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Annually, the Comprehensive Error Rate Testing (CERT) program measures improper payments in the Medicare Fee-For-Service (FFS) program. As shared in a related MMP article, “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.” This article focuses on the trend in common causes of improper payments.  

Fiscal Year 2020 Supplemental Improper Payment Data - Common Causes of Improper Payments

The CERT groups improper payments into five categories. The following table compares common causes of improper payments broken out by the type of error for past four years. While Medical Necessity and Incorrect Coding errors are on the decline, there is an increasing trend in the percentage of errors due to insufficient documentation.

Insufficient Documentation

The increase in “insufficient documentation” errors is further evidenced in the 2020 Report, Table D4: Top 20 Service Types with Highest Improper Payments: Part A Hospital IPPS. It should come as no surprise that the DRGs in this table with a high percentage of “insufficient documentation” errors are surgical procedures. Following are DRGs in Table D4 with an Insufficient Documentation error greater than 90%.

DRGs 266 & 267: Endovascular Cardiac Valve Replacement

In the 2020 Report, 97% of the overall error rate for this DRG pair was attributed to Insufficient Documentation. Structural heart procedures Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR) both sequence to DRGs 266 & 267. Both procedures have a related National Coverage Determination (NCD) outlining the requirements for the procedures to be considered medically necessary. (TAVR NCD 20.32 and TMVR NCD 20.33).

June 30, 2020, CMS released a Proposed Decision Memo for TMVR procedures and includes significant changes in coverage indications. The comment period ended July 30, 2020. The Final Decision memo should have been published in September 2020. Well past the September 2020 deadline, CMS finally published the Final Decision Memo (CAG-00438R) on January 19, 2021. At first glance, there are significant changes in the Final Decision Memo when compared to what was proposed.

DRGs 273 & 274: Percutaneous Intracardiac Procedures

In the 2020 Report, 100% of the overall error rate for this DRG pair is attributed to insufficient documentation. The structural heart procedure Left Atrial Appendage Closure (LAAC) sequences to DRGs 273 and 274. Similar to the TAVR and TMVR procedures, the LAAC procedure has an NCD.

DRGs 226 & 227: Cardiac Defibrillator without Cardiac Cath

In the 2020 Report, 90.8% of the overall error rate for this DRG pair is attributed to insufficient documentation. The related coverage determination is NCD 20.4. Additionally, almost all Medicare Administrative Contractors have published a Local Coverage and Billing Article.

Cardiac Defibrillator Shared Decision Making

NCD 20.4 was revised in 2018 and now requires documentation of Shared Decision Making with the patient prior to the procedure being performed. This continues to be challenge for hospitals.

In the Public Comment section of the February 18, 2018 Cardiac Defibrillator Final Decision Memo (CAG-00157R4), CMS responded to a comment with the following statement:

“CMS believes in the importance of an evidenced based tool but they are not specifying the type of tool that is required. They do provide an example of an evidence based decision aid for patients with heart failure who are at risk for sudden cardiac death and are considering an ICD. This tool was funded by the National Institutes on Aging and the Patient-Centered Outcomes Research Institute and can be found at https://patientdecisionaid.org/wp-content/uploads/2017/01/ICD-Infographic-5.23.16.pdf. CMS notes that this tool is based on published clinical research and interviews with patients and includes discussion of the option for future ICD deactivation.”

On December 21, 2020, WPS, the Medicare Administrative Contractor for Jurisdictions 5 and 8, posted the following information in their e-newsletter:

“The Comprehensive Error Rate Testing (CERT) contractor recently issued errors related to formal shared decision making encounter using an evidence-based tool prior to ICD implantation. In these cases, submitted emergency room, history and physical, consultation, and other progress notes did not include adequate documentation to support this encounter took place prior to surgery.

For more information regarding coverage criteria for ICDs, see the CMS Internet-Only Manual (IOM) Publication 100-03, Chapter 1 , section 20.4.”

As recent as last week, Palmetto GBA, the Medicare Administrative Contractor for Jurisdiction J and M, announced a new education module available to providers related to DRG 227. They indicate that the “purpose of this module is to educate providers on this DRG so claims can be submitted correctly.”

Moving Forward

Preventing “insufficient documentation” errors is not an insurmountable challenge. It is important to identify when a procedure has a related National or Local Coverage Determination. If the answer is yes, read the NCD carefully and make sure you are following all of Medicare’s requirements to support the medical necessity for the procedure and make sure the information is documented in the record.

This week we highlight key updates spanning from January 12th through January 18th, 2021.

Resource Spotlight: AMA Resource – Find your COVID-19 Vaccine CPT® Codes

The AMA has created this resource “to help you determine the appropriate CPT code combination for the type and dose of vaccine that you are using.” You will be asked to answer questions on the left side of the screen regarding the vaccine manufacturer and dose being administered. Once you have done this the appropriate CPT code combinations will appear on the right side of the webpage.

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 7, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing Document Updated

This now 166 page document added the following FAQ on January 7th:

“Question: How did CMS implement the increased payment under the IPPS for COVID-19 patients under the provisions of section 3710 of the CARES Act?

