CMS published its revised guidance on the Inflation Reduction Act (IRA), both for Part D and Part B. In the Part D revised guidance, CMS stated that it continues to evaluate different options for identifying 340B units and will finalize a policy for excluding 340B units by plan year 2026. For a fact sheet on CMS’ revised IRA guidance, click here. For CMS’ press release, click here.

Pharmacies that have 20 or fewer full-time employees that do not otherwise meet an exemption will be required to report a “beneficial ownership information (BOI) report” with the US Treasury’s Financial Crimes Enforcement Network (FinCEN) beginning Jan. 1, 2024 under the Corporate Transparency Act. A pharmacy created or registered before Jan. 1, 2024, will have until Jan.1, 2025, to file their initial BOI reports with FinCEN. A pharmacy created or registered in 2024 will have 90 calendar days from the time the company receives actual notice from its state of incorporation that its creation or registration is effective, or after a secretary of state or similar office first provides public notice of its creation or registration, whichever is earlier, to file their initial reports.

On Dec. 18, the FTC and the Justice Department lowered the threshold for scrutiny and challenge for mergers in a set of newly released guidelines, effectively making corporate concentration more difficult and making competition more fulsome. If a merger might result in more than a 30 percent market share, or if a newly vertically integrated company would gain control of 50 percent of a related market, then that triggers this increased scrutiny — in response to more than 30,000 comments from across the American economy, from consumers to workers to enforcement agencies to interest groups (like NCPA).

Mexican authorities raided dozens of pharmacies in Ensenada and seized thousands of boxes of pills as part of a broader effort to crack down on drugstores suspected of selling counterfeit and fentanyl-tainted medications.

The joint effort by the Mexican navy and federal health authorities is at least the third such operation this year; over the spring and summer, local and federal agencies conducted similar raids in Los Cabos and the Yucatán Peninsula. Though the searches in Cabo San Lucas and San José del Cabo led to four arrests, it’s unclear whether anyone was arrested this time. Neither the navy nor the health officials responded to requests for comment.

CVS Pharmacy is promising to make its drug pricing system simpler and more transparent. But that may not translate into lower costs or more clarity for consumers. The company announced that its new CVS CostVantage model will revamp how its pharmacies are paid for prescription medications. It will use a formula that includes “the cost of the drug, a set markup and a fee that reflects the care and value of pharmacy services.” The model is designed to increase savings, but savings will be passed along to the PBMs and payors, and it’s up to them to decide how much they’ll pass along to their members. In effect, the new model may be "sloshing money around within the company."

This week, the House is scheduled to vote on H.R. 5378, the Lower Costs, More Transparency Act, a health care package that includes several provisions vital to lowering prescription drug costs and bringing transparency to anticompetitive practices of pharmacy benefit managers. One of those provisions is H.R. 1613, the Drug Price Transparency in Medicaid Act, introduced by Reps. Buddy Carter (R-Ga.) and Vicente Gonzalez (D-Texas). It reforms Medicaid managed care pharmacy payments by prohibiting the use of spread pricing in Medicaid managed care programs and by requiring reimbursements based on average acquisition costs plus the state’s Medicaid fee-for-service dispensing fee. It requires all pharmacies to respond to the Centers for Medicare & Medicaid Services’ National Average Drug Acquisition Costs survey, which would provide more transparency on drug pricing.

This week, the Energy and Commerce Committee passed HR 2880, the Protecting Patients Against PBM Abuses Act, in a 46-0 unanimous vote. HR 2880 amends title XVIII of the Social Security Act to establish certain requirements for pharmacy benefit managers under part D of the Medicare program. It mandates that PBMS should not income with respect to any services provided in connection with covered part D drugs, furnished under such plan, from any entity other than flat dollar amount service fees. It also mandates that service fees cannot be based on the price of any covered drug or discounts, rebates, or other remunerations.

Walmart is running an HIV screening pilot at two Walmart pharmacies in Virginia, which will offer free HIV screenings and results during the test phase. Set to last three months, the pilot is operating at Walmart pharmacies in Petersburg and Ashland, VA., which are HIV-focused Specialty Pharmacies of the Community (SPOC) staffed with HIV-trained pharmacists and community health workers who are equipped to support HIV/AIDS patients throughout their treatment. These tests are screenings, not diagnoses. In the event of a positive test, Walmart will help patients work with their primary care physician or the Department of Health to order a confirmatory test.

U.S. households can once again order four free COVID-⁠19 rapid tests through COVIDTests.gov. These tests will detect the currently circulating COVID-19 variants. Individuals are encouraged to use the free tests immediately to prepare for travel and gatherings with friends and family throughout the 2023 holiday season. Households that ordered tests earlier this fall can order four more tests, and those that have not ordered this fall can submit two orders for a total of eight tests. Visit the Food and Drug Administration website to check the expiration dates of COVID-19 tests.

