- Pharma lobbies Congress for big—and expensive—changes to patent rules (biopharmadive.com)
According to the Congressional Budget Office, Inter Partes Review exemptions currently being sought by the pharmaceutical industry could cost Medicare $1.3 billion over the next decade… IPR system is used as an alternative way for generic companies to challenge patents, as opposed to using the federal court system. IPR challenges are generally decided within 15 to 18 months… IPR is a quicker process…On one side in this fight are major industry trade groups… On the other side: IPR advocates, including the health insurance industry…
- Notice of Intent to Act Upon a Regulation – Nevada Board of Pharmacy (bop.nv.gov)
- Amendment of Nevada Administrative Code 453.510 - Schedule 1 - The proposed amendment to NAC 453.510 will add newly identified synthetic drugs to the list of controlled substances listed on Schedule 1, and provides for other matters properly related thereto.
- A REGULATION relating to pharmacy; revising provisions governing the licensure of a third-party logistics provider; and providing other matters properly relating thereto.
- A REGULATION relating to the practice of pharmacy; requiring certain entities collecting controlled substances to provide certain notification and a copy of a certain federally required form to the State Board of Pharmacy; clarifying standards for the disposal of controlled substances; and providing other matters properly relating thereto.
- A REGULATION relating to pharmacy; requiring, under certain circumstances, an outsourcing facility to obtain a license from the State Board of Pharmacy as a manufacturer; and providing other matters properly relating thereto.
- QS1 offers myDataMart through FDS partnership (drugstorenews.com)
QS1 announced…that it would be partnering with…FDS to brings(bring) its customers… business intelligence software myDataMart...pharmacy owners can receive detailed analytics into the state of their business operations and potentially increase their Centers for Medicare and Medicaid Services Star ratings,..aid in monitoring adherence among patients,..
- Nevadans to see premium increases in 2016 health insurance rates (reviewjournal.com)
Nevada Division of Insurance said…that it has approved 2016 health insurance rates for individual and small-group coverage…For small businesses and their employees, premiums will rise an average of 5 percent,…Consumers who buy a plan through the state's Nevada Health Link insurance exchange will see an average premium gain of 8.7 percent. Individual buyers off of the exchange will pay 9.6 percent more…
- Undeterred by PTO setbacks, Bass slaps new challenges on Acorda patents (fiercepharma.com)
Hedge-fund manager Kyle Bass may have hit some recent speed bumps in his quest to challenge pharma patents through a U.S. Patent and Trademark Office review system. But he's not giving up… not to be deterred, refiled the two Ampyra challenges…with more documentation, and he filed two new challenges against the drug's other IP shields, too… Bass has been using the inter partes review system to wage war on patents from companies such as Celgene, Shire, Biogen and Acorda that he thinks aren't up to snuff,...Bass and his partners want "to line their own pockets at the expense of public pharmaceutical companies and their shareholders,"…
- 340B “Mega-Guidance”: Stricter Contract Pharmacy Requirements (pharmacytimes.com)340B Drug Pricing Program Omnibus Guidance (gpo.gov)
340B Program "mega-guidance" recently released by the Health Resources Services Administration sets stricter standards for contract pharmacy use…This proposed guidance follows a 2011 report from the Government Accountability Office recommending better oversight of the 340B Drug Pricing Program to ensure that funds are used in a manner consistent with the program’s intent…primarily focuses on entity eligibility and program integrity measures.
- What Pharmacists Need to Know About HRSA Audits (pharmacytimes.com)
Chris Hatwig, MS, FASHP of Apexus discusses what health-system pharmacists need to know about the potential for HRSA audits to review 340B program compliance requirements. (video)
- UNLV, Ruvo center get $11M to research Alzheimer’s, Parkinson’s (reviewjournal.com)
UNLV (University of Nevada Las Vegas) and the Cleveland Clinic Lou Ruvo Center for Brain Health have been awarded an $11.1 million federal grant to advance the understanding of Alzheimer's and Parkinson's diseases…is aimed at increasing knowledge of dementia-related and age-associated degenerative disorders…will create a Center of Biomedical Research Excellence,..part of a program that promotes the study of medicine, molecular biology and public health.
- Pharmacists and Future HRSA Policy Updates (pharmacytimes.com)
Chris Hatwig, MS, FASHP of Apexus discusses what HRSA policy updates, including 340B "mega guidance," are poised to affect health-system pharmacists. (video)
- Doctor Charged in Illegal Sales of Prescriptions for Controlled Substances: Medical Practices at JFK International Airport and on Long Island (dea.gov)
Drug Enforcement Administration’s New York Division…announced today the indictment and arrest of Dr. Gerald Surya, an internist and senior aviation medical examiner with offices at JFK International Airport... sold prescriptions for oxycodone, a powerful opioid painkiller, and other controlled substances to a select group of "patients" in exchange for cash...allegedly wrote prescriptions in the names of individuals with no legitimate medical need for the controlled substances..







