IPD'S DRUG & CLINICAL REVIEW:
COVID-19 PODCAST EPISODES
December 7th, 2020 Update
IPD Analytics has released its fifth publicly available podcast on COVID-19. In this episode, Leslie Fish, R.Ph, Pharm.D., Julee Oh, Pharm.D., and Tom Comcowich, R.Ph, MBA discuss the most recent news on the coronavirus vaccines, including:
National and Global Status (02:28)
Moderna and Pfizer Vaccine Overview (03:00)
Storage Challenges (03:57)
Number of Doses (10:02)
Vaccine Prioritization (13:05)
Pharmacy-Specific Planning (14:12)
At-home Tests (16:41)
Current Emergency Use Authorized Treatments (18:02)
Convalescent Plasma (21:10)
Monoclonal Antibodies (22:07)
Baricitinib/Remdesivir Combination (24:50)
Coding and Reimbursement Overview (27:12)
Medical vs. Pharmacy Benefit (30:00)
Reimbursement for Vaccines (30:38)
Reimbursement for Treatments (33:03)
Transcript for COVID-19 Update from IPD Analytics December 7th, 2020
Veronica Fowler (00:21):
Welcome to IPD’s Drug and Clinical Review, the premier podcast for drug intelligence and pharmacy and therapeutic management strategy. I'm Veronica Fowler, your host, and I'm here today with Dr. Julee Oh, Dr. Leslie Fish, and our coding and reimbursement expert, Tom Comcowich, three members of our executive clinical pharmacy team here at IPD.
Leslie Fish (00:42):
Julee Oh (00:44):
Tom Comcowich (00:46):
Veronica Fowler (00:49):
Welcome back to the show. Now, for our listeners today that aren't IPD subscribers, this may be your first time listening. If that's the case, I encourage you to go back and listen to our previous episodes on this topic for additional context. And for those of you that aren't familiar with IPD Analytics, we provide insight, transparency, and efficiency to stakeholders across the pharmaceutical industry, including managed care organizations, hospitals and IDNs, drug manufacturers, and institutional investors. We offer varying subscription-based products with data analysis and consultations, and our show is normally available exclusively to our subscribers. But as we navigate this pandemic alongside the rest of the world, we wanted to do our part and allow this valuable information to be accessed by the public. So, with that, for further updates from us, follow our company page on LinkedIn, or check out our website at ipdanalytics.com.
Now, today, we plan to talk primarily about the two vaccines that could be approved with Emergency Use Authorizations through the FDA in the coming days. Specifically, we'll cover storage, transportation and distribution, allocation, timing, pharmacy-specific planning, and coding and reimbursement. We'll also touch briefly on any updates to testing and the Emergency Use Authorized treatments for COVID-19. But before we get into that, as usual, I'd like to start out with an update of the numbers, which will be relevant for the time of this recording, which is December 7th, 2020. So, Julee, can you start us off with a brief overview of confirmed cases and deaths nationally and globally?
Julee Oh (02:28):
As of today, December 7th, 2020, the number of global confirmed cases of COVID-19 is 67, 189,474 cases with 1,538,097 deaths. And in the United States, the number of COVID-19 infections is 14,761,730 cases with 282,345 deaths.
Veronica Fowler (03:00):
Thanks, Julee. Now, let's get into what I think most of us want to know more about, the vaccines. Leslie, where are we as far as approval?
Leslie Fish (03:10):
So, both Moderna's and Pfizer's vaccines could be approved as Emergency Use Authorizations, or EUAs, which I'll refer to from now on, through the FDA shortly. Pfizer's vaccine is set to go before the FDA's Vaccines and Related Biological Products Advisory Committee on December 10th. The FDA Committee will be meeting on December 17th to discuss an EUA for Moderna's vaccine. If approved, both vaccines are expected to be shipped out shortly after. However, needed storage conditions, limited supplies, transportation, accessibility, allocation, and a variety of other issues could hamper the distribution and administration of the vaccine.
Veronica Fowler (03:57):
So, Leslie, let's talk more about those challenges. How do these vaccines differ as far as storage needs? I know that there are some concerns with the low temperatures, is that right?
