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Over the years, hyperbaric oxygen (HBO) therapy has been and continues to be a review focus by Medicare Review Contractors. Most recently, Palmetto GBA published their findings from a Post-Payment review of claims in their Medicare Administrative Contractor (MAC) Jurisdiction M. But first, let’s take a look back at who else has been reviewing HBO therapy services.

Strategic Health Solutions, LLC: April 2012 to March 31, 2013 Claims Review

In 2014, Strategic Health Solutions, LLC, the first Supplemental Medical Review Contractor (SMRC), completed a review of 2,000 HBO claims with dates of service April 1, 2012 to March 31, 2013. Of the 2,000 claims, 594 were denied for no response and 570 were denied after review resulting in an error rate of 58%. Documentation cited as not being in the record included:

• Specific timelines and goals for therapy. For example, the documentation simply stated “continue HBO” or “until healed”
• Radiology and pathology reports confirming diagnoses such as osteomyelitis or gas gangrene
• Monitoring for improvement or lack of improvement

In addition, when documentation was provided, descriptions of diabetic wounds did not meet Wagner Criteria for Grade three (III) or four (IV) wounds and therapy was provided beyond the 30 days allowed under Medicare coverage guidelines.

OIG: February 2018 Report: Wisconsin Physicians Service Paid Providers for HBO Services that Did Not Comply with Medicare Requirements

For this audit (link), the OIG focused on WPS who is the current Medicare Administrative Contractor for Jurisdictions 5 and 8. Based on their results, the OIG estimated that WPS overpaid providers in Jurisdiction 5 $42.6 million dollars during the audit period of claims paid in 2013 and 2014.

OIG: December 2018 Report: First Coast Options, Inc., Paid Providers for HBO Services that Did Not Comply with Medicare Requirements

Similar to the WPS Audit, the OIG focused on 2013 and 2014 claims and estimated that First Coast overpaid providers in Jurisdiction N $39.7 million (link).

Noridian SMRC: October 2020 Outpatient HBO Notification of Medical Review

In October 2020, the current SMRC announced a post-payment review of HBO therapy with dates of service from January 1, 2018 through December 31, 2018 (link). Noridian indicates in the notification that, “over the years, HBO therapy services formed the basis of several Office of Inspector (OIG) reports. Findings from these OIG reports note that Medicare beneficiaries received treatments for non-covered conditions, medical documentation did not adequately support treatments, and that Medicare beneficiaries received more treatments than were considered medically necessary.”

Palmetto GBA: January to March 2021 Claims Review

As mentioned at the beginning of this article, Palmetto GBA has completed a post-payment service specific probe review of HBO therapy for North Carolina, South Carolina, Virginia and West Virginia (link)). Cumulatively, 285 claims were reviewed and 144 were completely or partially denied resulting in an overall claim denial rate of 50.53 percent. Examples of top denial reasons includes:

• No documentation of medical necessity,
• The recommended protocol was not ordered and/or followed,
• Billing Error,
• Units billed more than ordered, and
• Services not documented,

Based on the “medium to high impact severity errors,” Palmetto plans to continue this targeted medical review.

Moving Forward:

If your facility provides HBO therapy, make sure you are aware of Medicare’s requirements for HBO therapy, which can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy (link)). Note, this NCD includes a list of covered indications and a longer list of non-covered indications.

Also, I recommend reading Palmetto’s review article as it includes ways to avoid denials. Palmetto GBA has two education resources related to HBO for Providers:

• An HBO Checklist that you can use as an audit tool to assure you are submitting all required documentation (link)), and
• An HBO Module (link)), which provides an overview of HBO therapy and information about physician responsibilities, the treatment plan, and administration of HBO therapy.

Question:

You mentioned in last week’s Wednesday@One outpatient FAQ (link) that Palmetto GBA considers the drug ‘Imitrex’ to be a self-administered drug. Does that apply only to the Imitrex brand, or does it also apply to the other Imitrex formulations / brands?

