{"id":2036,"date":"2021-03-01T18:09:56","date_gmt":"2021-03-01T18:09:56","guid":{"rendered":"https:\/\/thornrun.com\/health-policy-report-3-1\/"},"modified":"2023-08-08T21:25:30","modified_gmt":"2023-08-08T21:25:30","slug":"health-policy-report-3-1","status":"publish","type":"post","link":"https:\/\/thornrun.com\/health-policy-report-3-1\/","title":{"rendered":"Health Policy Report (3\/1)"},"content":{"rendered":"\n

Capitol Hill Update<\/strong><\/p>\n\n\n\n

Early Saturday morning, House lawmakers passed (219-210<\/a>) the $1.9 trillion “American Rescue Plan,” sending it to the Senate for consideration this week. The current version of the measure will be subject to additional changes in the upper chamber after the Senate Parliamentarian ruled last week that the proposed $15 minimum wage increase would violate budget reconciliation rules. As a result of the ruling, Democrats in the Senate are going back to the drawing board with respect to this provision, exploring possible changes to the tax code to incentivize businesses to pay their workers higher wages. House leadership has targeted the week of March 8 to vote on the package again, given the fact Senators will need to make changes to the underlying bill. <\/p>\n\n\n\n\n\n\n\n

In addition to the\nforthcoming vote on the COVID-19 relief bill, Senators will resume\nconsideration of pending presidential nominations this week. Today, the upper\nchamber will vote on Miguel Cardona’s nomination to lead the Department of\nEducation. It is also expected that the Senate will take up Gov. Gina\nRaimondo’s nomination to lead the Department of Commerce at some point this\nweek barring any last-minute hiccups with respect to holds on her nomination.\nSen. Ted Cruz (R-TX) had originally placed a hold on Gov. Raimondo’s nomination\nover his concerns about the Biden administration’s approach to Huawei and\nChinese state-run entities.<\/p>\n\n\n\n

In the House,\nlawmakers are scheduled to consider two pieces of legislation that passed the\nchamber late last year that touch on key Democratic policy priorities. The\nfirst is a package<\/a> of policing reforms that seek to overhaul use of force\nguidelines, promote more transparency within law enforcement entities, and\nreform qualified immunity and no-knock warrants, among other things. Members\nwill also take up the Democrats’ For The People Act<\/a>,\nwhich would renew the Voting Rights Act along with a number of reforms that\nseek to reduce barriers to voting and strengthen ethics rules for public\nofficials. <\/p>\n\n\n\n

Biden Directs Review\nof Pharmaceutical Supply Chain <\/strong><\/p>\n\n\n\n

Last Wednesday,\nPresident Joe Biden signed an executive order (EO<\/a>, fact sheet<\/a>) directing a\nreview of critical U.S. supply chains, including pharmaceuticals and public\nhealth goods and services. The EO directs a 100-day review to identify risks in\nthe supply chain for pharmaceuticals and active pharmaceutical ingredients and\nthe development of recommendations to address any identified risks. It also\ndirects a yearlong review of supply chains for the public health and biological\npreparedness industrial base. In addition to the pharmaceutical and public\nhealth sectors, the EO directs reviews on the supply chains for the\ncommunications, transportation, energy, defense, and agriculture sectors. <\/p>\n\n\n\n

The 100-day review\nfocuses specifically on active pharmaceutical ingredients, or APIs. The\nadministration notes that in recent decades, more than 70 percent of API\nproduction facilitators supplying the U.S. have moved offshore. Under the\norder, it is required to review goods and materials critical to the supply\nchain, global risks, the American manufacturing base, and the needs of the U.S.\nA particular focus is single points of failure in supply chains. While this\nreport will include policy recommendations, more in-depth recommendations are\nlikely to come in the yearlong review. This effort will be spearheaded by the\nSecretary of Health and Human Services (HHS); Jake Sullivan, the Assistant to\nthe President for National Security Affairs (APSNA); and Brian Deese, the\nAssistant to the President for Economic Policy (APEP). The APSNA and APEP will\nultimately submit the report to the President.<\/p>\n\n\n\n

The government review\nwill comprise an in-depth examination of critical goods and services,\nmanufacturing capabilities, global risks, and resiliency. Essentially, it will\nserve as an end-to-end review of the supply chain for public health and\nbiological preparedness. The review will also include specific policy\nrecommendations for the supply chain, including: (1) reshoring supply chains\nand developing domestic supplies, cooperating with allies and partners to\nidentify alternative supply chains, building redundancy into domestic supply\nchains; (2) ensuring and enlarging stockpiles; (3) developing workforce\ncapabilities; (4) enhancing access to financing; (5) expanding research and\ndevelopment to broaden supply chains; (6) addressing risks due to vulnerabilities\nin digital products relied on by supply chains; and (7) addressing risks posed\nby climate change. It also will include legislative and regulatory policy\nchanges needed to address identified vulnerabilities. The HHS Secretary will\nspearhead this effort, with the APSNA and APEP reviewing the report and\nsubmitting it to the President.<\/p>\n\n\n\n

Senate Finance, HELP\nCommittees Consider HHS Secretary Nominee<\/strong><\/p>\n\n\n\n

California Attorney\nGeneral Xavier Becerra appeared before the Senate Finance Committee and Health,\nEducation, Labor, and Pensions Committee last week to discuss his nomination to\nserve as Secretary for the Department of Health and Human Services. Republicans\nopenly opposed his nomination, stating he did not have the necessary experience\nor skills to take the position on. Ranking Member Richard Burr said that Mr.\nBecerra lacked the \u201cappropriate respect\u201d for the private sector, innovation,\nand intellectual property necessary to strike a fair balance in the position.\nMany found fault with his stance on abortion and religious exemptions, focusing\nsolely on his work as California\u2019s Attorney General on these issues. Democrats\nexplained that Becerra had critical experience working with Congress during his\ntime as a Member and had demonstrated his leadership in fighting for patients\nas California Attorney General.<\/p>\n\n\n\n