Leslie Fish (04:10):
So, yes, Pfizer's vaccine must be kept at very cold temperatures. It can be kept at -70 °C for up to 6 months and at 2–8 °C for 5 days. This means that the distribution, transportation, storage, and administration must be quick and efficient. Pfizer has developed packaging and storage plans. Although Moderna's vaccine also needs to be kept frozen, it only needs to be kept at -20 °C, which is more like a regular freezer. The vaccine remains stable at 2–8 °C, or 36–46 °F, the temperature of a standard home or medical refrigerator, for 30 days. The vaccine also remains stable at -20 °C for up to 6 months, at refrigerated conditions for up to 30 days, and at room temperature for up to 12 hours.
Veronica Fowler (05:04):
And so how does all of this effect transportation and distribution?
Leslie Fish (05:10):
So, we're really going to mainly talk about Pfizer here. Pfizer will be shipping frozen vaccine vials to the point of vaccinations from the distribution center in Kalamazoo, Michigan, where it has positioned refrigerated storage sites. They are also working to boost capacity at distribution sites in Pleasant Prairie, Wisconsin, and Karlsruhe, Germany. Pfizer has developed temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of -70 °C for up to 10 days. The intent is to utilize Pfizer's strategic transportation partners to ship by air to major hubs within a country or region, and by ground transportation to dosing locations.
Once a vaccination shipment gets to the point of vaccinations, there are three options for storage. (The) first one is an ultra-low temperature freezer, which are commercially available and can extend shelf life up to 6 months. The second is refrigerated units that are commonly available in hospitals. The vaccine can be stored for 5 days at these refrigerated units at 2–8 °C. [The] third way is the Pfizer thermal shippers, in which the doses will arrive that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. After storage of 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2–8 °C storage conditions for an additional 5 days, or for a total of 20 days.
Once thawed and stored in 2–8 °C conditions, the vials cannot be refrozen or stored under frozen condition. Pfizer has developed specialized GPS-monitored coolers that can keep the vaccine at required temperatures for up to 10 days. It has also developed real-time GPS capability to report potential temperature variations, reducing the odds that the shot will lose its potency before it reaches the patient.
Veronica Fowler (07:18):
Okay. Well, that sounds like a lot of planning. And for Moderna's vaccine, will they be able to take advantage of existing storage systems because of the temperature difference?
Leslie Fish (07:31):
So, the answer to your question, Veronica, is yes. The Moderna vaccine will be stored and shipped at temperatures commonly found in the readily available pharmaceutical freezers and refrigerators. The vaccine can be stored up to 6 months at -20 °C, including up to 30 days at normal refrigerator conditions after thawing. But after thawing, to facilitate storage at points of administration, Moderna expects that they will remain stable at standard refrigerator conditions of 2–8 °C for up to 30 days within the 6-month shelf life. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, and physicians' offices.
Veronica Fowler (08:13):
So, I think that covers what's needed to store these vaccines. What have we heard as far as air and ground transportation?
Leslie Fish (08:23):
So, there's a few different things here, Veronica. On Friday, November 27th, United Airlines began to operate chartered flights for Pfizer's vaccine. On Sunday, November 29th, the U.S. Department of Health and Human Services confirmed that early doses of Pfizer's vaccine were en route from Belgium, but declined to reveal exactly where the shots would end up in the U.S. in an effort to minimize the potential risk to delivery and distribution. In addition, on Friday, November 27th, American Airlines said that it had successfully completed a trial flight that tested the airline's thermal packaging and stress test processes for the vaccine. Also, the Federal Aviation Administration gave United Airlines the go-ahead to move 15,000 pounds of dry ice per flight, more than five times what's normally permitted. Dry ice, which the FDA classifies as a hazardous material, can only be moved in limited quantities.
Pfizer has also been running dry rehearsals of its rollout at more than 50 distribution sites across the U.S. The dry runs include taking the sites through the process of receiving the vaccine, opening, and administering them. They also have developed videos for staffers to consult during the process.
Now, there are two other companies, FedEx and DHL. They have also rolled out temperature monitor systems to keep tabs on future vaccine shipments. United Parcel Service, or UPS, and Lufthansa are building so-called freezer farms comprised of multiple freezers at airport hubs to store vaccines during their journey to the distributors.
Veronica Fowler (10:02):
It's actually sort of exciting to hear everyone coming together to make this happen, regardless of competitive boundaries. So, Leslie, just how many doses do we think will be available at the outset?
