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Pharmacy Laws & Regulations

Federal

Pharmacy Laws & Regulations

(All States)

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Pfizer’s Lyme Disease Vaccine Enters Late-Stage Clinical Trial

On August 8, Pfizer announced the start of a late-stage clinical trial to test a new Lyme Disease vaccine. Pfizer aims to enroll approximately 6,000 healthy adults and children 5 years and older in the trial, which will evaluate whether the vaccine, called VLA15, is safe and effective. VLA15 is a three-dose regimen, administered over a five-to-nine month period, followed by a booster dose 12 months later. If Pfizer’s trial succeeds, the VLA15 would be the first of its kind in 20 years.

Source:  

NBC News

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New Inflation Reduction Act Could Affect Pharmacies

The US Senate recently passed the Inflation Reduction Act, which affects climate, tax, and healthcare. The Inflation Reduction Act includes several provisions for community pharmacy: 1. negotiations for drug pricing, 2. frameworks for negotiations, 3. annual out-of-pocket caps for Medicare Part D beneficiaries, 4. optional “smoothing” of patient cost sharing, 5. cost-sharing for adult vaccines, 6. changes to drug rebates, and 7. changes to insulin copays. The Inflation Reduction Act now heads to the House, which will consider its provisions on August 12.

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NCPA

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Pharmacists In Limbo After Overturning of Roe v. Wade

On June 24, the Supreme Court overturned Roe v. Wade, the 1973 case that established a constitutional right to abortion. Now, abortion rights are up to the states; but in states that have already issued abortion bans, pharmacists face new challenges. These challenges include managing abortion pills and medications that have the potential to induce abortion, including misoprostol, mifepristone, and methotrexate. To avoid legal liability, pharmacists have used workarounds: like putting a blanket pause on filling certain medications or asking prescribers to obtain diagnostic codes explaining why they’ve prescribed a certain medication. As pharmacists navigate this gray area, pharmacy organizations around the country are asking federal and state governments to issue more clear guidance on how pharmacists should move forward.

Source:  

Dallas Morning News

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FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine

On July 13,  the FDA issued an emergency use authorization for the Novavax COVID-19 Vaccine. Novavax is a protein-based vaccine intended to prevent COVID-19 in individuals 18 years of age and older. In a clinical trial, Novavax was found to be 78.6% effective among individuals 65 years of age and older. It is administered as a two-dose primary series, three weeks apart. Under the EUA, Novavax will continue its clinical trials to obtain additional safety and effectiveness data and pursue approval (licensure).

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Food and Drug Administration (FDA)

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FDA Rejects Pharmacist-Prescribed Molnupiravir

The FDA recently authorized pharmacists to prescribe Paxlovid, a COVID-19 oral antiviral, under an EUA. However, the FDA did not extend that authorization to Merck’s Lagevrio (molunpiravir), Paxlovid’s “twin oral antiviral.” The FDA explained that “Lageviro should only be prescribed by traditional prescribers… This determination is based on several factors, including the drug’s side effect profiles and the need for provider-patient consultation.” Controversy surrounds this claim, but the decision still stands.

Source:  

Fierce Pharma

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FDA Allows Pharmacists to Prescribe Paxlovid

Nearly 8 months after the FDA issued its EUA for Pfizer’s Paxlovid, a COVID-19 oral antiviral, it has now revised its initial authorization. The revised EUA now allows state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing. The FDA is hopeful that the revised EUA will expand access to timely treatments — since Paxlovid must be taken within five days after COVID-19 symptoms begin — and provide pharmacists with more authority.

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CNN

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FTC Launches Investigation into Pharmacy Benefit Managers

The Federal Trade Commission (FTC) has launched an inquiry into the largest pharmacy benefit managers in the United States, including CVS Caremark, Express Scripts, OptumRx, and Humana. The inquiry aims to scrutinize PBMs’ practices and influence on the pharmaceutical industry, especially those concerning the “competitive impact of the contracting and business practices PBMs.” In effect, the inquiry will highlight ongoing problems within PBMs and provide possible solutions.

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JD Supra

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New Act Would Allow Import of Drugs from Canada

The US Senate is currently considering a bipartisan bill to lower drug costs by way of importation. This bill, called the FDA Safety and Landmark Advancements (FDASLA) Act, aims to bring more competition to the market and create a path for prescription drugs to be imported from Canada. The legislation also includes provisions for other areas. The FDASLA Act aims to improve the regulation of diagnostic tests, increase the safe disposal of opioids, update the process of determining therapeutic equivalence of certain drugs, expedite consumer access to OTC hearing aids, and improve transparency and accountability at the FDA. The FDASLA Act passed the Health, Education, Labor and Pensions (HELP) Committee and awaits further consideration in the Senate.

