News & Press

Pandemic Saw Rise in Opioid Prescriptions Given After Childbirth

Wed, 5 Apr 2023 19:24:00 GMT

HealthDay News
Cara Muraz

New mothers who gave birth early in the pandemic filled far more opioid prescriptions than American women did previously, raising concerns about the potential for narcotic misuse.

About 38% of more than 460,000 women who gave birth from July 2018 through December 2020 were prescribed opioids for postpartum pain management, according to the University of Georgia study.

But there was a nearly 3 percentage point increase in the number of opioid prescriptions filled after March 2020 — when a national emergency was declared in the United States — than before the health crisis began.

The opioids these mothers were prescribed were also higher strength, the researchers noted.

"A lot of women receive opioids for treatment of pain during the postpartum period, but they are a particularly vulnerable group because many of them haven't used opioid medications before," said Emily Lawler, co-author of the study and an assistant professor in the School of Public and International Affairs.

"That makes them high risk for potential opioid abuse," Lawler said in a university news release.

The findings were especially concerning because opioid overdose deaths increased during the pandemic, surpassing 100,000 deaths annually, the study authors said.

Opioids are typically a last resort for pain management after pregnancy.

The American College of Obstetricians and Gynecologists (ACOG) recommends health care providers use an approach for postpartum pain that starts with a basic pain reliever like ibuprofen (such as Motrin or Advil) or acetaminophen (Tylenol). If that doesn't alleviate the pain, physicians are advised to then move to a low-strength opioid, such as codeine or tramadol.

HIPAA Breach in 2025? Notification to HHS is Required

Thu, 4 Dec 2025 19:04:00 GMT

What is significant about March 1, 2026? According to the website

Days Of The Year, it is National Barista Day, Share a Smile Day, and Endometriosis Awareness Day. While these are all great causes, the date carries additional significance for any covered entity (e.g., a pharmacy) who had a HIPAA breach of less than 500 patients in 2025. This is because breach notifications for 2025 are due to the Secretary of Health and Human Services no later than 60 days after the end of the calendar year in which the breach occurred.

Notification to the Secretary

For breaches which involve less than 500 patients (even one patient), the pharmacy can report the event to the Secretary right away, or they may maintain a record of the breaches which occurred within the single calendar year and report them to the Secretary no later than 60 days after the end of the calendar year. For breaches of 500 or more patients, the breach must be reported to the Secretary as soon as possible but no later than 60 days after discovery of the breach to be in compliance with the HIPAA Breach Notification Rule.

Notification to the Patient

Regardless of the size of the breach, the patient must be notified as soon as possible but no later than 60 days after the discovery of the breach. At a minimum, the notice must contain:

A brief description of what happened including the date of the breach and the date of discovery, if known.
A description of the types of unsecure PHI involved (e.g., name, social security number, date of birth, prescription number).
Any steps the patient should take to protect themselves from potential harm.
A brief description of what the pharmacy is doing to investigate the breach, reduce the harm to the patient and protect against future breaches.
The contact information for the pharmacy’s Privacy Officer, including phone, email and/or address.

All notices must be provided via first-class mail to the last known address of the patient or their next of kin, if the patient is deceased. Patient notices may be sent electronically if the patient has previously requested or agreed to receive electronic communications. If the pharmacy has insufficient or out-of-date contact information for less than 10 patients affected by the breach, they may provide the notice by an alternative written form, telephone, or other means. If the pharmacy has insufficient or out-of-date contact information for 10 or more patients, they must post a conspicuous notice on the homepage of the pharmacy website or post in a major print or broadcast media in the area that patients are likely to reside. The print or broadcast media posting must be up for a period of 90 days and contain a toll-free number for patients to call to learn if they were affected by the breach.

Notification to the Media

For any breach that involves more than 500 residents of a State or jurisdiction, the pharmacy must also notify prominent media outlets within the State or jurisdiction. The notification shall be provided as soon as possible but no later than 60 days after the discovery of the breach. The notification must include the same required elements as the notification to the patient.