Leslie Fish (10:16):
So, it is expected that during December, Pfizer will give the U.S. government 25 million doses, and Moderna, 15 million. The U.S. government has agreed to acquire 100 million doses of each vaccine with the option to purchase more.
Jose Ramiro, committee chair of the CDC's Advisory Committee on Immunization Practices, or ACIP, has stated that they expect to have enough vaccine from Pfizer and Moderna to vaccinate 20 million Americans in December and another 25 million in January. Eventually, Pfizer and Moderna combined could potentially be sending 70 million doses to the U.S. per month, which is enough for 35 million people. Pfizer and BioNTech hope to manufacture up to 1.3 billion doses in 2021 to serve the entire world. Moderna said it is on track to produce 500 million to 1 billion doses of its vaccine globally in 2021. If other companies receive approval for their vaccine, the total number of shipped product each month could reach 150 million by March.
Veronica Fowler (11:26):
And the question that's on everyone's mind: What information do you have on who will get the vaccine and when?
Leslie Fish (11:35):
So, Robert Redfield, the director of the CDC, and others have suggested the vaccinations of Americans could begin by the end of the second week in December if the FDA grants EUA for the Pfizer vaccine after the December 10th meeting. However, the FDA's Peter Marks has said that it may take a few weeks after that.
The CDC's ACIP had a meeting to discuss how to divvy up the vaccines on December 1st. However, on a state level, it will be up to the governors to decide who receives the first slate of shots.
As far as the CDC, the ACIP has defined different groups of people that could potentially be identified as high priority for getting the vaccine: First, our healthcare workers. There are approximately 21 million people in the U.S. working in healthcare. About 230,000 of them have contracted COVID-19, with about 822 dying from it. Next, residents of long-term care facilities. These long-term care residents make up 6% of the country's COVID-19 cases and 39% of deaths. Essential workers come next, which number about 87 million. And then adults 65 years and older, for which there are about 53 million. And finally, people with health conditions that put them at risk of developing severe disease, which number about 100 million.
Veronica Fowler (13:05):
And how are they coming up with those prioritizations?
Leslie Fish (13:10):
That's a good question, Veronica. So, on Tuesday, December 1, 2020, the CDC's ACIP met to discuss the highest priority people. The summary of the discussions were, Phase 1, which is December, the highest priority group should be the healthcare personnel, because of the risk of exposure, and residents and employees of long-term care facilities due to the high death rate in those populations. The vote was 13 to 1 to prioritize those two groups.
Although the committee has not yet voted on the next group of people to get the vaccine, they have discussed it. It is comprised of the essential workers, which would be Phase 1B for a January rollout, and then people 65 and older and adults with underlying conditions, and that would be Phase 1C for a February and March rollout. This means that people not included in those higher-risk groups could be vaccinated by April, May, or June.
Veronica Fowler (14:12):
So, Leslie, how are the pharmacies planning to handle all of this? I'm sure everyone has slightly different plans.
Leslie Fish (14:21):
Yes. We have heard from a few different corporations and institutions.
So, the first one is CVS Caremark. CVS wants to distribute the vaccine to long-term care facilities. They also have stated that they would like to allow pharmacy technicians to administer the vaccine.
And on a little bit of a different note, as both Pfizer and Moderna's vaccines require two doses, CVS has suggested that they have the ability to ensure that patients receive the second dose.
The next corporation we heard from is McKesson. McKesson has stated that they plan on expanding their existing partnership with the CDC as a centralized distributor of future COVID-19 vaccines and ancillary supplies needed to administer the vaccination. Vaccinations and related supplies will be delivered to the point-of-care sites across the U.S. with direction from the government.
Currently, McKesson distributes vaccines through the CDC's Vaccines For Children program. McKesson is also the largest seasonal flu vaccine distributor in the United States, distributing about 150 million doses of all vaccines annually to public health clinics, hospitals, physician offices, nursing homes, pharmacies, and other healthcare facilities.
Another corporation we've heard from is Walgreens. They've announced an agreement with the Department of Defense to provide and administer COVID-19 vaccines to residents of long-term care facilities nationwide with no out-of-pocket cost.
