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A California law allowing pharmacists to prescribe birth control sought to make it easier for women to obtain contraception, but few drug stores provide the service... Only 11 percent of retailers in the state offered pharmacist-prescribed contraception one year after the law went into effect, the research shows...Our findings strongly suggest that more pharmacies need to offer this service to live up to the promise of widespread, easier access to birth control...Four states - California, Oregon, Colorado and New Mexico - allow pharmacists to prescribe contraceptive pills, patches, rings and injections after training about how to assess health risks and counsel women on contraceptive choices... Most stores that offered the service charged a fee...Under the Affordable Care Act, insurance carriers must pay for family planning consultations with healthcare providers. But the law does not cover pharmacists...Oregon requires Medicaid to pay pharmacists for the service. California’s law has a similar provision, but it doesn’t take effect until 2021...

A medical charity that lost a crucial stamp of approval from the U.S. government because it had worked too closely with its drug-company donors said it will decide in January whether it can continue to help patients pay for their prescriptions...the Caring Voice Coalition, one of the biggest patient-assistance charities in the U.S., said it is delaying offering patients financial help for 2018 until it decides what to do...“We are very concerned that we may not be able to remain as a long-term viable resource for individuals with chronic illness,”...the Office of Inspector General of the Department of Health and Human Services rescinded its favorable advisory opinion of the Caring Voice Coalition, in part because the charity had provided drugmakers with data that could help them see if their contributions were helping their own customers. That could potentially give drug companies greater power to raise prices, the HHS said. It was the first time the HHS has rescinded a favorable advisory opinion for a patient-assistance charity.

The Centers for Medicare and Medicaid Services...offered further insight into how the Meaningful Measures program works...deputy director of CMS' Center for Clinical Standards and Quality, said the initiative to streamline quality reporting was launched in recognition that "there's a fine line between being helpful and being a hindrance."...CMS has heard the feedback from industry stakeholders that there are too many often-overlapping quality measures...Tracking these measures does not always lead to better outcomes for patients...there are two key problems CMS wants to solve with Meaningful Measures...The first is to focus on the highest-priority measures for quality reporting and quality improvement. The second...is to improve the agency's communications with patients, clinicians and stakeholders about what measures they should be paying most attention to...the important concepts we want every measure to be filtered through...Those are: reduce regulatory burden, improve access for rural communities, achieve cost savings, safeguard public health, track to measurable outcomes and impact and eliminate disparities...Those principals...represent the guiding framework for 18 different Meaningful Measure areas that CMS wants health systems to prioritize – they're further grouped under six thematic headings:

1. Make Care Safer by Reducing Harm Caused in the Delivery of Care
2. Strengthen Person and Family Engagement as Partners in their Care
3. Promote Effective Communication and Coordination of Care
4. Promote Effective Prevention and Treatment of Chronic Disease
5. Work with Communities to Promote Best Practices of Healthy Living
6. Make Care Affordable

New proposed rule offers insurers more plan flexibility and eases regulations...The proposed rule released last week by the Centers for Medicare and Medicaid Services would strengthen and improve the Medicare Advantage and Part D programs...CMS's proposed 2019 Medicare Advantage and Part D rule offers insurers greater flexibility in reporting and makes changes to how star ratings are calculated...Star ratings determine bonuses for insurers. Another plus for plans that have an overall 5-star rating is the ability to offer a year-round open enrollment period for Medicare Advantage...The rule has an open enrollment period for MA plans of Jan. 1 through March 31, 2019. It allows enrolled individuals to make a one-time election to go to another plan or to original Medicare...The proposed rule would get rid of artificial limits on the variety of plans an insurer can offer in a certain region, ease the medical loss ratio, allow for more tailored benefits and would revise regulations for maximum out-of-pocket limits, among other changes.