Mr. Becerra committed\nto a federally coordinated COVID-19 response driven by science, as well as to\nworking with partners to ensure states receive vaccine doses as quickly and\nequitably as possible. He also named tackling drug prices as a top priority and\nadvocated for increased transparency behind pricing decisions across the entire\nhealth care system. Addressing concerns from several Republican members, he\nnoted he would work to strengthen the Medicare program and ensure Medicare\ntrust fund solvency does not become an issue. Additionally, the nominee\nstressed the importance of strengthening the childcare system to ensure\nfamilies have critical supports to get back to work and enforcing mental health\nparity laws.<\/p>\n\n\n\n

Attorney General\nBecerra\u2019s appearance before the Senate HELP Committee was a courtesy, and the\nSenate Finance Committee will ultimately be responsible for sending the Health\nSecretary\u2019s confirmation to the Senate floor. No vote has yet been scheduled to\nsend Mr. Becerra\u2019s nomination to the Senate floor. However, given the\napparently unified Democratic support for the nominee in the Finance Committee,\nit appears as though Mr. Becerra\u2019s nomination is on track to be considered by\nthe full Senate in March, where it may compete for floor time with\nreconciliation legislation.<\/p>\n\n\n\n

NASEM Report\nDetermines that Discarded Drugs Have \u2018Limited Economic Value\u2019<\/strong><\/p>\n\n\n\n

The National\nAcademy of Sciences, Engineering, and Medicine (NASEM) released a\nCongressionally-mandated study on pharmaceutical vials and discarded drugs (report<\/a>, press release<\/a>) last\nThursday. The NASEM committee tasked with the study found that leftover product\nin single-use vials has essentially no economic value and recommended against\nstrategies to seek reimbursements from drug manufacturers for unused product.\nHowever, regardless of the economic value of leftover product, the committee\ncalled for reducing inefficiencies and waste, in particular by the Food and\nDrug Administration\u2019s (FDA) requirement that pivotal trials use fixed dosing\nrather than weight-based dosing unless safety or efficacy would be compromised.\nThe study committee broadly recommended that stakeholders focus on reducing\ninefficiencies in drug development, delivery, and payment rather than recouping\npayments for discarded drugs, and made eight specific recommendations. The\nreport includes several recommendations for CMS, FDA, and Congress. These would\nneed to be implemented through legislation, regulation, or through the Center\nfor Medicare and Medicaid Innovation. <\/p>\n\n\n\n

The study committee\nasserts that estimating financial waste on discarded drugs by looking at the\nunused portion of single-use vials is improper as prices are generally\ndetermined based on willingness to pay for therapeutic benefit, not the\nquantity used. Treating unused portion as rebatable or sharing single-use vials\nbetween multiple patients, the committee wrote, would likely lead to higher\nprices. First, there are costs associated with finding and using a method to\nsafely treat multiple patients with single use vials. Second, more patients would\nbe treated with the same amount of a given product. Since price is determined\nby willingness to pay, this would create an incentive for manufacturers to\nraise prices, the study committee found.<\/p>\n\n\n\n

Rather than seeking to\nrecoup funds from discarded drugs or find a way to safely use remaining product\nin a single-use vial, the study committee recommended that FDA require future\npivotal trials be based on fixed doses rather than variable doses, except where\nsafety or efficacy would be compromised. Such a move would mean that the\nentirety of single-dose vials would be used. It also recommended that\nconflicting guidance on single-use vials from various federal agencies be\nharmonized. Finally, the committee made broader recommendations on Part B\npayment, including uncoupling payments for drug administration from average\nsales price or instituting new models based on treatment episode.<\/p>\n\n\n\n

Biden Asks SCOTUS to Drop Medicaid Work Requirement Cases <\/strong> <\/p>\n\n\n\n

The Biden administration asked the Supreme Court last Monday to not<\/em> hear arguments in two cases considering the legality of Medicaid work requirement waivers approved under the Trump Administration. Arguments in the cases from Arkansas and New Hampshire are currently scheduled to be heard March 29, although the Biden administration cited \u201cgreatly changed circumstances\u201d as the Centers for Medicare and Medicaid Services took action in February to roll back the waivers. The state of Arkansas immediately opposed dropping the cases, stating that the \u201ccentral question in these cases \u2014 what Medicaid’s objectives are \u2014 will likely return” before the highest court and its \u201cpressing\u201d that the cases be decided now. The Department of Justice countered that the COVID-19 pandemic had changed the environment in which Arkansas\u2019 Medicaid work requirements were approved, and the 1115 waiver demonstration is likely to end before the pandemic is over. New Hampshire did not issue a position on removing the arguments from the Supreme Court\u2019s calendar.\u00a0 <\/p>\n","protected":false},"excerpt":{"rendered":"

Capitol Hill Update Early Saturday morning, House lawmakers passed (219-210) the $1.9 trillion “American Rescue Plan,” sending it to the Senate for consideration this week. The current version of the measure will be subject to additional changes in the upper chamber after the Senate Parliamentarian ruled last week that the proposed $15 minimum wage increase […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,7],"tags":[],"acf":[],"yoast_head":"\nHealth Policy Report (3\/1) - thornrun<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/thornrun.com\/health-policy-report-3-1\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Policy Report (3\/1) - thornrun\" \/>\n<meta property=\"og:description\" content=\"Capitol Hill Update Early Saturday morning, House lawmakers passed (219-210) the $1.9 trillion “American Rescue Plan,” sending it to the Senate for consideration this week. 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