Answer

All formulations of Imitrex would be considered a self-administered drug under Palmetto. Take a look at Palmetto’s self-administered drug list link and in the Imitrex section, you will see other names of Imitrex listed, which include:

• Imitrex Statdose Pen
• Zembrace Sym touch
• Alsuma
• Sumavel DosePro

Although not listed, this should also include the drug Tosymra, which is another brand name for Imitrex.

This week we highlight key updates spanning from May 4th through May 10th, 2021.

May 3, 2021: New COVID-19 Coverage Assistance Fund: Paying for COVID-19 Vaccine Administration

HHS posted a Press Release (link) announcing the new COVID-19 Coverage Assistance Fund (CAF). This program will cover the cost of administering a COVID-19 vaccine for individuals enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing.

May 4, 2021: Funding to Increase COVID-19 Vaccinations in Underserved & Rural Communities

HHS announced (link) the availability of $250 million, through the American Rescue Plan, “to develop and support a community-based workforce who will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.”

In addition to underserved communities, HHS announced (link) the availability of nearly $1 billion to increase vaccination efforts in rural communities.

May 5, 2021: FDA Issues Roadmap for FDA Inspectional Oversight

The FDA has issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight” (link). This report outlines their “inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.”

At the onset of the pandemic, FDA inspections began to be reserved for what they describe as “mission-critical issues” based on the following four factors:

• Product received breakthrough therapy or regenerative medicine advanced therapy designation,
• Product is used to treat a serious disease or medical condition and there is no substitute,
• Product required follow-up due to recall, or there is evidence of serious adverse events or outbreaks of a foodborne illness, and
• Product is related to FDA’s COVID-19 response (e.g., drug shortages).

May 6, 2021: Increased Payment for COVID-19 Monoclonal Antibody Infusions & Two New HCPCS Codes

CMS announced (link) an increase in the national average payment rate, for administering monoclonal antibodies to treat COVID-19, from $310 to $450 for most health care settings. Further, “in support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish a higher national payment rate of $750 when monoclonal antibodies are administered in the beneficiary’s home, including the beneficiary’s permanent residence or temporary lodging (e.g., hotel/motel, cruise ship, hostel, or homeless shelter.)” CMS has updated the COVID-19 Vaccines and Monoclonal Antibodies webpage (link) to reflect the payment updates.

Along with CMS establishing a higher national payment rate for monoclonal antibodies in the beneficiary’s home, CMS has added two new HCPCS codes for the administration of the monoclonal antibodies infusion in the home (M0244 and M0246). Note, these will be paid in the same manner as HCPCS codes, M0243 and M0245.

May 7, 2021: CDC Updates SARS-CoV-2 Mode of Transmission

The CDC had updated their Scientific Brief: SARS-CoV-2 Transmission (link). Recent updates to this brief includes:

• Updates have been made to reflect current knowledge about SARS-CoV-2 transmission,
• “Modes of SARS-CoV-2 transmission are now categorized as inhalation of virus, deposition of virus on exposed mucous membranes, and touching mucous membranes with soiled hands contaminated with virus.
• Although how we understand transmission occurs has shifted, the ways to prevent infection with this virus have not. All prevention measures that CDC recommends remain effective for these forms of transmission.”

May 10, 2021: EUA Expanded for Pfizer-BioNTech COVID-19 Vaccine

The FDA announced (link) the expansion of the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. “The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.”

CMS issued the FY 2022 IPPS Proposed Rule (CMS-1762-IFC) on Tuesday April 27, 2021. Following are highlights from the Proposed Rule.

Proposed Payment Rate Changes

The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) use is approximately 2.8 percent.

Overall, CMS estimates hospitals payments will increase by $2.5 billion.

COVID-19 Impact on Inpatient Hospitalization Utilization Data

CMS notes, in a related Fact Sheet, that their goal when setting inpatient hospital payment rates is to use the best available data. Given the impact that the COVID-19 Public Health Emergency (PHE) had during FY 2020, CMS is proposing to use the FY 2019 data to approximate the expected FY 2022 inpatient hospital utilization.

