Knowledge Base Category -

MLN Matter Article MM12175 was released March 9th and highlights changes in related CR12175 that have an effective date of April 1, 2021 and an implementation date of April 5, 2021. Following is a list of changes effective April 1st along with what you need to know:

Revised APC Assignments for Pfizer-BioNTech and Moderna COVID-19 CPT Administration Codes - What you need to know:

The APC assignments for the administration codes are being reassigned.

• CPT codes 0001A (Pfizer Administration/Immunization code – first dose) and 0011A (Moderna Administration/Immunization code – first dose) from APC 1492 to APC 9397, and
• CPT codes 0002A (Pfizer Administration/Immunization code – second dose) and 0012A (Moderna Administration/Immunization code – second dose) from APC 1493 to APC 9398.

You will find a link to Table 1 of CR 12175 that lists the APC titles for the two new COVID-19 vaccine administration codes in this article.

Janssen/Johnson & Johnson COVID-19 Vaccine and Vaccine Administration Code – What you need to know:

The American Medical Association (AMA) released 2 new CPT codes associated with this vaccine:

• CPT code 91303 – vaccine product code, and
• CPT cod 0031A – Administration/Immunization code.

The FDA issued an emergency use authorization (EUA) for this vaccine on February 27, 2021.

New Monoclonal Antibody Therapy Product Administration Codes – What you need to know:

Following is a list of new HCPCS codes for therapies that have been granted a EUA by the FDA and the effective date for the codes:

• M0239 and Q0239 established effective November 9, 2020 for bamlanivimab,
• M0243 and Q0243 established effective November 21, 2020 for casirivimab and imdevimab,
• M0245 and Q0245 established effective February 9, 2021 for bamlanivimab and etesevimab administered together.

The MLN article provides detail regarding payment for a monoclonal antibody product.

CPT Proprietary Laboratory Analyses (PLA) Coding Change Effective April 1, 2021 – What you need to know:

Six new PLA codes have been established by the AMA CPT Editorial Panel with an effective date of April 1, 2021. This article provides a link to the table of new codes, which includes the code, long descriptor of the code and the OPPS Status Indicator (SI) for each code.

New HCPCS Codes – What you need to know:

The following two new HCPCS codes were established and are effective April 1, 2021:

• HCPCS code C9776: describes the application of intraoperative near-infrared fluorescence imaging using indocyanine green on the extrahepatic ducts. The administration of this is associated with laparscopy cholecystectomy, and
• HCPCS code C9777: describes the technology associated with esophageal mucosal integrity testing by Electrical Impedance.

Drugs, Biologicals, and Radiopharmaceuticals – What you need to know:

• Three new HCPCS codes have been created and are effective April 1, 2021 for reporting drugs and biologicals in the hospital outpatient setting where there was no specific code available.
• C9074 – Injection, lumasiran, 0.5 mg (Status Indicator G and APC 9407),
• J7212 – Factor viia (antihemophilic factor, recombinant)-jncw (sevenfact), 1 microgram (Status Indicator G and APC 9395), and
• Q5122 – Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg (Status Indicator G and APC 9406).
• 10 HCPCS codes will have their pass-through status end on March 31, 2021. Table 11 of CR 12175 lists these codes and can be linked to from the MLN article. Effective April 1, 2021, the status indicator for all 10 HCPCS codes will change from G to K.
• Seven new drug, biological, and radiopharmaceutical HCPCS codes have been established with an effective date of April 1, 2021. These codes are listed in Table 12 of CR 12175.
• Two drug, biological, and radiopharmaceutical HCPCS codes will be deleted April 1, 2021:
• J7333 – Hyaluronan or derivative, visco-3, for intra-articular injection, per dose, and
• J7401 – Mometasone furoate sinus implant, 10 micrograms.
• HCPCS code Q5122 (injection, pegfilgrasim-apgf, biosimilar, (Nyveprio), 0.5 mg) status indicator for January 1, 2021 through March 31, 2021 will be changed retroactively from E2 to K in the April I/OCE.

Drugs and Biologicals with Payments Based on Average Sale Price (ASP)

“Effective April 1, 2021, payment rates for many drugs and biologicals will change from the values published in the CY 2021 OPPS/ASC final rule with comment period as a result of the new ASP calculations based on sales price submissions from the third quarter of CY 2020. In cases where adjustments to payment rates are necessary, they will be incorporated into the April 2021 Fiscal Intermediary Shared System (FISS) release. We are not publishing updated payment rates in this CR implementing the April 2021 OPPS update. However, the updated payment rates effective April 1, 2021, are in the April 2021 update of the OPPS Addendums A and B.”

Note, this MLN article also includes additional changes to specific HCPCS codes (i.e. changes to the long descriptor of a code and status indicator changes/corrections). I encourage key stakeholders in your facility to read MLN MM12175 and Change Request 12175.

This week we highlight key updates spanning from March 10th through 15th of 2021.

Resource Spotlight: Long COVID Alliance

The Long COVID Alliance began in 2020 with a group of 21 science, post-viral disease and patient advocacy organizations calling for the government to invest in Long COVID research. To date 50+ partners have joined this alliance. Why is this collective so important? Long COVID also known as Post-acute COVID-19 syndrome, Long Haulers, Long-term COVID-19, or LTC-19 as a group, have lingering symptoms and has to date impacted 3.2 million Americans. In fact, “these symptoms persist in an estimated 25-35% of COVID-19 patients, regardless of infection severity, even after the patient no longer tests positive for the virus or antibodies…Long COVID generally refers to cases where symptoms continue to persist for 90 days or more.” I encourage you to check out the Alliance’s website to learn about their goals, and the impact to date that their efforts have made.

March 10, 2021: Trust for America’s Health Ready or Not 2021 Report

The Trust for America’s Health (TFAH) “develops reports and other resources and initiatives, and recommends policies, to advance an evidence-based public health system that is ready to meet the challenges of the 21st century.” On March 10th, TFAH released the report, Ready or Not 2021: Protecting the Public's Health Against Diseases, Disaster and Bioterrorism, measuring states’ performance on specific indicators. John Auerbach, President and CEO of TFAH is quoted in the announcement about this report that “The importance of this report is that it gives states actionable data to adopt policies that save lives. The COVID-19 crisis shows that we have much more work to do to protect Americans from health threats, particularly in the ways in which structural racism create and exacerbate health risks within communities of color. States need to take aggressive steps to shore up their preparedness for all types of public health emergencies.”

March 10, 2021: CMS Revises Nursing Home Visitation Recommendations

CMS has updated the September 17, 2020 memorandum titled Nursing Home Visitation – COVID-19. Revisions include new guidance for visitation in nursing homes during the COVID-19 Public Health Emergency (PHE), including the impact of COVID-19 vaccination. First and foremost, the Core Principles of COVID-19 Infection Prevention remains in place. The first principle has been updated to now include denial of entry to a facility for “those who have had close contact with someone with COVID-19 infection in the prior 14 days (regardless of the visitor’s vaccination status).” You can also read more about the revisions in a related CMS Fact Sheet.

March 11, 2021: HHS News: Vaccine Program Expanded to 950 Community Health Centers

HHS announced in this Press Release that an additional 700 Health Resource and Services Administration (HRSA) supported health centers are to be invited to join the Health Center COVID-19 Vaccine Program. These 700 centers “serve high proportions of low-income and minority patients, provides services to rural or frontier populations, operate Tribal/Urban Indian Health Programs, and/or utilize mobile vans to deliver services.” 

March 11, 2021: Adults 18 and over Eligible for Vaccination no later than May 1st

President Biden announced in his first Prime Time speech to the nation that “All adult Americans will be eligible to get a vaccine no later than May 1. That's much earlier than expected. Let me be clear. That doesn't mean everyone's going to have that shot immediately, but it means you'll be able to get in line beginning May 1. Every adult will be eligible to get their shot, and to do this, we're going to go from a million shots a day that I promised in December before I was sworn in to beating our current pace of two million shots a day, outpacing the rest of the world.”