And then we have AmerisourceBergen. AmerisourceBergen is also working with the CDC to help distribute vaccines. It will serve as a network administrator and place orders with the CDC on behalf of qualified and eligible Good Neighbor Pharmacy and Elevate Provider Network members. It will also receive a direct allocation of COVID-19 vaccines for independent retail pharmacy customers once there is an adequate supply of the vaccine. COVID-19 vaccines will be distributed by the CDC's central distributor.
And finally, a forthcoming survey by the American Pharmacists Association showed that more than one-third of pharmacies in the U.S. have fully prepared to administer the vaccines once they are available, with more pharmacies still preparing.
Veronica Fowler (16:41):
Great. Well, it definitely sounds like everyone is working hard to get ready for this. Now, turning to the testing side of things, I know there's been an increase in the availability of testing, and depending on your location, it's becoming a lot more accessible. But have you heard anything about the at-home test?
Leslie Fish (16:59):
Yeah, Veronica, and this actually is fairly interesting, and it's exciting. But there are some caveats to it. So, the FDA announced it has issued an EUA for the Lucira COVID-19 All-In-One Test Kit, which is a molecular single-use test that can be used at home. It is fully self-administered and provides results in 30 minutes or less. But the caveats that I do want to mention right here are that it is by prescription only, [and] it's for people 14 years of age and older. If it is administered to people younger than 14, it must be administered by a healthcare provider in a doctor's office, hospital, or urgent care center, or an emergency room. And the way it's used is to collect a nasal swab sample and then swirl the swab in a vial and place it in the test unit. The results will appear on the test unit's light-up display in 30 minutes or less. The FDA states that the healthcare providers must report all test results to public health authorities.
Veronica Fowler (18:02):
Well, I have to be honest, Leslie, that does sound pretty convenient, despite the limitations.
So, Julee, now let's turn to the treatments for COVID-19. What's the news there?
Julee Oh (18:14):
Thanks, Veronica. I'm going to discuss some of the treatments that are currently approved for COVID-19 through an Emergency Use Authorization, which I will also refer to as EUA.
On February 4th, 2020, the Health and Human Services Secretary determined that there was a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad that involves the virus that causes COVID-19. On the basis of this determination, the secretary then declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic effective March 27th, 2020.
So, to date, there have been eight drugs or biologics approved for EUA. Two of the products are used to provide continuous renal replacement therapy for patients in a critical care setting. One is to maintain sedation in COVID-19 patients who require mechanical ventilation in an ICU setting. And the other five therapies that have received a lot more publicity are remdesivir, convalescent plasma, bamlanivimab, baricitinib in combination with remdesivir, and casirivimab and imdevimab.
Veronica Fowler (19:37):
So, of those five therapies, I know remdesivir is still a hot topic. Can you briefly touch on how that's being used?
Julee Oh (19:46):
Yes, Veronica. Remdesivir, or Veklury, by Gilead, is currently the only drug that has full FDA approval, which occurred on October 22nd after the original EUA was issued on May 1st, 2020. On August 28th, 2020, the FDA broadened the EUA to allow use in all hospitalized patients irrespective of disease severity. In response to the official FDA approval of remdesivir for use in adults and pediatric patients 12 years of age or greater weighing at least 40 kilograms, the remdesivir EUA was issued on October 22nd to allow continued use in pediatric patients less than 12 years of age weighing 3.5 to less than 40 kilograms.
Remdesivir is a broad-spectrum antiviral with activity against various viruses, including coronaviruses. There is still some skepticism around remdesivir's benefits, however. Although the data shows a quicker discharge for hospitalized patients, there has been no statistically significant evidence that it actually prevents deaths from COVID-19. On November 19th, the World Health Organization recommended against using remdesivir, concluding that, based on published trials so far, evidence of its benefits is lacking.
Veronica Fowler (21:10):
Okay, great. And anything new on convalescent plasma?
Julee Oh (21:14):
Well, as we know, the controversial and likely political EUA for convalescent plasma was issued on August 23rd, 2020, for the treatment of hospitalized COVID-19 patients. A recent study published in New England Journal of Medicine on November 24th showed no significant differences in clinical status or mortality for patients receiving convalescent plasma versus placebo.
The NIH COVID-19 Treatment Guidelines panel emphasized the importance of further investigation on convalescent plasma effectiveness, stating that there is insufficient data to recommend either for or against use of convalescent plasma for the treatment of COVID-19. There are large randomized clinical trials currently ongoing, [but] they're struggling to enroll enough participants because patients are worried they'll receive the placebo.