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US Senate Committee on Health, Education, Labor and Pensions

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New Bill Empowers FTC Action Against PBMs

A new piece of legislation may change the way PBMs operate at the federal level. This bill, the Pharmacy Benefit Manager Transparency Act, would give the Federal Trade Commission (FTC) and state attorneys general the ability to penalize and/or initiate legal action against pharmacy benefit managers for certain unfair or deceptive business practices. The bill was introduced by Senators Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) and is supported by dozens of pharmacy organizations, including NCPA. It is currently under consideration in the Senate.

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NCPA

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CMS Adopts New 2023 Medicare Part D Final Rule

The Centers for Medicare and Medicaid Services (CMS) recently issued its Medicare Part D final rule for contract year 2023. The final rule will revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations. The new rule includes several wins for independent pharmacies. These include redefining a negotiated price, closing coverage gap loopholes, addressing pharmacist cash flow concerns, addressing pharmacy administrative service fees, defining pharmacy “price concession” for the first time, and discussing reasonable pharmacy reimbursement. CMS’s final rule is effective on June 29, 2022, except for price concession changes, which are effective on January 1, 2024.

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NCPA

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All DEA Registrations Must Be Done Online Now

On April 11, 2022, the Drug Enforcement Administration (DEA) released a final rule which amends DEA regulations to now require all applications for DEA registrations to be submitted online. With this new rule, the DEA aims to mitigate issues created by paper applications and simplify the process by which registrants submit or renew applications for registration. It also ensures registrants keep a valid email address on file with the DEA to ensure receipt of renewal notices. The final rule is effective May 12, 2022.

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Drug Enforcement Administration (DEA)

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New Bill Would Expand COVID-19 Reimbursement

The United States House of Representatives recently introduced a new bill that would expand access to pharmacy services and enable pharmacists to get paid for those services. The bill, HR 7213 — or the Equitable Access to Pharmacist Services Act —, would continue pharmacists’ ability to test and treat COVID-19, flu, and strep patients. It would also provide coverage for those services under Medicare Part B and allow pharmacists to get reimbursed. HR 7213 marks an important step in expanding pandemic-related health services and enabling pharmacists to provide those services.

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NCPA

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Medication Flavoring May Be at Risk

Many pharmacies flavor medications in order to increase adherence, especially in children. But a new proposed rule may make medication flavoring more difficult. This new rule would place medication flavoring under the scope of nonsterile compounding, tightening up regulations on what a pharmacist can and can’t do when flavoring. Under the new rule, flavoring would be subject to the onerous provisions of the United States Pharmacopeia (USP) <795>. USP <795> would require pharmacists to implement several new flavoring practices: 1. installing a hood or closed-system processing device, 2. implementing hours of additional employee training, and 3. performing additional testing of the flavored products.

Many pharmacy professionals deem these new requirements unnecessary, and 25 state boards of pharmacy have done the same by opposing the rule. Opposing pharmacists warn that the new rule “would present the undeniable risk that simple flavoring would be subjected to a new set of detailed requirements for nonsterile compounding.” The rule is subject to the state board of pharmacy in each state.

Source:  

Pharmacy Times

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Biden Administration Launches "Test to Treat" Initiative

Pharmacists have been on the frontlines all throughout the COVID-19 pandemic, and now, a new initiative from the Biden Administration aims to expand their role. The “Test to Treat” initiative enables pharmacies to offer COVID-19 testing and provide antiviral treatments on the spot, at no cost. Despite its initial potential, though, many pharmacists argue that “Test to Treat” isn’t as promising as it seems. The FDA’s EUAs for Paxlovid and molnupiravir specify that they can only be prescribed by physicians, advanced practice nurses, and physician assistants. Only a fraction of pharmacies have these providers on-site to write a prescription, which does little for independents in particular. According to many pharmacists, then, the “Test to Treat” initiative is promising in theory, but in practice, it needs revision to be fully effective.