PAAS Tips:

Pharmacies must take their breach notification requirements seriously
Patients whose PHI was compromised are more likely to file a complaint that can be the impetus for an OCR investigation – better to dot your ‘I’s and cross your ‘T’s when an accidental disclosure has occurred
Several recent cases investigated by the OCR (for failing to report a breach) have led to settlements, including Syracuse ASC ($250K - July 2025) and Cadia HealthCare Facilities ($182K - Sept 2025)

By Trenton Thiede, PharmD, MBA, President at PAAS National^®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

DEA Suffixes: A Quick Reference for Pharmacists

Thu, 4 Dec 2025 19:04:00 GMT

According to 21 CFR 1306.03, a prescriber must be authorized to prescribe controlled substances in the place they are licensed to practice and must either be registered with the DEA or exempted from registration (typically reserved for officials of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons). There is also an exception for prescribers working in a hospital or institutional setting who are allowed to prescribe under the registration of that hospital or institution. The most common exception PAAS National^® analysts see are for medical residents in training who work in a hospital setting but do not yet have their own DEA registration. Prescription documentation requirements for these exceptions are different from a prescriber with a DEA registration, so it is important to understand what is necessary to avoid audit troubles when PBMs flag a claim due to an NPI being billed without a known prescribing authority for a controlled substance.

Controlled substance prescriptions must contain the DEA registration number of the prescriber per 21 CFR 1306.05, but what if the prescriber has one of the above exceptions?

As per 21 CFR 1301.22:

(c) An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered him/herself, provided that:

Such dispensing, administering or prescribing is done in the usual course of his/her professional practice;
Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he/she is practicing;
The hospital or other institution by whom he/she is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction;
Such individual practitioner is acting only within the scope of his/her employment in the hospital or institution;
The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's DEA registration number, preceded by a hyphen (e.g., APO123456-10 or APO123456-A12); and
A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.

In short, a prescriber authorized by a hospital or institution to prescribe controlled substances using the DEA registration of that hospital or institution must add, as a suffix, the internal code assigned to them by the hospital or institution. PBMs may require proof a prescriber has been authorized to issue controlled substance prescriptions under the DEA registration of the hospital or institution they work for, so being able to obtain their current list of internal codes and corresponding practitioners is key. You may need to cite the law above in order to get the hospital or institution to release those records to you.

Similarly, military and other personnel exempted from DEA registration under 21 CFR 1301.23 shall state their branch of service or agency on the prescription and their service identification number in lieu of the DEA registration number required on prescription forms. Public Health Service employees would use their Social Security number as their service identification number.

PAAS Tips:

Ensure all elements required for a controlled substance are present on your prescriptions, including the patient’s address, prescriber’s address, and DEA registration number.
If the prescriber is exempted from registering with the DEA, ensure that the proper documentation exists like the DEA suffix or branch of service and service identification number.
If there is a question about whether a prescriber has a valid DEA registration, use the DEA’s CSA Registration Validation Tool.
Be able to cite 21 CFR 1301.22 to get a copy of the hospital’s or institution’s list of current internal codes and corresponding individual practitioners, if needed.

By Trenton Thiede, PharmD, MBA, President at PAAS National^®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

Medicare Drug Price Negotiation: MTF Data Module Enrollment & Caremark Attestation

Thu, 4 Dec 2025 19:03:00 GMT

Starting in 2026, Medicare has negotiated the price of 10 brand drugs under the Medicare Drug Price Negotiation Program as part of the Inflation Reduction Act of 2022. The negotiations between CMS and drug manufacturers have resulted in Maximum Fair Prices (MFPs).

To implement this program, CMS has created the Medicare Transaction Facilitator (MTF) which will capture pharmacy dispensing data for respective Part D claims and send it to drug manufacturers via the “Data Module” (DM) and then return refund payments from manufacturers back to pharmacies via the “Payment Module” (PM).

Medicare Part D contracts require that network pharmacies enroll in this MTF. Failure to enroll will result in pharmacies losing out on manufacturer rebate dollars that will be necessary to cover the cost of the drugs. There will be a lag time between dispensing claims and receipt of refund payments, which is likely to create a cash flow problem for pharmacies – for this reason, CMS is encouraging manufacturers to expedite payments to pharmacies that self-identify (during enrollment) as having material cashflow concerns.

In addition to enrolling in the MTF DM, we have seen that PBMs also want assurances that pharmacies are completing this enrollment. Caremark sent a Pharmacy Update in October, requiring that pharmacies attest by December 31, 2025 on Caremark’s website confirming enrollment in the MTF DM. Caremark threatens a non-compliance fee for failing to attest.

The negotiated MFPs are not publicly available, however enrolled pharmacies should be able to see claims/refund data on the Beacon website which is managing the DM/PM.