Veronica Fowler (22:07):
And how about the monoclonal antibodies?
Julee Oh (22:11):
So, in addition to convalescent plasma, another method of administering passive immunity is through monoclonal antibodies. These are synthetic copies of neutralizing antibodies that were obtained from the first few recovered COVID-19 patients in the United States.
Eli Lilly's monoclonal antibody, bamlanivimab, received EUA on November 9th, 2020, after releasing interim data from its BLAZE-1 trial that showed that viral clearance on Day 11 was statistically significantly better than placebo in outpatients with mild to moderate disease. The study in hospitalized patients, however, was terminated due to lack of any benefit in more serious patients. The EUA is for the treatment of mild to moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms who are at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA Facts Sheet describes criteria for high-risk patients.
Lilly is also conducting studies with a cocktail of two monoclonal antibodies, bamlanivimab and etesevimab as well, and we believe the combination will also receive EUA approval shortly.
In addition to Lilly's monoclonal antibodies, we have Regeneron's monoclonal antibody cocktail that was approved for EUA on November 21st. Regeneron's monoclonal antibody cocktail, casirivimab and imdevimab, received EUA approval on November 21st. These two monoclonal antibodies, administered together, are approved for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kilograms with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Similar to Lilly's monoclonal antibody, this EUA Fact Sheet also describes similar criteria for high-risk patients. Unlike Lilly's monoclonal antibody, however, Regeneron's cocktail is being allowed to continue its hospitalized patient trial even though, initially, it was thought that the risks outweighed the benefits there as well. Both Lilly and Regeneron are also conducting prevention trials with their monoclonal antibodies.
Veronica Fowler (24:50):
And I know they're using baricitinib in combination with remdesivir. What can you tell us about that?
Julee Oh (24:57):
Yes. On November 19th, 2020, the combination of baricitinib (Olumiant) by Lilly, was issued an EUA in combination with remdesivir for the treatment of COVID-19 in hospitalized adult and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Baricitinib is a JAK inhibitor, which blocks the inflammation pathway. In the large ACTT-2 trial conducted by NIAID of hospitalized patients with COVID-19, baricitinib in combination with remdesivir was compared to placebo plus remdesivir.
The trial followed patients with moderate or severe COVID-19 for 29 days. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 7 days for baricitinib plus remdesivir, and 8 days for placebo plus remdesivir. The odds of a patient's condition progressing to death or being ventilated on Day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group.
The odds of clinical improvement at Day 15 was higher in the baricitinib plus remdesivir group versus the placebo plus remdesivir group.
For all of these endpoints, the results were determined to be statistically significant, although I'm not quite sure how clinically significant they are, as again, there is no mortality data. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
So basically, none of these EUA treatments have shown improvement in mortality. Some of these drugs are not only controversial, but the data seems to be underwhelming at best. With COVID-19 rates on the rise and hospitals nearing full capacity, we're pinning our hopes on the vaccines to provide the herd immunity we need as soon as possible so we can learn from this pandemic and continue our lives with some semblance of pre-COVID life.
Veronica Fowler (27:12):
Thanks, Julee. So, Tom, now that we've covered the basics on these vaccines and treatments, let's talk about coding and reimbursement. With such rapid development, how are we planning to bill and reimburse for all of this?
Tom Comcowich (27:28):
Well, that's a great question, Veronica.
The interesting aspect about the COVID-19 vaccines and antibodies is that both the American Medical Association (or the AMA) and the Centers for Medicare and Medicaid Services (or CMS) have been very aggressive in creating billing codes to be used in conjunction with the COVID vaccines and antibodies, as well as the related administrative services.
As you may recall, the AMA is responsible for the creation of CPT-related codes. And while many of these codes are procedural in nature, there are a subset of those codes that are related to vaccine, toxoid, and immune globulin billing. In the case of COVID vaccine billing, the AMA has created unique billing codes for each of the soon-to-be-available COVID-19 vaccines, as well as specific administration codes for each vaccine.