March 12, 2021: Emergency Use Authorization (EUA) for Propofol-Lipuro

The FDA’s March 12th COVID-19 Update Bulletin included the announcement of an EUA for Propofol-Lipuro 1% injection emulsion for use in patients older than 16 requiring sedation via continuous infusion who are in an intensive care unit on mechanical ventilation. The FDA notes that “Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.”

March 12, 2021: Palmetto GBA Article – COVID-19 Laboratory Test Place of Service Limitation

Included in Palmetto GBA’s March 12, 2021 Daily Newsletter was an article indicating that “CMS has directed Medicare Administrative Contractors (MACs) to make any necessary Part B claim editing changes to ensure the following COVID-19 laboratory tests when billed with place of service 19 (off-campus outpatient hospital), 21 (inpatient hospital), 22 (on-campus outpatient hospital), or 23 (emergency room-hospital) are denied.”

March 15, 2021: OIG COVID-19 Portal Redesign

The OIG announced that their COVID-19 Portal has been redesigned and features additional resources, including a searchable list of their COVID-19 reports and downloadable graphics.

March 15, 2021: CMS Increases Medicare Payment for Administering COVID-19 Vaccine

CMS announced in a Press Release that the payment amount for administering the COVID-19 is increasing and noted that “this new and higher payment rate will support important actions taken by providers that are designed to increase the number of vaccines they can furnish each day.” Effective for COVID-19 vaccines administered on or after March 15, 2021, the national average payment rate for physicians, hospitals, pharmacies and other immunizers is increasing from approximately $28 to administer each dose of the vaccine to $40.

I was first introduced to the concept of Clinical Documentation Improvement (CDI) in 1998. Fast forward to 2021 to CDI now being an acronym for Clinical Documentation Integrity (CDI). Put simply, CDI is a collaboration between Physicians, CDI Specialists, and Coding Professionals with an end goal of accurately telling the patient’s story. On the Physicians end, the story is told through what he or she documents in the medical record. The CDI Specialist works as a bridge between the Physician and the Coding Professional who interprets documentation and tells the story through codes (ICD-10-CM, ICD-10-PCS, CPT, etc.).

On February 24, 2021, the OIG released a Data Brief titled Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and Warrants Further Scrutiny. Hospitals and more specifically Physicians, CDI Specialists and Coding professionals should be aware that the OIG is calling into question the story that is being told about patient hospitalizations across the country. This is evident by the Data Brief’s three takeaways:  

• Hospitals increasingly billed for inpatient stays at the highest severity level – the most expensive level – from FY 2014 through FY 2019.
• There are indications that these stays are vulnerable to inappropriate billing practices, such as upcoding.
• We recommend that CMS conduct targeted reviews of MS-DRGs and stays that are vulnerable to upcoding, as well as the hospitals that frequently bill for them.

Key OIG Findings by the Numbers

The OIG reviewed inpatient hospital claims with dates of service from CMS Fiscal Year (FY) 2014 through FY 2019. Listed below are key findings that led the OIG to conclude that hospitals may be upcoding.

OIG Findings from FY 2014 to FY 2019

• There was an almost 20% increase in claims billed to Medicare Severity Diagnostic Related Groups (MS-DRGs) with a major co-morbidity or complication (MCC).
• The Average Length of Stay (ALOS) for this group of claims decreased while the overall ALOS remained fairly flat.

In general, MCC’s are diagnoses that when present, you would anticipate the need to use more resources to care for the patient and the patient would have a longer length of stay. For example, you would expect the patient admitted with simple pneumonia that develops acute respiratory failure (which is an MCC) would require more resources and remain in the hospital longer than the patient admitted and discharges with only simple pneumonia.

FY 2019 Specific OIG Findings:

• $3.5 million (40%) of claims were billed to MS-DRGs with an MCC,
• Medicare spent $109.8 billion for inpatient stays and nearly half of this amount ($54.6 billion) was for claims billed to MS-DRGs with an MCC,
• The MS-DRG severity split in FY 2019 was found to be
• 7% were MS-DRGs with MCC,
• 1% were MS-DRGs with CC,
• 5% were MS-DRGS with a CC or MCC, and
• 7% of the claims were for claims where an MCC or CC does not impact the MS-DRG assignment (i.e. MS-DRG 313 [Chest Pain] or MS-DRG 312 [Syncope]),
• The average payment for stays with an MCC was $15,500, and
• Septicemia or severe sepsis with an MCC (MS-DRG 871) was the most frequently billed MS-DRG in FY 2019 (581,000 claims). Medicare paid $7.4 billion to hospitals for this one MS-DRG.

Short Length of Stay Claims

For this data review, the OIG defined short stays as MS-DRGs with LOS 20% shorter than the geometric mean length of stay (GMLOS) for the MS-DRG. Certain discharge dispositions were also excluded where a short stay would be expected (patient expired, patient left against medical advice (AMA), patient transferred to another acute care facility or patient elected hospice care).

The OIG provides specific examples of MS-DRGs with MCC that were more likely to have a short LOS. Specifically, they found that a third of the claims billed to the following MS-DRGs were short stays:

• MS-DRG 193: Simple Pneumonia and Pleurisy with MCC,
• MS-DRG 291: Heart Failure and Shock with MCC, and
• MS-DRG 682: Renal Failure with MCC.

MS-DRGs with One MCC

Over half (54%) of the claims billed with an MCC in FY 2019 were assigned to an MS-DRG based one just one diagnosis designated as an MCC. The OIG notes in their data brief that “stays that reach the highest severity level because of one diagnosis are particularly vulnerable to upcoding. Previous OIG work has found that inappropriate billing of a single major complication can lead to significant Medicare overpayments. In addition, CMS states that a high amount of stays with a single major complication could indicate “over-coding” (i.e., upcoding) of the complications.”

Similar to short length of stay claims, the OIG provides specific examples of MS-DRGs with MCC that were more likely to have only one diagnosis designated as an MCC.

• Over 80% of claims billed to MS-DRG 689 (Kidney and Urinary Traction Infections with MCC) only had one MCC on the claim.
• Nearly 70% of the following three MS-DRGs had only one MCC on the claim:
• MS-DRG 190: Chronic Obstructive Pulmonary Disease with MCC,
• MS-DRG 193: Simple Pneumonia and Pleurisy with MCC, and
• MS-DRG 682: Renal Failure with MCC.

OIG Acknowledges Limitations of Study

The OIG does note their study was based on claims data and not medical record reviews. In saying that, they acknowledge that record reviews would be necessary to validate whether or not individual claims were inappropriately billed. Examples of specific factors considered by the OIG that may have impacted the data includes:

• The transition to ICD-10,
• The 2-midnight policy,
• Shifts of surgical procedures to the outpatient setting,
• Increases in efficiencies of care, and
• Advancements in technology.

However, they note that “None fully account for the trends described in the report. For example, the fact that the average length of all hospital stays largely remained the same undermines the idea that efficiencies of care or advancements in technology are driving factors. In addition, the billing trends described in this report began before the transition to ICD-10 in FY 2016 and continued well after, refuting that as a significant factor as well.”

There are a couple of things that I believe the OIG did not consider. First, is the Association for Clinical Documentation Integrity Specialists (ACDIS). This Association began on October 1, 2007 which coincided with the go-live date for the transition to the new MS-DRG system which brought about the advent of MCCs. Per the ACDIS Code of Ethics, Clinical documentation improvement specialists shall “Facilitate accurate, complete, and consistent clinical documentation within the health record to support coding and reporting of high-quality healthcare data.”

Speaking only for myself, I believe this group of dedicated professionals collaborating with and educating physicians has resulted in more accurate and complete medical record documentation. The end result being an increase in CMI and reimbursement that is not due to up-coding.

