The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2023,[1] which clarified the timeline for increased COVID-19 vaccine administration fees and coverage of monoclonal antibody (mAb) products for the remainder of the public health emergency (PHE) and into the future.
The CY 2023 PFS proposed rule will become effective in 2023, and the deadline for public comment is September 6, 2022.
More broadly, CMS has reiterated that its goal for CY 2023 includes program expansions that create a more equitable health care system by providing better accessibility, quality, affordability, and innovation.[2] CMSs CY 2023 PFS proposed rule highlights the federal agencys goals to promote broad and timely access to both COVID-19 vaccines and mAb products.[3]
This Insight highlights four Medicare coverage and payment changes related to COVID-19 vaccines and mAb products in the CY 2023 PFS proposed rule and provides key takeaways for the commercialization of preventive vaccines and mAb products in the near future.
Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, COVID-19 was added to the vaccine coverage benefit under Part B of the Medicare program.[4] In its CY 2022 PFS final rule,[5] CMS established payments under Part B for COVID-19 vaccine administration at $40 per dose while existing preventive vaccines, such as pneumococcal, influenza, and Hepatitis B (HBV), remained at a payment rate of $30.[6]
CMS continues its efforts to establish payment for vaccine administration for the long-term in the CY 2023 PFS proposed rule. Through 2021, vaccine administration payment rates for pneumococcal, influenza, or HBV vaccines were established using a crosswalk for similar services paid under the PFS. In its CY 2022 PFS final rule, CMS responded to commenters concerns that the codes were improperly linked and did not reflect the unique costs of administering vaccines. Therefore, CMS finalized administration fees for non-COVID-19 vaccines (pneumococcal, influenza, and HBV) at $30, while establishing a $40 administration fee for COVID-19 vaccines.
CMS now proposes to update the payment for Part B vaccine administration by making adjustments to reflect cost differences for the geographic locality.[7]
CMS also proposes to continue the $40 administration fee for COVID-19. The agency anticipates vaccinating providers will continue to experience rising costs associated with staffing, scheduling, and reporting requirements as the number of patients increases, especially as boosters remain an important tool in the COVID-19 response. While CMS previously intended to maintain increased payment for COVID-19 vaccine administration through the end of the PHE, it has determined this transition will occur on January 1 in the year following the termination of the March 27, 2020, Emergency Use Authorization Declaration (EUA Declaration). The payment rate for COVID-19 vaccine administration will then be set at a rate that aligns with other Part B preventive vaccine administration payment rates, which are currently at $30.[8]
In June 2021, CMS announced an add-on payment with a national rate of $35 for COVID-19 vaccine in-home (at-home) administration, bringing the national average for at-home COVID-19 vaccine administration payments to $75 per dose ($40 for the COVID-19 vaccine administration and an additional $35 for administration in the home). By August 2021, CMS had expanded the circumstance for when the add-on payment was available, allowing providers and suppliers who administered the COVID-19 vaccine at a patients home to bill Medicare. These policies were established to ensure beneficiaries received access to COVID-19 vaccines during the PHE.
After hearing multiple requests from commenters to extend the add-on payment past the PHE, CMS acknowledged in the CY 2022 PFS final rule that the costs of at-home COVID-19 vaccine administration would not diminish immediately after the PHE, thereby stating that it would allow the $35 add-on payment to continue until the end of the calendar year of the PHE. CMSs CY 2023 PFS proposed rule suggests the continuation of the additional $35 payment for at-home vaccination beyond the PHE, which allows the agency to maintain expanded COVID-19 vaccine access for vulnerable housebound beneficiaries. The CY 2023 PFS proposed rule also underscores the agencys need to better understand COVID-19 vaccine inaccessibility barriers in the Medicare population.[9]
While the CY 2023 PFS proposed rule provides a continuation of the additional $35 payment for at-home COVID-19 vaccine administration, it does not include other preventive vaccines. CMS requests comments related to the inclusion of other Part B preventive vaccines (such as pneumococcal, influenza, and HBV).