New Technology Add-On Payment (NTAP) Policy

There is good news for hospitals regarding the proposal being made related to the New Technology Add-On Payment (NTAP) policy. As background, the NTAP policy provides additional payment beyond the MS-DRG for cases where a CMS designated new technology was used and coded on the claim. Note, this “is not budget neutral and is generally limited to the 2-to 3-year period following the date of the FDA approval or clearance for marketing.”

“CMS is proposing a one-year extension of new technology add-on payments for 14 technologies for which the new technology add-on payment would otherwise be discontinued beginning FY 2022.”

New COVID-19 Treatments Add-on Payment (NCTAP)

CMS established the NCTAP policy for eligible discharges during the PHE. This policy was “designed to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments. CMS is proposing to extend this policy for eligible products through the end of the fiscal year in which the COVID-19 PHE ends.

The PHE was once again extended in April 2021 and is currently set to expire on July 20, 2021. (link to release) However, in January of this year, HHS sent a letter (link to letter) to governors indicating the likelihood that the PHE will remain in place for all of 2021. If this proposal is finalized, and the PHE ends on December 31, 2021, that would mean the NCTAP policy will be in place until September 30, 2022.

To learn more about the NCTAP policy visit the CMS NCTAP webpage by clicking here.

Quality Program Proposals

CMS is proposing a measure suppression policy that would allow CMS to suppress use of measure data if they determine that the COVID-19 PHE has affected quality measures and resulting quality scores significantly. This measure suppression policy is being proposed for:

• The Hospital Readmission Reduction Program (HRRP),
• The Hospital-Acquired Condition (HAC) Reduction Program, and
• The Hospital Value-Based Purchasing (VBP) Program.

Also, with the Hospital Compare website now being the Care Compare website, CMS is proposing to update regulatory text for the HRRP and HAC Reduction Program to reflect the name change. The new Care Compare webpage ( link to site ) allows you to compare care by providers across the continuum of care (i.e. hospitals, nursing homes, home health, and hospice).

Specific to the HRRP, CMS is “seeking public comment on closing the gap in health equity through possible future stratification of results by race and ethnicity for condition/procedure-specific readmission measures and by expansion of standardized data collection to additional social factors, such as language preference and disability status.”

The Hospital VBP Program is funded by reducing participating hospitals base operating MS-DRG payments by 2%. The total estimated amount is then redistributed to hospitals based on their Total Performance Score (TPS). It is possible for your hospital to earn back a value-based incentive payment percentage that is less than, equal to, or more than the applicable reduction for that FY. The estimated amount available for incentive payments to hospitals in the current FY 2021 is $1.9 billion.

Due to the proposed measure suppression for the Hospital VBP Program, CMS is “proposing to not calculate a TPS for any hospitals based on one domain and to instead award to all hospitals value based payment amount for each discharge that is equal to the amount withheld.”

Graduate Medical Education (GME)

The Consolidated Appropriations Act (CAA), 2021, Section 126, “requires the distribution of an additional 1,000 new Medicare-funded medical residency positions to train physicians. CMS is proposing to distribute the slots to qualifying hospitals, as specified by the law, including those located in rural areas and those serving areas with a shortage of health care professionals.”

The 1,000 new slots would be phased in at no more than 200 per years beginning in FY 2023 (October 1, 2022). The estimated additional funding will total approximately $1.8 billion from FY 2023 through FY 2031.

Repeal of Hospital Negotiated Charges with Medicare Advantage Payers

Tom Nickels, Executive Vice President of the American Hospital Association, indicated in an April 27, 2021 AHA Statement on the release of the Proposed Rule that “based on our initial review, we are very pleased CMS is proposing to repeal the requirement that hospitals and health systems disclose privately negotiated contract terms with payers on the Medicare cost report. We have long said that privately negotiated rates take into account any number of unique circumstances between a private payer and a hospital and their disclosure will not further CMS's goal of paying market rates that reflect the cost of delivering care. We once again urge the agency to focus on transparency efforts that help patients access their specific financial information based on their coverage and care.” (Link to statement)

CMS is accepting comments on the proposed rule through 5 p.m. EDT on June 28, 2021.