PAAS Tips:

Complete your Caremark Attestation by December 31, 2025
Make sure your NCPDP profile information is accurate
Enroll in MTF before 2026 to ensure you receive appropriate manufacturer refunds
If you are concerned about cashflow concerns, make sure you identify as having “material cashflow concerns” during MTF enrollment
See NCPA and CMS for additional resources

By Trenton Thiede, PharmD, MBA, President at PAAS National^®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

Pharmacist and Brother Sentenced to Prison for $15M Health Care and Wire Fraud Scheme

Mon, 24 Nov 2025 17:38:00 GMT

A former Michigan pharmacist and his brother were sentenced yesterday to eight years in prison and five years in prison, respectively, for their roles in a conspiracy to commit health care fraud and wire fraud.

According to court documents and evidence presented at trial, from approximately 2010 to 2019, Raad Kouza, 59, of Wayne County, a pharmacist, and his brother, Ramis Kouza, 46, of Oakland County, a pharmacy manager, billed Medicare, Medicaid and Blue Cross Blue Shield of Michigan for prescription medications that they did not dispense at pharmacies they owned or operated in Michigan. The defendants executed this fraud by targeting the billing of expensive medications, such as antipsychotics and inhalers, and by concealing inventory shortages at their pharmacies from multiple auditors. As a result of their criminal conduct, the defendants caused a total of over $15 million loss to Medicare, Medicaid and Blue Cross Blue Shield of Michigan.

In November 2024, Raad Kouza and Ramis Kouza were convicted of conspiracy to commit health care fraud and wire fraud by a federal jury in the Eastern District of Michigan. At sentencing, the Court ordered the brothers to pay approximately $15.5 million in restitution and the same amount in forfeiture.

USP 800: What Community Pharmacies Need to Know

Mon, 6 Oct 2025 18:03:00 GMT

Most community pharmacies don’t compound with hazardous drugs, but that doesn’t mean you’re off the hook when it comes to USP 800 compliance. This standard, USP General Chapter <800> Hazardous Drugs: Handling in Healthcare Settings¹, applies to anyone who receives, stores, or dispenses hazardous drugs (HDs). And yes, that includes community pharmacies.

What Makes a Drug Hazardous?

NIOSH² defines a drug as hazardous if it’s linked to cancer, reproductive harm, organ damage, or genetic effects. There are over 250 medications that need to be handled safely to reduce potential harm to employees including medications commonly stocked in community pharmacies such as: azathioprine, carbamazepine, colchicine, finasteride, methotrexate, phenytoin, topiramate, warfarin, as well as hormone products including oral contraceptives.

Illegible Signature? Auditors Are Taking Note!

Mon, 6 Oct 2025 17:42:00 GMT

A recent audit trend shows that some major PBMs are challenging the perceived legitimacy of patient signatures. In particular, Humana and OptumRx have been citing signature logs as discrepant when there is only a line, squiggle, printed first or last name, or initials in lieu of a “proper signature”. The auditor asserts that the pharmacy, not the patient, signed these prescriptions out, negating the proof that the patient confirmed receipt of the medication.

Humana uses the discrepancy code “ISL” and notes that the “signature log sent does not contain a signature.” OptumRx uses the discrepancy code “2B” and notes that “no signature…present on received receipt/log.” While some avenues exist for appeal, it’s predicated on the PBM and best to avoid this nuisance altogether.

PAAS National® also continues to see audit trouble when pharmacy staff sign “delivery/DEL/mail” when delivering or mailing out the prescription to a patient or “DT/drive thru” when the patient picks up their medication from the drive thru (or curbside). If a pin pad needs to be signed out in this fashion to complete an electronic transaction, it’s advisable to collect a manual signature from the patient for your records. Many POS systems allow you to scan these signatures back into the system for electronic recordkeeping.

CDC Immunization Schedule Adopts Individual-Based Decision-Making for Vaccines

Mon, 6 Oct 2025 16:28:00 GMT

The Centers for Disease Control and Prevention (CDC) today updated its adult and child immunization schedules to apply individual-based decision-making to COVID-19 vaccination and recommend that toddlers receive protection from varicella (chickenpox) as a standalone immunization rather than in combination with measles, mumps, and rubella vaccination.

The immunization schedules adopt recent recommendations by the CDC Advisory Committee on Immunization Practices (ACIP), which were approved last week by Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O'Neill. The schedules will be updated on CDC.gov by October 7, 2025.

"Informed consent is back," said Deputy Secretary O'Neill. "CDC's 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today.

"I commend the doctors and public health experts of ACIP for educating Americans about important vaccine safety signals. I also thank President Trump for his leadership in making sure we protect children from unintended side effects during routine immunization."

