Legal Notes for Independent Pharmacies
Legal Notes is AAP’s news source about federal and state laws and pending legislation that affects independent and community pharmacies.
Legal Notes is AAP’s news source about federal and state laws and pending legislation that affects independent and community pharmacies.
The Food and Drug Administration has issued a one-year delay on the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA). Those requirements were set to take effect in November. The new date will be Nov. 27, 2024.
The decision to delay the DSCSA requirements was made after several advocates warned the FDA that the supply chain was not ready to comply. The extended time aims to allow each sector of the pharmaceutical supply chain time to develop the systems and processes necessary for efficient transactions. Read more.
In this Weekly Rx Roundup, Moderna reports an initial study data showed its updated COVID-19 vaccine to be effective against the “Eris” and “Fornax” subvariants in humans.
The company expects the updated shot to be available, pending approval from the FDA, in the coming weeks for the fall vaccination season.
Pfizer has reported that its updated COVID-19 shot showed success at neutralizing activity against the Eris subvariant in a study conducted on mice. Pfizer has yet to complete its study in humans.
Eris, the nickname for EG.5, is a sub-lineage of the still-dominant Omicron variant. EG.5 accounted for about more than 17% of COVID-19 cases in the U.S., according to the latest government data. Infections from Fornax, officially known as FL 1.5.1, are also rising across the country.
Shares of CVS Health plunged 8% on Thursday after Blue Shield of California said it will drop the company’s pharmacy benefit management services and instead partner with Mark Cuban’s Cost Plus Drugs company and Amazon Pharmacy to save on drug costs for its nearly 5 million members.
The announcement hints at the potential for health insurers to abandon the traditional pharmacy benefit manager, or PBM, system and sent shares of other companies that offer PBM services lower.
CVS Health’s Caremark has been Blue Shield’s PBM partner for more than 15 years.
The other big story is that the United States Tenth Circuit Court of Appeals on Tuesday issued an unfavorable decision in the Pharmaceutical Care Management Association (PCMA) v. Mulready appeal.
The decision overturns Oklahoma’s effort to regulate pharmaceutical benefit managers (PBMs) – and likely would have implications for other states as well. The ruling allowing PBMs to escape certain state regulation by hiding behind the alleged preemption of that law by federal ERISA and Medicare Part D laws.
“The Tenth Circuit decision is inconsistent with what other federal courts have decided, and it departs from the Supreme Court’s unanimous Rutledge decision, which clearly held that PBMs can’t hide behind ERISA. It must be overturned,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association.
AAP is following this story closely and will keep you updated as it unfolds.
The August legislative recess is here. This is the perfect time to invite your local state and federal policymakers to your store and explain how they can help your business.
With the flurry of activity this year on Capitol Hill lawmakers looking to hold PBMs’ feet to the fire, AAP and NCPA members have testified before the House Oversight and Accountability Committee and the Ways and Means Health Subcommittee, as well as the Senate Commerce Committee.
Additionally, the Drug Price Transparency in Medicaid Act, was unanimously advanced out of the Energy and Commerce Committee to the House floor as part of the PATIENT Act. These are all encouraging developments, but we need to keep the pressure on policymakers to finish the job and send a comprehensive PBM reform bill to the president’s desk.
This can best be accomplished by hosting members of Congress and candidates in your pharmacy for one-on-one meetings, giving them a firsthand look at the important role you play in your community and in helping your patients, and highlighting the harm abusive PBM practices have on both your pharmacy and your patients. If you aren’t sure how to contact them, you can look up their information here.
During the August legislative recess, members of Congress are usually home meeting with constituents. This is a very opportune time to host your legislators in your pharmacy.
We need all community and LTC pharmacists to participate in this important month of action and keep the pressure on our elected officials to take strong legislative action.
When you do host your local lawmaker, let AAP know. Send us an email and pictures so we can share with our other Members on social media and in our weekly newsletter.
Take advantage of this great opportunity to promote yours and every independent and community pharmacy.
More good news for independent pharmacies – a PBM reform bill advances in Senate vote. On July 26, the U. S. Senate voted 26-1 to advance the Modernizing and Ensuring PBM Accountability Act to a vote of the full Senate. This vote is a big step for independent pharmacies because this PBM reform package contains several provisions to enhance transparency into PBM-insurer operations, improve patient access to community pharmacies, and ensure fair pharmacy reimbursements that are based on actual acquisition and dispensing costs.
After a full U.S. Senate vote, the next step would be a vote in the House of Representatives. No date has been set for that, however.