Resources

• CMS FY 2022 IPPS Proposed Rule CMS Fact Sheet: Link
• CMS FY 2022 Proposed Rule web page: link

Question:

We have another question about self-administered drugs based on prior outpatient FAQs for Lovenox and insulin. (Click for the Lovenox article and for the insulin article.) Is the drug ‘Imitrex’ a self-administered drug for Medicare? Usually, we see this given to patients in the ER who present with migraine type headaches.

Answer

For Palmetto, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M, Imitrex is a self-administered drug when given by subcutaneous route. For Medicare, you would NEVER report a subcutaneous injection (CPT code 96372) for Imitrex. If you are under the jurisdiction of a different MAC, check their respective self-administered drug list as the drugs can vary from one MAC to the next.

Here is a link to Palmetto’s self admin drug list. It is a very handy reference to see which injectable drugs are considered self-administered drugs at least – for hospitals under the jurisdiction of Palmetto GBA.

Local Coverage Article for Self-Administered Drug Exclusion List

This week we highlight key updates spanning from April 27th through May 3rd, 2021.

Spotlight: Noridian JF Ask the Contractor (ACT) Question and Answer: Targeted Probe & Educate during the Pandemic

Noridian JF recently posted Questions and Answers from their January ACT Call (link). Following is an excerpt from one of the Q&A’s regarding the Medicare Administrative Contractors (MACs) Targeted Probe and Educate (TPE) program:

“Q8: Our facility has not received a Targeted Probe and Education (TPE) audit or an Additional Documentation Request (ADR) since the pandemic started. Can Noridian please clarify whether these audits have been restarted?

---

A8: MACs have not received direction from CMS to resume TPE audits. Currently MACs are conducting service specific claim reviews. More information can be found on Noridian’s Medical Review webpage under Post-Pay Reviews. Individual providers will be notified if they have an open, pending TPE file when we have direction from CMS to resume TPE activities.”

April 26, 2021: QW Modifier Added to HCPCS 87636

CMS published MLN MM12269 (link) to inform providers of the addition of the QW modifier to HCPCS code 87636 [Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza type virus types A and B, multiplex amplified probe technique].

CMS ends this MLN article by noting that “claims for tests you perform in facilities having a CLIA certificate of waiver must include the QW modifier. MACs won’t search their files to either retract payment for claims already paid or to retroactively pay claims. However, they will adjust claims you bring to their attention.”

April 27, 2021: CDC Clinical Outreach & Communication Activity Call: Johnson & Johnson/Janssen COVID-19 Vaccine and TTS Update for Clinicians

The CDC conducted an initial call related to the Johnson & Johnson vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia (CVST) on April 15, 2021. The April 27th call provided updates for clinicians about the Johnson & Johnson vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) (link). For those that missed this call, the CDC webpage for this call includes a video of the session and call materials.

April 27, 2021: Memorandum Update to Interim Final Rule – Additional Policy & Regulatory Revisions in Response to the COVID-19 PHD related to Long-Term care Facility Testing Requirements and Revised COVID-19 Focused Survey Tool e

CMS has updated this Memorandum (link) that was initially provided to State Survey Agency Directors in August of 2020. CMS has revised the COVID-19 Focused Survey Tool for surveyors. They “are also adding to the survey process the assessment of compliance with the requirements for facilities to designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility's infection prevention and control program (IPCP) at 42 CFR § 483.80(b).” Additionally, they “are making a number of revisions to the survey tool to reflect other COVID-19 guidance updates.”

April 29, 2021: Expanding COVID-19 Training and Support for Health Centers

HHS announced (link) that 122 organizations, including Primary Care Associations (PCAs), National Training and Technical Assistance Partners (NTTAPs), and Health Center Controlled Networks (HCCNs), have been awarded $32 million to “use the funds to provide health centers with critical COVID-19 related training, technical assistance, and health information technology.” This was made possible through the American Rescue Plan.

