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Pharmacy Laws & Regulations

Federal

Pharmacy Laws & Regulations

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CDC Issues Guidelines for Prescribing Opioids

The Centers for Disease Control and Prevention has finalized its 2022 clinical practice guidelines for prescribing opioids for pain. The guidelines include 12 recommendations for clinicians providing pain care for outpatients aged 18 years or older with acute pain (duration less than one month), subacute pain (duration of one to three months), or chronic pain (duration of more than three months). This guidelines are intended to improve communication between clinicians and patients about the benefits and risks of pain treatments, including opioid therapy; improve the effectiveness and safety of pain treatment; mitigate pain; improve function and quality of life for patients with pain; and reduce risks associated with opioid pain therapy, including opioid use disorder, overdose, and death.

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NCPA

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DOJ Fights Back Against UnitedHealthcare Merger

On November 18, 2022, the U.S Department of Justice, along with New York and Minnesota, filed an appeal with the D.C. Circuit Court of Appeals challenging a lower court ruling permitting the $13 billion merger of UnitedHealthcare, the country’s largest insurer, and Change Healthcare, a dominant health care data firm. Pharmacy organizations like NCPA strongly oppose the merger because it exposes sensitive patient data from Change’s “switch” that UnitedHealthcare and its PBM, OptumRx, will use to create an unfair competitive advantage.

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NCPA

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FDA Makes Preliminary Endorsement for OTC Naloxone

The U.S. Food and Drug Administration (FDA) recently released its preliminary assessment that certain naloxone products “may be approvable" — i.e., safe and effective — for over-the-counter use. The decision — while not a formal OTC approval determination — is many years in the making and could ease development and approval of nonprescription naloxone, the agency said in a release. This could include transforming the approvals for existing prescription naloxone products into OTC nods. The OTC endorsement specifically covers naloxone nasal spray and intramuscular autoinjector delivery formats up to 4 mg and 2 mg, respectively.

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Fierce Pharma

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Fake Eli Lilly Twitter Account Proclaims Free Insulin For All

Eli Lilly has become the first Big Pharma to fall victim to the uptick of fake Twitter handles cropping up under the new Twitter Blue paid accounts that Elon Musk recently pushed through. A user pretending to be the Indianapolis company tweeted out a message, saying: “We are excited to announce insulin is free now.” Lilly's shares took a battering the day after the tweet, dropping more than 6% and wiping billions of dollars from its market cap. A similar but less severe stock drop happened to fellow insulin makers Novo Nordisk and Sanofi, with commentators suggesting that the false tweet did much to reignite the debate around insulin pricing, negatively hitting investor sentiment. 

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Fierce Pharma

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AstraZeneca Withdraws US COVID Vaccine Application

AstraZeneca has decided to withdraw its application for COVID vaccine Vaxzevria with the FDA, CEO Pascal Soriot recently announced. The U.S. market is already well supplied, and the demand for vaccines is declining, Soriot said. Instead, the company’s anti-COVID efforts are shifting to its long-acting antibody combo drug Evusheld, Soriot said. Evusheld is currently authorized to prevent COVID in immunocompromised people in the U.S. and is cleared in Europe both as a preexposure prophylactic and as a treatment. In the third quarter, Evusheld reeled in $536 million in revenue, bringing its total so far this year to $1.45 billion.

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Fierce Pharma

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Pfizer, GSK Race for World’s First-Ever RSV Vaccine

Pfizer and GSK are already prepping for battle as the pair race into the new respiratory syncytial virus (RSV) market. This week, both companies moved closer to regulatory approvals, and they could each see the first-ever approvals for an RSV vaccine in 2023. GSK nabbed a priority review and a May 3 approval action date for its RSV vaccine in older adults. Pfizer isn't far behind, with an early stop for the trial of its vaccine given to pregnant women to protect infants and eyeing an approval filing by year-end. The other major COVID vaccine player in the U.S., Moderna, is also looking to get into the RSV vaccine market but is further back compared to Pfizer and GSK.

Source:  

Fierce Pharma

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US Pharmacy Chains Offer $13.8B to Settle Opioid Cases

Three of the largest pharmacy chains in the United States agreed in principle on Wednesday to pay $13.8 billion to resolve thousands of lawsuits accusing them of mishandling opioid painkillers. CVS would pay $4.9 billion to local governments and about $130 million to Native American tribes over a decade. Walgreens would pay $4.8 billion to state and municipal governments and $155 million to tribes over 15 years. Several US outlets, quoting sources familiar with the matter, reported Walmart also reached a tentative agreement to pay $3.1 billion. The proposed pharmacy deal comes after other major players, including drugmakers and distributors, have reached settlements totaling more than $33 billion.