The package also contains language from two other bills: the Drug Price Transparency in Medicaid Act (S. 1038), which creates a fairer reimbursement rate for pharmacies operating in Medicaid managed care, and the Protect Patient Access to Pharmacies Act (S. 2052), which reforms Medicare Part D by clarifying and providing enforcement tools for the any willing pharmacy law. NCPA has more details about the PBM reform bill that advanced in Senate vote
Another blow to was dealt to the PBM industry last week. Federal Trade Commission voted unanimously to warn that some of its previous advocacy statements related to PBMs no longer reflect current market realities. The decision effectively removes a major line of defense for the PBM-insurers in litigation, arbitration, and lobbying against state and federal reforms.
Our friends at NCPA were instrumental in persuading the commissioners to reconsider the agency’s prior statements and ultimately bring it to a vote. Read more on NCPA.org.
While many Americans may not initially notice the sunsetting of the declaration, they are likely to feel it if they come down with COVID-19 or suspect they might have it. They could have to start paying for testing and treatment that they’ve grown used to being free during the pandemic. Just how much depends on the type of health coverage they have. Get the testing and vaccine details here.
Advisers to the Food and Drug Administration on Wednesday voted unanimously to recommend making a birth control pill available without a prescription.
The 17-0 vote by two advisory panels came despite concerns from agency officials about the quality of the data used to support switching Opill from prescription to over the counter. The agency did not have concerns about the safety and effectiveness of the drug.
The FDA is not required to follow the recommendation but the panel’s opinion will weigh heavily on the FDA’s final decision, which is expected later this summer. Read more here.
It is now the first FDA-approved treatment indicated for AAD in the U.S. According to John J. Miller, MD, Editor in Chief of Psychiatric Times. “Baby boomers are retiring and Alzheimer disease is on the rise, and AAD in one of the most difficult complications of dementia. Meanwhile, the need for treatments of Alzheimer disease and dementia remains huge and largely unaddressed. This approval parallels nicely with recent drug development and research working on decreasing disease progression by removing amyloid plaque with monoclonal antibodies and improving cognitive function.” Read more.
A group of pricey breakthrough prescription drugs are poised to shake up the market this year — including an Alzheimer’s treatment that could be approved today by the FDA.
Why it matters: Though the drugs offer hope to patients with hard-to-treat conditions like Alzheimer’s or sickle cell disease, or who struggle with obesity, their potentially eye-popping prices are sure to create dilemmas for insurers, government programs and patients themselves.
The big picture: The approvals could fuel already-contentious debates around affordability and equity, giving ammunition both to those who say innovation doesn’t come cheap and others who contend medical advances are meaningless if patients can’t access them.
Driving the news: The FDA is expected to today decide whether to approve Eisai and Biogen’s lecanemab, a treatment for Alzheimer’s disease, setting into motion another round of debate over how much the drug should cost and whether Medicare should cover it.
State of play: The drug pipeline is brimming with other experimental cures that could make headlines this year.
Between the lines: Some novel drugs present an inherent dilemma: They’re worth a lot of money because of the way they can dramatically improve patients’ lives. Even so, manufacturers can still price these drugs well above what experts say they’re worth.
Yes, but: The final cost burden hinges on several factors, starting with where manufacturers set the launch price.
CMS has issued the final physician fee schedule for CY 2023, which updates vaccine payment information. The CY 2023 payment amount for influenza, pneumococcal, and HBV vaccine administration is $31.14. This amount will be geographically adjusted based upon the fee schedule area where the preventive vaccine is administered. With regard to COVID-19 vaccine administration, for CY 2023 the payment amount is $41.52. This differential will remain in place until the end of the calendar year in which the current Emergency Use Authorization declaration for drugs and biologicals with respect to COVID-19 ends. Thereafter, the payment amount for COVID-19 vaccine administration will be adjusted to align with the payment rate for the other Medicare Part B preventive vaccines. Learn more.
Two of the largest U.S. pharmacy chains, CVS Health and Walgreen Co., announced agreements in principle Wednesday to pay about $5 billion each to settle lawsuits nationwide over the toll of opioids, and a lawyer said Walmart is in discussions for a deal.
Together, the developments amount to what could be the last round of huge settlements after years of litigation over the drug industry’s role in an overdose crisis that has been linked to more than 500,000 deaths in the U.S. over the past two decades. Read more.
