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COVID-19 Updates

March 29, 2023: FAQs Issued on Coverage of COVID-19 Testing and Vaccines by Health Plans After the Public Health Emergency Ends

A set of FAQs were issued to help group health plans and health insurance issuers in the private market understand their obligations under the Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security Act (CARES Act) related to coverage for COVID-19 diagnostic testing and vaccines following the expiration of the PHE. The FAQs were issued jointly by HHS, the Department of Labor, and the Department of Treasury.

https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58

April 10, 2023: New COVID-19 Treatments Add-On Payment (NCTAP)

This webpage was updated to let providers know Medicare will provide an enhanced payment through September 30, 2023, for eligible inpatient cases using certain new products with current FDA approval or emergency use authorization (EUA) to treat COVID-19.

https://www.cms.gov/medicare/covid-19/new-covid-19-treatments-add-payment-nctap

April 5, 2023: COVID-19 Over the Counter (OTC) Test Coverage Ends May 11, 2023

“Effective May 12, 2023, COVID-19 OTC tests (HCPCS K1034) are no longer a covered benefit for Medicare. Any providers or suppliers providing monthly supplies to their patients should notify their patients of this change before providing further services.”

https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/covid-19-over-the-counter-otc-test-coverage-ends-may-11-2023

Other Updates

April 4, 2023: Special Edition MLN Connects: Proposed Rules

CMS announced the release of the FY 2024 proposed rules for Hospice, Medicare Inpatient Psychiatric Facilities, Inpatient Rehabilitation Facilities, and Skilled Nursing Facilities. Included in the announcement are links to related Fact Sheets. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-04-04-oce

April 6, 2023: Advance Beneficiary Notice of Noncoverage: Form Renewal         

CMS posted a notice in the March 6, 2023 edition of MLN Connects letting providers know the OMB has approved the Advance Beneficiary Notice of Noncoverage (Form CMS-R-131) for renewal. The expiration date is the only change to the form and must be used beginning June 30, 2023.

April 17, 2023: New Resources to Address Rising Threat of Cyberattacks in Health and Public Health Sector

HHS issued a Press Release announcing new resources made available by the U.S. HHS 405(d) Program to address cybersecurity concerns in the Healthcare and Public Health (HPH) sector including a Knowledge on Demand – platform offering free educational cybersecurity trainings, the 2023 edition of the Health Industry Cybersecurity Practices (HICP) report, and a Hospital Cyber Resiliency Initiative Landscape Analysis reporting on the current state of domestic hospitals’ cybersecurity preparedness.

The HICP report indicates that “healthcare records continue to be one of the most lucrative items on the underground market, ranging from $250 to $1,000 compared to other items like credit cards only selling for an average of $100,” driver’s license an average of $20, and SSN’s average of $1.

April 21, 2023: CMS Issues Two More Civil Monetary Penalties for Failure to Meet Hospital Price Transparency Requirements

COVID-19 Updates

January 24, 2023 CDC Call: Updates to COVID-19 Testing and Treatment for the Current SARS-CoV-2 Variants: This CDC call included an overview of COVID-19 epidemiology and the current variant landscape, addressed current CDC testing guidance and the National Institutes of Health and Infectious Disease Society of America COVID-19 treatment guidelines, and discussed risk assessment and considerations for treatment options. You can access a recording of this session and slides on the CDC website.

February 9, 2023: Letter to U.S. Governors from HHS Secretary Xavier Becerra: HHS Secretary Xavier Becerra published a letter to Governors (https://www.hhs.gov/about/news/2023/02/09/letter-us-governors-hhs-secretary-xavier-becerra-renewing-covid-19-public-health-emergency.html), informing them “that effective February 11, 2023, I am renewing for 90 days the COVID-19 Public Health Emergency (PHE)…the U.S. Department of Health and Human Services is planning for this to be the final renewal and for the COVID-19 PHE to end on May 11, 2023. Rather than 60 days’ notice, I am providing 90 days’ notice before the COVID-19 PHE ends to give you and your communities ample time to transition.” HHS also published the Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap (https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html).

February 23, 2023: PHE 1135 Waivers: Updated Guidance for Providers: CMS published an MLN Connects (https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-02-23-oce), letting providers know the COVID-19 PHE Provider-specific fact sheets have been updated and in the coming weeks they will be hosting stakeholder calls and office hours to provide additional information.

February 27, 2023: What Do I Need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 PHE: CMS released a new overview fact sheet providing clarity on several topics including: COVID-19 vaccines, testing and treatments, telehealth services, and healthcare access (https://www.cms.gov/files/document/what-do-i-need-know-cms-waivers-flexibilities-and-transition-forward-covid-19-public-health.pdf).

Other Updates

January 23, 2023: The MOON and IM/DND Receive OMB Approval: A January 23, 2023, update on the Beneficiary Notices Initiative webpage (https://www.cms.gov/medicare/medicare-general-information/bni) alerted providers that the Medicare Outpatient Observation Notice (MOON), Important Message from Medicare (IM), and Detailed Notice of Discharge (DND) have received OMB approval and the updated versions are now available. The new versions must be used no later than April 27, 2023.

January 26, 2023: Guidance for Newest Medicare Provider Type – Rural Emergency Hospitals (REH): This memorandum (https://www.cms.gov/files/document/qso-23-07-reh.pdf) provides guidance regarding the REH enrollment and conversion process for eligible facilities, FAQs, and a newly developed State Operations Manual Appendix (Appendix O) with survey procedures and Conditions of Participation (CoP) regulatory text. CMS notes the interpretive guidance is pending and will be provided in a future release. You can learn more about REHs in an October 2022 MLN Fact Sheet (https://www.cms.gov/files/document/mln2259384-rural-emergency-hospitals.pdf).