For reporting the Pfizer-BioNTech COVID-19 vaccine, the AMA has assigned CPT Code 91300 as the code for the billing of the vaccine. And they've created two unique administration codes to be used along with 91300. Those two administration codes, 0001A and 0002A, are specific to the administration of the first and second dose of the vaccine. For reporting of the Moderna COVID-19 vaccine, the AMA has assigned CPT Code 91301 as the code for the billing of the vaccine, and two additional administration codes to be billed along with 91301. Those two codes are 0011A, which is for the first dose of the vaccine, and 0012A, which is for the second dose of the vaccine. All of these CPT codes are effective immediately upon the vaccines receipt of Emergency Use Authorization or approval from the FDA.
In the case of the COVID antibody, CMS has created a unique HCPCS code, Q0239 for the billing of Eli Lilly's bamlanivimab, as well as a unique code for the administration of the product, M0239.
Veronica Fowler (29:39):
And what about Veklury (or remdesivir)?
Tom Comcowich (29:43):
Well, since Veklury is generally administered in the hospital inpatient setting, billing would be through the diagnostic-related group coding system rather than the outpatient coding system. So, currently there are no specific HCPCS or CPT codes for the billing of this product.
Veronica Fowler (30:00):
So, Tom, at this point, is it fair to say that since these products and administration procedures have CPT and HCPCS codes, that they would be generally billed under the medical benefit?
Tom Comcowich (30:12):
Yes, it is. For the antibodies and the vaccines, Medicare has clearly stated that coverage for Medicare beneficiaries will be under the Part B benefit for both the vaccines, the antibodies, and their administration. And while many commercial payers will do the same, some may opt to cover these products and services under the pharmacy benefit, provided they can establish appropriate billing procedures and can adhere to any reporting requirements.
Veronica Fowler (30:38):
Okay, Tom, let's shift now to reimbursement. Can you talk about what's happening on the reimbursement front for these codes?
Tom Comcowich (30:47):
Sure. Let me start by providing an overview of reimbursement related to vaccines.
At least initially, there will be no charge, and therefore no reimbursement for the vaccine itself, since the vaccine will be paid for through funding authorized by the CARES Act. This is regardless of the member's insurance type; Medicare, Medicaid, or commercial insurance. However, providers will be reimbursed for the administration of the vaccine using the codes previously mentioned.
For Medicare and patients enrolled in Medicare Advantage plans, providers should bill original fee-for-service Medicare to the appropriate Medicare administrative contractor. Commercial and Medicaid payers would be responsible for reimbursement or the administration cost. If a provider were to administer the vaccine to a patient with no health insurance or whose insurance does not provide coverage of the vaccine administration fees, the provider may be able to file a claim with the Provider Relief Fund.
In all cases, providers may not charge patients for the vaccine or its administration, including any balanced billing, regardless of what any deductible, copay, or coinsurance the patient may have. When submitting a claim for the vaccine administration, the provider should only include the appropriate administration code for the first or second dose given to the patient. The code for the vaccine itself should not be included on a claim during the time that the vaccine is provided free of charge.
Veronica Fowler (32:14):
And is there any available information regarding what the reimbursement rates will look like for the administration of the vaccine?
Tom Comcowich (32:23):
Yes, there is. CMS has indicated that the Medicare payment rates for the administration of the COVID-19 vaccine will be $28.39 for a single-dose vaccine when available, and $16.94 for the first dose, and $28.39 for the second dose of a vaccine that is given in a two-dose schedule.
The rates are intended to also cover the provider cost of required public health reporting, patient outreach and education, including answering any questions patients may have about the vaccine. As is the case with many Medicare rates, these amounts could be adjusted based on geographic area.
Veronica Fowler (33:03):
And so, on the treatment side, I know we've received a lot of questions about coding and reimbursement for Eli Lilly's bamlanivimab monoclonal antibody treatment for COVID-19. What's going on there?
Tom Comcowich (33:18):
Well, there's a lot happening here, and it's similar to the vaccine distribution, which we previously discussed. Bamlanivimab will be purchased by the federal government and provided at no cost to states and various sites of care. Therefore, there will be no patient cost associated with the antibody itself, and Medicare will not reimburse providers for bamlanivimab as long as it is provided free of charge. Medicare will reimburse for the infusion associated with bamlanivimab administration. And again, Medicare beneficiaries will have no out-of-pocket costs for the administration. When billing for bamlanivimab and the related infusion, providers should only include the code for the administration of the antibody, which is M0239, and not the Q code for the antibody itself during the time that the antibody is provided free of charge. Also, similar to the vaccine billing, providers participating in Medicare Advantage plans should submit claims for bamlanivimab administration to original fee-for- service Medicare.