Answer: To implement this temporary statutory adjustment, the IPPS Pricer will apply an adjustment factor to increase the Medicare Severity-Diagnosis Related Group (MS-DRG) relative weight that would otherwise apply by 20 percent when determining IPPS operating payments (including the calculation of payments such as for disproportionate share hospitals (DSHs), indirect medical education (IME), outliers, new technologies, and low volume hospitals and the hospital specific rates for sole community hospitals (SCHs) and Medicare-dependent hospitals (MDHs)) for discharges of patients with a principal or secondary diagnosis of COVID-19. For additional information regarding which claims are eligible for the 20 percent increase in the MS-DRG weighting factor, please see the Medicare Learning Network (MLN) Matters article “New COVID-19 Policies for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act” available on the CMS website at https://www.cms.gov/files/document/se20015.pdf.

Updated: 1/7/21”

January 11, 2021: New Web Platform for 1135 Waivers and Inquiries

In a January 11, 2021 memorandum to State Survey Agency Directors, CMS announced a new platform for submission of 1135 waiver requests and inquiries. They indicate in the memorandum summary that “with very limited exception, the new web system should be sued for all 1135 waiver requests and/or PHE-related inquiries submitted on or after January 11, 2021.” CMS is providing training on this new system on YouTube at CMS YouTube 1135 Waiver and Inquiry Web Training.

January 12, 2021: Negative COVID-19 Test Required for All Air Passengers Entering United States

The CDC Director signed an order on January 12, 2021 expanding the requirement for a negative COVID-19 test to all air passengers entering the United States. The CDC notes that “testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans.” The order will become effective on January 26, 2021.

January 14, 2021: Federal COVID-19 Testing Report: Data Insights from Six Federal Health Care Programs

The OIG released this Full Report and an Accompanying Release “that provides insights and data on the COVID-19 testing efforts of six federal health care programs from February 1, 2020, to August 31, 2020—the first seven months following the declaration of a public health emergency in the United States. Although this report does not represent a comprehensive view of the Federal Government’s testing efforts, it provides insights on the populations covered by a variety of federal health care programs. The insights summarized below are intended to help stakeholders—such as Congress; federal and state agencies; and health care entities—understand and plan for current and future response efforts.”

January 14, 2021: CDC Clinician Outreach and Communication Activity (COCA) Call Announced: Treating Long COVID: Clinician Experience with Post-Acute COVID-19 Care

This call will be Thursday, January 28, 2021 from 2:00PM – 3:00 PM ET. “During this COCA Call, presenters will share their firsthand experiences with treating long COVID, focusing on the pulmonary, neurologic, and psychological aspects. They will also describe their experiences with establishing clinics that provide care for patients with these long-term effects.”

CDC COVID Data Tracker – United States COVID-19 Cases

In September 2020, CMS released the proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). Per a related CMS Press Release, “Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The lag time between the two has been called the “valley of death” for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.” Further, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, stated that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.”

CMS issued Final Rule (CMS-3372-F) on January 12th which was published in the Federal Register on January 14, 2021. This Final Rule will take effective on March 15, 2021. CMS notes in a related Press Release that “after the final rule takes effect, upon manufacturer request, Medicare may cover through MCIT eligible breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date, giving Medicare beneficiaries access to these innovative and potentially life-saving devices.”

Current Medicare Coverage Pathways

The MCIT pathway was proposed because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limits CMS’ ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCDs) take, on average, 9 to 12 months to finalize.

CMS detailed current Medicare coverage pathways in the proposed rule. Each pathway is highlighted in the following table. 

FDA Breakthrough Devices Program

The Breakthrough Devices Program is specifically for medical devices and device-led combination products meeting the following two criteria:

• The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
• The device must satisfy one of the following elements:
• It represents a breakthrough technology;
• No approved or cleared alternatives exist; or
• It offers significant advantages over existing approved or cleared alternatives.

MCIT Coverage Pathway

CMS will coordinate with FDA and manufacturers as medical devices move through the FDA regulatory processes to ensure seamless Medicare coverage. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

Unlike the pathways in the above table, the MCIT Pathway will allow for immediate national coverage upon the date of FDA market authorization (that is the date the medical device received Premarket Approval (PMA); 510K clearance; or the granting of a De Novo classification request) for the breakthrough device.

Medical Device Eligibility

The MCIT Coverage Pathway is available only to medical devices that meet all of the following:

• A device is an FDA-designated breakthrough device,
• A device that was FDA market authorized two years prior to the effective date of the final rule (March 15, 2021) and thereafter,
• A device is used according to their FDA approved or cleared indication for use,
• A device that falls within a Medicare benefit category,
• A device that is not the subject of a Medicare national coverage determination, and
• A device that is not otherwise excluded from coverage through law or regulation.

Coverage Period

The pathway is a voluntary, opt-in model and will begin when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. CMS finalized that manufacturers may opt-in using no more than an email from the manufacturer to CMS indicating a desire to opt-in and the requested start date of MCIT coverage.

