Knowledge Base - Full Library

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.

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.

Q:

As a follow-up to the outpatient Rabies Immune Globulin FAQ, we have another question. What CPT codes should be billed when three separate intramuscular (I.M.) injections are given: (1) rabies vaccine, (2) TDAP vaccine, and (3) rabies immune globulin?

A:

For the rabies vaccine, use CPT code 90471 (immunization administration, 1 vaccine).

For the TDAP vaccine, use CPT code 90472 (immunization administration, each additional vaccine)

For the rabies immune globulin, use CPT code 96372 (IM / subcutaneous injection of a therapeutic drug.

Remember, you should also charge for the respective drugs/vaccines in addition to the injections / administrations.

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

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.

Q:

We have ER patients who get intramuscular (I.M.) injections of Rabies Immune Globulin. What CPT code should be billed for the injection of Rabies Immune Globulin?

A:

When an I.M. injection of an immune globulin is administered, use CPT code 96372, representing an intramuscular / subcutaneous injection of a therapeutic drug. This applies to all immune globulins given by I.M. route, such as Rhogam, Hepatitis B immune globulin, and the others listed on the first page of the Medicine section in CPT. This instruction is part of the parenthetical CPT guidelines on the same page, and as such, would apply to all payers.

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. 

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

 

April 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: February 23, 2021
• What You Need to Know: This article informs providers about the Average Sales Price (ASP) methodology, which is based on quarterly data manufacturers submit to CMS.
• MLN Article MM12133: https://www.cms.gov/files/document/mm12133.pdf

Quarterly Updated for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) – April 2021

• Article Release Date: February 23, 2021
• What You Need to Know: The DMEPOS CBP files are updated on a quarterly basis to implement necessary changes to HCPCS codes, ZIP codes, single payment amounts, and supplier files.
• MLN Article MM12128: https://www.cms.gov/files/document/mm12128.pdf

 

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

 

Review of Hospital Compliance with Medicare’s Transfer Policy with Resumption of Home Health Services & Other Information on Patient Discharge Status Codes

• Article Release Date: February 22, 2021
• What You Need to Know: CMS reminds providers that an accurate discharge status code is essential to assure proper payment under the Medicare Severity-Diagnosis Related Group (MS-DRG) payment system. Detailed information regarding the CMS Transfer Policy is included in this article.
• MLN Article SE21001: https://www.cms.gov/files/document/se21001.pdf

Billing for Services when Medicare is a Secondary Payer

• Article Release Date: February 23, 2021
• What You Need to Know: CMS details what to do if you think a claim was inappropriately paid and provides key reminders related to billing for services when Medicare is a secondary payer.
• MLN Article SE21002: https://www.cms.gov/files/document/se21002.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

• Article Release Date: February 23, 2021
• What You Need to Know: New HCPCS codes for 2021 that are subject to and excluded from CLIA edits are discussed in this article.
• MLN Article MM12131: https://www.cms.gov/files/document/mm12131.pdf

 

MEDICARE EDUCATIONAL RESOURCES

 

MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration (Demonstration Ends on December 31, 2023)

The IVIG demonstration began in October 2014, has been extended twice, and is now set to end on December 31, 2023. This MLN Fact Sheet, dated February 2021, provides education on the IVIG demonstration and includes information on:

• Supplier eligibility and participation,
• Beneficiary eligibility and participation, and
• Billing and coding requirements.

 

OTHER MEDICARE UPDATES

Medicare Mid-Build Off-Campus Outpatient Department Exception Audit Results

On February 2nd CMS posted a webpage dedicated to their 21st Century Cures Act Mid-Build Audits. In overview, the Cures Act provided the criteria which off-campus departments of a provider must meet to comply with Mid-build exception requirements. CMS completed 334 provider audits that requested the mid-build exception. They found that 202 of the facilities failed to qualify for the exception. They note in the audit findings that “Providers that failed the mid-build exception audit and have been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have received overpayments. Also, providers that have passed the mid-build exception audit and have not been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have been underpaid.

CMS will issue audit determination letters to all affected providers on January 19, 2021. The letter will provide the final determination on meeting the exception, the appropriate point of contact information, and further instructions. The 21st Century Cures Act states that the mid-build exception audit determinations are final and may not be appealed.” The Audit Results and FAQ documents are available on this CMS webpage.

Improving Accuracy of Medicare Payments

CMS shared the following information in the Thursday February 4, 2021 Edition of MLN Connects:  

The U.S. Bureau of Labor Statistics (BLS) conducts numerous surveys of hospitals and health care providers that are used by the government to make economic decisions that affect the entire medical care system. Key users include CMS, the Federal Reserve Bank, and the U.S. Congress.  CMS uses these surveys to adjust Medicare Fee-for-Service payments each year, affecting approximately $300 billion in payments.

If you’re contacted by BLS, please participate in the survey to help ensure the data are as accurate as possible. Recently, many health care providers didn’t complete the survey, which can reduce the representativeness of the data and increase volatility in estimates. Your participation in these surveys helps address these issues and increase the validity of the data. Participation is voluntary, confidential, and the data are only used for statistical purposes.

More Information:

• BLS Survey Respondentswebpage
• BLS Confidentiality Pledge and Lawswebpage
• CMS Market Basket Datawebpage
• BLS Geographic Informationwebpage: Contact a BLS expert or get information on surveys, data, and reports”

February 22, 2021: OIG Report – $4 Million in improper payments for Spinal Facet-Joint Injections

The OIG found that 49 of 100 sampled claims were inappropriately paid by Noridian Healthcare Solutions, LLC to physicians in Jurisdiction E for spinal facet-joint injections. They note that improper payments occurred due to insufficient education to physicians and their billing staff. Based on their findings, the OIG estimated that $4.2 million was improperly paid to physicians. Recommendations for Noridian included recovering the $12,546 in improper payments found in the sampled claims, notify appropriate physicians so they can identify, report, and return any overpayments in accordance with the 60-day rule and provide annual training to physicians and their billing staff. You can read the entire report at https://oig.hhs.gov/oas/reports/region9/92003010.pdf.

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

Q:

We have a record with documentation of Recurrent Depression (F33.x) and Bipolar Disorder (F31.x).  The excludes1 note under each code seem to exclude each other.  Do we code both conditions?

A:

Bipolar Disorder includes Depression, so only the code for Bipolar Disorder (F31.9) would be coded and reported.  A separate code for Depression would not be reported in addition.

Reference

Coding Clinic for ICD-10-CM/PCS, First Quarter 2020: Page 23