Source:  

TIME

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FTC Turns a Blind Eye to PBM Contracts

The Federal Trade Commission decided in a 2-2 deadlock not to study the contracting practices of pharmacy benefit managers (PBMs) — a sobering setback for pharmacists around the country. At the center of the FTC’s discussion were clawbacks, higher drug prices, and patient steering. But opponents were concerned about the objectivity of the study. One opponent, Christine Wilson said, “I have observed previously that stakeholders frequently attempt to co-opt the government in their battle against rivals. I am wary of having the FTC used as a pawn to boost the profitability of certain sectors or insulate them from competition.” Independent pharmacists everywhere criticized the decision but continue to work towards PBM progress in spite of the setback.

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Fierce Healthcare

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New Bill Calls on Pharmacists to Fight Opioid Crisis

On February 10, 2022, U.S. Senators Edward J. Markey (D-Mass.) and Dr. Rand Paul (R-Ky.) introduced a bipartisan bill, the Opioid Treatment Access Act, to fight the growing opioid crisis in the United States. The bill would revise outdated regulations on methadone treatment for opioid-use disorder (OUD) by reducing the time in treatment required for patients to receive take-home doses of medication. In addition, it would allow pharmacies to dispense methadone for OUD treatment for the first time. The Opioid Treatment Access Act marks an important step in public health and recognition for pharmacists across the country.

Source:  

Senator Ed Markey

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CMS Takes ‘Incremental Approach’ in Addressing DIR Fees

The Centers for Medicare and Medicaid Services (CMS) proposed a new rule that outlines major regulatory changes for MA and Part D starting in 2023. The rule includes several major changes, including one for DIR fees. Under CMS’s new rule, DIR fees must be recognized at the point of sale. CMS effects this change by amending the regulatory definition of “negotiated price” and adding a new definition for “price concession.” However, the proposed change would only apply to pharmacy DIR fees or adjustments and would not extend to formulary rebates paid by pharmaceutical manufacturers to Medicare Part D plans and PBMs. CMS characterizes this as "an incremental approach" by "only proposing policies related to pharmacy price concessions at this time." In addition to DIR fee changes, the new CMS rule requires additional marketing oversight, transparent medical loss ratio (MLR) reporting, and new network adequacy qualifications. Comments on the proposed rule are due by March 7, 2022.

Source:  

JD Supra

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FDA Authorizes 1st Oral Antiviral Treatment for COVID-19

The U.S. Food & Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 oral antiviral treatment. Created by Pfizer, Paxlovid is available by prescription only, and its use is intended for COVID-positive patients ages 12 and older weighing at least 40 kg. The Paxlovid pill is for patients who are at high risk for a severe case of the disease and the treatment should be taken as soon as possible, within 5 days of symptom onset. It is important to note that this treatment is not a substitute for the vaccine, and it is still highly recommended to get the vaccine and booster to fully protect against COVID-19.

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U.S. Food & Drug Administration (FDA)

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House Overwhelmingly Passes Federal Opioid Bill

In a vote of 410-15, the House has passed H.B. 2355 - the Opioid Prescription Verification Act. This bill now moves on to the Senate to consider and vote on the legislation. This new Act would incentivize and kickstart more effective prescription drug monitoring programs in the states. It would also define how pharmacists would be required to help verify the identity of patients that are prescribed opioids and outline the process for declining to fill a prescription. This new legislation aims to help establish greater preventative measures in combating the opioid epidemic.

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Business Insurance News

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CMS Requires States to Cover COVID-19 Vax Counseling for Kids on Medicaid

The U.S. Centers for Medicare & Medicaid Services (CMS), in response to the Biden-Harris Administration, is now requiring states to fully cover all counseling visits in regards to COVID-19 vaccination for children. All providers that visit with families to counsel them on the importance of getting their children vaccinated must be reimbursed for their services, and all of the state expenditures under this program must be matched 100% by federal funds. This move hopes to encourage conversations between families and health care providers to provide accurate information about vaccination and create a safe space for their questions. This will hopefully break down barriers to vaccination and facilitate higher immunization rates.

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Centers for Medicare & Medicaid Services (CMS)

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District Courts Issue Key Decisions in 340B Contract Pharmacy Cases

There have been recent developments in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and the agency in charge of the 340B program, HRSA. This is related to the group of manufacturers that, this summer, began to impose restrictions on 340B covered entities working with contract pharmacies. These manufacturers include Eli Lilly, Novartis, Novo Nordisk, Astra Zeneca, Novartis, United Therapeutics, and Sanofi. This article breaks down the background of the case and highlights/summarizes key takeaways from the lengthy court decision documents in recent weeks.