Pharmacists within CVS, Walgreens, and other retailers are in the process of unionizing, reports Crain’s Chicago Business. The organizing group is calling themselves the “Pharmacy Guild.” The move comes on the heels of scattered walkouts across the nation to protest poor working conditions within pharmacies. IAM Healthcare, a union of health care professionals, is leading the charge, alongside online pharmacist communities. Understaffing is one of the top complaints, with pharmacists citing an increased pressure for vaccinations.

The New York Times reported on a lack of foresight at the FDA, whose approval of about 350 medical software products for sale that incorporate artificial intelligence has led to mixed results. On one hand, AI offers the promise of efficiency — from auto-fill content to help staff who repeatedly enter intake information to sharper diagnostic suggestions based on data and patient symptoms. AI’s “large language models,” or LLMs, can crunch vast amounts of data about frequency and probability to deliver information to providers quickly and, many say, with a reasonable margin of error.

On the other hand, many feel that the range of what AI does imperfectly has an unacceptable margin for error related to patient privacy or, at the very worst, poor recommendations on how patients should be prioritized by providers during the acute care phase.

The report came on the heels of President Biden’s executive order on Monday calling for AI regulations among government agencies, and just two days ahead of a Bletchley Park summit about the future of AI regulation, hosted by British Prime Minister Rishi Sunak, who will welcome representatives from the U.S., including Vice President Kamala Harris, as well as from the European Commission and Italy.

In incidents scattered around the country, pharmacists have refused to go to work or walked off the job. There are signs that a larger strike is brewing, with more walkouts targeting large chains like Walgreens, CVS and Rite Aid in early November. The pharmacists don't have a union, so there is no way to tell how many people might participate or how many locations could be affected. In a nonrandomized survey in 2021, the American Pharmacists Association and National Alliance of State Pharmacy Associations reported that 74% of 4,482 pharmacy workers said they did not have enough time to safely perform nonclinical work, and 75% said there were not enough other staff, like techs and nurses, to safely perform clinical work. Strikes raise awareness about these mounting concerns.

The National Community Pharmacists Association (NCPA) recently set up TRUST LLC, a legal entity that will potentially arbitrate or litigate PBM lawsuits on behalf of individual pharmacies, most of which could never afford to do so on their own. PBMs have weaponized their nearly unlimited resources — money, time, and attorneys — and they have set up dispute-resolution processes that make gaining access to justice next to impossible. TRUST LLC allows individual pharmacies to pool their claims and hire the best attorneys in the country to represent them. NCPA member locations can join the trust for free.

CVS Health will remove from its shelves certain oral cough and cold products with phenylephrine as the only active ingredient, the U.S. pharmacy chain said. A panel of advisers to the U.S. health regulator last month refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, which is widely used in cold and cough syrups. The U.S. Food and Drug Administration (FDA) is yet to remove phenylephrine from its list of ingredients for OTC use and plans to seek public opinion before making a decision. Rival pharmacy chain Walgreens said it will follow FDA regulations and continue monitoring the situation.

Amazon Pharmacy is currently testing a new drone delivery system in select locations, including College Station, TX. Customers in College Station can get their prescription medications dropped outside their door via Amazon’s drone delivery service within 60 minutes of placing their order, at no additional cost. Eligible Amazon Pharmacy customers can select “free drone delivery in less than 60 minutes” at checkout. The drones offer access to more than 500 medications that treat common conditions, including flu, asthma, and pneumonia. This new service offers an interesting business model for independents to consider.

Rite Aid, one of the largest pharmacy chains in the United States, filed for bankruptcy on Sunday, weighed down by billions of dollars in debt, declining sales and more than a thousand federal, state and local lawsuits claiming it filled thousands of illegal prescriptions for painkillers. The company filed for Chapter 11 bankruptcy protection in New Jersey. Its largest creditors include the pharmaceutical company McKesson Corporation and the insurer Humana Health. The pharmacy has raised $3.45 billion to fund its operations while it is in bankruptcy, during which it expects to continue to operate its stores and serve its customers.

Employees at Walgreens stores across the country are reportedly planning to stage a walkout next week to protest against harsh working conditions. The demonstration, set to take place between Oct. 9 and 11, will include pharmacists, technicians and support staff working at the nation’s second-largest pharmacy store chain, one of the organizers told CNN. Employees at more than 500 stores across the U.S. have expressed interest in taking part in the walkout. However, it’s unclear how many will end up joining the demonstration. Some of the workers are expected to hold the protest over three days, while others are expected to walk out for just one day, according to the organizer, who asked to remain anonymous.

The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services (HHS) announced a Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Second Extension”). This is a follow-up to a May of 2023 extension of telemedicine flexibilities implemented during the COVID-19 Public Health Emergency (PHE).This latest extension becomes effective November 11, 2023, and lasts through December 31, 2024. There is currently no official date for the two proposed rules to be implemented. The DEA and HHS anticipate promulgating a final set of regulations in the near future to provide more clarity on telemedicine prescribing requirements for controlled substances.

