With the enactment of Public Act 18-41 on May 31, 2018, Connecticut joined the growing list of states (see our posts here and here) requiring drug manufacturers to submit reports on price increases. Three different reporting requirements are imposed on manufacturers under the law. First, …
On June 1, 2018, the Health Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the 340B Drug Discount Program (“Substantive Final Rule”). The Substantive Final Rule, which was originally …
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the Vermont Agency of Human Services (VAHS) to design a wholesale prescription drug importation program that …
On Friday, April 13, 2018, the U.S. Court of Appeals for the Fourth Circuit ruled that Maryland’s law prohibiting “price gouging” by generic pharmaceutical manufacturers (HB 631) is unconstitutional because it violates the dormant commerce clause by directly regulating transactions that occur outside of Maryland. …
In order for their outpatient drugs to be covered under Medicaid and Medicare Part B, drug manufacturers must enter into a National Drug Rebate Agreement (“Agreement”) with the Department of Health and Human Services. The Agreement requires the manufacturer to pay quarterly rebates to state …
On March 13, 2018, Oregon became the latest state to enact a law focused on transparency in drug pricing (see our roundup of other recent state laws). The Prescription Drug Price Transparency Act, H.B. 4005, places new reporting requirements on drug manufacturers related to price …
Buried in the 250 pages of the Bipartisan Budget Act of 2018 (BBA 2018), which was signed by President Trump on Friday, February 9, are several provisions directly affecting the discounts brand drug manufacturers must pay under federal drug benefit programs: Increase in Part D Coverage …
As we previously reported, in October 2017, the New Jersey Attorney General and Division of Consumer Affairs issued a proposed rule in response to concerns about the amount of money being paid to prescribers in the state of New Jersey. On December 22, 2017, the …
On December 20, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) published a report entitled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.” This report is the result of Congress’ September 2016 …
On December 8, 2017, the pharmaceutical manufacturers’ trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), filed a complaint in federal district court in the Eastern District of California seeking declaratory and injunctive relief against implementation and enforcement of California’s recently enacted California Senate Bill …
In June, we reported on Nevada S.B 539, a new law that, among other things, requires manufacturers of “essential diabetes drugs” to report certain sensitive financial information concerning these drugs. On October 31, the Nevada Department of Health and Human Services took the first step …
Despite relative inaction on drug pricing at the federal level so far this year, 2017 has been a banner year for state legislation involving pharmaceutical pricing, price reporting, and discounting. Because it is becoming increasingly difficult to keep track of these recent laws, we thought …
On September 1, 2017, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), jointly filed a civil action seeking declaratory and injunctive relief against the Nevada Governor and Director of the Nevada Department of Health and Human Services …
On August 21, 2017, the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a Notice of Proposed Rulemaking (“NPRM”) that would delay until July 1, 2018 the implementation of the Final …
Nevada has become the most recent state to enact a law addressing drug prices. S.B. 539, enacted on June 15, 2017, places new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider (“HCP”) payments. Patient advocacy …