Unlike the COVID-19 primary series vaccination pioneered by Operation Warp Speed (OWS) that reached a estimated nearly 85% of the U.S. adult population, just 23% of adults followed the CDC's most recent seasonal booster recommendation according to its National Immunization Survey. The booster shots prompted widespread risk-benefit concerns about their safety and efficacy as the COVID-19 virus became endemic following population-wide immunity acquired during the pandemic and OWS.

Pfizer-Trump Deal Blindsides Other Drug Companies

Thu, 2 Oct 2025 19:10:00 GMT

Pfizer's decision to announce a deal with the Trump administration on drug prices Tuesday caused an uproar within much of the pharmaceutical industry, most of which was caught off guard by the announcement.

Why it matters: Pfizer CEO Albert Bourla's acquiescence to President Trump's demands — broadcast live from the Oval Office as the two men stood side by side — puts much more pressure on other drug companies to fall in line after months of unified resistance to Trump's "most favored nation" pricing plan.

Driving the news: Pharmaceutical lobbyists said the agreement was more far-reaching than they expected and would put pressure on other companies to reach similar terms on international pricing parity and other issues.

President Trump said that he expects other companies to individually make deals in the coming weeks, naming Eli Lilly as one possible company.
He raised the threat of additional tariffs on companies that do not come to the table.
Between the lines: "The interesting element to me is how many companies sort of knew something was going on but refused to allow themselves to believe a deal would get cut," said one source familiar with the negotiations between drug companies and the administration.

Pfizer’s Drug Price Deal with White House Gives Big Pharma a Booster Shot

Thu, 2 Oct 2025 18:49:00 GMT

Take a chill pill, investors. Pfizer plans to cut US medication prices as part of an agreement with the White House that analysts say can help restore confidence in the prescription drug industry after months of policy tumult.

In exchange, Washington will grant Pfizer a three-year exemption from potentially onerous tariffs on pharmaceutical imports, provided it maintains a commitment to expand US research and manufacturing capacity.

Double Trouble
The Trump administration has focused on two issues that directly impact the pharmaceutical industry’s bottom line. First, there are prices. A 2024 RAND study found that US drug prices are 278% higher than in 33 other developed countries in the Organization for Economic Cooperation and Development. For brand-name drugs, that climbs to a staggering 422%. The Trump administration announced in May that it would attempt to address the disparity through a “most favored nation” policy that pressures pharmaceutical companies to slash US price tags to equal the lowest offered in comparable developed economies. In May, the president sent letters to 17 pharma CEOs, including Pfizer’s, urging them to commit to most-favored-nation prices for all treatments to Medicaid patients — and for all patients on future drugs — by September 29.

Second, there’s manufacturing. A study by supply chain and risk compliance firm Exiger earlier this year found that 75% of essential medicines in the US are imported, the majority from China and India. “The fundamental problem is we’ve incentivized people to move everything offshore,” Mark Ey, the COO of the National Community Pharmacists Association, told an Axios roundtable in May. Trump said the US will place a 100% tariff on brand-name or patented pharmaceutical imports starting today. The Pfizer deal, meanwhile, set a key precedent for how drugmakers can earn slack in exchange for compliance, with markets signaling approval:

Trump Outlines Plan for Third Round of Medicare Drug Price Talks

Wed, 1 Oct 2025 18:59:00 GMT

The Trump administration issued a final plan Tuesday for how it will carry out the third round of the Medicare drug price negotiations, pushing forward a Biden-era program despite ongoing opposition from the pharmaceutical industry.

The 381-page final guidance by the Centers for Medicare & Medicaid Services outlines how the US government plans to set the prices of up to additional 15 drugs in the program. The negotiations for the third cycle are slated to begin in 2026 and prices will go into effect in 2028.

“CMS is working to lower healthcare and prescription drug costs for Americans while ensuring the negotiation process is open, fair, and responsive to changes in the market and patient needs,” Mehmet Oz, administrator for the CMS, said in a statement.

“We’ve listened to stakeholders, and their feedback helped us make the Negotiation Program more transparent, more workable for manufacturers, and more responsive to the needs of Medicare beneficiaries,” he said.

The program was created under former President Joe Biden’s signature Inflation Reduction Act and allows the US government to be in back-and-forth talks with manufacturers over drug prices covered under Medicare.

The pharmaceutical industry criticized the Trump administration’s draft guidance earlier this year, claiming it doubled down on Biden’s implementation plans.

Trump is Tested on Drug Price Threat

Tue, 30 Sep 2025 19:20:00 GMT

President Trump's deadline for drug price concessions has come and gone. And so far the pharmaceutical industry's expanding list of commitments has included everything but what Trump really wants.

