medicare Payment for each of the target areas.

Why is this a Valuable Resource for your Hospital?

The PEPPER User’s Guide notes that the Office of Inspector General (OIG) “encourages hospitals to develop and implement a compliance program to protect operations from fraud and abuse. As part of a compliance program, a hospital should conduct regular audits to ensure charges for Medicare services are correctly documented and billed.”

It is important to understand that “PEPPER does not identify the presence of payment errors, but it can be used as a guide for auditing and monitoring efforts. A hospital can use PEPPER to compare its claims data over time to identify areas of potential concern:

• Significant changes in billing practices,
• Possible over- or under-coding,
• Changes in lengths of stay.”

PEPPER User’s Guide, 31st Edition, effective with Q3FY 2020 Release, What’s New?

The 31st Edition of the PEPPER User’s Guide includes a new target area called Total Knee Replacement. Following are the Total Knee Target Area definitions for the numerator and denominator in the User’s Guide:

• Numerator: the count of discharges with at least one of the ICD-10-PCS knee replacement procedures codes in Appendix 6 of the User’s Guide.
• Denominator: the count of discharges with at least one of the ICD-10-PCS knee replacement procedure codes plus outpatient claims with CPT® code 27447.

The CY 2018 OPPS Final Rule finalized the removal of this procedure from the Medicare Inpatient Only (IPO) List. This new target area will monitor the proportion of all knee surgeries that are performed on an inpatient basis in short-term acute care hospitals.

The User’s Guide indicates that high outlier hospitals may have “unnecessary admissions related to the use of outpatient observation or inappropriate use of admission screening criteria associated with total knee replacement procedures. A sample of medical records for these procedures should be reviewed to determine whether care could have been provided more efficiently on an outpatient basis. Documentation should support the need for an inpatient admission.”

RealTime Medicare Data (RTMD) Analysis of Total Knee Claims

In addition to total knee procedures being a new PEPPER Target Area, Total Knee Arthroplasty Medical Necessity and Documentation Requirements Reviews became an approved RAC Issue (0185) on August 3, 2020. The RACs will be performing complex medical reviews for inpatient hospital, outpatient hospital, ambulatory surgical center and professional services.

Given that Total Knee Claims seem to be an ongoing review for Medicare Contractors, I turned to our sister company, RTMD, to perform an analysis of Total Knee claims for Palmetto GBA Jurisdiction J which includes Alabama, Georgia and Tennessee. Specifically parameters of my analysis included:

• Claims with dates of service from January to June for calendar years 2017 (the year prior to total knee procedures being removed from the Medicare Inpatient Only (IPO) list) through 2020.
• Total knee inpatient claims with the list of ICD-10-PCS knee replacement codes found in Appendix 6 of the User’s Guide, and
• Total knee outpatient claims with a CPT® code 27447, again as per the parameters of the PEPPER Review Target. This is important to keep in mind as the RAC issue also includes additional knee procedure CPT® codes 27445, 27486 and 27487.

Key Findings

• While there were outpatient claims in all three states in 2017, in general hospitals received no payment for CPT 27447.
• All three states have seen a shift from inpatient to outpatient total knee claims with the most significant shift being in Georgia.
• Inpatient volumes appear to have been impacted more as a result of the COVID-19 pandemic.

Potential Next Steps

• Download your PEPPER Report prior to December 15, 2020.
• Whether or not you are an outlier, consider reviewing a sample of claims for documentation supporting the billing patient status and medical necessity of the surgical procedure.
• Prior to reviewing a sample of claims, determine whether or not your MAC has created a Local Coverage Determination (LCD) and Local Coding and Billing Coverage Article (LCA) for total knee procedures.
• I encourage you to spend some time on the PEPPER Resources website where you can find a copy of the most recent User’s Guide, Training and Resources available to you including testimonials and training sessions.
• One last resource, at the same time Total Knee Procedure became an approved issue for the RACs, CMS released an updated Major Joint Replacement (Hip or Knee) MLN Booklet in August. This is a useful tool as it provides information related to documentation, coverage requirements and coding major joint replacements.