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IPPS FY 2022 Final Rule: New Technology Add-On Payments (NTAPs)
Published on Aug 11, 2021
20210811
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“The primary objective of the IPPS and the LTCH PPS is to create incentives for hospitals to operate efficiently and minimize unnecessary costs, while at the same time ensuring that payments are sufficient to adequately compensate hospitals for their legitimate costs in delivering necessary care to Medicare beneficiaries.”
- Source: Appendix A: Economic Analysis of FY 2022 IPPS Final Rule

CMS released the display copy of the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) Final Rule (CMS-1752-F) on Monday August 2, 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2022.

New Technology Add-On Payment Pathways

There are now several pathways for a new services or technology to be approved for New Technology Add-On Payments (NTAPs) including:

  • Traditional Pathway: To meet this pathway, the medical service or technology must be new, must be costly such that the DRG rate otherwise applicable to discharges involving the NTAP is inadequate, and must demonstrate a substantial clinical improvement over existing services or technologies.
  • Certain Antimicrobial Products Alternative Pathway: In FY 2021 the alternative pathway for Qualified Infectious Disease Products (QIDPs) was expanded to include products approved under the Limited Population for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying FDA programs for antimicrobials (i.e., QIDPs and LPADs). Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.
  • Certain Transformative New Devices Alternative Pathway: Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Additional Payment for NTAP’s

Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

  • For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
  • For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015. CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.

NTAPs for FY 2022 by the Numbers

NTAPs are not budget neutral and generally this add-on payment is limited to the 2-to-3-year period after the date a technology becomes available. Due to the COVID-19 Public Health Emergency (PHE) impacting hospital volumes, CMS finalized using FY 2019 data for rate setting. They also finalized a one-year extension of NTAPs for technologies that would have otherwise been discontinued beginning October 1, 2021.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in Appendix A of the Final Rule. Appendix A begins on page 2,174 of the display version of the Final Rule.

  • A total of 42 services or technologies have been approved for NTAPs,
  • The estimated total amount to be paid to hospitals is $1,424,341,317.63, and
  • The estimated number of patients is 468,206.
  • The estimated number one NTAP by volume and payment is Veklury® (remdesivir) with an estimated 174,996 cases and estimated total payment of $354,891,888.00. This drug is used in the treatment of COVID-19 patients.

NTAPs FY Trend: Number of Services or Technologies Approved for NTAP

  • FY 2020: 18
  • FY 2021: 24
  • FY 2022: 40

NTAPs FY Trend: Estimated Number of Patients to Receive a New Technology during an Inpatient Stay

  • FY 2020: 71,659
  • FY 2021: 259,201
  • FY 2022: 468,206

New COVID-19 Treatment Add-on Payments (NCTAPs)

As new therapies were approved in response to the COVID-19 PHE, New COVID-19 Treatments Add-on Payment (NCTAP) were created. CMS finalized the following related to NCTAPs in the FY 2022 IPPS Final Rule:

  • The NCTAP for eligible COVID-19 products will extend through the end of the fiscal year in which the PHE ends, and
  • A hospital will be eligible to receive the NCTAP and the traditional NTAP for qualifying patient stays, through the end of the fiscal year in which the PHE ends, with the NTAP reducing the amount of the NCTAP.

You can learn more about NCTAP’s on the related CMS COVID-19 NCTAP specific webpage (link).

Moving Forward

Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

  • Is your hospital providing any of these medical services or technology?
  • Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
  • What process do you have in place to alert your Coding Staff of the need to code the new technologies?

Resources:

CMS August 2, 2021, Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0

FY 2022 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page

‍

Beth Cobb

Four FY 2022 CMS Final Rules Christmas in July
Published on Aug 04, 2021
20210804
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In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.

FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)

Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:

  • FY 2022 Updates to the SNF Payment Rates,
  • Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
  • Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
  • Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
  • Changes in the PDPM ICD-10 Code Mappings,
  • SNF Quality Reporting Program (SNF QRP) update, and
  • SNF Value-Based Purchasing (SNF VBP) Program.

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

  • FY 2022 Routine Annual Rate Setting Changes,
  • Other Medicare Hospice Payment Policies,
  • Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
  • Hospice Quality Reporting Program, and
  • Home Health Quality Reporting Program.

FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) Final Rule (CMS-1748-F)

Major provisions in this final rule in a related CMS Fact Sheet (link) includes:

  • Updates to IRF Payment Rates,
  • IRF Quality Reporting Program (IRF QRP) Updates, and
  • Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.

FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

  • FY 2022 Updates to the IPF Payment Rates,
  • Updates to the IPF Teaching Policy, and
  • IPF Quality Reporting Program (IPF QRP) Updates.

Beth Cobb

FAQ: Ambulatory Surgery Center (ASC) Covered Procedure List
Published on Aug 04, 2021
20210804
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Question

In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?