Why it matters: Not committing to lower U.S. drug prices will test how much Trump is willing to throw behind his threat of regulations.

Driving the news: PhRMA, the drugmakers' top trade group, yesterday announced several actions it's taking or has already taken to answer Trump's "call to put America first," as CEO Stephen Ubl put it in a press release.

It highlighted the $500 billion that member companies have committed to spending on U.S.-based infrastructure, financial assistance programs they're providing to patients and the launch of a new website that will connect patients with drug companies' direct-purchasing programs.

Some companies, including AstraZeneca and Bristol Myers Squibb, have already announced that they'll let patients buy certain drugs directly, cutting out the middlemen that the drug industry blames for high patient costs.

Trump Gives Announcement Amid Battle Over Drug Prices

Tue, 30 Sep 2025 19:18:00 GMT

President Trump gave an announcement on Tuesday from the White House as his deadline for drugmakers to lower prices arrives.

“President Trump is doing more to lower healthcare costs than anyone else in Washington, D.C. While Democrats are threatening to shut down the federal government to subsidize health care for illegal aliens, President Trump is leveraging the power of the federal government to drastically cut drug prices for everyday Americans,” White House spokesperson Kush Desai told The Hill in a statement ahead of the comments.

Desai added, “Democrats talked the talk for decades about drug prices, but only President Trump is actually walking the walk.”
White House press secretary Karoline Leavitt also teased TrumpRx in a post on Truth Social — a “direct-to-consumer website for Americans to buy drugs.”

The president’s remarks also came as the government faces a looming shutdown — and as Democrats stand their ground on wanting the GOP to address Affordable Care Act subsidies and Medicaid cuts — and after his speech alongside Defense Secretary Pete Hegseth to a large gathering of military leaders.

Solutions to Solve Pharmacy Deserts are Elusive

Tue, 30 Sep 2025 19:14:00 GMT

The role of a community pharmacy remains vital when it comes to serving the most vulnerable populations. That rings true, even in places many wouldn’t expect it to be, according to Lindsey Angelotti, one of the owners of Ella Community Pharmacy in Hamilton County.

That operation has two well-established locations in Westfield and Sheridan with young owners who are committed to the long haul. Angelotti owns the pharmacies with her husband, Erik. They took over ownership of Ella Community Pharmacy in 2017.

“If you took both of our pharmacies off the map, I can assure you that Sheridan would be bordering on the official definition of a pharmacy desert,” Lindsey Angelotti said. “In (both) our communities, we attract the patients who have complex medical needs … we provide access to patients that don’t have the resources or means or technology or family members or the support that your average, affluent adult in Hamilton County would take advantage of.”

There have been plenty of pharmacies that have gone away, both within the state of Indiana and across the country. The Indiana Professional Licensing Agency reported 1,354 licensed pharmacies in November 2024 and that is down to 1,328 in July 2025.

What’s causing many of these closures? It comes down to money. For many, it’s just not worth keeping the doors open from a financial standpoint anymore.

Plenty in the industry and outside of it point the finger in one direction when it comes to who is to blame – toward PBMs, which is short for Pharmacy Benefit Managers. These companies work, as representatives of the drug plans that hire them, with insurance companies and pharmacies to administer benefits and negotiate drug prices. Issues about how those prices are set – and how much money should return to the pharmacy – are at the heart of the debate.

NCPA Blasts Gambit by PBMs to “Self-Regulate”

Tue, 30 Sep 2025 18:57:00 GMT

ALEXANDRIA, Va. (Sept. 24, 2025) – The National Community Pharmacists Association (NCPA) issued the following statement today on behalf of CEO B. Douglas Hoey in response to a news report that the lobbying group for PBMs, which represents the same massive corporations under scrutiny by federal regulators, Congress and state lawmakers for bilking taxpayers and rigging competition, is working on a deal with the administration that would let them police themselves:

“If this news report is accurate, we would strongly urge the administration to reject this gambit. Whatever they are promising to do, it would be foolish for the administration to trust the PBMs to regulate their behavior. They could have been doing that all along. But they have refused. In fact, they’ve litigated against every effort to regulate their behavior or just ignored the law.

“The fact is that the big PBMs are chronically and consistently the worst actors in health care. They’ve been found to overcharge states and have been fined hundreds of millions of dollars by multiple states for ripping off public benefits programs, driving up costs for American taxpayers. Their anticompetitive behavior is well documented by Congress, the Federal Trade Commission, and multiple national news investigations. Their self-dealing and cutthroat practices have triggered legislation in nearly every state. Thousands of patients are frustrated at the pharmacy counter every day as the PBMs overrule their doctor’s medication choice for a different medication that pays a bigger kickback to the PBM. And they are systematically destroying small business pharmacies across the country, driving up drug costs, and robbing patients of health care access. Allowing self-regulation would be like letting Al Capone police himself.”