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JD Supra

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New Federal Vaccination Mandate for Employers

In addition to the regulation for Medicare/Medicaid facilities listed below, the Biden administration has issued a new vaccination mandate that may affect your pharmacy. If your pharmacy has more than 100 employees across the entire company, you will be required to mandate your employees to either be fully vaccinated against COVID-19, or require weekly Covid testing and mandatory wearing of face masks at work. Please note that if you offer vaccinations, even if you have less than 100 employees at your pharmacy, you will still be required to follow the previous health care ETS requirements including the use of PPE, social distancing, and other cleaning/training protocols.

Source:  

National Community Pharmacists Association (NCPA)

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CMS Rule Requires COVID-19 Vaccination for Healthcare Workers

The Centers for Medicare & Medicaid Services (CMS) has issued a new regulation that will require vaccination against COVID-19 for all "eligible staff" at health care facilities that participate in Medicare and Medicaid programs. All eligible staff must have their first dose by December 5th, 2021, and must be fully vaccinated by January 4th, 2022. Independent pharmacies can take this opportunity to help vaccinate staff at their local health care facilities.

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National Community Pharmacists Association (NCPA)

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CDC Recommends COVID-19 Vaccine for Children 5-11 Years

The U.S. Centers for Disease Control and Prevention (CDC) has just released an official statement recommending that children from ages 5 to 11 can now also be vaccinated against COVID-19, specifically with the Pfizer-BioNTech pediatric vaccine. NCPA will be hosting a webinar on Thursday, November 4th, at 8pm E.T. that will cover all of the proper dosages, techniques, and best practices for administering the vaccine to children - as some of the rules are different than with adults. You can sign up for the webinar here. You can also watch this pre-recorded video produced by NCPA that goes over the basics of administration of pediatric vaccines.

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Centers for Disease Control and Prevention (CDC)

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Mark Cuban's Drug Company to Launch New PBM

Entrepreneur Mark Cuban is moving into the PBM business. Cuban currently owns a generic drug company that was created early this year in order to help provide transparency in drug pricing and produce low-cost versions of expensive prescription drugs. His drug company has now announced plans to launch a new pharmacy benefit manager (PBM) company with the aim of producing higher transparency and sharing cost-savings with its customers. The PBM will begin building its network next year and aims to be operational by 2023.

Source:  

Becker's Hospital Review

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CDC Expands Eligibility for COVID-19 Booster Shots

The U.S. Centers for Disease Control and Prevention (CDC), has issued an official statement updating the eligibility and best practices for receiving COVID-19 booster shots. This update is relevant information to all pharmacies that are currently offering these COVID-19 vaccinations in their communities. Individuals who have received their Pfizer or Moderna vaccine over 6 months ago are eligible for a booster if they are over 65 years old, or are over 18 years old and are in a high-risk group. For those who received the Johnson & Johnson vaccine, booster shots are recommended for those 18 and older that were vaccinated at least 2 months ago. As far as mix-and-matching the type of vaccine for a booster shot, the CDC states that individuals can choose whichever brand of vaccine they prefer, despite which one they received for their original immunization dose.

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Centers for Disease Control and Prevention (CDC)

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FDA Issues Landmark Proposal for OTC Hearing Aids

The U.S. Food & Drug Administration has just issued a landmark proposal to improve access to affordable hearing aids. Under the proposal, patients with mild-to-moderate hearing loss would no longer require a hearing exam and a prescription from a doctor in order to obtain hearing aids. These devices could instead be bought online or over-the-counter (OTC) at local community pharmacies without a prescription. This decision comes after years of advocacy from medical experts and consumer advocates, and most recently, an Executive Order from President Joe Biden.

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ABC News

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FDA Withdrawing Temporary Guidance for Alcohol-Based Hand Sanitizers

The FDA is withdrawing temporary gudiances for alcohol-based hand sanitizers that were implemented in response to the COVID-19 pandemic. This includes compounding pharmacies that have been making and selling their own hand sanitizer. Now, the FDA is announcing that starting December 31, 2021, this production must stop. Any stock that has been produced before the end of the year must be sold to wholesalers by March 31, 2022. If any pharmacies wish to continue making hand sanitizer, they must comply with the monograph and follow the FDA's current manufacturing practice requirements.

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U.S. Food & Drug Administration

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New DEA Form Mandatory Beginning October 30

Starting on October 30th, the US Drug Enforcement Administration (DEA) is getting rid of the triplicate forms for ordering and transferring Schedule I and Schedule II controlled substances. These old forms will no longer be available or accepted. Instead, the DEA will now be requiring the use of a single sheet DEA 222 order form. Follow the link below to place an order for the new DEA 22 forms.