A manufacturer’s requested start date must be no early than the date a device receives market authorization and no later than 2 years after the date of market authorization.

In the proposed rule, CMS indicated that they anticipate two MCIT pathway participants in the first year based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles.

MCIT Pathway End Date

MCIT coverage will expire four years after the date of FDA approval, irrespective of when the manufacturer requested activation of their MCIT coverage, at which point, the manufacturer may request CMS to undertake an NCD for the breakthrough device.

Reasons that the MCIT Pathway may End Prior to 4 years

• The manufacturer withdraws the breakthrough device from the MCIT pathway,
• The device becomes subject to an NCD,
• The device becomes non-covered through law, regulation, or at the discretion of the Secretary subsequent to an FDA medical device safety communication or warning letter, or
• The FDA removes authorization of a device.

When an MCIT Coverage Pathway Ends, What Next?

At the end of the 4-year MCIT pathway, coverage of a device would be subject to one of the following three possible outcomes:

• NCD affirmative coverage, which may include facility or patient criteria;
• NCD non-coverage; or
• MAC discretion (claim-by-claim adjudication or NCD).

CMS encourages interested manufacturers to submit an NCD request during the third year of MCIT to allow time for NCD development.

Definition of “Reasonable and Necessary” Codified

In addition to the MCIT Pathway, CMS proposed and has finalized their intent to “codify in regulations the Program Integrity Manual definition of ‘‘reasonable and necessary’’ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.”

Reasonable and Necessary Definition

An item or service would be considered ‘‘reasonable and necessary’’ if it is— (i) safe and effective; (ii) not experimental or investigational; and (iii) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:

(A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;

(B) Furnished in a setting appropriate to the patient’s medical needs and condition;

(C) Ordered and furnished by qualified personnel;

(D) Meets, but does not exceed, the patient’s medical needs; and

(E) Is at least as beneficial as an existing and available medically appropriate alternative.

(F) “Not later than March 15, 2022, CMS will issue guidance on the methodology of which commercial insurers are relevant based on the measurement of majority of covered lives. For national and local coverage determinations, which have insufficient evidence to meet paragraphs (b)(3)(i) through (v) of this section, CMS will consider coverage to the extent the items or services are covered by a majority of commercial insurers. As part of CMS’ consideration, CMS will include in the national or local coverage determination its reasoning for its decision if coverage is different than the majority of commercial insurers.”

CMS intends to list MCIT pathway covered devices on the CMS website to ensure all stakeholders will be aware of what is covered through this pathway.

Resources

CMS Press Release: CMS Unleashes Innovation to Ensure our Nation’s Seniors have Access to the Latest Advancements

 https://www.cms.gov/newsroom/press-releases/cms-unleashes-innovation-ensure-our-nations-seniors-have-access-latest-advancements

CMS Fact Sheet: Medicare Coverage of Innovative Technology (CMS-3372-F)

https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f

Final Rule (CMS-3372-F)

https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf

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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.

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.”

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

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

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.

Q:

Where can one find information about the Most Favored Nation Model and are there any recent updates?

A:

CMS announced the Most Favored Nation (MFN) Model on November 20, 2020. Information about this Model is available on the MFN Model web page on the CMS Innovation Center.

This model was set to begin January 1, 2021 and end December 31, 2027. Similar to the Comprehensive Care for Joint Replacement (CJR) Model, this is a “mandatory nationwide model that requires participation from Medicare-participating providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions.” Specifically MFN participants includes:

• Medicare-participating physicians,
• non-physician practitioners, supplier groups (such as group practices),
• hospital outpatient departments (HOPDs) including 340B covered entities,
• ambulatory surgical centers (ASCs), and
• other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions

This Model focuses on approximately 50 Medicare Part B drugs that accounts for a high percentage of Medicare Part B drug spending. The January 2021 MFN Model Drug HCPCS Codes List and January 2021 MFN Model Drug Pricing File have both been posted on the MFN Model webpage.

Also available on the MFN webpage is an MLN Fact Sheet (ICN MLN2761019 December 2020) titled Billing Information for Most Favored Nation (MFN) Model Drugs.

You will note that earlier I mentioned that this model “was set to begin January 1, 2021.” However, a December 28, 2020 Update available on the MFN webpage indicates that “on December 28, 2020, the U.S. District Court for the Northern District of California issued a preliminary injunction in Biotechnology Innovation Organization v. Azar, No. 3:20-cv-08603, which preliminarily enjoins HHS from implementing the Most Favored Nations Rule.”

On December 31, 2020, the U.S. District Court for the Southern District of New York issued a preliminary injunction in Regeneron Pharmaceuticals v. United States Department of Health and Human Services, No. 7:20-cv-10488, which preliminarily enjoins HHS from applying the Most Favored Nation Rule to Regeneron's drug EYLEA.

Additionally, the public comment period for the MFN Model Interim Final Rule with Comment Period (IFC) does not end until January 26, 2021. If you have concerns I encourage you to submit comments to CMS.

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.