Last week, the Senate Finance Committee introduced S. 2973, the Modernizing and Ensuring PBM Accountability Act. Chairman Ron Wyden (D-Oregon) and Ranking Member Mike Crapo (R-Idaho) stated that this package would bring more transparency, accountability and competition to pharmacy benefit manager (PBM) practices in the pharmaceutical supply chain. This bill reflects the Chairman’s Mark that was reported out of the Finance Committee in July, including The Drug Price Transparency in Medicaid Act (S. 1038) and The Protect Patient Access to Pharmacies Act (S. 2052). Additional provisions of note would delink PBM compensation from the cost of medications so that PBMs are no longer benefiting from ever-increasing list prices and rebates and would require PBMs to disclose criteria used to classify drugs as specialty to prevent patient steering to PBM-affiliated specialty pharmacies.

Independent pharmacist Matt Osterhaus (Osterhsaus Pharmacy, Maquoketa, IA) has filed a class action lawsuit against vertically consolidated CVS Health, Caremark, and Aetna that aims to recoup for all independent pharmacies millions of dollars in what his lawyers say are wrongfully assessed pharmacy DIR fees for Medicare Part D prescriptions. Representing the class are the law firms of Berger Montague PC and Cohen & Gresser LLP. The suit claims that Caremark has been assessing pharmacy DIR fees in violation of federal antitrust laws and state laws governing contracts. It also challenges Caremark's agreements to arbitrate claims as being unfair and unenforceable.

A group of conservative Republicans in the House of Representatives’ proposed Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368) would rescind the Food and Drug Administration (FDA)’s January 2023 change to the Risk Evaluation and Mitigation Strategy (REMS) program to allow certified retail pharmacies to dispense mifepristone as part of a medication abortion regimen. The proposal would effectively limit retail pharmacy dispensing of the only medication that is labeled for medication abortion. The atmosphere surrounding the government funding bills is so unsettled that it is not clear whether this act will pass the House.

Nearly two dozen pharmacists at the nation’s largest retail pharmacy chain staged a walkout in the Kansas City metro area this week over working conditions they say put CVS Health pharmacists and patients at risk. The walkout began Thursday and continued into Friday. Organizers said they had shuttered numerous pharmacies across the metro area, which covers a portion of eastern Kansas and western Missouri. Some pharmacies outside the metro area also have joined. They estimated at least 22 locations had closed. While the group’s specific complaints focus on store staffing and quotas, the walkout reflects a rising outcry from pharmacists at several national pharmacy chains. They say their work requirements leave them unable to safely fill and verify prescriptions, putting patients at risk of serious harm or even death.

Walmart is cutting hours at its busy pharmacies, while Rite Aid — which is already selling off stores — is expected to file for bankruptcy protection. The news comes after inspectors have found that CVS’s understaffed stores in some instances lacked controls to protect patients. Last week, Reuters reported that Walmart was trying to reduce costs by asking 16,000 pharmacists to work fewer hours. Earlier this year, the company reduced the hours at 4,500 of its 5,000 pharmacies by two a day. Meanwhile, Rite Aid is reportedly planning to file for Chapter 11 bankruptcy protection — a move that would likely involve the company closing 400 of its roughly 2,000 stores. Finally, in 2021, CVS announced that it was closing 900 of its stores over the next three years, citing declining sales due to online competition as part of the reason.

Emergent BioSolutions has launched an over-the-counter version of its opioid overdose treatment Narcan, putting the emphasis on the potential for the product to keep loved ones safe with the tagline “anyone can save a life.” Emergent recently began shipping OTC products to “leading mass, drug/pharmacy and grocery stores, as well as online retailers.” The nasal spray is scheduled to hit shelves in early September with a suggested retail price of $44.99. The price works out to $22.50 per dose.

CMS recently announced 10 drugs covered under Medicare Part D that it will negotiate with manufacturers on price under the Inflation Reduction Act (IRA) to establish a “maximum fair price” (MFP) of these drugs, effective in 2026. The list of the ten drugs includes: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. Under the IRA, pharmacies will be reimbursed the difference between the acquisition cost of the drugs and the MFP.

After admitting to running a price-fixing scheme as part of a deal with the Department of Justice, not only will generic makers Teva and Glenmark Pharmaceuticals pay hefty fines, but they'll also be forced to divest certain products. The two companies reached a deferred prosecution agreement (DPA) with the government, meaning the U.S. will charge the companies but it won’t move forward with the case as long as Teva and Glenmark follow certain terms. If they hold up their end of the agreement, the charges will then be dismissed.