Once COVID-19 mAb products for treatment and post-exposure prophylaxis were granted EUAs, CMSs CY 2022 PFS final rule finalized coverage and payment for COVID-19 mAb products under the Part B vaccine benefit. Notably, this determination absolved beneficiaries of cost-sharing responsibility for both the mAb product and its administration.
The payment for administration of mAb products for treatment or post-exposure prophylaxis under Part B ranges between $150.50 and $750.00. CMS intends to continue coverage under the Part B vaccine benefit at these reimbursement levels until the EUA Declaration is terminated. In the year following termination of the EUA Declaration, CMS intends to then transition coverage of these products to ordinary system coverage for complex biological products under Part B.
Following the CY 2022 PFS final rule, a mAb product was granted an EUA for use as pre-exposure prophylaxis prevention of COVID-19. Although the CMS policies regarding coverage of COVID-19 mAb products did not address mAb products used for prevention of COVID-19, the agency covered and paid for them without subjecting patients to out-of-pocket costs.
CMS proposes to continue coverage of preventive mAb products under the Part B vaccine benefit beyond the termination of the EUA Declaration, so long as a product has market authorization. CMS also proposes to maintain the current payment amounts for administration for pre-exposure prophylaxis mAb products under Part B of either $150.50 or $250.50, depending on a products administration setting.
While the Biden administration has yet to detail plans for a full market transition for COVID-19 vaccines and therapeutics,[10] CMSs articulation of timelines for coverage of vaccines and monoclonals provides a degree of future payment clarity for these products under Medicare.
CMSs decision to cover mAb products the same as vaccines under the Part B benefit is potentially precedent setting as future prophylactic monoclonals are licensed.[11] The agencys decision to shift coverage of mAb products for treatment to ordinary biological product coverage under Part B means that patients will begin to bear out-of-pocket costs for these products once the EUA Declaration is terminated.
CMSs continued consideration of its methods for setting vaccine administration fees and intent to extend at-home administration add-ons provides opportunities for commenters to encourage policies that promote better access to vaccines for Medicare beneficiaries.
Nija Chappel, a Summer Associate (not admitted to the practice of law) in the firms Washington, DC, office, contributed to the preparation of this Insight.
[1] CMS Proposed Rule, CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, 87 Fed. Reg. 45860 (July 29, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-14562.pdf (hereinafter CMS CY 2023 PFS Proposed Rule).
[2] CMS Fact Sheet, Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule (July 7, 2022), available at https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule.
[3] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46225-46226.
[4] Id. at 46218.
[5] CMS Final Rule, Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies (Nov. 19, 2021), available at https://www.federalregister.gov/documents/2021/11/19/2021-23972/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.
[6] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46219.
[7] Id. at 46222.
[8] Id.; CMS uses this example: [I]f the COVID-19 PHE ends in CY 2022, the payment amount for COVID-19 vaccine administration would change from $40 to $30 effective January 1, 2023, and would apply the proposed geographic adjustments and the proposed annual update as proposed for the other preventive vaccine administration services . . . .
[9] Inaccessibility barriers include patients having a condition due to illness or injury that limits their ability to leave home without a device or help from a caregiver, a condition that makes the patient more likely to contract COVID-19, or the patient is generally unable to leave the home and if they do, they consider it a considerable and taxing effort. CMS CY 2023 PFS Proposed Rule, supra note 1, at 46223.
[10] See Richard Hughes, As Congress, Biden administration squabble over COVID-19 funds, an ongoing pandemic response posture strains public health, HealthCareDive (July 14, 2022), available at https://www.healthcaredive.com/news/biden-administration-covid-19-funds-oped/627105/.
[11] Sara Rosenbaum, A Twenty-First Century Vaccines for Children Program, Health Affairs (July 12, 2022), available at https://www.healthaffairs.org/content/forefront/twenty-first-century-vaccines-children-program.
