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Federal

(All States)

Pharmacy Laws & Regulations

Federal

Pharmacy Laws & Regulations

(All States)

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SIGNED INTO LAW
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nEWS UPDATE

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

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.

Source:  

HHS.gov

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