Veronica Fowler (34:19):
And has CMS set a reimbursement rate for administration?
Tom Comcowich (34:23):
Yes, they have. The rate for administration of bamlanivimab will be $309.60, which is based on 1 hour of infusion and post-administration monitoring. This rate, like other rates from CMS, is also subject to geographic variations.
Veronica Fowler (34:41):
And so, what about the other Emergency Use Authorized treatments?
Tom Comcowich (34:47):
Well, although several have received Emergency Use Authorization so far, specific codes have not yet been assigned for those particular products.
Veronica Fowler (34:55):
And we'll definitely be watching to see if those are assigned and reporting back.
So, Tom, what happens in the event that providers are required to begin purchasing the vaccines and antibodies in the near future?
Tom Comcowich (35:09):
Well, should that occur, under Medicare, reimbursement for providers for the vaccine and the antibodies would be the same as it is for other vaccines. And that is, it would be based on average wholesale price minus 5% when given in the provider office setting.
When provided in a hospital outpatient department setting, reimbursement will be based on reasonable cost. Commercial payers would most likely follow their standard contractual arrangements with providers when reimbursing for these.
Veronica Fowler (35:37):
Well, we're about out of time, but before we wrap up, Tom, what can we expect in the future as we move forward in this space?
Tom Comcowich (35:45):
Well, with so much happening at such a rapid pace, we need to continue to closely monitor any new developments in this space. We already know that there are more vaccines and antibodies in development, as both Leslie and Julee mentioned. And while we don't know for certain how these products may be handled from a billing perspective, at this point in time, we can only anticipate that they will be handled in a similar manner to those just discussed.
Veronica Fowler (36:08):
Well, Julee, Leslie, Tom, that covers the agenda for today's discussion. I thank you all for coming on and sharing your knowledge with us. As always at IPD, we'll continue to monitor the situation, and any information that we're able to share will be provided on our Infectious Disease pages of our Payer and Provider Insights portal, which provides formulary management decision-making support and drug information to payers, providers, and suppliers across the United States.
Now, if you're not a current IPD subscriber and would like to be, inquire about a subscription by emailing . And any subsequent episodes will be posted to our LinkedIn page and also our website, so be sure to follow us there. Thank you for listening — and stay healthy.
May 18th, 2020 Update
IPD Analytics has released its fourth publicly available podcast on COVID-19. In this episode, Leslie Fish, R.Ph, Pharm.D. and Julee Oh, Pharm.D. discuss the most recent news on the coronavirus, including:
National and Global Status (2:22)
Vaccine Status (2:48)
Remdesivir from Gilead Sciences, Inc. (04:50)
Emergency Use Authorization (06:39)
Clinical Trial Updates (9:49)
Dosing and Administration (15:56)
Warnings and Precautions (17:05)
Manufacturer and Clinical Trial Impacts (20:20)
STI-1499 Antibody from Sorrento Therapeutics (23:38)
April 27th, 2020 Update
March 31st, 2020 Update
IPD Analytics has released another publicly available podcast on COVI-19. In this episode, Leslie Fish, R.Ph, Pharm.D. and Julee Oh, Pharm.D. discuss the most recent news on the coronavirus, including:
National and Global Status
Potential Therapies, Clinical Trials, and Outcomes
FDA Approval Delays
Manufacturer Clinical Trial Delays
March 19th, 2020 Update
In order to shed light on this critical topic, IPD Analytics has made a publicly available podcast. Listen to IPD’s Executive Clinical Pharmacy Team discuss the most recent news on the coronavirus, including:
Clinical Development Pipeline and Trials
Pharmaceutical Industry Impacts
IPD Analytics has released its third publicly available podcast on COVID-19. In this episode, Leslie Fish, R.Ph, Pharm.D. and Julee Oh, Pharm.D. discuss the most recent news on the coronavirus, including:
National and Global Status (2:34)
Potential Therapies, Clinical Trials, and Outcomes (3:03)
FDA Approval Delays (22:00)
Provider Impacts (24:24)
At-home Test Approval (29:53)