{"id":2113,"date":"2022-05-31T21:01:24","date_gmt":"2022-05-31T21:01:24","guid":{"rendered":"https:\/\/thornrun.com\/health-policy-report-5-31\/"},"modified":"2023-08-08T21:25:44","modified_gmt":"2023-08-08T21:25:44","slug":"health-policy-report-5-31","status":"publish","type":"post","link":"https:\/\/thornrun.com\/health-policy-report-5-31\/","title":{"rendered":"Health Policy Report (5\/31)"},"content":{"rendered":"\n

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

Senate Democrats are reviving their push to clinch a filibuster-proof legislative package for various elements of President Joe Biden’s economic agenda. According to intel from Capitol Hill, Sen. Joe Manchin (D-WV) has been recently engaged in talks with Majority Leader Chuck Schumer (D-NY) over a package of climate, energy, health, and deficit reduction provisions that could potentially clear the upper chamber by a party-line vote ahead of November’s midterm election. Notable policies that have been floated in these discussions include: (1) clean energy tax credits; (2) extending the Affordable Care Act (ACA) premium tax credits; (3) prescription drug pricing policies contained in the House-passed Build Back Better (BBB) Act (H.R. 5376<\/a>); and (4) additional tax provisions, including money for IRS enforcement and a 15 percent domestic minimum rate. In total, this latest BBB iteration could include close to $800 billion in new spending, coupled with $1.4 trillion in funding offsets. <\/p>\n\n\n\n\n\n\n\n

Discussions between\nLeader Schumer and Sen. Manchin are expected to continue in the weeks ahead as\nDemocrats look to deliver a legislative win for President Biden \u2014 whose\napproval ratings have been hovering in the low 40s \u2014 ahead of the November 8\ngeneral election. However, considerable skepticism abounds, and Sen. Manchin,\nwho has been trying to broker a bipartisan deal on clean energy tax credits\nover the past month, cautioned in an interview with Axios<\/em><\/a> that the\nrevived reconciliation talks could still falter absent buy-in from the totality\nof the Democratic caucus. This includes some of the House progressives who have\npushed for a more ambitious social spending package that mirrors the original\nBBB legislation, as well as moderate Sen. Kyrsten Sinema (D-AZ), who has\npreviously expressed concerns over some of the tax and drug pricing proposals\nthat have been offered. <\/p>\n\n\n\n

Meanwhile, <\/strong>both\nchambers of Congress have adjourned for a week-long state work period for the\nMemorial Day holiday, and will return to Capitol Hill the week of June 6.\nDespite lawmakers being out, negotiations on a potential bipartisan gun safety\npackage are expected to continue among a group of senators following two recent\nmass shootings in Buffalo, NY and Uvalde, TX. Members on both sides of the\naisle are facing increased pressure to address the issue of gun violence, but\nit is too early to tell whether this bipartisan Senate group can reach a deal\nthat earns 60 votes in the evenly-divided chamber. <\/p>\n\n\n\n

Looking ahead to the\nrest of the summer work period, lawmakers will aim to make significant progress\non advancing fiscal year (FY) 2023 spending bills, starting with markups in the\nHouse Appropriations Committee next month. While leadership is hopeful that the\nappropriations process can move swiftly for FY 2023, it remains possible that a\nshort-term funding bill will be needed to give lawmakers more time to address\ngovernment funding and expiring programs during the “lame duck”\nsession in November and December.<\/p>\n\n\n\n

Senate HELP Introduces\nUser Fee Package<\/strong><\/p>\n\n\n\n

On Friday, the Senate\nCommittee on Health, Education, Labor, and Pensions (HELP) Committee unveiledlegislative text<\/a> (TRP analysis<\/a>; section-by-section<\/a>) to\nreauthorize the Food and Drug Administration (FDA) user fee agreements\n(UFA). Varying from the discussion draft<\/a> (press release<\/a>) offered\nby the Committee earlier this month, the legislation includes additional\nprovisions related to: (1) the accelerated approval process;\n(2) therapeutic equivalence; (3) over-the-counter (OTC) hearing aids;\nand (4) FDA domestic and foreign inspections. Specifically, such additions\nwould allow for the use of real-world evidence (RWE) in certain\npost-approval studies, provide guidelines for an expedited procedure\nfor withdrawal of an accelerated approval product, and require the\nDepartment of Health and Human Services (HHS) to issue guidance on the use\nof novel endpoints and clinical trial designs in accelerated\napproval, among other items. <\/p>\n\n\n\n