The Food and Drug Administration has issued guidance on 3D printing and the role it plays in manufacturing healthcare products...While the guidance focuses largely on medical devices, Commissioner Scott Gottlieb acknowledged in a Monday statement that the innovative technology also holds the potential to disrupt drug development. Already, the agency has approved one medicine crafted with 3D printers, Aprecia Pharmaceutical Co.’s Spritam..."This is likely just the tip of the iceberg given the exponential growth of innovative research in this field," Gottlieb said, referring to the 3D-printed products on the market. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs."...The promise of 3D printing, however, could spark new innovation and invention in how drugs, and the devices that deliver them, are formulated and made. In response, the FDA is moving to stay ahead of the technology's advances....

Manufacturers and trading partners struggle to meet drug tracking requirements...As FDA and industry near the halfway mark in the 10-year process for establishing a national electronic drug tracking system by 2023, there’s considerable concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline. The process for establishing the rules and infrastructure for the track-and-trace system envisioned in the Drug Supply Chain Security Act, part of the Drug Quality and Security Act of 2013, is proving to be complex and challenging for all parties...FDA recently delayed requiring drug manufacturers to imprint unique product identifiers on individual packages by November of 2017, saying it would not enforce that policy until Nov. 27, 2018. While major pharma companies are meeting the earlier time-frame for serializing and identifying drug packages, many generic-drug makers and contract manufacturers reported confusion over who is responsible for devising the identifiers and for confirming compliance with requirements. And while manufacturers applauded gaining an additional year to fully identify individual drug packages, pharmacists and other supply chain partners raised concerns that the delay would make it even more difficult for them to comply with reporting requirements for 2018 and 2019...

Massachusetts' state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value..."This is a serious demonstration proposal,"..."They're not simply using [this idea] as an excuse to cut Medicaid. They're trying to take a step toward efficiency."...If the Department of Health and Human Services approves the...plan, others will likely take similar action...Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs -- typically based on a set percentage of the list price...The idea is Medicaid's vulnerable beneficiaries get medications they need and the state doesn't go broke paying for them...Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries' medical needs and which medicines demonstrate the highest rates of cost effectiveness...It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients' access to needed therapies...

Schenectady County, N.Y., is on track to pay 20 percent less on prescription drugs for its employees this year than in 2003...Flagler County, Fla., expects to save nearly $200,000 in 2017 on brand-name medicines for its 800 workers, thanks to drug costs that have fallen 10 percent since 2016...dozens of cities, counties and school districts have found a solution they say protects their budgets and saves workers money: They are helping employees buy medicines from Canada and overseas, where prices are up to 80 percent cheaper...“We love it. . . . It’s a win-win,” said Anita Stoker, benefits and wellness manager for Flagler County, which has a program enabling its employees to get drugs from pharmacies in Canada, Britain, Australia and New Zealand...The number of municipalities offering this benefit is growing, even though the Food and Drug Administration considers such drug importation to be illegal and this fall began stepping up enforcement against storefronts advertising the same service. In October it raided nine central Florida locations that helped a mostly senior population order drugs from pharmacies in other countries. Investigators warned the stores’ owners that they were operating illegally and could face fines or jail time...Drugs ordered from overseas often come with the same packaging as in the United States. CanaRx, based in Windsor, Ontario, and ElectRx, based in Detroit, say they vet pharmacies to ensure customers get the real product. Counties, cities and schools, plus an increasing number of private companies, contract with one of these businesses for online service.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars...On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” about how to conduct analytical evaluation of similarity in biosimilars, was published...Several biopharma majors were among the commenters, including Amgen, Boehringer Ingelheim, Genentech, a Roche company, Novartis, Pfizer, Sanofi, and Shire. Other industry stakeholders include the Association for Accessible Medicines, the Biosimilars Forum, and the Biotechnology Innovation Organization...FDA introduced the draft guidance in September 2017, which specifically describes the type of information that sponsors of proposed biosimilar products should obtain regarding the structural/physicochemical and functional attributes of the reference product. In addition, the guidance describes how that information can be used in the development of an analytical similarity assessment plan for the proposed biosimilar, as well as recommends the statistical approaches for evaluating analytical similarity.

When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available...The answer was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been available for decades and is no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators...the Food and Drug Administration announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others...The FDA guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended...Dr. Scott Gottlieb, said.."Under this guidance, so long as the generic applicant is able to demonstrate with data, where appropriate, that differences in design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met,"...