Another issue I believe the OIG did not consider is hospital coding productivity requirements. When discussing review findings with our clients, it is not uncommon that we are told that once they find an MCC or CC to impact the MS-DRG assignment, they do not continue to look for additional MCCs or CCs.

OIG Recommendations

As mentioned earlier in this article, the OIG is recommending that in general, CMS conduct targeted reviews of MS-DRGs and hospital stays that are vulnerable to upcoding, which they define as claims billed with an MCC and the hospitals that frequently bill them. More specifically, review targets should be directed at hospitals that bill MS-DRGs with the following characteristics:   

• MS-DRGs with an MCC with a short stay,
• MS-DRGs with only one MCC driving the MS-DRG assignment, and
• Specific MS-DRGs with MCC with a high proportion of stays that are a short stay and or only have one MCC driving the MS-DRG (i.e. MS-DRG 193: Simple Pneumonia and Pleurisy with MCC).

The OIG notes that in addition to using targeted review results to recoup overpayments, “CMS should use them to educate hospitals about appropriate billing, modify coding policies, and consider whether further steps should be taken to disincentivize inappropriate billing.”

CMS Response to Recommendations

CMS does not agree with the targeted reviews recommendations stating “that there is more work to be done to determine conclusively which changes in billing are attributable to upcoding. CMS also said that it would share our findings with its Recover Audit Contractors for their consideration in updating their strategies for reviewing MS-DRGs.”

MMP Recommendations Moving Forward

Hospitals should carefully read the story that this OIG Data Brief provides and find answers to the following questions:

• Has there been an increase in your short stays where the claim codes to an MS-DRG with an MCC? Is this true for your claims coding to MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC), MS-DRG 291 (Heart Failure and Shock with MCC), and MS-DRG 682 (Renal Failure with MCC)?
• Do your claims coded to MS-DRGs with MCC only have one MCC? Is this true for your claims coding to MS-DRG 689 (Kidney and Urinary Tract Infections with MCC), MS-DRG 190 (Chronic Obstructive Pulmonary Disease with MCC), MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC) and MS-DRG 682 (Renal Failure with MCC)?

While you can data mine internally to answer these questions. Do you know how you compare to other hospitals? If not, do you know where you can find answers?

PEPPER

One resource is the Short-Term Acute Care Program for Evaluating Payment Patterns Electronic Report or PEPPER. This report provides a hospital with a compare to their state, their Medicare Administrative Contractor (MAC) Jurisdiction and the nation for specific review targets “at risk for improper payment due to billing, coding, and/or admission necessity items.” Related to the OIG Data Brief, the PEPPER provides a compare of your discharges for MS-DRGs assigned on the bases of only one CC or MCC being coded on the claim.

RealTime Medicare Data

Another potential resource is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 1.2 billion Medicare claims annually from 48 states and the District of Columbia, and allows for searching of over 10 billion historical claims and counting.

One report available in their suite of Inpatient Hospital reports is a One Day Stay Report. Similar to the OIGs definition of short stays, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused.

Another report available is a DRG Severity Report that can help you trend your mix of claims coded to MS-DRGs with MCC, with CC, and without CC/MCC respectively. This report provides a compare to your state, your defined market and specific hospitals within your defined market.

For further information on all that RTMD has to offer you can visit their website at https://rtmd.org.

This week we highlight key updates spanning from March 2nd through 9th of 2021.

Resource Spotlight: CDC Guidance when You’ve Been Fully Vaccinated

The CDC has updated their guidance for when you have been fully vaccinated. Following is what has changed: If you’ve been fully vaccinated:

• “You can gather indoors with fully vaccinated people without wearing a mask.

• You can gather indoors with unvaccinated people from one other household (for example, visiting with relatives who all live together) without masks, unless any of those people or anyone they live with has an increased risk for severe illness from COVID-19.
• If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.
• However, if you live in a group setting (like a correctional or detention facility or group home) and are around someone who has COVID-19, you should still stay away from others for 14 days and get tested, even if you don’t have symptoms.”

March 2, 2021: Merck and Johnson & Johnson COVID-19 Production Collaboration

An HHS Press Release details that that HHS will be coordinating with Merck to “repurpose some of its existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies included the current pandemic.” Janssen Pharmaceuticals will be the first federal partner to use these facilities to manufacture COVID-19 vaccines.

March 4, 2021: Alabama Safer at Home Order Extended until April 9, 2021 at 5 p.m.

On March 4th, Alabama Governor Kay Ivey once again extended the Safer at Home order. While the mask requirements did not change there are a few new changes to the order, for example:

• Hospitals and Nursing Homes: Subject to reasonable restrictions, patients and residents will be allowed visits from as many as two caregivers (up from one) or as many as two visitors (up from one) at a time and
• Senior Citizen Centers: Programs other than congregate meals may resume, but only outdoors and subject to guidelines by the Alabama Department of Senior Services. Meals still available by curbside pick-up or delivery.

March 4, 2021: COVID-19 Health Equity Task Force Meeting

HHS has filed a notice in the Federal Register to provide notice that the COVID-19 Health Equity Task Force is conducting a virtual meeting on Friday March 26, 2021 from approximately 12 p.m. to 3 p.m. ET. They do note the time is tentative and subject to change. The purpose of this meeting is to discuss equitable vaccine access and acceptance. The meeting is open to the public and will be live streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website at www.minorityhealth.hhs.gov/healthequitytaskforce/.

March 4, 2021: MLN Connects – COVID Vaccine Resources for Hard to Reach Patients

CMS provided the following information in their March 4th edition of MLN Connects:

“The COVID-19 pandemic is disproportionately affecting Medicare-Medicaid dually eligible individuals, racial and ethnic minority groups, and individuals with disabilities. You can help make sure hard to reach Medicare patients get COVID-19 vaccination information during this public health emergency.

More Information:

• CMS Office of Minority Health COVID-19 Resources on Vulnerable Populationswith fact sheets in multiple languages to assist organizations who work with those most vulnerable, such as older adults, those with underlying medical conditions, racial and ethnic minorities, rural communities, and people with disabilities
• CDC Communication Toolkitfor migrants, refugees, and other limited-English-proficient populations”

March 5, 2021: COVID-19 Scams

The OIG updated their Fraud Alert: COVID-19 Scams webpage to alert the public about fraudulent offers of COVID-19 tests, HHS grants, and Medicare prescription cards in exchange for personal details including Medicare information. “These scammers use the coronavirus pandemic to benefit themselves, and beneficiaries face potential harm. The personal information collected can be used to fraudulently bill federal health care programs and commit medical identity theft.”

March 5, 2021: First Molecular Non-Prescription, At-Home COVID-19 Test Granted Emergency Use Authorization

The FDA issued a EUA for Cue COVID-19 Test for Home and Over the Counter (OTC) Use. “Cue COVID-19 Test for Home and Over The Counter (OTC) Use test is authorized for non-prescription home use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. This test is intended for use in adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.”

March 5, 2021: EUA for Adaptive Biotechnologies T-Detect COVID Test

The FDA announced in a bulletin the issuance of a EUA for the T-Detect COVID test developed by Adaptive Biotechnologies. The test can aid in identifying people with recent or prior infection with SARS-CoV-2 and “is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset.”

CDC COVID Data Tracker – United States COVID-19 Cases

This week we highlight key updates spanning from February 23rd through March 2nd, 2020.

Resource Spotlight: VaccineFinder

According to the CDC, “VaccineFinder is a free, online service where users can search for pharmacies and providers that offer vaccination. Information about where COVID-19 vaccines are available is provided directly by pharmacies and providers, in collaboration with states, and is updated daily. VaccineFinder is operated by Boston Children’s Hospital, in partnership with CDC.”