Answer

In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:

  • Table 59 listed procedures added under the standard review process, and
  • Table 60 listed procedures added under the second alternative proposal considered for CY 2021.

The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:

  • 0266T: Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed),
  • 0268T: Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
  • 0404T: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency,
  • 21365: Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
  • 27130: Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft,
  • 27412: Autologous chondrocyte implantation, knee,
  • 57282: Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus),
  • 57283: Colpopexy, vaginal; intra-peritoneal approach (uteroscacral, levator myorrhaphy),
  • 57425: Laparoscopy, surgical, colpopexy (suspension of vaginal apex),
  • C9764: Revascularization, endovascular, open or percutaneous, and vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed, and
  • C9766: Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.

Resources:

Beth Cobb

CY 2022 OPPS and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List
Published on Jul 27, 2021
20210727
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The Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (link) was released on July 19, 2021.

CMS estimates “that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2022 would be approximately $82.704 billion, an increase of approximately $10.757 billion compared to estimated CY 2021 OPPS payments.”

CMS, in general, plans to use 2019 claims data for rate setting due to the COVID-19 PHE. Examples of specific decreases or increases in claims in CY 2020 cited by CMS includes:

  • An approximate 20 percent decrease in the overall volume of outpatient hospital claims,
  • An approximate 30 percent decrease in volume in the APCs for hospital emergency department and clinic visits,
  • For HCPCS code Q3013 (Telehealth originating site facility fee) in the hospital outpatient claims, the approximate 35,000 services billed in CY 2019 increased to 1.8 million services in the CY 2020.

Inpatient Only Procedure List

Historically, CMS used the following five criteria to assess for removal of a procedure from the Inpatient Only (IPO) list.

  • Most outpatient departments are equipped to provide the services to the Medicare population.
  • The simplest procedure described by the code may be furnished in most outpatient departments.
  • The procedure is related to codes that we have already removed from the IPO list.
  • A determination is made that the procedure is being furnished in numerous hospitals on an outpatient basis.
  • A determination is made that the procedure can be appropriately and safely furnished in an ASC and is on the list of approved ASC services or has been proposed by us for addition to the ASC list

In a complete one-eighty, CMS has proposed to halt the elimination of the IPO list and, “after clinical review of the services removed from the IPO list in CY 2021,” add the 298 services removed in CY 2021 back to the IPO list beginning in CY 2022. CMS has also proposed to codify the five longstanding criteria for potential removal from the IPO list.

CMS noted that “many commenters, including hospital associations and hospital systems, professional associations, and medical specialty societies, vociferously opposed eliminating the IPO list. These commenters primarily cited patient safety concerns, stating that the IPO list serves as an important programmatic safeguard and maintains a common standard of medical judgment in the Medicare program.”

CMS requests public comments on several questions related to the IPO list. For example, “what information or support would be helpful for providers and physicians in their considerations of site-of-service selections?

Proposed Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2022 and Subsequent Years

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS reminds providers that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the appropriate setting on a case-by-case basis.”

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

For CY 2021, CMS finalized “that procedures removed from the IPO list after January 1, 2021, were indefinitely exempted from site-of-service claims denials under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance with the 2-Midngiht rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data indicated a procedure was being performed more than 50 percent of the time in the outpatient setting.

On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:

For CY 2022, CMS has proposed to “rescind the indefinite exemption and instead apply a 2-year exemption from two midnight medical review activities for services removed from the IPO list on or after January 1, 2021.”

As a provider, keep in mind this exemption is specific to site-of-service claim denials and does not include exemption from medical necessity reviews of services provided based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable.

Proposed Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)

CMS is also doing an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS has proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.

CMS notes, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”

A complete list of the 258 procedures can be found in table 45 of the proposed rule.

Proposed Revisions to the CY 2022 ASC CPL Criteria

In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have proposed to revise the requirements for covered surgical procedures to reinstate the specifications established prior to CY 2021. One key proposal would once again define covered surgical procedures as surgical procedures specified by the Secretary and published in the Federal Register and/or via the Internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.

While this article highlights a couple of topics in the proposed rule, I encourage you to review the entire document for other key proposals such as the proposed increase in civil monetary penalties (CMP) for hospital noncompliance with the Price Transparency requirements. You can also read more about what is being proposed in a related CMS Fact Sheet (link).

Beth Cobb

COVID-19 in the News February March 16th through March 22nd, 2021
Published on Mar 23, 2021
20210323
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This week we highlight key updates spanning from March 16th through 22nd of 2021.

 

March 15, 2021: FDA Launches COVID-19 Adverse Events Reporting System (FAERS) Public Dashboard

The FDA has launched this dashboard with the intent to make adverse event data publically available. In the Public Dashboard announcement, the FDA does note that there are limitations to the data. “For example, while FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event.”