Courtesy of Apotex
With the adjournment of the California Assembly on August 31, only four state legislatures remain in session for 2022—Michigan, Pennsylvania, Ohio, and New Jersey. (As of this writing, Missouri is in Special Session to deal with state tax issues; a state legislature calendar is available here.) The National Conference of State Legislatures bill tracking database shows that through August, 418 bills had been introduced, in 47 states, directly addressing prescription drug-related issues. Read more.
Courtesy of Apotex
At last! After nearly a year of committee hearings and political maneuvering, Congress finally has approved legislation to reauthorize FDA’s user fee programs for brand and generic drugs, biosimilars, and medical devices. The current programs expire with the close of fiscal year 2022 on September 30. Reauthorization will enable FDA to continue collecting application and facility user fees from industry for fiscal years 2023 through 2027, a 5-year period that begins October 1. Read more.
A federal judge ruled on September 19, 2022, against a Justice Department antitrust challenge to UnitedHealth‘s $13 billion acquisition of health-technology firm Change Healthcare, rejecting government claims that the deal would unlawfully suppress competition and limit innovation in health-insurance markets.
U.S. District Judge Carl Nichols ruled for the companies in an opinion that he kept under seal for now because he said it “may contain competitively sensitive information.” The judge said he would release a redacted public version of the ruling in the coming days. In a one-page public order, he denied the Justice Department’s request to block the companies from completing the deal. Read more
Under the new law, the U.S. government is now able to negotiate prices on the costliest prescription drugs, cap costs at $2,000 per year for people on Medicare, limit the monthly cost of insulin to $35 for seniors, and extend subsidies for people buying their own health coverage through the Affordable Care Act, also known as Obamacare. The law also provides free vaccines for seniors. Read more.
The US Senate passed the Inflation Reduction Act on Sunday. The bill includes provisions that will impact community pharmacies, like Medicare pricing, drug rebates and insulin copays. Read more about the bill here.
Flu season is fast approaching. And it’s more important than ever for patients, particularly those who are at risk, to be vaccinated against influenza. Adults 65 and older, along with those with severe health problems, people of color and those of lower socio-economic status are at higher risk of developing severe complications from the illness. Getting vaccinated can help protect these vulnerable populations. Learn more about the selected strains, changes to vaccine recommendations and what to expect next.
Did you know that more than one-third of health care organizations in the United States were hit by ransomware attacks in 2020? Approximately 65% of these attacks were successful, and approximately one-third of the organizations that had data stolen paid up. However, only 69% of organizations that paid ransom actually got their data back. Here are some tips to help you protect your patients’ information. Read more.
With PCMA’s failure to file its appeal by the July 11, 2022 deadline, North Dakota can regulate PBMs as it sees fit. PCMA has exhausted its legal options. So, the ruling in PCMA vs. Wehbi is now the law of the land for the states in the 8th Circuit (Arkansas, Iowa, Minnesota, Missouri, Nebraska, North Dakota and South Dakota). Read more
As expected, Florida Governor Ron DeSantis signed the PBM transparency order. The order is aimed at lowering the price of prescription drugs. AAP Member Ben Levine was at the governor’s side during the signing. Levine calls this order a victory for all Floridians. “This transparency will really help drive down drug prices, and also improve access for patients in our community so that they can go to the pharmacy they choose.” Read more about the executive order.
Florida Gov. Ron DeSantis (R) today announced plans to sign an executive order that would hold PBMs accountable and provide drug cost transparency. Under the order, state agencies will be directed to reevaluate their contracts with PBMs to ensure “that costs to the state of Florida are justified.” Read more about the order.
It’s a win for pharmacies, which had been pushing for the FDA to allow them to prescribe the medication, saying that it would ultimately expand access to the antivirals.
Paxlovid is authorized for the treatment of “mild-to-moderate” COVID-19 in adults and pediatric patients that have tested positive and are considered to be at high risk of developing severe disease.
Many Americans across the political spectrum are clamoring for federal action on guns in the wake of a mass shooting at an Uvalde, Texas, elementary school, a Buffalo, N.Y., grocery store and hundreds of other places.
But buried in a bipartisan compromise hashed out by the U.S. Senate on Tuesday is an unrelated provision they might not be so happy about.
Businesses owners, including those who work within the pharmacy industry, often face situations in which legal advice becomes useful. Getting the right legal advice can be pricey, but it can save a lot of time, money and hassle in the long term. Here are some situations where getting good advice is crucial.
Cardinal Health issued a new alert regarding recently reported fraudulent activity. There are reports of individuals falsely claiming to be representatives from pharmaceutical wholesalers and courier service employees. This is an industry-wide issue, as criminals attempt to place orders and intercept delivery of the product. Be on the lookout, and read the full alert here.