At this time VaccineFinder is launching in four states and will expand information for additional states in the coming weeks. If information is not yet available where you live, the CDC has advised that you visit your state health department’s website. Links to State and Territorial Health Department websites are available on the CDC website.  

February 24, 2021: FDA’s New Webpage: COVID-19 Vaccination & the Food and Agriculture Sector

The FDA launched this new webpage to provide information for the food and agriculture sector about the following:

• Safety and effectiveness of COVID-19 vaccines authorized for emergency use by the FDA,
• Benefits of COVID-19 vaccination, and
• Information about the availability of vaccines in your community.

February 25, 2021: FDA Flexibilities for Storing Pfizer-BioNTech COVID-19 Vaccine

In an FDA Bulletin, the FDA announced their decision to allow “undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.” This announcement includes an updated Fact Sheet for Health Providers Administering Vaccine.

February 26, 2021: FDA Vaccine Advisory Committee working towards Emergency Use Authorization for Janssen Biotech Inc. COVID-19 Vaccine

Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research announced in an FDA bulletin that “Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.”

February 27, 2020: Janssen COVID-19 Vaccine Granted Emergency Use Authorization

A little over twenty four hours after the FDA’s Vaccine Advisory Committee met they published a bulletin announcing emergency use authorization for the Janssen COVID-19 vaccine for individuals 18 years of age and older. “The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”

February 27, 2020: Johnson & Johnson COVID-19 Vaccine Press Release

Johnson & Johnson announced the EUA for their vaccine indicating that the “vaccine was 85 percent effective in preventing severe disease across all regions studies, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.” Unique to this COVID-19 vaccine, it is a single shot vaccine. Side effects that have been reported with the vaccine include:

• Injection site reactions: pain, redness of the skin, and swelling
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.

Johnson & Johnson indicates that the company has already started shipping the vaccine and “expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.”

March 1, 2021: CMS COVID-19 Vaccines and Monoclonal Antibodies Webpage

CMS continues to add to this webpage as additional COVID-19 vaccines and certain monoclonal antibodies receive Emergency Use Authorization. On this page you will find tables for COVID-19 vaccines and monoclonal antibodies detailing the code, CPT descriptor, the vaccine/procedure name, payment allowance and effective dates. There is also a wealth of information available in the Additional Resources section. Most recently added is a Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction download.  This webpage was last modified on March 1, 2021 to include information about the new Janssen COVID-19 vaccine by Johnson & Johnson. I encourage you to check this webpage often for updates.

March 1, 2021: Quidel QuickVue At-Home COVID-19 Test

The FDA issued a EUA for the Quidel QuickVue At-Home COVID-19 Test. Specifically, The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.”

March 2, 2021: CDC Call – What Clinicians Need to Know about Johnson & Johnson’s Janssen COVID-19 Vaccine

The CDC hosted a Clinical Outreach and Communication Activity (COCA) call on March 2nd to provide clinicians an overview of the J&J Janssen COVID-19 vaccine including vaccine characteristics and administration, vaccinating special populations, and contraindications. You can access call materials from this presentation on the CDC website. 

This week we highlight key updates spanning from February 16th through February 22nd, 2021.

Resource Spotlight: CMS Memorandum – Hospital Survey Priorities Revised

On February 18, 2021, CMS published a revised version of a January 20, 2021 Memorandum regarding Hospital Survey Priorities. This memorandum clarifies expectations of State Survey Agencies and Accrediting Organizations as “CMS is committed to taking critical steps to protect vulnerable individuals to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency PHE.” Specifically, CMS is extending the hospital survey limitations for an additional 30 days from the date of the revised memo (March 22, 2021).

February 16, 2021: Moderna Press Release – U.S. COVID-19 Vaccine Supply Update

Moderna, Inc.’s press release opened with the following numbers:

• 4 million – the number of doses the company has supplied to the U.S. Government to date,
• 5 million – the number of doses that have been administered in the U.S. as communicated by the CDC,
• 2 million – The number of additional doses that have been produced and are filled in vials and in the final stages of final production and testing before release,
• 100 million – the number of doses the company expected to deliver to the U.S. Government by the end of March 2021, and
• 100 million – the number of additional doses the company expects to deliver by the end of May 2021 followed by another 100 million by the end of July 2021.

The Press Release goes on to provide information about the Moderna COVID-19 vaccine and important safety information.

February 17, 2021: Actions to Expand COVID-19 Testing

HHS announced new actions to expand COVID-19 testing capacity nationwide. They go on to note in the Press Release that “these actions will improve the availability of tests, including for schools and underserved populations; increase domestic manufacturing of tests and testing supplies; and better prepare the nation for the threat of variants by rapidly increasing virus genome sequencing.” Three specific actions outlined includes:

• Expansion of COVID-19 testing for schools and underserved populations,
• Increase domestic manufacturing of testing supplies and materials to address testing shortages, and
• Having the CDC “rapidly increase genomic sequencing of the virus to better prepare for the treat of variants and slow the spread of the disease.”

February 18, 2021: CMS MLN Connects News – Further Steps to Provide Wide Access to COVID-19 Antibody Treatment

As reported in last week’s article, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab being administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients at risk for progressing to severe COVID-19. Later in the week, CMS published the following information regarding this EUA in the February 18, 2021 edition of MLN Connects:

“The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab and etesevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP) EUA effective February 9, 2021:

Q0245:

• Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg
• Short descriptor: bamlanivimab and etesevima

M0245:

• Long Descriptor: intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
• Short Descriptor: bamlan and etesev infusion”

February 18, 2021 FDA Bulletin: COVID-19 Transmission is not through Food or Food Packaging

In a Bulletin attributed to Acting USDA Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock, M.D., the authors indicate that “considering the more than 100 million cases of COVID-19, we have not seen epidemiological evidence of food or food packaging as the source of SARS-CoV-2 transmission to humans. Furthermore, transmission has not been attributed to food products or packaging through national and international surveillance systems. Food business operations continue to produce a steady supply of safe food following current Good Manufacturing Practices and preventive controls, focusing on good hygiene practices and keeping workers safe.”

February 19, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): COVID-19 Vaccine Safety Monitoring

This CDC MMWR provides insight into the first month (December 14, 2020 – January 13, 2021) of COVID-19 vaccine safety monitoring in the United States. 13.8 million Doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines were administered to the U.S. population in this first month. The most frequently reported symptoms by those vaccinated includes headache, fatigue, dizziness, chills and nausea. The authors of this article (Gee J, Marquez P, Su J, et al.) note in their summary that “monitoring, conducted as part of the U.S. vaccination program, indicates reassuring safety profiles for COVID-19 vaccines. Local and systemic reactions were common; rare reports of anaphylaxis were received. No unusual or unexpected reporting patterns were detected.”

CDC COVID Data Tracker – United States COVID-19 Cases

Spotlight: Cigna Updates Authorization Policy for CTA and FFR-CT Analysis

The Society of Cardiovascular Computed Tomography (SCCT) announced in a January 29, 2021 Press Release that effective February 1, 2021, Cigna no longer requires pre-authorization for Computed Tomography Angiogram (CTA) of the heart, coronary arteries and bypass grafts with contrast material, including 3D imaging post-processing.

Cigna also removed pre-authorization, effective February 1, 2021, for Fractional Flow Reserve-Computed Tomography (FFR-CT).

Dustin Thomas, MD, FSCCT, Chair, Advocacy Committee, SCCT indicated in the Press Release that “the favorable policy update shows that Cigna recognized the use of CTA and FFR-CT as front-line test which can lead to improved patient outcomes.”

The Local Scene

January 25, 2021: CMS Fact Sheet: MAC COVID-19 Test Pricing

CMS notes that “Local Medicare Administrative Contractors (MACs) are responsible for developing the payment amount for claims they receive for newly created HCPCS codes in their respective jurisdictions until Medicare establishes national payment rates.” Included in this Fact Sheet is a table of newly created COVID-19 Test HCPCS codes and the payment amounts for each of the twelve MAC jurisdictions.