This week we highlight key updates spanning from April 20th through April 26th, 2021.

Resource Spotlight: HHS’ COVID-19 Public Education Campaign & Community Corps

HHS has launched a public education campaign “to increase public confidence in and uptake of the COVID-19 vaccines while reinforcing basic prevention measures such as mask wearing and social distancing.” HHS is expanding the campaign through the creation of the COVID-19 Community Corps. Members of this group will receive resources to build vaccine confidence in your community, including:

• Fact Sheets,
• Social Media Content, and
• Regular email updates with the latest vaccine news and resources to share.

You can sign up to be a member of the COVID-19 Community Corps at https://wecandothis.hhs.gov/covidcommunitycorps.

April 20, 2021: I Received the Johnson & Johnson Vaccine, Now What?

The CDC has created a Johnson & Johnson/Janssen COVID-19 vaccine update page (link). The April 20th update highlights the following “What you need to know” information:

• “The use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine is paused for now. This is because the safety systems that make sure vaccines are safe received a small number of reports of people who got this vaccine experiencing a rare and severe type of blood clot with low platelets.
• Seek medical care right away if you develop any of the symptoms listed in the question and answer – what if I got the J&J/Janssen COVID-19 vaccine?
• If you have any questions at all, call your doctor, nurse, or clinic.”

April 20, 2021: COVID-19 Update – FDA Revoked EUA for Bamlanivimab When Administered Alone

In last week’s article, I reported that on April 16th, the FDA revoked the Emergency Use Authorization (EUA) for Bamlanivimab when administered alone. CMS released a Special Edition MLN Connects related to this revocation (link). They note that they will cover and pay for Bamlanivimab, when administered alone, for dates of service from November 10, 2020 through April 16, 2021.

April 22, 2021: CDC & Dialysis Organizations Partner to Provide COVID-19 Vaccine

The CDC announced in the Thursday April 22nd MLN Connects newsletter (link) that they are partnering with dialysis organizations nationwide to make the COVID-19 vaccine available to patients and health care personnel in outpatient dialysis clinics. CMS reminds you that there is no copayment, coinsurance or deductible for receiving a COVID-19 vaccine.

April 22, 2021: New Acute Care Delivery at Home Tip Sheet

Also in the April 22nd MLN Connects, CMS provides a link to a new Acute Care Delivery at Home Tip Sheet (link). In addition to the Tip Sheet a link is provided to the CMS Acute Hospital Care at Home webpage where you will find an overview of this program, reporting measures participating hospitals are required to provide, additional resources, and access to past webinars.

April 22, 2021: HHS’ “We Can Do This: Live” Initiative

Building upon the “We Can Do This” public education campaign, HHS announced the launch of their “We Can Do This: Live” series “to pair medical experts with prominent influencers and organizations with large social followings to meet people where they are with the information they need to feel confident about receiving the vaccine. Events will include conversations to answer direct questions about COVID-19, Instagram Live Q&As, and social media account takeovers where doctors, scientists and health officials can provide the public with factual, scientific information about vaccines.” HHS notes in the Press Release (link) that this initiative follows the launch of the COVID-19 Community Corps initiative.

April 23, 2021: Johnson & Johnson (Janssen) COVID-19 Vaccine Pause Lifted

After a “thorough safety review,” the CDC and FDA announced that use of the Johnson & Johnson (Janssen) COVID-19 vaccine should resume. The Fact Sheets related to this vaccine have all been revised to include information about the risk of thrombosis-thrombocytopenia syndrome (TTS). The FDA goes on to note that as of April 23rd they can confirm 15 cases of TTS. All cases were women between 18 and 59 years old, with a median age of 37 years. Symptom onset was between 6 and 15 days after vaccination. (link)

Question:

As a follow-up to last week’s question about Lovenox, (link) we have the same question regarding insulin: We have NOT been charging for insulin administration given in any form (ex. IM, Infusion), but should we?