CY 2023 Therapy Services Threshold Amounts: The February 2, 2023 edition of MLN Connects included the CY 2023 per-beneficiary threshold amounts for therapy services. Claims must include the KX modifier to confirm services were medically necessary and justified by appropriate documentation. Threshold Amounts for CY 2023 are:

• $2,230 for Physical Therapy (PT) and Speech-Language Therapy (SLT) combined, and
• $2,230 for Occupational Therapy (OT) services.

To learn more about therapy services, visit the CMS Therapy Services webpage (https://www.cms.gov/medicare/billing/therapyservices).

CMS recently published the following information about expanding the use of (bivalent) COVID-19 vaccines and new bivalent vaccine CPT codes in the Thursday, October 27, 2022 edition of MLN Connects (link).

The CDC recently expanded the use of updated (bivalent) COVID-19 vaccines to children ages 5 through 11 years. This followed the FDA’s authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years and from Moderna for children and adolescents ages 6 through 17 years. People with Medicare, Medicaid, Children’s Health Insurance Program coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines, including the updated Moderna and Pfizer-BioNTech COVID-19 vaccines, at no cost, for as long as the federal government continues purchasing and distributing these COVID-19 vaccines.

CMS issued 4 new CPT codes effective October 12, 2022:

Code 91314 for Moderna COVID-19 Vaccine, Bivalent Product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 25 mcg/0.25 mL dosage, for intramuscular use
• Short descriptor: SARSCOV2 VAC BVL 25MCG/.25ML

Code 91315 for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
• Short descriptor: SARSCOV2 VAC BVL 10MCG/0.2ML

Code 0144A for Moderna COVID-19 Vaccine, Bivalent - Administration – Booster Dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 25 mcg/0.25 mL dosage, booster dose
• Short descriptor: ADM SRSCV2 BVL 25MCG/.25ML B

Code 0154A for Pfizer-BioNTech COVID-19 Vaccine, Bivalent - Administration – Booster Dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, booster dose
• Short descriptor: ADM SARSCV2 BVL 10MCG/.2ML B

Visit the COVID-19 Vaccine Provider Toolkit (link) for more information, and get the most current list of billing codes, payment allowances, and effective dates (link).

See the full news alert (link)

Source: Thursday October 27, 2022 MLN Connects: https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-10-27-mlnc

Did You Know?

Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) is a new COVID-19 vaccination that the FDA has approved for Emergency Use Authorization (PHE) for individuals 18 years or older (link).

Why is Matters?

This is the first protein-based COVID-19 vaccine to receive Emergency Use Authorization and CDC endorsement (link) in the United States. This vaccine is to be administered as a series of two doses given three weeks apart. It is not authorized for use as a booster dose.

According to an HHS Press Release (link), “The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax COVID-19 vaccine contains SARS-CoV-2 recombinant spike protein, which is also known as an “antigen” of the SARS-CoV-2 virus, in combination with an adjuvant, which enhances the immune system response to the spike protein.

FDA-approved protein-based vaccines have been used widely for decades; examples of more recently approved vaccines that contain a purified protein combined with an adjuvant include vaccines to prevent hepatitis B and shingles. The Novavax COVID-19 vaccine offers an option to individuals who may be allergic to a component in the mRNA vaccines, or who have a personal preference for receiving a vaccine other than an mRNA-based vaccine.”

What Can You Do?

As a health care professional review the CDC’s overview and safety information about this vaccine (link), and become familiar with how to code and bill for this newly vaccine.

Coding and Billing

CMS issued new codes for this vaccine, effective July 13.

• Vaccine code: 91304,
• Administration codes: 0041A and 0042A,

Question:

We are having skilled nursing facilities (SNFs) not take patients until they have had a 3 midnight stay. Is the COVID-19 waiver still in effect?

Answer:

Effective March 1, 2020, CMS implemented 1135 blanket waivers to expand the Administration’s efforts against COVID-19. These waivers are in effect through the end of the emergency declaration or at such time CMS believes it is appropriate to terminate them.

The COVID-19 PHE declaration was last renewed on April 12, 2022 with an effective date of April 16, 2022 (link). When the Secretary of the Department of Health and Human Services (HHS) makes a PHE declaration, it lasts for the duration of the PHE or 90 days but may be extended by the Secretary for as long as the PHE continues to exist.

On April 7, 2022, CMS issued a Memorandum (link) alerting certain providers (i.e., SNFs, NFs, inpatient hospices) of the termination of several COVID-19 blanket waivers. The Memorandum Summary indicates that “applicable waivers will remain in effect for hospitals and critical access hospitals (CAH).”

The 3-Day Prior Hospitalization waiver falls under the Long-Term Care Facilities and Skilled Nursing Facilities (SNFs) and/or Nursing Facilities (NFs) section of the CMS COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers document (link). That said, it is not one of the waivers that is being terminated at this time. You will find the full description of this waiver on page sixteen of the April 7, 2022, iteration of the document.

In January 2021, acting HHS Secretary Norris Cochran sent a letter to governors across the country to share details about the COVID-19 PHE indicating that “when a decision is made to terminate the declaration or let it expire, HHS will provide states with 60 days’ notice prior to termination.”

In a May 10, 2022 letter to HHS Secretary Becerra (link), the American Hospital Association along with several other organizations (i.e., AARP, American Diabetes Association, American Medical and Nurses Associations) urged the PHE be maintained “until we experience an extended period of greater stability and, guided by science and data, can safely unwind the resulting flexibilities.”

As we are now less than 60 days out to the end of the current COVID-19 PHE declaration, it is likely that it will be extended at least through October 2022.