Nine states are pushing back to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it inflated the price of its lucrative insulin product Humalog. The states argue Lilly is trying to use the deal to ward off future lawsuits by U.S. states. In a recent filing in New Jersey federal court, lawyers for Arizona, Mississippi and Minnesota urged U.S. District Judge Brian Martinotti to delay approval of the deal unless it’s altered to make sure states can still file their own lawsuits over insulin prices. The states joined Illinois, Nebraska, Utah, Arkansas, Kansas and Montana in making their objections known this week.

Historically, a retail pharmacy unable to fill an initial electronic prescription for Schedule II-V controlled substances could not transfer it to another pharmacy – even if the two pharmacies were affiliated and part of a larger organization. However, CMS published a final rule to amend Drug Enforcement Administration (DEA) Regulation 21 CFR 1306.08. The amended rule will become effective on Aug. 28, 2023, and will allow for the transfer of electronic prescriptions for Schedule II-V controlled substances. The rule applies to retail pharmacies for initial filling on a one-time transfer basis only, upon request from the patient. Additionally, any authorized refills included on a prescription for a Schedule III, IV or V controlled substance may be transferred with the original prescription.

CVS Health is laying off 5,000 employees as part of an effort to shed costs, the retail and pharmacy chain confirmed recently. The layoffs will primarily affect "non-customer facing positions" such as corporate roles, the company said, adding that it does not expect the move to impact brick-and-mortar stores, pharmacies and clinics. As of December, CVS employed roughly 300,000 workers worldwide, according to a securities filing. The just-announced layoffs will eliminate less than 2% of the company's workforce.

U.S. Senator Sherrod Brown (D-OH) introduced bipartisan legislation to lower out-of-pocket costs of medicines for chronic conditions in the deductible or when patients owe coinsurance. The Share the Savings with Seniors Act would require pharmacy benefit managers (PBMs) and insurers to pass on all savings they negotiate on the list price of a chronic condition drug to the patient to lower the cost of their drug at the pharmacy counter. Brown introduced the bill with John Cornyn (R-TX), Tom Carper (D-DE), and Thom Tillis (R-NC).

New bipartisan healthcare legislation on pharmacy benefit managers (PBMs) and healthcare transparency is moving through both the House and Senate. H.R. 4527, the Health DATA Act, would ensure that health plan fiduciaries are not contractually restricted from receiving cost or quality of care information about their plan, including by adding PBMs to the list of groups that can be liable for violating gag clause provisions. The bill advanced by a vote of 38–1.

New bipartisan healthcare legislation on pharmacy benefit managers (PBMs) and healthcare transparency is moving through both the House and Senate. H.R. 4508, the Hidden Fee Disclosure Act, would strengthen requirements that PBMs and Third-Party Administrators disclose compensation to plan fiduciaries. The bill advanced by a vote of 39–1.

New bipartisan healthcare legislation on pharmacy benefit managers (PBMs) and healthcare transparency is moving through both the House and Senate. H.R. 4509, the Transparency in Billing Act, would require accurate billing practices by hospitals, ensuring that group health plans pay for appropriately billed services. The bill advanced the House by a vote of 39–0.

New bipartisan healthcare legislation on pharmacy benefit managers (PBMs) and healthcare transparency is moving through both the House and Senate. H.R. 4507, the Transparency in Coverage Act, would codify the Transparency in Coverage final rule, which would provide consumers with price transparency for medical services and prescription drugs, and bring light to PBM practices. The bill advanced by a vote of 38–1.

Last week, the Senate Finance Committee introduced a new bill to promote PBM reform. Sens. Joe Manchin (D-WV) and Marsha Blackburn (R-TN) introduced S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act. This bill would explicitly require CMS to define what reasonable and relevant contract terms are to ensure that PBMs are required to comply with this standard in Medicare Part D and pharmacies can continue participating in networks.

Several pieces of PBM reform legislation were introduced in the Senate in advance of the Finance Committee’s markup of its PBM reform proposal. John Thune (R-SD), Sherrod Brown (D-OH), John Barrasso (R-WY), and Debbie Stabenow (D-MI) introduced S. 2405, the Strengthening Pharmacy Access for Seniors Act. The bill would specifically require PBMs to reveal the criteria used to classify drugs as specialty and prevent PBMs from steering patients to PBM-affiliated specialty pharmacies that limit patients’ options.

The U.S. Food and Drug Administration has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Both Sanofi and AstraZenica plan to make Beyfortus available in the U.S. ahead of the upcoming 2023-2024 RSV season.

The U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy — the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. The timeline for availability and price of this nonprescription product is determined by the manufacturer.

Insulin products covered under Medicare Part D now have a $35 cost-sharing cap for a month’s supply. This includes any new insulin products that become available during the plan year. The cost-sharing cap also applies to insulin delivered through a pump that is covered under the durable medical equipment benefit under both Medicare Part B and Medicare Advantage.