Answer

Palmetto, GBA considers Insulin to be a self-administered drug when given by subcutaneous route. For Medicare, you would NEVER report a subcutaneous injection for insulin (CPT code 96372). Palmetto says if you give insulin by a different route, it is appropriate to report the administration CPT code, such as IM or IV.

Cahaba, GBA the prior Medicare Administrative Contractor (MAC) for Jurisdiction J, had told Provider that insulin is a self-administered drug regardless of the route. The Palmetto policy is not as strict as Cahaba’s.

Again, here is a link to Palmetto’s self-administered drug list, which includes discussion about drugs on the list given by other than subcutaneous route.
Local Coverage Article for Self-Administered Drug Exclusion List

Remember, insulin is sometimes documented using other names, and it is easy to miss these drugs if you are not familiar with some of the brand names. If you need a reminder, review the Wednesday@One article at the link below from September 2018 which lists some of the more common insulin names and types.

Do You Know When to Code Z79.4?
https://www.mmplusinc.com/kb-articles/do-you-know-when-to-code-z79-4

Medicare MLN Articles & Transmittals – Recurring Updates

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.2, Effective July 1, 2021

• Article Release Date: March 31, 2021
• What You Need to Know: NCCI edits were developed to promote national correct coding methodologies and to control improper coding that leads to inappropriate payment in Part B claims. This article alerts providers about the quarterly updates to the NCCI PTP edits in Change Request (CR) 12226 effective July 1, 2021. CMS includes the following bolded statement in the CR, “the edits previously contained in the Mutually Exclusive edit file are NOT being deleted but are being moved to the Column One/Column Two Correct Coding edit file.”
• MLN MM12226: link

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

• Article Release Date: April 1, 2021
• What You Need to Know: Billing instructions for various payment policies CMS made in the April 2021 ACS payment system update are referenced in this article.
• MLN MM12183: link

Other Medicare MLN Articles&Transmittals

Updated to the Payment for Grandfathered Tribal Federally Qualified Health Centers (FQHCs) for Calendar Year (CY) 2021

• Article Release Date: March 31, 2021
• What You Need to Know: This article is for FQHCs billing MACs for services provided to Medicare patients.
• MLN MM12202: link

Revised Medicare MLN Articles&Transmittals

Penalty for Delayed Request for Anticipated (RAP) Submission – Implementation

• Article Release Date: July 31, 2020 – Most recent revision April 1, 2021
• What You Need to Know: This is the third revision to the original July 31, 2020 MLN article. Information in the article is for Home Health Agencies (HHA) who bill MACs for services provided. The April 1, 2021 revision reflects the revised CR 11855. The revised CR changes the principal diagnosis code reporting instructions in Chapter 10, Section 40.1 and the service date reporting instructions in Chapter 10, Section 40.2 of the Medicare Claims Processing Manual. The changes make sure claims successfully match their corresponding RAP. Changes in the text of the document are in red print.
• MLN MM11855: link

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

• Article Release Date: March 18, 2021 – Revised April 6, 2021
• What You Need to Know: This article reflects a revised Change Request CR 12068. The substance of the article did not change.
• MLN MM12068: link

Medicare Coverage Updates

April 13, 2021: Final Decision Memo for AlloMap® Molecular Expression Testing for Detection of Reject of Cardiac Allografts

CMS indicates in the background section of this Decision Memo (link), that the “AlloMap is intended to give physicians information on the risk of acute cellular rejection in their patients following heart transplant.” CMS received a request in January of 2013 to non-cover this assay as the requester felt this particular assay “does not perform adequately,” has “poor sensitivity,” and “no intrinsic predictive capability.” A national coverage analysis was issued October 16, 2020. CMS received three comments. CMS did not issue a National Coverage Determination for this testing and notes in the Final Decision Memo that, “in the absence of an NCD, coverage determinations for AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts…will continue to be made by the local Medicare Administrative Contractors (MACs).”