NCPA: MFN is Part of a Bigger Solution that Includes PBM Reform

Tue, 30 Sep 2025 16:37:00 GMT

Trump’s effort to negotiate lower drug prices is positive, but incomplete without cracking down on the insurance plans and their PBMs that are gaming the system

ALEXANDRIA, Va. (Sept. 30, 2025) – President Trump’s announcement today of an agreement with the pharmaceutical company Pfizer to bring down U.S. drug prices is a step in the right direction, but it won’t solve the problem unless he and Congress also get tough on the pharmacy benefit managers (PBMs) and insurance companies that are rigging the system, said the National Community Pharmacists Association (NCPA) today.

“The president is absolutely right that American patients and taxpayers should not be subsidizing lower drug prices around the world,” said NCPA CEO B. Douglas Hoey. “He is also right that we need to reduce our reliance on foreign countries that now supply the active ingredients for some of our most critical drugs. However, we don’t want the president or Congress to lose their focus on reforming the health insurance/PBM conglomerates that have created this crisis in the first place.”

In addition to the Pfizer agreement (the administration is currently negotiating with other companies on similar deals), the White House also rolled out TrumpRx, which it says will allow patients to buy some drugs online at lower rates negotiated by the government. Several of the big drug makers already sell some of their drugs directly to consumers. The proliferation of websites, said Hoey, is an attempt to bypass PBMs and insurance companies that make massive profits from a confusing web of schemes that raise drug costs for patients and taxpayers. But it doesn’t solve the problem for the millions of Americans with prescription drug coverage whose drug costs are hyperinflated by rebates, fees and other PBM deceptive practices because these direct-to-consumer programs are cash-based models.

“The insurance companies and their PBMs get paid more when patients and taxpayers pay more. That’s the problem. All these manufacturer websites are workarounds. They don’t fix the heart of the problem,” said Hoey. “Reforming the way PBMs and insurance companies operate is the only solution. There’s a reform package in Congress that has wide bipartisan support. Congress should pass it now. With the president’s signature, Americans will benefit from the lower prescription drug prices they deserve.”

Hoey also stressed that any solution must preserve the patient-pharmacist relationship.

“While there are very few details, TrumpRx appears to bypass the relationship between patients and their local physicians and pharmacists. Direct-to-Patient programs can be dangerous,” he said. “A website can’t counsel patients, recognize other potential health risks, or follow up to make sure patients are taking their medicines at the right time and in the right amount. The unreliability, unpredictability, and risks of mail order drugs is already well documented. We strongly support the president’s goal of lowering drug prices, which is why we urge him to maintain his focus on PBM reform even as he implements these new programs.”

For more information about NCPA, please visit www.ncpa.org.

APhA Alarmed by Claims of Harm from Acetaminophen Without Substantive Science

Tue, 23 Sep 2025 20:35:00 GMT

As the medication experts, APhA affirms there has been no new evidence in two decades that the use of acetaminophen (Tylenol) in pregnancy causes autism. The two most reputable studies, including one last year, found no significant associations between the use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability. The American public relies upon our nation’s pharmacists to make recommendations for the use of products to treat minor, self-limiting illnesses with nonprescription drugs, including acetaminophen. As the health care providers responsible for ensuring the appropriate outcomes from medicines, including nonprescription drugs, pharmacists rigorously review the science to ensure their recommendations are best for the patients under their care. Americans should continue to trust the advice of their personal pharmacist and other health care providers.

As stated by FDA, at usual doses for treating fever in pregnancy, acetaminophen remains safe and effective. The occurrence of untreated fever in pregnancy has serious adverse implications for the fetus. Acetaminophen is the only FDA-approved medication known to be safe at usual doses in people who are pregnant. This has not changed.

While it is appropriate to continuously monitor drug safety signals and review emerging research, claims that are not rooted in science are confusing to patients and health care providers who are caring for and counseling patients during pregnancy.

Optum Rx Increasing Reimbursement for Brand-Name Drugs for Independent Pharmacies

Wed, 17 Sep 2025 20:06:00 GMT

The new model is intended to provide pharmacies with better financial means to stock more medicines, which is expected to alleviate drug shortages.