Pharmacy chain Walgreens plans to close 150 of its locations in the U.S. and 300 more in the United Kingdom. This continues ongoing cost-saving initiatives at the company, including more than 500 corporate personnel jobs being cut. The company has not announced which locations will be closed, but the closings are expected to occur before the end of Walgreens' 2024 fiscal year in May 2024. Store closings are just some of the company's cost-saving measures, which come as Walgreens reported net income of $118 million, about 59% below the previous year, and failed to meet earnings expectations, based on analysts polled by S&P Global Market Intelligence.

The U.S. government revised its guidance for its Medicare drug price negotiation process, allowing drug companies to publicly discuss the talks, but did not make major changes likely to convince drugmakers to end their suits seeking to halt the program. The program was established under the Inflation Reduction Act (IRA), which President Joe Biden signed into law last year. It will for the first time allow Medicare, the government health insurance program for millions of Americans age 65 and older, to negotiate prices on prescription drugs, beginning with the ones on which it spends the most. Merck & Co (MRK.N), Bristol Myers Squibb (BMY.N), the U.S. Chamber of Commerce and the leading industry lobby have filed separate suits against the U.S. government over the program, claiming it is unconstitutional.

A federal court judge ordered CVS Caremark to comply with a 2022 arbitrator’s award directing the PBM to reimburse a San Francisco pharmacy for the improper assessment of DIR fees. Chief District Court Judge for Arizona G. Murray Snow upheld last year’s finding that Caremark failed to comply with the Any Willing Provider Law (AWPL) and pay Mission Wellness Pharmacy $3.6 million plus interest. Under AWPL, the court said, Caremark is obligated to provide "reasonable and relevant" reimbursement rates to Mission Wellness for lost revenue while participating in Caremark’s Medicare Part D networks.

A new report reveals the most expensive prescription drugs in 2023. Some of the top contenders include gene therapy drugs, from Bluebird’s thalassemia therapy Zynteglo at $2.8 million for a one-time dose to CSL and uniQure’s $3.5 million hemophilia B treatment Hemgenix. Orphan drugs such as Eiger BioPharmaceuticals’ Zokinvy — the first drug cleared in the U.S. for Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies — costs about $1.7 million a year. Other costly drugs outside the gene therapy realm include Y-mAbs’ Danyelza for relapsed or refractory high-risk neuroblastoma, Chiesi’s leptin deficiency drug Myalept and Immunocore’s T-cell receptor therapy for uveal melanoma, called Kimmtrak.

A bipartisan group of senators introduced the Patients Before Middlemen (PBM) Act, which aims to decouple PBM compensation from drug price and utilization, aligning incentives to lower prescription drug costs for Medicare Part D beneficiaries. Specifically, the PBM Act would prohibit PBM compensation based on the price of a drug as a condition of entering into a contract with a Medicare Part D plan, and provides that service fees will not be connected to the price of a drug, discounts, rebates, or other fees. The bill would also create an enforcement mechanism requiring PBMs to pay the secretary of Health and Human Services any amount that exceeds the designated service fees.

Senators Jon Tester (D-Mont.), Shelley Moore-Capito (R-W.Va.), Sherrod Brown (D-Ohio), and James Lankford (R-Okla.) introduced the Protect Patient Access to Pharmacies Act (S. 2052). This bill provides long-sought reform of abusive business practices that have permitted the monstrous growth of direct and indirect remuneration fees collected by Medicare Part D plans from pharmacies. The bill also helps to secure Medicare patients’ freedom to receive medications and care from the pharmacy of their choice by improving enforcement of the “any willing pharmacy” law intended to prevent the exclusion of pharmacies from Part D plan networks. Specifically, the legislation ensures that, at a minimum, a pharmacy’s costs to acquire and to dispense a covered Part D drug to beneficiaries are covered so that pharmacies have at least the option to participate in a Part D network.

As supply chain issues sweep across the industry, Pfizer is warning about expected supply shortfalls of its penicillin offerings. After the FDA first reported a nationwide penicillin shortage in April, Pfizer updated its hospital customers on the expected limited supply of its Bicillin prefilled syringes. As it stands, all doses of the company's combination penicillin syringes are expected to run out during this year’s third quarter. Supply of the long-acting version and its pediatric dosing will diminish by the end of the second quarter. Out of the six dosage forms Pfizer makes, two combination doses are estimated to be back in stock by 2024’s third quarter and two long-acting forms should be back in by the second quarter of 2024.

On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers. The suit is the first attempt by a pharmaceutical company to challenge the IRA’s Medicare drug price negotiation program. Merck argues that the Medicare negotiation program “is not ‘negotiation’” but rather “is tantamount to extortion,” and that the price negotiation program violates Merck’s constitutional rights. Merck’s top-selling drug Keytruda, a cancer immunotherapy, will likely be subject to the Medicare drug pricing negotiations in subsequent rounds and could be subject to reduced pricing starting in 2028.