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DW

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FDA Warns of Amoxicillin Shortage

The U.S. Food and Drug Administration (FDA) has reported a shortage of the antibiotic amoxicillin after three key amoxicillin manufacturers — Hikma Pharmaceuticals, headquartered in the United Kingdom; Sandoz, based in Switzerland; and Teva Pharmaceutical Industries Ltd., headquartered in Israel — noted limited supplies. Supplies of amoxicillin — commonly prescribed to treat various bacterial infections including ear infections, pneumonia, and bronchitis — have been dwindling for weeks. In some cases, drug wholesalers are limiting how much of the medication pharmacies can purchase at one time, likely to avoid running out of them. Pharmacists said they are worried if the shortage lingers through the winter, when infections can surge and antibiotic use typically increases.

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NBC News

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FDA Proposes Drug Category Between OTCs and Prescriptions

In June of this year, the FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use — a category of nonprescription drugs where the FDA determines that labeling alone is insufficient to ensure safe use by consumers without supervision by a healthcare professional. The proposed rule would establish requirements for certain drugs to be sold over the counter with additional requirements to ensure appropriate self-selection and/or use by consumers. The proposed rule is available for comment until October 26, 2022.

Source:  

Dechert, LLP

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Novavax Booster Gets Emergency Use Authorization

Novavax announced last week that its COVID-19 vaccine, Adjuvanted, received an EUA from the FDA. This vaccine is intended to provide a first booster dose at least six months after primary vaccination to those 18 and older for whom an FDA-authorized mRNA bivalent booster vaccine is not accessible or clinically appropriate. 

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NCPA

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CDC Allows Novavax Boosters for Ages 18 and Up

The Centers for Disease Control and Prevention (CDC) will now allow Novavax monovalent COVID-19 boosters for adults. This action gives people ages 18 years and older the option to receive a Novavax monovalent booster instead of an updated (bivalent) Pfizer-BioNTech or Moderna booster if they have completed primary series vaccination but have not previously received a COVID-19 booster — and if they cannot or will not receive mRNA vaccines.

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CDC

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OTC Hearing Aids Rolling Out to Pharmacies

Retailers are now allowed to sell over-the-counter lower-cost hearing aids without a prescription or medical exam under final Biden administration rules that took effect yesterday. The Food and Drug Administration in August approved the sale of OTC hearing aids, allowing millions of Americans to buy hearing aids without seeing an audiologist and potentially saving individuals thousands of dollars. The rules apply to hearing aids for people with mild to moderate hearing loss. The aids will be available directly from stores or online without medical exams, a prescription, or audiologist fitting adjustment.

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NCPA

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COVID-19 Public Health Emergency Extended Another 90 Days

The Biden administration extended the nation’s COVID-19 public health emergency for the next 90 days as officials brace for a potential surge of infections over the winter. The declaration comes as daily deaths and case rates have been falling, though the U.S. continues to see more than 300 people dying due to COVID-19 each day. The public health emergency was first declared in January 2020, and has been renewed every 90 days since. The extension ensures that policies like expanded Medicaid benefits, telehealth coverage, and extra payments to hospitals and doctors will continue.

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MSN

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FDA Proposes Rule to Standardize National Drug Format

The U.S. Food and Drug Administration (FDA) proposed an amendment to regulations governing the format of the National Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products marketed in the U.S. This action, if finalized, would standardize the format of all NDCs. Specifically, all NDCs would be required to be 12 digits in length with 3 distinct segments and 1 uniform format. Electronic or written comments on the proposed rule can be submitted by November 22, 2022.

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Federal Register

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7 of 9 US Adderall Suppliers Face Supply Problems

Camber Pharmaceuticals and Sun Pharma, two of the nation’s largest Adderall suppliers, are the latest to report supply problems — as other suppliers also struggle to keep up. While the most recent nationwide shortage began two months ago, inadequate supply of Adderall has been an ongoing problem since 2019, with nine providers of the drug in the United States often struggling to meet surging demand.

Source:  

Fierce Pharma

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1,200 Drugs’ Prices Rose Past Inflation in 2021

The Department of Health and Human Services (HHS) released a new report detailing prescription drug prices. The report found that from July 2021 to July 2022, 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5%, with an average hike of 31.6%. In 2021, the healthcare system spent $603B on prescription drugs. 50% of those drugs were specialty drugs. The top 10% of drugs by price made up fewer than 1% of all prescriptions but accounted for 15% of retail spending and 20-25% of non-retail spending. HHS released the report to highlight that the Inflation Reduction Act, starting October 1st, has a new requirement that would cap any price hikes in Medicare Part D that go beyond the rate of inflation.

Source:  

Fierce Healthcare

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FDA Approves New Treatment Option for Patients with ALS

The U.S. Food and Drug Administration (FDA) approved a new drug to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. The new drug, Relyvrio, slows the progression of ALS by protecting nerve cells in the brain and spinal cord damaged by the disease. In a 24-week study, patients receiving Relyvrio experienced a 25% slower rate of decline in performing activities such as walking, taking, and cutting food compared with those receiving a placebo. The treatment is expected to be available in four to six weeks.