April 13, 2021: Final Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds

CMS indicates in this Decision Memo (link) that they “will cover autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds under section 1862(a)(1)(A) of the Social Security Act (the Act) for a duration of 20 weeks, when prepared by devices whose FDA cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks will be determined by local Medicare Administrative Contractors (MACs). Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by local Medicare Administrative Contractors (MACs) under section 1862(a)(1)(A) of the Act.”

April 13, 2021: National Coverage Analysis (NCA) Tracking Sheet for Transvenous (Catheter) Pulmonary Embolectomy

Currently, this procedure is non-covered. CMS internally generated this NCA reconsideration (link) based on stakeholder feedback and have had several requests for this NCD to be removed. The public comment period is from April 13, 2021 through May 13, 2021. The proposed decision memo due date is October 13, 2021.

Medicare Educational Resources

New MLN Booklet: How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools

CMS has issued a new Medicare Learning Network booklet titled How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools (link). This publication is aimed at helping providers learn to navigate the CMS Medicaid NCCI webpages, work with Medicaid Procedure-to-Procedure edits, and manually unlikely edits. CMS notes that the Medicare NCCI Program has significant differences from the Medicaid NCCI initiative and provides related links to the Medicaid NCCI Initiative and Medicare NCCI Program.

Revised MLN Booklet: Behavioral Health Integration Services

CMS has issued a revised version of the Behavioral Health Integration Services MLN Booklet (link) to add CY 2021 MPFS Final Rule CMS-1734-F Updates and add new HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional).

CMS’ Diagnosis Coding: Using ICD-10-CM and ICD-10-PCS Web-Based Training Courses Revised

CMS has updated their ICD-10-CM and PCS web-based training courses. These courses can help you learn how to identify structure and format, recognize features and find codes. You can access both revised courses on the CMS MLN Web-Based Training webpage at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/WebBasedTraining.

Revised MLN Booklet: Medicare Billing: Form CMS-1450 and the 837 Institutional

In mid-April, CMS published a revised version of this MLN Booklet (link. In the revised version, CMS updated MSP information in the Medicare Claims Submission section of the booklet and added a new Where to Submit FFS Claims section.

Medicare Wellness Visits Educational Tool Revised

CMS noted in the April 22, 2021 edition of MLN Connects (link) that their Medicare Wellness Visit Education Tool has been revised. Providers can use this tool to learn about the annual wellness visit (AWV) and Initial preventive physical exam (IPPE).

Other Medicare Updates

April 8, 2021: CMS Issues FY 2022 Proposed Rules

In a Special Edition MLN Connects (link), CMS issued Proposed Rules for:

• SNF Prospective Payment System: FY 2022 Proposed Rule
• Hospice Payment Rate Update for FY 2022,
• IRF Prospective Payment System: FY 2022 Proposed Rule, and
• IPF: Proposed Medicare Payment&Quality Reporting Updates.

Links to each proposed rule and a related Fact Sheet are available in this announcement. CMS is accepting comments on all four proposed rules until June 7, 2021.

This week we highlight key updates spanning from April 13th through April 19th, 2021.

April 13, 2021: CDC Health Alert: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Johnson & Johnson COVID-19 Vaccination

The CDC issued an official Health Alert relaying information about six cases of cerebral venous sinus thrombosis (CVST) in the U.S. after receiving the Johnson & Johnson COVID-19 vaccine. All six cases were women aged 18 – 48 years and the lag time from vaccination to onset of symptoms ranged from 6 – 13 days. Five of the six women had an initial presenting symptom of a headache. One woman died.

The CDC indicated they would convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14th… “until this process is complete, CDC and FDA are recommending a pause in the J&J COVID-19 vaccine out of an abundance of caution.”

Recommendations for Clinicians, Public Health, and the general public are also included in this Alert.

April 13, 2021: New Legal Guidance & Resources to Ensure Expansion of Access to COVID-19 Vaccines

HHS issued a Press Release announcing new resources that have been published to assist in ensuring people with disabilities and older adults access to COVID-19 vaccines. HHS notes that “these resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them to ensure accessibility.”