[View source.]
Continue reading here:
- Let's hear scientists with different Covid-19 views, not attack them - STAT [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Why are more men dying from COVID-19? - Livescience.com [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Doctors find more cases of 'COVID toes' in dermatological registry. Here's what they learned. - USA TODAY [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- North Dakota reports 24th COVID-19 death as drive-up testing is underway in Bismarck - Bismarck Tribune [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- WHO and European Investment Bank strengthen efforts to combat COVID-19 and build resilient health systems to face future pandemics - World Health... [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- COVID-19: Could Europe's countries be flattening the curve? - World Economic Forum [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Nine new COVID-19 deaths reported in NH Friday - The Union Leader [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- WHO Director-General's opening remarks at the media briefing on COVID-19 - 1 May 2020 - World Health Organization [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Where The Latest COVID-19 Models Think We're Headed And Why They Disagree - FiveThirtyEight [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- US consumers rush to buy meat amid concerns over Covid-19 shortages - The Guardian [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- The effect of human mobility and control measures on the COVID-19 epidemic in China - Science Magazine [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Gov. Kate Brown Lays Out COVID-19 Testing And Contact Tracing As Keys To Reopening Oregon - OPB News [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Britons will suffer health problems from Covid-19 for years, warn doctors - The Guardian [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Congress is investigating cruise ship company Carnival over COVID-19 outbreaks - The Verge [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- COVID-19 death reported in Dakota County Saturday; believed to be Tyson worker - Sioux City Journal [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Antibody, Antigen And PCR Tests For COVID-19: Know The Differences : Shots - Health News - NPR [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Russia now has second-highest rate of Covid-19 spread as other countries ease restrictions - The Guardian [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- New Hanover County tests more than 180 people for COVID-19 in first week - WWAY NewsChannel 3 [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- A service trip to Peru offers lessons for treating Covid-19 in the US - STAT [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- How Long Does COVID-19 Coronavirus Live On Clothes? How To Wash Them - Forbes [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- COVID-19: What you need to know about the coronavirus pandemic on 2 May - World Economic Forum [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Amid Ongoing COVID-19 Pandemic, Governor Cuomo Announces Results of Completed Antibody Testing Study of 15000 People Showing 12.3 Percent of... [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Coronavirus Update (Live): 3,173,442 Cases and ... - zonix.net [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- How Patients Die After Contracting COVID-19, The New ... [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Coronavirus gets official name from WHO: COVID-19 [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Coronavirus disease 2019 (COVID-19) - Symptoms and causes ... [Last Updated On: May 2nd, 2020] [Originally Added On: May 2nd, 2020]
- Mick Jagger and Will Smith to perform in India Covid-19 concert - The Guardian [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Where did Covid-19 come from? What we know about its origins - The Guardian [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Apple and Google release first seed of COVID-19 exposure notification API for contact tracing app developers - TechCrunch [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- IDPH reports one McHenry County COVID-19 death Saturday, bringing total to 39 - Northwest Herald [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Poor air quality has been linked to Covid-19 impacts. Trump's EPA is still limiting pollution restrictions. - CNN [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Janesville hospitals hoping to add on-site COVID-19 test processing - Janesville Gazette [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- After Covid-19: How will a socially distanced high street actually work? - The Guardian [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Drive Thru Covid-19 Testing Hosted in Cleveland - WDEF News 12 [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Majority of Alexandria COVID-19 deaths were in long-term care sites, as city seeks better pay, benefits for workers - WTOP [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Covid-19 in prisons and meatpacking plants shed a light on Americas moral failures - Vox.com [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- While the west fixates on Covid-19, vulnerable countries pay the price - The Guardian [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Anger as Italy slowly emerges from long Covid-19 lockdown - The Guardian [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- The Health Department confirms 22 new cases of COVID-19 - ConchoValleyHomepage.com [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- 50th COVID-19 death reported in WV - WSAZ-TV [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- Illinois Seeing More and More COVID-19 Cases as Testing Continues to Increase - WTTW News [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- COVID-19: Why Does the Disease's Name Matter? | Time [Last Updated On: May 3rd, 2020] [Originally Added On: May 3rd, 2020]