The Medicare over-the-counter (OTC) COVID-19 test demonstration program has ended, which means Medicare will no longer reimburse providers for furnishing home tests to Medicare beneficiaries. Although the program is over, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Justice (DOJ) have taken an interest in reviewing whether providers complied with the requirements for the program. The government has multiple options to either audit or investigate providers that received reimbursement under the program. Such review could come from (1) administrative audits conducted by a CMS contractor, (2) a civil investigation under the False Claims Act (FCA) or (3) a criminal investigation. The DOJ has already indicted at least one provider for claims submitted under this program, and more enforcement activity is expected.

Walmart has trained pharmacists on specialty HIV treatments in communities that are highly affected by the virus, and it plans to expand the program to nearly a dozen states this year. The chain launched an HIV specialty-pharmacy pilot program in late 2021, targeting just over half a dozen communities. Now, Walmart plans to expand its program to more than 80 HIV-specialty facilities across nearly a dozen states by the end of this year. CVS and Walgreens have launched similar programs, partnering with an initiative from the federal government that aims to reduce the HIV epidemic by 2030.

About a month after GSK won the world's first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the CDC will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should CDC members put their support behind the vaccine.

On June 1, the U.S. Supreme Court made a unanimous decision about the False Claims Act (FCA) and its scienter element, which focuses on a defendant's intent when making false claims. The Court ruled that the defendant's subjective belief at the time of the alleged false claim is crucial in determining whether or not they are liable to the FCA, even if there is an ambiguous or reasonable interpretation of the law. The decision identified three types of scienter that can lead to FCA liability: actual knowledge, deliberate ignorance, and reckless disregard. For pharmacies, this means they must consider their subjective beliefs and intentions when submitting claims. While it may be easier for pharmacies to prevail in FCA cases by demonstrating good-faith subjective belief, they should also ensure proper documentation to support compliance with ambiguous laws and regulations.

Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. The lawsuit was filed in 2017, against insulin makers Lilly, Novo Nordisk and Sanofi. Plaintiffs claimed the companies joined in an “arms race” to raise list prices of their meds while the “real” price to pharmacy benefit managers remained constant or in some cases dipped. The companies did this, the suit claims, to leverage the growing “spread” between public and private prices and win favorable formulary positioning. As part of the settlement, which was recorded (PDF) in federal district court in New Jersey, Lilly has agreed to cap out-of-pocket cost its insulin at $35 per month for four years.

CMS released a Medicaid proposed rule. The proposed rule clarifies and establishes requirements for state fee-for-service (FFS) pharmacy reimbursement, including that both ingredient cost reimbursement and professional dispensing fee reimbursement under Medicaid fee for service must be based on pharmacy-established cost data, and that market-based research (such as third-party payments accepted by pharmacies) will not qualify as supporting data. CMS is also proposing that managed care plans structure contracts with PBMs to be transparent about spread pricing. CMS proposes to require PBMs report the cost of the covered outpatient drug and dispensing separately from any other fees charged to the plan by the PBM.

The U.S. Food and Drug Administration approved the oral antiviral Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug —and first oral antiviral pill— approved by the FDA to treat COVID-19 in adults. Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval.

As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the Federal Trade Commission has issued compulsory orders to two group purchasing organizations (GPOs) that negotiate drug rebates on behalf of other PBMs. The compulsory orders will require Zinc Health Services, LLC and Ascent Health Services, LLC to provide information and records on their business practices. Zinc was founded in 2020 and operates as the GPO for CVS Caremark. Ascent was founded in 2019 and operates as a GPO for Express Scripts, Prime Therapeutics, Envolve Pharmacy Solutions, and Humana Pharmacy Solutions. The FTC is issuing the orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies without a specific law enforcement purpose. The companies will have 90 days from the date they receive the order to respond.

The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule, effective May 11, that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE) for controlled medicines. The set of telemedicine flexibilities regarding prescription of controlled medications that were in place during the COVID-19 PHE will remain in place through November 11, 2023. Additionally, for any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications that were in place during the COVID-19 PHE will continue to be permitted via a one-year grace period through November 11, 2024.

In a unanimous vote, 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill. If approved, the pill would be sold by Perrigo under the brand name Opill. It is a so-called progestin-only pill that contains only a synthetic version of the hormone progesterone to prevent pregnancy. Most pills also contain estrogen. While the FDA typically follows the recommendation of its advisory committees, it isn't required to. The recommendation, which came at the conclusion of a two-day public meeting, was welcomed by major medical groups.

Based on current COVID-19 trends, the Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. Addressing COVID-19 remains a significant public health priority for the Administration, and over the next few months COVID-19 policies will transition, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients. HHS will work closely with partners, including state, local, tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition.

HHS Secretary Becerra announced that in the coming weeks, he will issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19. By issuing this amendment, the Secretary of HHS intends to allow pharmacies to continue their critical roles in our response, even after certain products transition to traditional health care pathways. The end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures.

