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This year, pharmacies should receive
a transaction history that identifies the chain-of-custody with each
drug shipment.
Drug Cost-Trends, Coverage and Access
At the end of the 113th Congress, the proliferation of specialty therapies was discussed in the context of broader trends in healthcare spending. Patient advocacy groups remain concerned over the increasing frequency of pre- scription drug benefits or policies that disrupt the patient-physician interaction and shift drug costs back to the affected individual. This phenomenon has per- sisted for therapies used by individuals affected by rare and chronic conditions, and has begun to crossover to oncology and other, more prevalent conditions. Voluntary health groups are working to add the human element to the debate in
an effort to ensure Medicare, Medicaid and private insurance companies adopt coverage and access policies that are patient-centered, first and foremost.
Track-and-Trace Implementation
Legislators passed and the president signed the Drug Supply Chain Security Act, more commonly known as “track- and-trace,” in 2013. The FDA issued guidance in 2014 and worked to imple- ment a number of provisions that are set to come online in 2015. Beginning this year, pharmacies should receive
a transaction history that identifies the chain-of-custody with each drug shipment. Later this year, pharmacies
will be asked to report any product that appears suspicious and assist the FDA to investigate supply-chain disruptions. The ultimate goal remains to prevent adulterated or counterfeit products from entering U.S. sales channels. Over the coming years, additional provisions will be implemented, including the adoption of a unit tracking bar code and a com- prehensive electronic tracking system.
IVIG Home-Infusion Demonstration Project
The Medicare IVIG Access Act, signed by President Obama in 2013, estab- lished a demonstration project to study the feasibility of implementing a benefit that covers the items and services
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