- COVID-19: What you need to know about the coronavirus pandemic on 1 May - World Economic Forum [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- More than 300,000 UK smokers may have quit owing to Covid-19 fears - The Guardian [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- How Cybercriminals are Weathering COVID-19 - Krebs on Security [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- You don't need an appointment to get tested for COVID-19 at this site on Monday - KMOV.com [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- More than 1 Million People Recover from COVID-19 : Coronavirus Live Updates - dineshr [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Employers Could Terminate Your 401(k) Plan Due to COVID-19. What to Do if It Happens. - The Motley Fool [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Port Huron offering city employees voluntary furloughs in wake of COVID-19 - The Times Herald [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Greater Lansing sees one more COVID-19 case and no further deaths - Lansing State Journal [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- These Scientists Saw COVID-19 Coming. Now They're Trying to Stop the Next Pandemic Before It Starts. - Mother Jones [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Museum of Covid-19: the story of the crisis told through everyday objects - The Guardian [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- No new COVID-19 deaths reported in Oregon - KGW.com [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- The roads into this New Mexico town remain closed as lockdown is extended to slow Covid-19 outbreak - CNN [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- New Zealand records first day with no new Covid-19 cases since before lockdown - The Guardian [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Amid Ongoing COVID-19 Pandemic - ny.gov [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Travel - The indigenous communities that predicted Covid-19 - BBC News [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Covid-19s Race and Class Warfare - The New York Times [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- The Covid-19 Riddle: Why Does the Virus Wallop Some Places and Spare Others? - The New York Times [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- Singapore Was Praised For Controlling Coronavirus. Now It Has The Most Cases In Southeast Asia : Goats and Soda - NPR [Last Updated On: May 4th, 2020] [Originally Added On: May 4th, 2020]
- ICUs Transformed To Care For COVID-19 Patients : Shots - Health News - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Family devastated after father dies of COVID-19 can only comfort mother from a distance - INFORUM [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- One of Trumps personal valets tests positive for Covid-19 - The Guardian [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Clinical trials press on for conditions other than COVID-19. Will the pandemic's effects sneak into their data? - Science Magazine [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Medical delivery drones are helping fight COVID-19 in Africa, and soon the US - World Economic Forum [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- How Lyft intends to navigate and survive COVID-19 - TechCrunch [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- How a New Mexico hospital rebelled against its bosses as Covid-19 hit - The Guardian [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Tell the Stories of the New Yorkers Lost to COVID-19 - THE CITY [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- COVID-19 update: South Dakota death toll up to 31, active cases at 846 as 698 new test results announced - KELOLAND.com [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Covid-19 Parties Probably Didnt Involve Intentional Spread - The New York Times [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Is It COVID-19 Or Something Else? What Experts Are Learning About Symptoms : Goats and Soda - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- China Says It Contained COVID-19. Now It Fights To Control The Story - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- COVID-19 Is The End Of The Higher Education Buffet - Forbes [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Covid-19 taking toll on blues community - CNN [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- U.S. Field Hospitals Stand Down, Most Without Treating Any COVID-19 Patients - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Even for a nurse who has dealt with infectious diseases, COVID-19 is scary; National Nurses Week - PennLive [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Mental health care will undergo a revolution post COVID-19 - World Economic Forum [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Mystery Inflammatory Syndrome In Kids And Teens Likely Linked To COVID-19 - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Do Antibodies Against The Novel Coronavirus Prevent Reinfection? : Shots - Health News - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- 'This Is ... Personal': After Surviving COVID-19, A Mom And Daughter Mourn Loved Ones - NPR [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]