Pharmacy benefit manager Optum Rx will increase reimbursement minimums for brand-name drugs for about 2,300 independent pharmacies around the country – those that are not affiliated with a pharmacy services administrative organization, chain or other entity.

The announcement is an extension of a commitment Optum Rx made in March to update its pharmacy reimbursement model, one that's intended to have pharmacies pay more for brand-name drugs and less for generics.

Optum Rx said at the time that the payment model more closely aligns with the costs pharmacies often face due to "manufacturer pricing actions.”

The change will begin immediately, and full implementation will be achieved by January 2028, Optum Rx said, adding that the move will also make medications more affordable for consumers.

WHAT'S THE IMPACT

While the industry-wide pharmacy model was designed to help promote the use of more affordable generics, Optum Rx said that with generic adoption now quite strong, more high-cost branded drugs are entering the market, raising costs for pharmacies and creating a payment imbalance.

The new reimbursement model is intended to provide pharmacies with better financial means to stock more medicines, which is expected to alleviate drug shortages and improve medication access.

Optum Rx said it was making the investment to improve pharmacies' long-term sustainability, especially community pharmacies that lack large-scale resources.

More States Protect Access to the COVID Shot as Feds Restrict Eligibility

Wed, 17 Sep 2025 20:04:00 GMT

At least 17 states have taken steps to ensure broader access to the COVID-19 vaccine since last month, when the federal government significantly restricted eligibility for the shot.

Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Maine, Massachusetts, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Virginia, Washington and Wisconsin have issued orders that aim to make it easier for people to get the COVID-19 vaccine. All but Virginia have Democratic governors.

Together, the moves represent an extraordinary state rebellion against the public health authority of the federal government.

For decades, states have followed the lead of the U.S. Food and Drug Administration and the federal Centers for Disease Control and Prevention on which vaccines Americans should get, and when they should get them. Now, rejecting the antivaccine stance of U.S. Health and Human Services Secretary Robert F. Kennedy, Jr., an increasing number of states say they will rely instead on their own public health experts and professional medical organizations for that advice.

Previously, the FDA recommended that the COVID-19 vaccine booster be available to anyone 6 months or older. But in August, the federal agency said the booster shot should be limited to two specific groups: people who are 65 and older, and anyone who is at least six 6 months old and has an underlying health condition, such as asthma or obesity, that increases the risk of a COVID-19 infection becoming severe.

Under the new guidelines, children under 18 without an underlying condition can only get the shot if a health care provider is consulted first, meaning parents can’t simply take their kids to a vaccination clinic or pharmacy.

A Visit to Five Fine Pharmacies in Southern California

Tue, 16 Sep 2025 16:28:00 GMT

One useful way for pharmacy owners to boost their profits is to learn from other pharmacy owners who are successful. The good news is there are a lot of pharmacies out therethat are doing quite well.

I know this because I just visited five of them.

This road trip took me to the suburbs of Los Angeles. It was a special trip for me as I grew up in the San Gabriel Valley, where four of the pharmacies included in this report are located. While each of these businesses dispense a lot of prescriptions, they have also found something just a little bit different to do that endears them to their patients or sets them apart from their chain competition.

So, let’s dive in.

REDISCOVERING ROOTS JOURNEY

Reps. Carter and Harshbarger Introduce 340B ACCESS Act

Mon, 15 Sep 2025 19:59:00 GMT

NCPA September 15, 2025

On Wednesday, Reps. Buddy Carter (R-Ga.) and Diana Harshbarger (R-Tenn.) introduced H.R. 5256, the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). This legislation looks to establish oversight and transparency into the 340B program by updating eligibility requirements and safeguards, creating a neutral 340B data clearinghouse, preventing middlemen and for-profit entities from profiting from the program, and establishing enforceable federal oversight of the program.

For a more detailed breakdown of the different sections, see here.

NCPA

Legislation Introduced to Aid Compounding Pharmacies and Improve Patient Access

Mon, 15 Sep 2025 19:58:00 GMT

NCPA September 15, 2025

Rep. Diana Harshbarger (R-Tenn.) introduced legislation on Sept. 11 to reform the Food and Drug Administration’s drug shortage list process and provide greater certainty to both 503A and 503B facilities. H.R. 5316, the Drug Shortage Compounding Patient Access Act, would codify into the Food, Drug and Cosmetic Act (FDCA) various ad hoc guidance issued by the FDA, as well as strike other provisions in the FDCA that are either now irrelevant or limit patient access. Harshbarger introduced the bill together with Rep. Buddy Carter (R-Ga.)