Source:  

National Community Pharmacists Association (NCPA)

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FDA Posts 4 Final Orders Under New OTC Monograph Process

The U.S. Food & Drug Administration (FDA) has posted 4 orders outlining a new process for OTC drug monographs. The CARES Act includes provisions to reform the monograph regulation process, including processes for issuing, revising, and amending monographs establishing active ingredients, indications, doses, labeling, and testing for safety and effectiveness. The orders outline the following OTC drugs: nighttime sleep-aid drug products, anti-flatulent drug products, topical otic drug products, and corn & callus remover drug products. Click the button to find links to each of the individual FDA orders.

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National Community Pharmacists Association (NCPA)

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FDA Panel Decision on COVID Booster Shots

An FDA Panel has met to discuss the approval of additional "booster" doses of the Pfizer-BioNTech Covid-19 vaccine. The panel voted against a booster shot for all people ages 16 and older, tabling that decision for now. However, they did vote in favor of a booster shot for people over the age of 65 and others at high risk of severe cases of COVID-19. Broader usage of a booster shot may be approved in the future, but for now it is recommended only for those in a higher risk category.

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National Public Radio (NPR)

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Expanding Access to COVID-19 Therapeutics

In the 9th amendment to the COVID-19 PREP Act Declaration, pharmacies have been authorized to help with administering COVID-19 therapeutic treatments - including monoclonal antibody therapy. Licensed pharmacists, as well as pharmacy technicians and pharmacy interns, have been given this expanded authority to order and administer FDA-approved treatments. This is a huge opportunity for pharmacies everywhere, allowing them to further help protect their patients and also diversify their revenue by billing for this new service.

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U.S. Department of Health & Human Services

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CMS Updates Additional Payments for Vaccinating At-Home Patients

The Centers for Medicare & Medicaid Services (CMS) has announced new guidelines for pharmacies administering COVID-19 vaccinations to at-home patients. Certain locations qualify for additional payment amounts from the CMS, including a private residence, temporary lodging, apartments in assisted-living facilities, communal living spaces, and assisted living facilities participating in the CDC's Pharmacy Partnership for Long-Term Care program. Now, Medicare will pay the additional amount of about $35 per dose administered for a maximum of 5 services per home unit - but only when less than 10 patients are vaccinated on the same day at the same location.

Note from NCPA: *Ask your medical billing intermediary how to flag a claim when it’s submitted that it is eligible for the additional payment for a home visit.

Source:  

National Community Pharmacists Association (NCPA)

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FDA Approves First COVID-19 Vaccine by Pfizer-BioNTech

In a significant achievement for public health in the US, the FDA has officially given full approval to the first COVID-19 vaccine. The Pfizer-BioNTech COVID-19 vaccine now has FDA approval for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine continues to have emergency use authorization (EUA) for those ages 12 - 15, as well as for a third dose (booster shot) in certain immunocompromised individuals. This is an important step towards increasing vaccination rates and helping combat vaccine hesitancy in the US.

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US Food and Drug Administration

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CMS Develops Emergency Regulation Requiring All LTC Staff to be Vaccinated

The Centers for Medicare & Medicaid Services (CMS), along with the Centers for Disease Control and Prevention (CDC), is developing an emergency regulation that will require all staff working at Medicare and Medicaid-participating nursing homes to be vaccinated against COVID-19. This regulation applies to over 15,000 nursing homes across the US, and the guidance aims to go into affect in September. This is a great opportunity for independent pharmacies to reach out to their local LTC facilities and offer to vaccinate their staff. The CMS recommends that these facilities start vaccinating immediately ahead of the new guidance implementation.

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Centers for Medicare & Medicaid Services (CMS)

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Pharmacy Technicians, Interns Can Administer Seasonal Flu Vaccines

HHS Secretary Becerra has issued an amendment to the federal Public Readiness and Emergency Preparedness (PREP) Act to expand the roles of pharmacy technicians and interns. Now, qualified pharmacy technicians and pharmacy interns - under the supervision of a licensed pharmacist - can administer seasonal influenza vaccines to people age 19 and over.

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NCPA

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HHS to Reimburse Providers for COVID-19 Testing

The Department of Health and Human Services (HHS) has announced that it will dedicate $4.8 billion from its American Rescue Plan to the COVID-19 Uninsured Program, which will reimburse providers for testing patients without insurance. Pharmacies can enroll in the program to receive their benefits.

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HHS.gov

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