The Centers for Medicare and Medicaid Services (CMS) issued the contract year 2024 changes to the Medicare Advantage and Medicare Prescription drug benefit program final rule, which will be published in the Federal Register on April 12. The final rule made the Medicare Limited Income Newly Eligible Transition (LI NET) program a permanent part of Medicare Part D, and it also expanded the low-income subsidies program under Part D as well. MA plans must now comply with national coverage determinations (NCD), local coverage determinations (LCD), and general coverage and benefit conditions included in traditional Medicare statutes and regulations as interpreted by CMS. CMS did not finalize its proposal of expanding the medication therapy management (MTM) program.

The FDA authorized vilobelimab injection (Gohibic, InflaRx) to treat COVID-19 in hospitalized adults. The emergency use authorization (EUA) allows for the initiation of vilobelimab within 48 hours of a COVID-19 patient receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. In a global clinical trial of hospitalized COVID-19 patients, results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared with placebo. The FDA recommends 800-mg doses of vilobelimab administered intravenously after dilution up to six times over the treatment period.

A new bipartisan bill has entered the Senate, known as the Drug Price Transparency in Medicaid Act (S. 1038). This bill, introduced by Sens. Peter Welch (D-Vt.) and Roger Marshall (R-Kan.), would improve transparency and protect taxpayers by preventing pharmacy benefit managers from using spread pricing in Medicaid managed care programs. Companion legislation (H.R. 1613) was introduced in the House by Reps. Buddy Carter (R-Ga.), Vicente Gonzalez (D-Texas), Rick Allen (R-Ga.), Jake Auchincloss (D-Mass.), Elise Stefanik (R-N.Y.), and Deborah Ross (D-N.C.). The bill awaits hearings in multiple Senate committees.

On March 29, the U.S. Food and Drug Administration (FDA) approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use. This is the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

The U.S. Senate Committee on Commerce, Science, and Transportation held markup of S. 127, the Pharmacy Benefit Manager Transparency Act of 2023. The committee advanced the bill in a bipartisan vote of 18-9. The PBM Transparency Act empowers the Federal Trade Commission to increase drug pricing transparency and would prohibit several abusive PBM practices. It also grants the FTC and state attorneys general the ability to penalize and/or initiate legal action against PBMs, for these prohibited practices, in the commercial health insurance market and directs the Government Accountability Office to conduct a study into PBM practices. It includes a new amendment which closes a loophole that could have allowed PBMs to continue to engage in the abusive practice of clawbacks and protects the DIR final rule that limited post-adjudication clawbacks.

The U.S. government on Monday sued Rite Aid Corp (RAD.N), accusing the pharmacy chain of missing "red flags" as it illegally filled hundreds of thousands of prescriptions for controlled substances, including opioids. In a complaint filed in Cleveland federal court, the Department of Justice said Rite Aid repeatedly filled prescriptions from May 2014 to June 2019 that were medically unnecessary, for off-label use, or not issued in the usual course of professional practice. The Justice Department also said Rite Aid intentionally deleted some pharmacists' internal warnings about suspicious prescribers, such as "cash only pill mill???", while admonishing them to "be mindful of everything that is put in writing." Rite Aid is one of the country's largest pharmacy chains, with more than 2,330 stores in 17 U.S. states

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Congressional lawmakers are calling on the State Department to issue a travel advisory warning Americans that some Mexican pharmacies are passing off counterfeit pills made of fentanyl and methamphetamine as legitimate pharmaceuticals. U.S. Sen. Edward J. Markey (D-Mass.) and Rep. David Trone (D-Md.) sent a letter Friday to Secretary of State Antony J. Blinken urging the department to immediately “warn Americans traveling to Mexico of the danger they face when purchasing pills from Mexican pharmacies.” In explaining the need for such a high-profile warning, the letter repeatedly cited an investigation by the Los Angeles Times as well as a study by UCLA researchers — both of which found dangerous counterfeit pills being sold over the counter at pharmacies in northwestern Mexico.

The key prize in Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals was blockbuster-to-be migraine pill Nurtec OTC. Now, five months after completing the purchase, Pfizer has taken a nasal spray with the same mechanism of action across the FDA finish line. On Friday, the regulator signed off on Zavzpret (zavegepant) for the treatment of migraine headaches in adults. Zavzpret and Nurtec are from the calcitonin gene-related peptide (CGRP) receptor antagonist class of medicines. After a dual approvals in 2020 and 2021, Nurtec became the first medicine to treat and prevent migraines. Now Zavzpret becomes the first CGRP in nasal spray form. Pfizer said it expects to launch the drug in July.