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U.S. Food and Drug Administration (FDA)

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Senate to Vote Again on Ending COVID-19 National Emergency

The Senate is expected to vote on a resolution to end the COVID-19 national emergency as pressure grows on the Biden administration to unwind emergencies. The Senate narrowly passed a similar resolution back in March by a 48-47 vote. The House did not take up the resolution, and the White House issued a veto threat if the legislation made its way to Biden’s desk. However, President Biden’s recent remarks that the pandemic “is over” have brought the vote back into question. It is important to note, though, that ending the national emergency will not affect the status of the public health emergency (PHE).

Source:  

Fierce Healthcare

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Walgreens Acquires Specialty Pharmacy Company for $1.37B

Walgreens Boots Alliance announced that it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37B. Last year, Walgreens spent $970M to increase its stake in the company to 71%, with the possibility of taking full ownership over the company. The transaction is expected to be completed by the end of the year. Shields currently names 30 health systems as partners, including 1,000 hospitals.

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Fierce Healthcare

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Federal Judge Rules UnitedHealth Merger May Proceed

On September 19, a federal judge gave UnitedHealth Group the green light to acquire Change Heathcare, a medical data firm. In February, the DOJ filed a suit to block the acquisition, arguing that it would grant UnitedHealth access to a treasure trove of data on other payers that it could potentially misuse to benefit UnitedHealthcare, its insurance arm. However, the recent ruling allows UHG to move forward, raising concern among many independent pharmacies. In response to the ruing, NCPA CEO Doug Hoey said, “The acquisition of Change Healthcare will give it a massive advantage over its competitors, and it will create an irresistible incentive for the insurance company to use patient data to steer business to its own pharmacy, and away from local, small-business pharmacies.”

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NCPA

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New Study Finds Telehealth Effective in Treating Opioid Use Disorder

A study by the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), and the National Institute on Drug Abuse (NIDA) suggests that telehealth expansions throughout COVID-19 led to a reduced risk of opioid overdoses in adults with opioid use disorder (OUD). When comparing individuals who received OUD-related telehealth services to those who did not, treatment retention was higher and overdose risk was lower. The study suggests that telehealth expansion should extend past the COVID-19 PHE allowance, which ends in October.

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JD Supra

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Novavax Vaccine Now Authorized for Ages 12 and Up

The U.S. Food and Drug Administrated has authorized the Noxavax COVID-19 Vaccine, Adjuvanted in patients age 12 and up. The Novavax vaccine is administered as a two-dose primary series. It is the first protein-based COVID-19 vaccine authorized in the US. Read the FDA’s Novavax fact sheet to learn more.

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US Food and Drug Administration (FDA)

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All COVID-19 Boosters Must Be Bivalent Formulations

On August 31, the FDA gave Pfizer and Moderna’s COVID-19 bivalent booster products emergency use authorization. The bivalent vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection from the omicron variant. The FDA no longer authorizes the monovalent product for boosters.

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US Food and Drug Administration (FDA)

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Teva Announces $4.25B Proposed Settlement

Teva Pharmaceutical Industries announced a $4.25 billion proposed nationwide settlement to resolve thousands of lawsuits over its alleged role in the United States opioid epidemic. Israel-based Teva would pay state and local governments up to $3.7 billion in cash over a thirteen-year period, plus a $1.2 billion contribution of Naloxone. Affected states include California, Illinois, Iowa, Massachusetts, New York, North Carolina, Pennsylvania, Tennessee, Texas, Vermont, Virginia, and Wisconsin.

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Policy & Medicine

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President Biden Signs Inflation Reduction Act

On August 16, President Biden signed the Inflation Reduction Act. The Inflation Reduction Act will affect pharmacies in 7 major ways: 1. drug prices will be negotiated, 2. negotiations will be given a new framework, 3. Medicare Part D beneficiaries will get annual out-of-pocket caps, 4. patient cost sharing will be smoothed out, 5. adult vaccine costs will be shared, 6. drug rebates will be changed, and 7. insulin copays will be changed. The Inflation Reduction Act is effective immediately.

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NCPA

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FDA Clears Path for Lower-Cost OTC Hearing Aids

On August 16, the U.S. Food and Drug Administration issued a final rule to improve millions of Americans' access to lower-cost hearing aids. The rule establishes a new category of over-the-counter hearing aids, enabling patients 18 years of age and older to purchase directly from retailers without a prescription. The rule is also expected to lower the cost of hearing aids to an estimated $300-$500 each. Close to 30 million adults in the US could benefit from hearing aids.

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US Food and Drug Administration (FDA)

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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.

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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.

Source:  

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.

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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.

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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.

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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.

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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.

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.

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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.

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.

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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.

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.

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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.

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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.

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.

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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.

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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.

Source:  

HHS.gov

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