IMPORTANT BREAKING STORY
Appeals court strikes down individual mandate in ACA case, but punts on severability: “In a blow to the ACA, federal appeals judges have ruled 2-1 that the landmark healthcare law's individual mandate is unconstitutional but punted on the question of whether that mandate can be excised from the remainder of the law…’The individual mandate is unconstitutional because it can no longer be read as a tax, and there is no other constitutional provision that justifies this exercise of congressional power,’ they wrote in their opinion (PDF).” I predict that the lower court will find the whole law is now invalid. The ruling will be appealed to the Supreme Court, where Chief Justice Roberts (who wrote the original opinion on the law) is still in charge. But the composition of the court is now Republican-leaning. The outcome is uncertain.
About pharma
US Unveils Proposed Rules to Allow Some Canadian Drug Imports: ‘The FDA and HHS will unveil a plan Wednesday to allow certain prescription drug imports from Canada—but one that leaves out, for now, many specialty medications and other therapies for chronic disease that cost patients the most. [Exclusions are controlled substances, biologics and intravenously injected drugs.] Through a Notice of Proposed Rulemaking and a draft guidance for industry, the FDA will seek request for comment on 2 pathways. One would allow states to submit proposals to the FDA to allow the importation of small molecule brand-name medicines sold at retail pharmacies— typically ones that have rebates attached to them…
the other… is draft guidance for industry, which would let manufacturers import the same versions of FDA-approved drugs they now sell in foreign countries. Under this pathway, drugmakers would use a new National Drug Code (NDC) and sell these drugs in the United States at cheaper prices.”
Lawmakers try to find next opportunity to tackle drug prices, surprise billing after setback: Both those initiatives will be pushed back to at least this coming May.
Lawmakers expand definition of biologics in year-end spending bill: Another proposed inclusion in the budget compromise: A “provision would change the definition of biologic drugs to include ‘chemically synthesized polypeptides,’ which includes such drugs as Novo Dordisk's diabetes medication Victoza and Eli Lilly's osteoporosis drug, Forteo.
Biologic drugs, which are made from living cells, get 12 years of market exclusivity, while ‘small molecule’ drugs get five years. The policy change would give more drugs longer periods of market exclusivity, which would give larger profits to drugmakers and force consumers to wait longer to get cheaper generic versions…” The provision would only apply to new drugs approved after the law passes.
Clearly the pharma industry remains very powerful.
About the public’s health
Trump Administration Proposes New Rules to Increase Accountability and Availability of the Organ Supply: This enhancement would be accomplished by reducing financial barriers by expanding “the scope of reimbursable expenses for living donors to include lost wages, and childcare and eldercare expenses for those donors who lack other forms of financial support,” and updating the criteria for Organ Procurement Organization (OPO) Conditions for Coverage. The question is: are the factors these solutions are aimed at fixing the ones that are responsible for delayed transplantations?
Weekly U.S. Influenza Surveillance Report: The CDC reports we are now into the flu season. The overall hospitalization rate is about the same as previous seasons while the mortality rate thus far is lower.
US permits sale of cigarettes with 95% less nicotine: “The Food and Drug Administration will allow 22nd Century Group to begin selling the first low-nicotine cigarettes reviewed by federal health regulators. The products contain roughly 95% less nicotine than standard cigarettes, according to the FDA…Regulators stressed that their ruling does not mean the new products are safer than regular cigarettes. The agency noted there are no safe tobacco products. Cigarettes cause cancer, lung disease, stroke and a number of other deadly diseases.” The question here is whether smokers will smoke more cigarettes to get the same amount of nicotine and thus be worse off than if they smoked traditional cigarettes.
About health insurance
In medical billing, fraudulent charges weirdly pass as legal: This story is by the Kaiser Health News Editor-in Chief and details from personal experience charges that she believes are mostly legal but unethical. Great discussion piece.
Hospitals avoid $4B payment cut — for now: Yet another measure in the budget bill: a temporary delay in cuts to Medicaid Disproportionate Share Hospitals payments.