April 14, 2021: H.R. 1868 Becomes a Law – Sequestration Suspension Extended

The Coronavirus Aid, Relief, and Economic Security (CARES) act was enacted on March 27, 2020 and suspended the 2% sequestration payment adjustment applied to all Medicare FFS claims from May 1 through December 31, 2020. This payment adjustment was included in the Budget Control Act signed into law in August 2011 and became effective April 1, 2013. This Act required that $1.2 trillion in federal spending cuts be achieved over the course of nine years. With no action from Congress, sequestration would last until 2022. You can read more about the 2013 Sequestration in an American Medical Association FAQ document.

Additional legislation extended the suspension through March 31, 2021. A subsequent House Resolution (H.R.) finally made its way through the House and Senate. On April 14, 2021, an Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes was signed into law extending the Sequestration suspension through December 31, 2021.

CMS noted in the Friday April 16, 2021 edition of MLN Connects that Medicare Administrative Contractors will:

• Release any previously held claims with dates of service on or after April 16, 2021, and
• The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

They ended the announcement by noting that you do not need to take any action.

April 15, 2021: CDC Clinical Outreach & Communication Call – Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia – Update for Clinicians on Early Detection and Treatment

The CDC held this call to present the latest evidence on cerebral venous sinus thrombosis (CVST) with thrombocytopenia associated with the Johnson & Johnson/Janssen COVID-19 vaccine. If you missed this April 15th call, you can download the call materials from this CDC webpage.

April 15, 2021: OIG Message on COVID-19 Vaccination Program and Provider Compliancet

The OIG released a letter reminding vaccine providers and the public that the Federal Government is providing this vaccine and must be provided at no cost to recipients. They go on to note they are aware of patient complaints about charges by providers when getting their COVID-19 vaccines.

April 15, 2021: COVID-19 Public Health Emergency Extended

Secretary of Health and Human Services, Xavier Becerra, renewed the Public Health Emergency (PHE) due to the continued consequences of the COVID-19 pandemic. This most current extension will expire on July 20, 2021. In January of this year, HHS sent a letter to governors indicating the likelihood that the PHE will remain in place for all of 2021. They also indicated that states would be given a 60 days’ notice to the states prior to the termination of the PHE due to COVID-19.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

HHS posted a “Notice of Meeting” regarding the next COVID-19 Health Equity Task Force (Task Force) virtual meeting scheduled for April 30, 2021. As background, this Task Force was established by a January 21, 2021 Executive Order and the group is tasked with making recommendations for “mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.” This meeting is open to the public and will be lived streamed at www.hhs.gov/live. The confirmed time and agenda will be posted on the Task Forces’ webpage at www.minorityhealth.hhs.gov/healthequitytaskforce/.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

CMS included the following information regarding COVID-19 Vaccine history in their Friday April 16, 2020 edition of MLN Connects:

“Starting April 16, in addition to screening your patients, you can check Medicare eligibility (PDF) for COVID-19 vaccine administration history from Fee-for-Service (FFS) claims paid for calendar years 2020 and 2021. This includes Medicare Advantage patients.

You can get the following eligibility information for each paid vaccine administration claim:

• CPT or HCPCS codes
• Date of service
• National provider identifier for who administered the vaccine

We can only provide this information if the provider billed Medicare for administering the vaccine. If your patients got vaccinated and the provider didn’t submit a Medicare claim (like if they got vaccinated at a free event), ask your patients about their COVID-19 vaccination history.”

April 16, 2021: Medicare Telehealth Services List Updated

CMS indicated in the April 16, 2021 edition of MLN Connects that CMS had published an updated list of Medicare telehealth services on March 30th. They noted that due to the public health emergency, many audiology and speech-language pathology services have been added to the list effective March 1, 2021.

April 16, 2021: FDA Revokes EUA for Monoclonal Antibody Bamlanivimab

The FDA announced that they have revoked the Emergency Use Authorization (EUA) for Bamlanivimab, when administered alone, to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. Patizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in this announcement that “while the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital.” .