January 27, 2021: NGS JK Article: Beneficiaries with Medicare Advantage must Provide Medicare Information to Receive COVID-19 Vaccination

In this NGS News and Alerts article, they discuss the problem Providers are facing in obtaining information needed to bill traditional Medicare when a patient has received the COVID-19 vaccine. They advise that “the provider should inform the beneficiary with MA coverage that the services to be rendered on that DOS must be billed to traditional Medicare. Health care providers who furnish monoclonal antibodies to treat COVID-19 and/or administer a COVID-19 vaccine to a patient enrolled with a MA plan should submit such claims to your traditional Medicare contractor, not the MA plan. Please note that when the provider did not pay for the vaccine then they may only bill Traditional Medicare for the administration.

If the beneficiary with MA refuses to provide their traditional Medicare insurance information for billing purposes, then the provider should inform the patient that their refusal to cooperate so that Medicare can be billed will result in that beneficiary becoming liable for the service(s). If your Medicare patient doesn’t want to give the SSN, tell your patient to log into mymedicare.gov to get the MBI.”

February 5, 2021: Novitas JH/JL Notice: New Local Coverage Determinations (LCDs) Effective March 21, 2021

Novitas issued a notice informing providers about the following new LCDs and related billing and coding articles that will become effective March 21, 2021. It is noteworthy that two of the LCDs in the announcement are for procedures that are part of the CMS Hospital Outpatient Prior Authorization Program that began July 1, 2020 (Blepharoplasty and Botulinum Toxins).

• Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (L35004)
• Billing and Coding: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A57618)
• Botulinum Toxins (L38809)
• Billing and Coding: Botulinum Toxins (A58423)
• Diagnostic Colonoscopy (L38812)
• Billing and Coding: Diagnostic Colonoscopy (A58428)

The following response to comments articles contain summaries of all comments received and Novitas’ responses:

• Response to Comments: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A58586)
• Response to Comments: Botulinum Toxins (A58584)
• Response to Comments: Diagnostic Colonoscopy (A58612)

February 4, 2021: First Coast JN - LCD and Article Updates

First Coast has posted new LCDs and related Billing and Coding Articles also effective on March 21, 2021. Similar to Novitas, two of the new LCDs are for procedures that are part of the Hospital Outpatient Prior Authorization Program.

• Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (L34028)
• Billing and Coding: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A57025)
• Botulinum Toxins (L33274)
• Billing and Coding: Botulinum Toxins (A57715)
• Diagnostic Colonoscopy (L33671)
• Billing and Coding: Diagnostic Colonoscopy (A55937)

The following Response to Comments Articles contain summaries of all comments received and First Coast’s responses:

• Response to Comments: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A58587)
• Response to Comments: Botulinum Toxins (A58585)
• Response to Comments: Diagnostic Colonoscopy (A58610)

February 4, 2021 Daily Newsletter Palmetto GBA JJ/JM OPD PA Alert!
Palmetto GBA posted the following Alert regarding the hospital Outpatient Department Prior Authorization Program prior authorization requests:

“OPD PAs cannot be sent retroactively, they must be submitted prior to the beneficiary receiving the service. Please review the FAQ on the CMS website.”

February 8, 2021: WPS J5/J8 Article – New CERT Contractor Update

WPS shared in an article that “The Comprehensive Error Rate Testing (CERT) contractor has a new website for provider information and resources. Providers can access the new website, the C3HUB at https://c3hub.certrc.cms.gov/.”

February 12, 2021: First Coast JN Article: Billing Condition Code (CC) 90 and 91

In this article, First Coast reminds providers that CMS issued MLN Matters® (MM) 12049  to implement two new condition codes (CCs):

• 90 – To allow providers to report when the service is provided as part of an Expanded Access approval
• 91 – To allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA)

They go on to note that while this MLN article was released on November 20, 2020, the implementation date for these codes is February 22, 2021 with an effective date for claims received on or after February 1, 2021.

“First Coast loaded the new CCs on February 10. This means the new codes were not in the Fiscal Intermediary Standard System (FISS) until February 10. Any claims submitted before February 10, with these new condition codes, were rejected prior to entering FISS.

Provider action

If you submitted claims before February 10, with either CC 90 or 91 and received a rejection, you can resubmit the claim.”

This week we highlight key updates spanning from February 9th through February 15th, 2021.

Resource Spotlight: CMS COVID-19 Toolkit for Healthcare Providers & CDC Toolkit for Older Adults & People at Higher Risk

In January “CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine.  These resources are designed to increase the number of providers that can administer the vaccine and ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID treatments that are approved by the FDA.” The CMS COVID-10 webpage provides information on several key topics such as Coding for COVID-19 Vaccine shots and Medicare Monoclonal Antibody COVID-19 infusion.

The CDC has developed a Toolkit for Older Adults & People at Higher Risk webpage designed to provide “guidance and tools to help older adults and people at higher risk and those who serve of care for them make decisions, protect their health, and communicate with their communities.” Several resources are available on this CDC webpage, for example, COVID-19 Vaccine Resources, Guidance and Planning Documents, Web Resources, FAQs, Fact Sheets and Posters.

February 9, 2021: FDA Authorization for Monoclonal Antibodies Treatment of COVID-19

The FDA announced that they have “issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds] who test positive for SARS-CoV-2 and who are high risk for progressing to severe COVID-19.” The UEA also authorizes treatment for patients 65 years or older with “certain chronic medical conditions.” As a reminder, the ICD-10-PCS codes for bamlanivimab and etesevimab are included in the list of 21 new procedure codes implemented by CMS with an effective date of January 1, 2021. CMS also has a webpage dedicated to Monoclonal Antibody COVID-19 infusion.

February 10, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): Maximizing Masks

In the MMWR titled Maximizing Fit for Cloth and Medical Procedure Masks to Improve Performance and Reduce SARS-CoV-2 Transmission and Exposure, 2021, the authors conducted experiments assessing two ways to improve the fit of medical masks to reduce transmission and exposure of COVID-19. They found that for the user to receive the most benefit from wearing mask(s), a better fit is more effective at slowing the spread of the disease.

The CDC has a dedicated webpage titled Masks Protect You & Me where you can download an educational poster and find links to information about masks (i.e. how to wear masks and how to store and wash masks). 

February 10, 2021: CDC Updates Clinical Considerations for Patients who have received COVID-19 Vaccine

The CDC updated their clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. One recent change is for vaccinated persons. Specifically, fully vaccinated persons meeting the following criteria are not required to quarantine when exposed to someone with suspected or confirmed COVID-19:

• A person is fully vaccinated (i.e., ≥ 2 weeks following the receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine),
• A person is within 3 months following receipt of the last dose in a series, and
• A person has remained asymptomatic since the current COVID-19 exposure.

February 11, 2021: Alabama Medicaid COVID-19 Emergency Expiration Date Extended

The Alabama Medicaid Agency notes in this Alert that “All previously published expiration dates related to the COVID-19 emergency are once again extended by the Alabama Medicaid Agency (Medicaid). The new expiration date is the earlier of March 31, 2021, the conclusion of the COVID-19 national emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.”

February 11, 2021: MLN Connects – COVID-19: Revised Clinician Codes Accepted with CS Modifier

CMS included the following information in their Thursday February 11th edition of MLN Connects:

“Effective March 18, 2020, the Families First Coronavirus Response Act requires Medicare Part B to cover beneficiary cost-sharing for provider visits when a COVID-19 diagnostic test is administered or ordered. CMS updated the list of codes (ZIP) that physicians and non-physician practitioners can use with the Cost-Sharing (CS) modifier.