Walgreens will not dispense abortion pills in nearly two dozen states after legal threats from GOP lawmakers, the retail pharmacy chain confirmed The Walgreens decision stems from a letter written by nearly two dozen Republican state attorneys general at the beginning of February that threatened legal action if the company began distributing mifepristone in their states. The states are: Missouri, Alabama, Alaska, Arkansas, Florida, Georgia, Indiana, Kentucky, Iowa, Louisiana, Montana, Mississippi, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah and West Virginia.

The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto privacy regulator. In a proposed order agreed to by the parties to settle the FTC’s claims, GoodRx would pay a $1.5 million penalty. According to the FTC’s complaint, GoodRx shared sensitive personal health information—such as prescriptions and health conditions—with third party advertising services like Facebook, Google, and Criteo and other third parties. The FTC alleged that GoodRx made those disclosures despite representing to consumers that it would “never” share health information with advertisers or other third parties and not otherwise obtaining consent or authorization for those disclosures.

The Biden administration announced that the COVID-19 national emergency and the COVID-19 public health emergency will end on May 11. Prior to the announcement, the COVID-19 national emergency was scheduled to expire March 1, and the PHE had been extended through April 11. For pharmacies, this means changes to Medicare, Medicaid, and CHIP policies. Some PREP Act authorities will also end in states that have not passed permanent legislation.

On January 31, 2023, Amjevita™ (adalimumab-atto) entered the U.S. market as the first biosimilar of Humira® (adalimumab). Amjevita will be available in a low-concentration, citrate-free formulation (40 mg/0.8mL and 20mg/0.4mL) in prefilled syringes and for autoinjectors. There will be two different pricing options, the first at a list price (wholesale acquisition cost) that is a 5% discount compared to Humira, and the other at a 55% discount. Amjevita is the first Humira biosimilar to enter the U.S. market, with at least seven additional biosimilars likely to launch this year based on settlement agreements.

Drug manufacturers can limit healthcare providers' use of outside pharmacies for dispensing drugs under a federal drug discount program, a federal appeals court ruled January 30, 2023. The ruling from a three-judge panel of the 3rd U.S. Circuit Court of Appeals based in Philadelphia is a victory for Sanofi SA, Novo Nordisk AS and AstraZeneca PLc. The companies had sued the U.S. Department of Health and Human Services (HHS) after it ordered them to stop restricting sales of discounted drugs to so-called contract pharmacies.

Senators Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) are reintroducing the PBM Transparency Act (S. 127), and the Prescription Pricing for the People Act (S. 113). The PBM Transparency Act (S. 127), which provides plan sponsors/employers much needed transparency on how PBMs administer their pharmacy benefit and clarifies the Federal Trade Commission’s enforcement authority to prohibit unfair or deceptive business practices, like spread pricing, that drive up the costs of prescription drugs at the expense of consumers. The Prescription Pricing for the People Act (S. 113), which keeps the pressure on the Federal Trade Commission to complete its probe into the role and recent merger activity of PBMs, including possible anticompetitive behavior.

Overseeing Medicare’s new authority to negotiate prices of the country’s highest-spending drugs is among the top priorities for lawmakers as Congress returns to Washington. Lawmakers and industry groups plan to put pressure on the Medicare agency as it prepares to start negotiating drug prices, including by holding congressional oversight hearings and pursuing clarity on the law’s provisions. “The industry as a whole is at an inflection point,” said Duane Wright, a senior research analyst at Bloomberg Intelligence. “They’ll be aiming a lot of their firepower at the regulatory process to shape the law, while focusing legislative efforts on other priorities,” including transparency around pharmacy benefit managers—the entities that manage drug coverage for health insurers, large employers, and others, he said.

The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, even as more states seek to ban medication abortion. Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful, they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.

Drugmakers including Pfizer, GlaxoSmithKline (GSK), Bristol Myers Squibb, AstraZeneca, and Sanofi plan to raise prices in the United States on more than 350 unique drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors. The increases are expected to come as the pharmaceutical industry prepares for the Biden Administration's Inflation Reduction Act (IRA), which allows the government's Medicare health program to negotiate prices directly for some drugs starting in 2026. In 2022, drugmakers raised prices on more than 1,400 drugs according to data published by 46brooklyn, a drug pricing non-profit that is related to 3 Axis. That is the most increases since 2015.

The Justice Department has filed a lawsuit against AmerisourceBergen, one of the country’s largest pharmaceutical distributors, accusing the company of knowingly distributing opioids that were later resold illegally. The suit, filed by the Justice Department's civil division in conjunction with federal prosecutors in New Jersey, Colorado, Pennsylvania and New York, accuses AmerisourceBergen and two of its subsidiaries of “at least hundreds of thousands” of violations of the Controlled Substances Act. In an 80-page complaint, the Justice Department said AmerisourceBergen of failing to report many of these suspicious orders for nearly a decade, in what it described as an “egregious failure” that had contributed to the opioid epidemic. If the company is found liable, it could face billions of dollars in fines.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.”

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.

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.

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.