Additionally, the\nproposed legislation would require the FDA to make timely therapeutic\nevaluations for follow-on drugs approved through the 505(b)(2) pathway that\nhave similar formulations as other approved products. The current\nfive-year authorization for the UFAs ends on September 30, 2022, which acts as\na deadline for current UFA negotiations. As both the House and Senate have\nformally released their draft legislation for these provisions, the two\nchambers will work to reconcile differences as committee hearings out of both\nchambers take place to consider the specifics of the text. Furthermore,\nadditional changes to the text are expected to be made through a managers’\namendment ahead of the Senate HELP Committee\u2019s markup of the bill \u2014 rumored to\nbe scheduled for June 8, 2022. <\/p>\n\n\n\n

Democrats Work to\nPrioritize ACA Premium Credits <\/strong><\/p>\n\n\n\n

Last Monday, Rep.\nLauren Underwood (D-IL) spearheaded aletter<\/a> along with 25 of\nher Democratic House colleagues to Senate Majority Leader Chuck Schumer (D-NY)\nand House Speaker Nancy Pelosi (D-CA) calling for the extension of Affordable\nCare Act (ACA) premium tax credits. The enhanced premium tax credits included\nin the American Rescue Plan are set to expire at the end of 2022, and the\nletter requests that a revised Build Back Better (BBB) agenda include an\nextension of the credits. Without an extension of the ACA credits, enrollees\nwill be notified of increased premiums right around mid-term election season. <\/p>\n\n\n\n

This timing does not\nbode well for the May 23 letter signees, who represent swing districts. A\npolicy to extend the subsidies was included in last year\u2019s House-passed BBB Act<\/a>, though negotiations\nover the package stalled. As discussions around a reconciliation package\nreemerge, Democrats facing uncertain midterm election prospects are hopeful\nthat they can deliver on their legislative agenda and retain their seats in\nCongress. Sen. Joe Manchin (D-WV) \u2014 who has dictated policies to be included in\nthe Democrats\u2019 legislative spending package \u2014 has indicated openness to the\nidea of extending the tax credits, though their ultimate inclusion in final\nlegislative text will depend on broader negotiations.  <\/p>\n\n\n\n

No Surprises Act\nYields Results <\/strong><\/p>\n\n\n\n

In the first two\nmonths of 2022, areport <\/a>conducted by\nAmerica\u2019s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield\nAssociation (BCBSA) found that implementation of the No Surprises Act (NSA<\/a>) blocked roughly two\nmillion surprise medical bills. The NSA is designed to shield patients from\nunforeseen medical bills from out-of-network providers operating at in-network\nfacilities. Leading up to its implementation, payers and providers pushed for the\nNSA to implement an independent dispute resolution (IDR) process that favors\ntheir respective interests, and the Centers for Medicare and Medicaid Services\n(CMS) recently revised its guidance<\/a> for the IDR\nprocess following a federal lawsuit. AHIP and BCBSA reached out to over 80\ninsurers to complete their report, of which 31 responded. The report predicts\nthat the NSA could prevent over 12 million surprise bills in 2022. <\/p>\n\n\n\n

FTC Shifts Focus to\nPBMs<\/strong><\/p>\n\n\n\n

With Alvaro Bedoya at\nthe helm of the agency, the Federal Trade Commission (FTC) has announced plans\nto investigate the impact of pharmacy benefit managers (PBM) on drug prices.\nBack in February, the FTC voted on party lines not to open a probe into PBM\npractices, but the new chair has decided to open a comment period to collect\npublic input on PBM practices, for which remarks were due May 25. Under its new\nDemocrat-appointed Commissioner, the FTC is expected to re-vote on a measure to\ninvestigate PBMs. <\/p>\n\n\n\n