For dates of service on or after January 1, 2021, through the end of the public health emergency, we’ll accept these codes with the CS modifier:

• HCPCS codes G2250, G2251, and G2252
• CPT codes 98970, 98971, and 98972 (These replace HCPCS codes G2061 – G2063, which are accepted for services provided in 2020)  

CPT codes 98966, 98967, and 98968 are accepted for services with the CS modifier provided on or after March 18, 2020.

More information about cost-sharing: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) (PDF) MLN Matters Article”

February 12, 2021: CDC Guidance – What to Expect After Getting a COVID-19 Vaccine

This CDC webpage provides COVID-19 vaccine information including the following:  

• Common side effects,
• Helpful tips,
• When to call the doctor,
• Scheduling your second shot,
• About the second shot,
• Additional reminders, and
• A printable handout for vaccine recipients.

February 13, 2021: CDC Updates Interim Guidance on Duration of Isolation and Precautions for Adults with COVID-19

The CDC indicates, on this webpage, that “Accumulating evidence supports ending isolation and precautions for adults with laboratory-confirmed COVID-19 using a symptom-based strategy.” Currently, the available data indicates the following:

• Adults with mild to moderate COVID-19 remain infectious no longer than 10 days after symptom onset,
• Most adults with more severe to critical illness “likely remain infectious no longer than 20 days after symptoms onset,
• Severely Immunocompromised patients have been found to remain infectious beyond 20 days,
• Once recovered from the virus, adults can shed detectable but non-infectious COVID-19 in upper respiratory specimens up to 3 months after illness onset.

The CDC notes that “These findings strengthen the justification for relying on a symptom-based rather than test-based strategy for ending isolation of most patients, so that adults who are no longer infectious are not kept unnecessarily isolated and excluded from work or other responsibilities.”

CDC COVID Data Tracker – United States COVID-19 Cases

This week we highlight key updates spanning from February 2nd through February 8th, 2021.

Resource Spotlight: CMS Notice – What Partners Need to Know About Medicare Fraud

On February 5th, CMS shared the following information about Medicare Fraud and COVID-19: “As COVID-19 vaccines begin rolling out across the country CMS is taking action to protect the health and safety of our nation’s patients and providers and keeping you updated on the latest COVID-19 resources from HHS, CDC and CMS.

With information coming from many different sources, CMS has compiled resources and materials to help you share important and relevant information on the COVID-19 vaccine with the people that you serve. You can find these and more resources on the COVID-19 Partner Resources Page and the HHS COVID Education Campaign page.

We look forward to partnering with you to promote vaccine safety and encourage our beneficiaries to get vaccinated when they have the opportunity.

COVID-19 Scams

As the country begins to distribute COVID-19 vaccines, scammers are taking advantage of the coronavirus pandemic. The HHS Office of Inspector General alerted the public about COVID-19 fraud schemes, with scammers using telemarketing calls, text messages, social media platforms, and door-to-door visits to perpetrate COVID-19-related scams.

Con artists may also try to get Medicare Numbers or personal information so they can steal identities and commit Medicare fraud. Medicare fraud results in higher health care costs and taxes for everyone. 

What can you do to help prevent Medicare beneficiaries from being a victim of fraud?

Share this important information with Medicare beneficiaries to help them protect themselves from Medicare fraud:  

Medicare covers the COVID-19 vaccine, so there will be no cost to you.  

• You will need to share your Medicare card with your health care provider or pharmacy when receiving your vaccine, even if you’re enrolled in a Medicare Advantage plan.
• If anyone else asks you to share your Medicare Number or pay for access to the vaccine, you can bet it's a scam.
• You can't pay to put your name on a list to get the vaccine.
• You can't pay to get early access to a vaccine.
• Don't share your personal or financial information if someone calls, texts, or emails you promising access to the vaccine for a fee.

Guard your Medicare card like it’s a credit card.

• Medicare will never contact you for your Medicare Number or other personal information unless you’ve given them permission in advance.
• Medicare will never call you to sell you anything.
• You may get calls from people promising you things if you give them a Medicare Number. Don’t do it. 
• Medicare will never visit you at your home.
• Medicare can’t enroll you over the phone unless you called first.  

Learn more tips to help prevent Medicare fraud.

• Learn How to Spot Medicare fraud. Review your Medicare claims and Medicare Summary Notices for any services billed to your Medicare Number you don’t recognize.
• Report anything suspicious to Medicare. If you suspect fraud, call 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.
• If you need to replace your card because it’s damaged or lost, log into (or create) your secure Medicare account to print an official copy of your Medicare card. You can also use your Medicare account to access your Medicare information anytime, add prescription drugs to help you find and compare health and drug plans in your area, and more. 

 What role can partners play in fighting healthcare fraud, waste and abuse?

• Become a HFPP partner. The Healthcare Fraud Prevention Partnership (HFPP) is a voluntary public-private partnership that helps detect and prevent healthcare fraud through data and information sharing. Partners include federal government, state agencies, law enforcement, private health insurance plans, employer organizations, and healthcare anti-fraud associations.
• By working together, we can be more effective at preventing health care fraud, waste, and abuse. The Healthcare Fraud Prevention Partnership (HFPP) continues to expand nationally by encouraging participation by all eligible public and private health care entities. The insights and input of each member contribute to the overall value of the Partnership.

Questions? Please e-mail us: Partnership@cms.hhs.gov”

February 2, 2021: Joint Commission Sentinel Event Alert – Special Pandemic Edition

This Joint Commission newsletter includes information related to:

• What they are hearing from healthcare workers, patients, families, government agencies and more,
• Five ways to support health care workers; and
• Several links to additional resources related to the COVID-19 pandemic developed by the Joint Commission.

February 3, 2021: CMS Updates Provider Specific Fact Sheets on Waivers and Flexibilities

CMS updated all of the Provider Specific Fact Sheets on New Waivers and Responsibilities. The Hospitals:   CMS Flexibilities to Fight COVID-19 Fact Sheet, was updated to include information related to coverage of monoclonal antibody therapies and Price Transparency for COVID-19 testing was added.

February 4, 2021: FDA Limits Use of Convalescent Plasma

The FDA revised the Letter of Authorization for COVID-19 convalescent plasma. The authorization limits “use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response.”

February 4, 2021: New COVID-19 Vaccine Coming Soon?

The FDA announced they have scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for February 26, 2021 to discuss Janssen Biotech Inc.’s request for emergency use authorization (EUA) for a COVID-19 vaccine. A meeting agenda and committee roster will be made available to the public no later than two business days prior to the meeting.

February 5, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): Decline in COVID-19 Hospitalization Growth Rate Associated with Statewide Mask Mandates

In this CDC MMWR Report, the authors found that from March 22 through October 17, 2020, “10 sites participating in the COVID-19-Associated Hospitalization Surveillance Network in states with statewide mask mandates reports a decline in weekly COVID-19-associated hospitalization growth rates by up to 5.5 percentage points for adults aged 18-64 years after mandate implementation, compared with growth rates during the 4 weeks preceding implementation of the mandate.” The implication for public health practice concluded by the author’s is that “mask-wearing is a component of a multipronged strategy to decrease exposure to and transmission of” COVID-19.

February 7, 2021: CDC Tracking COVID-19 Variants

The CDC has created a webpage to report cases of COVID-19 in the U.S. caused by variants. As of February 7, 2021 the CDC is tracking three variants (B.1.17, B.1.351 and P.1). To date B.1.1.7 is the most prevalent variant with 690 reported cases in 33 states. B.1.1.7 is the variant identified in the United Kingdom (UK). This variant was first detected in the US at the end of December 2020 and is noted to spread more easily and quickly than other variants. You can read more about all three variants on the CDC’s New COVID-19 variant webpage.

