Back in August I started an analysis of how biosimilars will be impacted in the new United States-Mexico-Canada Agreement (USMCA). To refresh, in a follow up on a 2016 campaign promise to renegotiate the North American Free Trade Agreement (NAFTA), the Administration has been engaging Mexico and Canada in an effort to create and ratify the USMCA.
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A new pilot program that allows states to import from Canada and allow manufacturers to voluntarily import has been announced via a draft rule through HHS and the FDA. The program would give states and nonfederal government entities the ability to import from Canada by applying to the FDA. Higher priced drugs such as biologics are not included in the draft rule.
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One case that pharmacy stakeholders have been closely monitoring is Rutledge v. Pharmaceutical Care Management Association.
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No matter if you are a hospital, physician, pharmacist, manufacturer, SAAS or Health IT provider, the lifeblood of your business is in your contracts. As an attorney what amazes me time after time is how contracts are often overlooked by businesses.
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A new US Food and Drug Administration (FDA) policy may help get novel biosimilar insulins to market more quickly, but it will be no guarantee that the products will be significantly less expensive than branded insulins, say analysts.
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The Centers for Medicare and Medicaid Services (CMS) star ratings system was created in 2007 for insurance plans operating under both the Medicare Advantage and Part D. This 1 to 5 system (with 5 being the highest rating) is a way for CMS to measure the value of a plan and determine whether to continue to allow it to be part of the program. However, it’s more than just the plan, since the plan’s providers play a key role in how CMS evaluates each plan.
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We are out with our December 2019 newsletter. This edition covers data oversight, a Medicaid white paper and upcoming webinars.
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Back in April 2019 we published an article through Specialty Pharmacy Times titled “Don’t Ignore the Steady Drumbeat of Drug Importation?” Click here to read the article
However; we have been noticing lately that there is a lot more chatter on importation, especially from the Administration.
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Our recently recorded webinar with WellSky is now available.
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We have a new webinar on December 4, 2019 via the American College of Apothecaries (ACA) on CBD.
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We have a new article in the American College of Apothecaries (ACA) titled “What’s Next for DIR Policy?”
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No matter what, technology will always move faster than the law. With this maxim and our ever increasing reliance on convenient information, we have seen technology companies try to bring us what we want to see while also collecting a staggering amount of information on consumers. With regulations scant on personal data, Congress is slowly becoming more active in making policy governing technology.
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Ron Lanton III, Esq. of Lanton Law discusses with Specialty Pharmacy Times the specialty pharmacist's role in educating patients about biosimilars and biologics
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With the release of the Administration’s American Patient’s First Blueprint in May 2018, price transparency was shown to be a centerpiece of the Administration’s governing agenda. Last week, the Administration released two rules, each at different points of the rulemaking process.
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Congresswoman Amy Spanberger (D-VA) has sponsored H.R. 2115 titled “Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act.” This is important for healthcare stakeholders, as this proposed legislation requires greater transparency for discounts provided by manufacturers. This bill also proposes to include real-time benefit information as part of a prescription drug plan’s electronic prescription program under Medicare.
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Following the launch of sofosbuvir (Sovaldi) in 2013, the pharmaceutical industry has been in the crosshairs of the government because of the drug's cost. Many industry stakeholders have been wrestling with difficult questions: How should the fair value of a drug be determined? What should the cost be for better outcomes? How much should a drug cost if it extends life? We have seen some political solutions advanced, such as the International Pricing Index, the Rebate Rule, and others, but no silver bullet to controlling costs has manifested to date.
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Ron Lanton III, Esq., discusses the specialty pharmacist's role in educating patients about biosimilars and biologics.
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Check out Ron Lanton’s interview with Specialty Pharmacy Times on “The Challenges to Launching Biosimilars” https://www.pharmacytimes.com/news/challenges-to-launching-biosimilars
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At this point in the legislative calendar, it is time to take a look at what may have a likely shot at passing Congress before the 2020 election season gets underway. With the contentious debate on drug pricing that has occurred during the last several months, insulin pricing is still garnering plenty of attention.
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