Specifically, the\ninvestigation would study \u201cthe competitive impact of contractual provisions,\nreimbursement adjustments, and other practices affecting drug prices, including\nthose practices that may disadvantage independent or specialty pharmacies.\u201d\nSeveral generic drug makers and numerous patient organizations have been\npushing for the FTC to investigate PBMs, though PBM stakeholders note that\ntheir industry is only one part of the drug pricing supply chain and urge the\nFTC to look into all aspects of drug pricing mechanisms. <\/p>\n\n\n\n

HCBS Providers Face\nNew Regulations <\/strong><\/p>\n\n\n\n

Last Tuesday, the\nCenters for Medicare and Medicaid Services (CMS)doubled down<\/a> on its 2014\nhome- and community-based services (HCBS) rule requiring that states and HCBS\nsettings comply with regulations by March 17, 2023. Due to the COVID-19\npandemic\u2019s impact on nursing homes, CMS had provided an extra year for\nproviders to come into compliance with the 2014 HCBS rule, but Tuesday\u2019s\nannouncement indicates that providers will not be granted another extension.\nStates must submit their Statewide Transition Plans (STP) to CMS by July 31,\n2022 \u2014 pending agency approval \u2014 in order to continue receiving federal funding\nfor HCBS. <\/p>\n\n\n\n

The STP must include an\noutline of how the state will comply with all HCBS settings criteria that are\nnot directly impacted by the COVID-19 pandemic. Specifically, these provisions\ninclude assurances that beneficiaries will have a lease, privacy in their\nunits, full access to food and visitors, and a person-centered service plan,\namong other provisions. Notably, CMS is allowing states to apply for corrective\naction plans that would push a state\u2019s compliance date under certain\nconditions. However, such plans are only viable if a state cannot meet\nrequirements due to a direct impact of the pandemic, such as employment\nopportunities, access to the community, and options for a private space, among\nother considerations. <\/p>\n\n\n\n

HHS Moves Forward on\nARPA-H<\/strong><\/p>\n\n\n\n

Department of Health and Human Services (HHS) Secretary Xavier Becerra announced<\/a> the creation of the Advanced Research Project Agency for Health (ARPA-H) within the National Institutes of Health (NIH). HHS assured the public that ARPA-H will not be subject to NIH policies and will instead be an independent agency within the NIH. Secretary Becerra also appointed the agency\u2019s first employee, Adam Russell, who will serve as ARPA-H\u2019s acting deputy director. Previously, Russell worked at the Intelligence Advanced Research Projects Activity (IARPA) and at the Defense Advanced Research Projects Agency (DARPA). <\/p>\n\n\n\n

Secretary Becerra said that President Biden will appoint an ARPA-H director who will report to HHS. However, the agency only has $1 billion from Congress, which is significantly short of President Biden\u2019s request to find the agency at $6.5 billion. The House Energy and Commerce Committee\u2019s bill<\/a> (TRP analysis<\/a>) to reauthorize the Food and Drug Administration\u2019s (FDA) user fee agreements (UFA) includes an additional $500 million per year from 2013 through 2027 for ARPA-H, though the Senate\u2019s companion bill does not currently include provisions for the agency.\u00a0 <\/p>\n","protected":false},"excerpt":{"rendered":"

Capitol Hill Update Senate Democrats are reviving their push to clinch a filibuster-proof legislative package for various elements of President Joe Biden’s economic agenda. According to intel from Capitol Hill, Sen. Joe Manchin (D-WV) has been recently engaged in talks with Majority Leader Chuck Schumer (D-NY) over a package of climate, energy, health, and deficit […]<\/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 (5\/31) - 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-5-31\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Policy Report (5\/31) - thornrun\" \/>\n<meta property=\"og:description\" content=\"Capitol Hill Update Senate Democrats are reviving their push to clinch a filibuster-proof legislative package for various elements of President Joe Biden’s economic agenda. 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