CDC COVID Data Tracker – United States COVID-19 Cases

On January 19, 2021, CMS at long last published a Final Decision Memo (CAG-00438R) for Transcatheter Mitral Valve Repair (TMVR). The proposed decision memo was a departure from the current TMVR National Coverage Determination (NCD) 20.33. Similarly, the final decision memo is a significant departure from what was proposed.

Background: From TMVR to TEER

August 2019

At the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo was to have been February 14, 2020.

National Coverage Analysis Issue

 TMVR is used in the treatment of mitral regurgitation (MR). There are two types of MR.

• Primary (degenerative) DMR results from structural failure of mitral valve, and
• Secondary (functional) FMR results from left ventricular (LV) dysfunction with a largely preserved mitral valve.

NCD 20.33 established coverage for the treatment of significant symptomatic Primary MR. CMS’ national tracking analysis focused on TMVR for the treatment of significant symptomatic Secondary MR.

June 30, 2020 Proposed Decision Memo for TMVR (CAG-00438R)

In review, what was proposed?

• A document title change from TMVR to Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation.
• A covered indication away from coverage for DMR to treatment for FMR.
• A proposal to remove the Coverage with Evidence Development (CED) requirement in NCD 20.33.
• A patient continuing to be symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) and also requiring a patient to meet several new approved FDA criteria (i.e. LVED 20% to 50%, and New York Heart Association (NYHA) Class II, III, or Iva (ambulatory)).
• Guideline Directed Medical Treatment (GDMT) “The specialty societies publish detailed guidelines for the diagnosis and management of heart failure.  The most recent full guideline was published in 2013, with a focused update in 2016. In addition to lifestyle changes, cornerstones of pharmacologic treatment of systolic heart failure include angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, mineralocorticoid antagonists (MRA), and diuretics.  For eligible patients, implantable cardiac defibrillators (ICD) can improve survival, while cardiac resynchronization therapy (CRT) can improve symptoms, reduce MR, reduce hospitalizations, and increase survival.”
• A detailed list of members to be included in the Heart Team that a patient is to be under the care of during the perioperative period.
• In NCD 20.33 there are two sets of qualifications for appropriate volume requirements (qualifications to begin a mitral valve TEER program and qualifications for mitral valve TEER experience). CMS proposed “to modify this requirement consistent with the same requirement for the interventional cardiologist as set forth in the June 2019 TAVR NCD Decision Memo. While clinically appropriate, this modification also establishes consistency across valve program areas.”
• CMS supporting a Shared Decision Making (SDM) discussion between the physician and the patient. At the same time, acknowledging that there is no fully developed tool for SDM for TEER at this time.
• Optimal Patient Selection for TEER: CMS acknowledged in the proposed decision memo that there are limitations in the trial/study evidence available to assist the heart team in optimal patient selection for TEER. They note in the proposed Decision Memo that they will carefully monitor treated patients for adherence to the criteria and will assess patient outcomes over the next four years through evidence published in the peer reviewed literature. At that time, contingent upon real-world demonstration of outcomes consistent with those achieved in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial), they will consider modifying criteria.
• Face-to-Face Examination during COVID-19 Public Health Emergency (PHE): Per the Proposed Decision Memo, “In the interim final rule with comment period [CMS-1744-IFC], CMS finalized that to the extent an NCD or LCD would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services those requirements would not apply during the public health emergency (PHE) for the COVID-19 pandemic.  This would include the proposed face-to-face examination by the heart team cardiac surgeon and interventional cardiologist.”
• A more extensive list of nationally non-covered indications for this procedure than the current NCD.

January 19, 2021 Final Decision Memo for TEER

What was finalized?

• A document title change from TMVR to Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation.
• A covered indication for DMR and FMR.
• Continued coverage of this procedure under Coverage with Evidence Development (CED).
• Coverage for a symptomatic moderate-to-severe or severe functional MR (FMR) patient when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy if applicable, or treatment for significant symptomatic degenerative MR (DMR) when furnished according to an FDA-approved indication.
• A heart team to include a cardiac surgeon, interventional cardiologist, interventional echocardiographer (cardiologist or anesthesiologist), heart failure cardiologist, and other providers from physician groups as well as advanced patient populations, nurses, research personnel and administration.
• One set of appropriate volume requirements to begin and maintain a mitral valve TEER program.
• CMS continuing to support a Shared Decision Making (SDM) discussion between the physician and the patient.
• Face-to-Face Exam requirements dependent on whether treatment is for FMR or DMR.
• Two indications for CMS non-covering this procedure
• For patients in whom existing co-morbidities would preclude the expected benefit from a mitral valve TEER procedure, and
• In patients with untreated severe aortic stenosis.

Final Decision Memo: CMS’ Response to Comments

CMS received 296 comments from 292 separate commenters during the second comment period. They organized comments and their responses into similar topic sections. I have found that taking the time to read comments from the health care community and CMS responses can provide insight into the why and how coverage determinations change or don’t change. Following are key highlights from several of the section types in the final decision memo:  

Timeline for Decision
In response to a commenters concern with the time elapsed between the FDA’s approval for TEER in functional mitral regurgitation patients and the finalized NCD, CMS acknowledged “the delayed publication of this final NCD.  CMS always aims to expeditiously complete rigorous national coverage analyses (NCAs) within statutory timeframes.  2020 was particularly challenging due to the COVID public health emergency.”

NCD Name Change and Scope

“Comment: One commenter recommended that CMS more clearly define technical features of therapies and their anatomical placement that will or will not fall within the parameters of the NCD.  Another commenter requested that TEER be clearly defined, and if it does not include the CARILLON system, a more inclusive term be used that does. 

Response:  This NCD addresses transcatheter edge-to-edge repair (TEER) of the mitral valve, which includes transcatheter devices that approximate the mitral leaflet edges by grasping the anterior and posterior mitral valve leaflets in a fashion analogous to a surgical Alfieri repair.  It does not include other potential transcatheter approaches, for example those that modify or supplement the mitral valve annulus or the chordal apparatus.  This NCD does not address transcatheter mitral valve replacement.”

Coverage with Evidence Development
Commenters overwhelmingly supported the application of coverage with evidence development (CED) for TEER and provided detailed reasons for their support.

“Response:  CMS appreciates these comments and has revised this NCD to cover TEER under CED for both DMR and FMR.  After careful review of the evidence, and consideration of the numerous public comments supportive of CED, CMS agrees with the consensus of the experts, including all of the professional societies and organizations that commented.  There are important evidence gaps that remain for both DMR and FMR and CED is the best path to address those.  It also permits more robust coverage than what we proposed. CMS also acknowledges that while DMR and FMR are important concepts, an important proportion of patients may have mixed degenerative and functional MR.  Furthermore, we believe that CED for both DMR and FMR better preserves the reliability of data submitted through registries and avoids potential reporting bias.”

Covered Indications

“Comment: Nine commenters disagreed with requiring the local heart team to determine that mitral valve surgery will not be offered as a treatment option because mitral valve surgery is not a treatment option for most FMR patients.  One commenter further asserted that this requirement unfairly favors surgical mitral valve replacement / repair (which has a lower level of evidence) over TEER (which has a higher level of evidence).

Response:  CMS appreciates these comments.  The COAPT study where benefit was demonstrated for FMR required that a cardiac surgeon determine that mitral valve surgery would not be offered as a treatment option.  However, CMS will finalize the TEER NCD under CED to the FDA labelling.  The CED paradigm allows coverage where evidence is promising but does not yet fully assess the appropriateness of TEER, which is a key element of meeting the reasonable and necessary standard, by conditioning coverage on further evidence development.  Consequently, CMS will remove the requirement that a cardiac surgeon examine the patient and determine that they are ineligible for mitral valve surgery.”