This bill was modeled largely on the Patient Access to Urgent-Use Pharmacy Compounding Act, introduced by Rep. Morgan Griffith (R-Va.) in the previous two Congresses. The Alliance for Pharmacy Compounding worked closely with the office of Harshbarger on this bill and NCPA is pleased to endorse this legislation.

Fear over RFK Jr. Vaccine Panel’s Looming Decisions on Childhood Shots

Mon, 15 Sep 2025 18:23:00 GMT

Vaccine advisers for the Centers for Disease Control and Prevention are expected this week to consider softening or eliminating recommendations for some routine childhood immunizations — which doctors say could significantly depress vaccination rates and trigger more infectious disease outbreaks.

Any decisions by the Advisory Committee on Immunization Practices — now mainly composed of members who share Health Secretary Robert F. Kennedy Jr.’s vaccine skepticism — will be closely scrutinized, given the dramatic events at the Department of Health and Human Services and in Congress in recent weeks.

At a Senate Finance Committee hearing earlier this month, Democrats and some Republicans grilled Kennedy about his vaccine policy decisions. The interrogation followed the uproar just days before over Kennedy’s ouster of former CDC Director Susan Monarez, who said she refused a request that she rubber-stamp vaccine recommendations — a charge Kennedy denies.
Monarez is now expected to testify under oath about her firing before the Senate Health, Education, Labor and Pensions Committee on the eve of the advisory committee meeting, which is scheduled for Sept. 18-19.

Richard Besser, CEO of the Robert Wood Johnson Foundation and a former acting CDC director when Barack Obama was president, noted that the panel’s meeting was announced in the Federal Register the day after Monarez’s removal.

What’s Next for Walgreens Following its Private Equity Sale?

Sun, 14 Sep 2025 18:22:00 GMT

Walgreens jumped on board the private equity rescue ship named Sycamore Partners earlier this year and late August the deal worth $10 billion was completed.

While some say the sale to private equity was necessary as retail health faces numerous headwinds, at least one industry follower is concerned about what’s ahead for Walgreens. Private equity firms typically try to exit a company five to seven years after buying it.

“Healthcare is a long-term industry. It’s about long-term health. It’s about maintaining people’s health over decades. Private equity’s business model just inherently is short-term based. They are looking to get a company, profit off of it, exit the company in whatever way that is, whether it be bankruptcy or IPO or selling it off to another private equity firm,” said Matt Parr, communications director of the Private Equity Stakeholder Project, a nonprofit that has been tracking private equity moves.

Upcoming NCPA Items for Pharmacy Teams: September and October 2025

Thu, 11 Sep 2025 18:44:00 GMT

ALEXANDRIA, Va. (Sept. 11, 2025) – The National Community Pharmacists Association is pleased to announce these upcoming events for pharmacists and pharmacy team members:

Sept. 11 – What Compounders Need to Know: Regulatory Advocacy and How to Build Your Business webinar, part of our NCPA Learning Hour series. Walk away with practical strategies to streamline workflow, maintain compliance, and strengthen the business side of their compounding practice. Learn more and register.
Sept. 18 – Navigating the Big Beautiful Bill: Tax Readiness and Accounting Essentials webinar, part of our NCPA Learning Hour series. Stay compliant, streamline daily operations, and navigate the new tax landscape with these essential accounting principles and proactive tax planning strategies. Learn more and register. Learn more and register.
Sept. 23 – Application deadline for the 2025 Community Pharmacy Residency and Fellowship Showcase, taking place at the NCPA Annual Convention. Pharmacy teams can highlight their post-graduate program while connecting with students who are eager to learn more about community pharmacy. Learn more and apply.
Ongoing –
- Registration is open for the Pre-Convention Growth and Profitability Programs being held in New Orleans ahead of the NCPA 2025 Annual Convention. This year’s offerings include the Business of Long-Term Care Workshop (Oct. 16-17), the Pharmacy Ownership Workshop (Oct. 16-17), and the New Route to Reimbursement: A Roadmap from Application to Activation (Oct. 17). Learn more and register.
- Registration is open for the NCPA 2025 Annual Convention and Expo. The convention will be held Oct. 18-21 in New Orleans and is the premier national business show for independent pharmacists and their teams. To take advantage of better hotel rates, attendees must register for the convention and book their housing by Sept. 23. Learn more and register.
- Enrollment for the NCPA Innovation Center/CPESN® Community Pharmacy Fellowship. This executive MBA-like program showcases outstanding pharmacy peers who walk participants through implementing successful services that generate revenue beyond dispensing. Learn more and register. Enrollment is open through Oct. 31, and the next class begins in November.
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