Medicare Part D plans will not be allowed to exclude drugs in protected classes from their formularies, and plans will be required to include information on lower-cost alternatives in monthly explanation of benefits reports sent to patients. Part D plans will be allowed to require prior authorization before covering some therapies.
New pricing models are needed for expensive cell-based and gene therapies, which require only a short treatment period or even a single dose and thus do not lend themselves to the conventional pay-as-you-go model, writes Novartis CEO Vasant Narasimhan. Alternatives include installment models with clawback provisions, but current Medicare and Medicaid rules impede implementation, and new legislation is needed, Narasimhan writes.
B. Braun Medical has announced a $1 billion investment in IV fluid manufacturing facilities to help alleviate the shortage of IV fluids in the US. B. Braun's initiative, called Solutions for Life, will include the expansion of its Allentown, Pa., and Irvine, Calif., facilities, as well as expansions of two distribution facilities, and the construction of a distribution plant in Daytona Beach, Fla.
The FDA has approved Takeda Pharmaceutical's Gattex, or teduglutide, injection as a treatment for pediatric patients at least 1 year old with short bowel syndrome who need additional nutrition or fluids via intravenous feeding. The drug was previously approved for adult patients with SBS.
A bill that supporters say would protect patients from unexpected out-of-network medical bills for emergency and non-emergency services was introduced by a bipartisan group of senators led by Sens. Bill Cassidy, R-La., and Maggie Hassan, D-N.H. The STOP Surprise Medical Bills Act would include an arbitration process and final payments would be based on "commercially-reasonable rates for that geographic area," according to Hassan's office.
The CMS said Friday it would delay a final national coverage determination for chimeric antigen receptor T-cell therapies for cancer treatment such as Novartis' Kymriah and Gilead Sciences' Yescarta. The agency didn't give any reason for the delay in finalizing the proposal, released in February.
Scientists from the Dana-Farber Cancer Institute and Moffitt Cancer Center studied how BCL2 inhibitor resistance evolves in B-cell lymphomas in response to venetoclax, or ABT-199, specifically in double-hit lymphoma and mantle cell lymphoma. The findings were reported in the journal Cancer Cell.
Physicians who have a financial tie to makers of drugs for inflammatory bowel disease have a high likelihood of prescribing those drugs to Medicare beneficiaries, and the higher the industry payments, the higher the value of prescriptions written, according to an analysis presented at the Digestive Disease Week conference.
Research published in the Journal of the American Medical Informatics Association cited slow progress on interoperability as one of seven factors related to poor physician experience with EHRs. Greater government regulation, obsolete servers and software, and training and implementation were also among the factors.