Non-Covered Indications

CMS Response to comments: “CMS appreciates these comments.  The COAPT study that demonstrated benefit for FMR included a broad range of specific inclusion and exclusion criteria.  By contrast, the MITRA-FR study, where inclusion and exclusion criteria were less stringent, did not demonstrate that TEER confers a benefit to patients with moderate to severe or severe FMR.  CMS is finalizing the TEER NCD with CED to the FDA labelling. 

Further evidence is needed to assess why the COAPT and MITRA-FR studies reached markedly different conclusions about the benefits of TEER in FMR.  The CED paradigm allows coverage where evidence is promising but does not yet fully assess the appropriateness of TEER, which is a key element of meeting the reasonable and necessary standard, by conditioning coverage on further evidence development.  In the context of CED, CMS will cover TEER to the FDA labelling. However, the presence of severe aortic stenosis may worsen heart failure symptoms and may substantially increase MR severity.58-60 Therefore, we are clarifying that TEER is non-covered in patients with untreated severe aortic stenosis because intervention to the mitral valve may be unnecessary after the aortic stenosis is addressed.”

Patient Evaluation

CMS received several commenters regarding who should evaluate a patient’s suitability for this procedure when the patient has functional mitral regurgitation.

“Response:  CMS appreciates these comments.  CMS has removed the requirement that a cardiac surgeon examine FMR patients to determine that they are ineligible for mitral valve surgery.  CMS agrees that for FMR, cardiac surgery is not generally the standard of care and requiring this consultation would present an undue burden; instead, optimization of GDMT with cardiac resynchronization therapy, if appropriate, is essential.  Therefore, for FMR, CMS is requiring that a cardiologist experienced in treating patients with advanced heart failure must independently examine the patient face-to-face. CMS recognizes that cardiologists may have extensive experience with advanced heart failure without being board eligible/board certified and that a board eligible/board certified Advanced Heart Failure/Transplant cardiologist is not available in some communities. Nonetheless, whenever possible, the heart failure cardiologist should be board certified in Advanced Heart Failure/Transplant.  For DMR, CMS continues to require that a cardiac surgeon independently examine the patient face-to-face because surgery is generally the standard of care.  CMS supports the concept of shared decision-making for all TEER patients.  Regarding the use of telehealth, CMS notes that this final NCD does not change telehealth rules and any services eligible to be furnished via telehealth under existing telehealth rules are allowable under this policy.”

Heart Team

CMS provided the following responses to comments about the composition of the heart team:

“Response: CMS believes the heart team must be comprised of multiple practitioners with the expertise to optimally treat patients with DMR and FMR.  CMS has determined that the heart team must be comprised of an interventional cardiologist, a cardiac surgeon, an interventional echocardiographer, a heart failure cardiologist with experience treating patients with advanced heart failure (for FMR patients only) and other providers from other specialty areas as appropriate, along with advanced patient practitioners, nurses, research personnel, and administrators.”

“Response:  This final NCD addresses both DMR and FMR and does not include a requirement for the cardiac surgeon to examine the patient face-to-face for FMR. However, the final NCD does require the cardiac surgeon to examine DMR patients face-to-face. CMS agrees that it is important to have the cardiac surgeon perspective on the heart team.”

“Response:  CMS has finalized the requirement for a cardiologist experienced in treating patients with advanced heart failure (the heart failure cardiologist) be included on the heart team specifically for patients with FMR.  For FMR, discrepancies in the outcomes achieved in the COAPT and MITRA-FR studies that included patients with ostensibly similar patient characteristics demonstrates clearly the critical role of patient selection and of reaching maximally tolerated GDMT prior to pursuing TEER.  CMS agrees with specialty societies and the FDA that optimization of GDMT is essential for achieving good patient outcomes, and therefore, CMS is requiring that the heart team heart failure cardiologist experienced in treating patients with advanced heart failure evaluate TEER candidates with FMR.  There is no requirement that patients with DMR be evaluated by the heart team heart failure cardiologist.  Because this NCD represents an expansion of coverage to FMR, CMS disagrees that a requirement for the heart team heart failure cardiologist to appropriately evaluate FMR patients for maximal GDMT will shut down TEER programs.”

“Response:  CMS agrees that the interventional echocardiographer is an important member of the heart team and is critical during TEER procedures.  We have more completely specified the role of the interventional echocardiographer in TEER procedures in the final NCD.”

General Volume Requirements

One “commenter asserted that there should be a common standard to begin or maintain a TEER program and that it should not change from the existing TMVR NCD.”

“Response: We agree.  Based on the comments and finalizing this decision as CED, we have finalized a common standard for all TEER programs under this NCD.  Further, we have reduced the cardiac surgical volume for hospitals to ≥ 20 per year which is half of what we proposed.  These final volume requirements reflect elements of the Expert Consensus document, our review of currently available clinical evidence, and our efforts to align with the TAVR NCD volume requirements for consistency across valve programs that perform both TEER and TAVR.

We note that evidence supports an association between procedural volumes and improved outcomes for both cardiac surgery and TEER, and we agree with the Expert Consensus document that volume requirements are appropriate to ensure good outcomes.  We are finalizing this decision to include CED which requires submission of data to a qualified registry. We believe that these data will assist hospitals in assessing and improving program quality which will be valuable in closely monitoring their TEER programs and ensuring good health outcomes for Medicare patients.”

“Response:  CMS supports the provision of high quality care for our beneficiaries.  Evidence supports an association between procedural volumes and improved outcomes for both cardiac surgery and TEER, and CMS agrees with the Expert Consensus document that volume requirements are appropriate.  Because TEER coverage under CED will require submission of data to a qualified registry, CMS believes that these data will assist hospitals in assessing and improving program quality.  Therefore, CMS is finalizing lower hospital cardiac surgery volume requirements than proposed and applying this requirement for both new and existing programs.  CMS agrees that ensuring patients have appropriate access to TEER is important but also recognizes that having access includes ensuring that patients have good quality care. We believe the reduced hospital surgical volume requirements and other requirements set forth in this final NCD are important to ensure Medicare beneficiaries have access to TEER in programs that deliver high quality care and achieve optimal health outcomes. The final NCD requirements reflect our intent to strike a balance between ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases with an evolving evidence base while also ensuring Medicare beneficiaries have access to needed treatment.”

Sunset of TEER CED NCD

“Based on public comments, CMS is aware that stakeholders desire clarity on how long CED will be required for TEER. CMS will consider published, peer-reviewed evidence periodically, following the effective date of this NCD and reconsider the policy when appropriate. The NCD will expire 10 years from the effective date if it is not reconsidered during that time. Upon expiration, coverage will be at the discretion of the MACs.”

Moving Forward

Do you know the potential financial impact for non-compliance with the NCD changes? To help find an answer I turned to our sister company, RealTime Medicare Data (RTMD). The following tables highlights  the procedure volumes, charges and payment for the Medicare Fee-for-Service (FFS) population in the RTMD foot print, which currently includes 48 states and DC. Specifically, the tables compare Medicare FFS paid claims for this procedure from January through September of 2018, 2019 and 2020.

You will note that the actual paid claims from 2019 to 2020 increased while volumes decreased. I believe the volume decrease is in part due to the COVID-19 pandemic. The increase in payment is likely due to the fact that CMS finalized regrouping this procedure from DRGs 228 and 229 (Other Cardiothoracic Procedures with MCC or without MCC respectively) to DRG 266 and 267 (Endovascular Cardiac Valve Replacement with MCC or without MCC respectively) in the FY 2020 IPPS Final Rule effective October 1, 2019.  The DRG pair 266 and 267 has a higher relative weight and national average reimbursement than the DRG pair 228 and 229.

Also of note, DRGs 228 and 229 are not part of the Transfer DRG List, but DRGs 266 and 267 are both special transfer DRGs.

Not all hospitals provide this and other structural heart procedures. However, if your hospital does MMP strongly encourages you to take the time to read the entire decision memo document and provide education around the changes to all key stakeholders in your facility.

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