Four items today, led by a California sentencing that every pharmacy owner should read. Also on the list: a new federal 340B reporting system that opens October 1, another manufacturer narrowing contract pharmacy access, and a hospital taking HRSA to court over how 340B registration works. The Federal Register also carried four DEA decisions against individual prescribers, none involving a pharmacy.
Thirty years in a $270 million Medi-Cal scheme that ran through a pharmacy
The Justice Department announced on September 9 that Paul Richard Randall was sentenced to 30 years in federal prison and ordered to pay $178,746,556 in restitution. Prosecutors said he caused roughly $269 million in claims to be submitted to Medi-Cal over eleven months through a pharmacy called Monte Vista, and that Medi-Cal paid about $178.7 million of it. Charged with him were the pharmacist who owned the pharmacy and a nurse practitioner who, according to the government, signed pre-filled prescriptions for patients she never met. The opening the scheme used is the part worth understanding. Medi-Cal had temporarily suspended its prior authorization requirement while it moved to a new prescription payment system, and the claims went in for high-reimbursing non-contracted generics during that window, including about $13,424 for a single meloxicam prescription. The case was built on kickbacks and medical necessity, not on billing arithmetic alone. If your pharmacy is being handed prescriptions by a marketing company, this is what that can become. Read more at the U.S. Department of Justice →
CMS opens its first Medicare 340B data repository on October 1
CMS is set to begin accepting Medicare Part D claims data from 340B covered entities next month through a new repository, the first of its kind. Participation is voluntary at launch. That word deserves attention, because voluntary reporting systems have a way of becoming the benchmark everyone is later measured against, and the entities that submit early tend to shape what the data looks like. If you participate in 340B, this is a decision worth making deliberately in the next few weeks instead of by default. Read the program details closely before deciding what to submit. Read more at 340B Report →
Takeda adds a blood cancer drug to its contract pharmacy restrictions
Takeda has added a blood cancer treatment to the list of drugs it restricts through contract pharmacy arrangements. Each addition of this kind narrows where a covered entity can have a 340B prescription filled, and the margin on that drug is what is at stake for the entity and for the specialty pharmacy dispensing under contract. Manufacturer policies differ from one another in their terms and in their exceptions, so the policy itself has to be read before anyone concludes what is still permitted. If this drug moves through your pharmacy under a 340B contract, check the policy now instead of finding out at the claim. Read more at 340B Report →
A Michigan hospital sues HRSA over the 340B registration process
A Michigan teaching hospital has filed suit against HRSA in federal court in Washington, D.C., arguing that the agency’s 340B registration process is unlawful. Eligibility and registration disputes usually stay inside the agency, so a court challenge aimed at the mechanism itself is worth following. What the complaint actually claims, and how far it reaches, cannot be characterized before the filing is read. For covered entities, the case is one to watch instead of act on for now. Read more at 340B Report →
This update is general information about developments in pharmacy law and regulation. It is not legal advice, it does not create an attorney-client relationship, and it should not be relied on as a substitute for advice about your own situation. Prior results do not guarantee a similar outcome. If you have a specific question about your pharmacy, call or write and we will talk about it properly.
Law Office of Bhavesh Desai | Bhavesh Desai, Pharm.D., Esq.
18085 Watson Way, Yorba Linda, CA 92886 | (909) 618-7299
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