 

March 16, 2021: CDC Updates Regarding SARS-CoV-2 Variants

The CDC updated their SARS-CoV-2 Variants webpage. Multiple variants have now been detected and a US government interagency group has developed a Variant Classification scheme to define the three classes of variants:

  • Variant of Interest,
  • Variant of concern, and
  • Variant of High Consequence.

To date, California has seen two variants of concern (B.1.427 and B.1.429). Both of the variants may be about 20 percent more transmissible.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html

Two variants in California are now considered “variants of concern”

 

March 17, 2021:  American Rescue Plan (ARP) Act of 2021 Funding for COVID-19

President Biden signed the ARP Act into law on March 11, 2021. The following list highlights how some of the $1.9 trillion will be allocated to continue the fight against COVID-19:

  • $10 billion will be used to ramp up screening testing to help schools reopen,
  • $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings, and
  • $255 million for the production and delivery of 50 million Abbot BinaxNOW rapid point-of-care antigen tests for COVID-19 to support continued screening testing in long-term care facilities.

You can read more about where funding is being allocated in a March 17, 2021 HHS Press Release. 

 

March 17, 2021: First SARS-CoV-2 Diagnostic Test Permitted to be Marketed beyond the Public Health Emergency

The FDA announced that the BioFire Respiratory Panel 2.1 (RP2.1) has been granted marketing authorization using the De Novo premarket review pathway. The BioFire Respiratory Panel is “a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.” This test is for use in patients suspected of respiratory tract infections, including COVID-19.

 

March 18, 2021: CPT Codes Inadvertently Added to Telehealth Services

The 2021 Physician Fee Schedule final rule was issued on December 1, 2020. A related CMS Fact Sheet indicates that CMS finalized a third temporary category of criteria for adding services to the list of Medicare telehealth services. “Category 3 describes services added to the Medicare telehealth list during the public health emergency (PHE)…for the COVID-19 pandemic that will remain on the list through the calendar year in which the PHE ends.”  CMS published final and interim final rule corrections in the March 18, 2021 Federal Register. Specific to the Category 3 list, CMS notes that the following four CPT codes were “inadvertently” added to the services for temporary addition to telehealth services list:

  • CPT code 96121: Neurobehavioral Status Examination,
  • CPT code 99221: New or established patient initial hospital inpatient care services,
  • CPT code 99222: New or established patient initial hospital inpatient care services, and
  • CPT code 99223: New or established patient initial hospital inpatient care services.

 

March 18, 2021: FDA Revises Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products under EUA

The FDA announced revisions to health care provider fact sheets “to include additional information on the susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) treatment of COVID-19.” Specifically, fact sheets for Bamlanivimab, Bamlanivimab and Etesevimab and REGEN_COV (Casirivimab and Imdevimab) has been revised.

 

March 19, 2021: U.S. House Passes Bill to Extend Halt on Sequestration

The Budget Control Act of 2011 included a 2.00% across-the-board sequestration reduction to Medicare Fee-for-Service claims payments. The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended this payment adjustment from May 1, 2020 through December 31, 2020. Subsequently, the Consolidated Appropriations Act, 2021 that was signed into law on December 27, 2020 extended this suspension to March 31, 2021. Now, as we are closing in on the end of March, the U.S. house has passed House Resolution (HR) 1868 that would extend this extension to December 31, 2021.

Beth Cobb

COVID-19 in the News March 10th through March 15th, 2021
Published on Mar 16, 2021
20210316
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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.

Beth Cobb

April 2021 Hospital Outpatient Prospective Payment System (OPPS) Update
Published on Mar 16, 2021
20210316
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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.

Beth Cobb

COVID-19 in the News February March 2nd through March 9th, 2021
Published on Mar 09, 2021
20210309
 | Case Management 
 | Coding 
 | Documentation 

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

Data Date Total Cases Total Deaths Cases in Last 7 Days
September 8, 2020 6,287,362 188,688 282,919
October 5, 2020 7,396,730 209,199 301,438
November 2, 2020 9,182,628 230,383 565,607
December 14, 2020 16,113,148 298,266 1,476,230
January 4, 2021 20,558,489 350,664 1,502,620
February 1, 2021 26,034,475 439,955 1,015,960
March 7, 2021 28,771,749 522,973 412,103
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

OIG Data Brief: Data Indicates Stays Vulnerable to Inappropriate Billing Practices
Published on Mar 09, 2021
20210309
 | Case Management 
 | Coding 
 | Documentation 

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.

Beth Cobb

COVID-19 in the News February 23rd through March 2nd, 2021
Published on Mar 02, 2021
20210302
 | Case Management 
 | Coding 
 | Documentation 

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. 

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