The CMS Chief Actuary is supposed to determine by the end of this week whether the Independent Payment Advisory Board will be triggered next year, which would give President Donald Trump a clear shot at making good on his campaign promise to curb drug prices, but the actuary is expected to release the determination several months late. An IPAB trigger also would add a pressing policy to Republicans' already complicated health care agenda.
House Republicans are reviving the American Health Care Act with an amendment that is drawing official support from the conservative House Freedom Caucus--which previously tanked the bill. A vote could happen as early as this week, according to one Freedom Caucus lawmaker, but some moderate Republicans are doubling down on their opposition to the measure because the amendment does not address their concerns.
Drug manufacturers are urging the Health Resources and Services Administration to rework the 340B ceiling price rule after HRSA pushed back its implementation citing ongoing questions, but 340B providers say the rule should be implemented immediately because it is already more than six years after the statutory deadline and stakeholders have had many chances to weigh in.
Congress' Medicaid commission recently spent nearly two-hours discussing the effects that the House GOP's American Health Care Act would have on Medicaid, and said the bill as written raises a number of questions. Commission staff also separately laid out examples of how cutting back Medicaid financing potentially could affect other health and social programs, which commissioner Alan Weil said is "perfect material for a governor to go to Congress and say if you pull the stick out of this structure, things will fall."
Many of the policies that the National Health Council recommended Tuesday (April 25) for curbing health care costs deal with the price of drugs, but the patient-led organization proposes policies that are among the least controversial within the drug industry. The group proposed to speed generic approvals, prevent brand drug makers from stymieing generic competition with post-market drug-monitoring plans, share savings from drug rebates with consumers, commission annual reports on price increases for select drugs and test outcomes-based contracts.
CMS will notify providers this month and next month whether they meet the volume thresholds for participating in the Merit-based Incentive Payment System (MIPS), the agency said Tuesday (April 25), though provider lobbyists said the notifications do not tell providers whether they get the flexibility afforded to those who either are based at hospitals or don't deal directly with patients.
Nevada's Silver State Health Insurance Exchange says the American Health Care Act's continuous coverage requirement, new tax credits and lack of clarity around cost-sharing reduction payments would lead to higher costs for consumers, insurer uncertainty and increased uncompensated care for hospitals. The exchange tells its board of director that continued funding of the ACA's cost-sharing payments and enforcement of the law's individual mandate penalty are needed to stabilize the individual market.
Puerto Rico's Medicaid program will need a $900 million infusion from Congress to operate through June 2018, HHS Secretary Tom Price told members of the Senate Puerto Rico commission. Price added that CMS has eased this year's deadline to finalize Medicaid managed care contracts -- which would allow funding for the program to be included in the upcoming budget bill.
Marathon Pharmaceuticals announced Thursday (April 20) that it is resigning from all of its trade association memberships, including the Pharmaceutical Research and Manufacturers of America, following closure of a deal to sell its Duchenne muscular dystrophy drug, Emflaza, which the company was accused of price gouging earlier this year. While Marathon's resignation letter, obtained by Inside Health Policy, cites the closure of the deal as the reason for leaving PhRMA, a drug pricing lobby group frequently critical of the brand industry claimed the departure was due to controversies over the company's pricing strategy. PhRMA announced it would reevaluate its membership criteria earlier this year in light of pricing controversies, and another company caught in drug pricing controversy left the trade group earlier this month.
Oregon state Democrats' language in an April 18 discussion document on elimination of the state's Medicaid expansion among the potential cuts was not intended as a recommendation, state Rep. Nancy Nathanson (D) told Inside Health Policy. Nathanson is co-chair of the state legislature's Joint Committee on Ways & Means.
The office of House New Jersey Republican Tom MacArthur said Wednesday the congressman will fix a provision in his amendment to the American Health Care Act that exempts members of Congress from key provisions in the American Health Care Act following an outcry after Vox reported on the provision.
House Republicans, armed with new language floated by moderate New Jersey Republican Tom MacArthur and pressed by the White House to produce a legislative victory, are gearing up to revive their failed effort to repeal and replace the Affordable Care Act as early as next week. It is unclear how many Republicans will be picked up by the amendment -- which retains the ACA's preexisting conditions requirement but lets states opt out of other benefits.
The White House Office of Management and Budget met with federal agencies Friday to prepare for a possible government shutdown should Congress doesn't pass a new spending bill when the Continuing Resolution runs out April 28, but HHS' prior contingency plan shows that many of CMS' functions would continue using mandatory funding. CMS has the most mandatory funding of any HHS department, according an agency contingency plan, and those mandatory funds wouldn't be affected by a break in annual appropriations.
Neomi Rao, President Donald Trump's pick to lead the White House Office of Information and Regulatory Affairs, if confirmed would likely aggressively push regulatory reform throughout the government and potentially ratchet back on agencies' use of guidance documents, according to regulatory experts and Rao's past writings. The nominee has advocated strong presidential oversight of federal agencies, including independent agencies, as well as regulatory budgeting -- signaling regulatory reforms laid out early in Trump's administration would likely continue should Rao assume the powerful Office of Management and Budget post.
President Trump on Friday (April 21) backed off a White House push to score a legislative victory on health reform next week ahead of his 100th day in office, telling reporters that "it doesn't matter" if the vote is next week, or any other week.
During Wednesday (April 26)'s oral arguments in a highly watched U.S. Supreme Court case, a key government attorney shot down an idea from Supreme Court Associate Justice Stephen Breyer that FDA should weigh in through notice-and-comment rulemaking on how to interpret the biosimilar pathway before the court interprets the statute, given the complexity of the topic. The attorney assured the court that FDA has in the past declined to engage in rulemaking on this topic after being petitioned. Sandoz's council also argued Congress did not give FDA this authority, and drew sharp distinctions between the biosimilar law and the generic pathway, which they argued more closely involves FDA.
The California drug lobby takes strong issue with drug pricing transparency legislation approved overwhelmingly by the state senate's health committee Wednesday (April 19), arguing the bill is counterproductive because it focuses on list prices and doesn't factor in the roles of pharmaceutical benefit mangers (PBMs) and insurer. State Sen. Ed Hernandez's (D) price transparency now heads to the California senate's appropriations committee.
FDA announced Friday (April 21) approval of Samsung Bioepsis Co LTD's biosimilar for Remicade, which appears to be the first biosimilar approved without an advisory committee weighing in, as well as the first biologic product to follow FDA's biologic naming scheme after the agency finalized the convention in January.
The rift between Anthem and Express Scripts makes a strong case for the government forcing pharmacy benefit managers to disclose rebates and price concessions they negotiate with drug makers, according to Sen. Ron Wyden (D-OR), who wrote a PBM transparency bill, and Avalere Health Vice President Rujul Desai said the fallout increases the likelihood of transparency legislation gaining traction.
CMS' recent $1.5 billion grant to Florida Medicaid's low-income pool is about $1 billion more than the Obama administration previously estimated the state needed, and could undermine Medicaid, two top Democratic lawmakers from the House and Senate said in letter to CMS Administrator Seema Verma on Tuesday (April 25). House Energy & Commerce ranking Democrat Frank Pallone (NJ) and Senate Finance Committee ranking Democrat Ron Wyden (OR) blasted a lack of transparency and documentation around the grant approval, and referred to CMS's previous "significant concerns" with the LIP.