{"id":2079,"date":"2021-10-06T18:44:11","date_gmt":"2021-10-06T18:44:11","guid":{"rendered":"https:\/\/thornrun.com\/health-policy-report-10-4\/"},"modified":"2023-08-08T21:25:38","modified_gmt":"2023-08-08T21:25:38","slug":"health-policy-report-10-4","status":"publish","type":"post","link":"https:\/\/thornrun.com\/health-policy-report-10-4\/","title":{"rendered":"Health Policy Report (10\/4)"},"content":{"rendered":"\n

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

Democratic leadership has brokered a new deadline for action on both the bipartisan infrastructure deal and the fiscal year (FY) 2022 reconciliation package amid lingering disagreements between progressives and moderates. Progressive Members pushed back against a vote on the Senate-passed infrastructure legislation due to a lack of progress on reconciliation, derailing last week\u2019s schedule and causing a temporary lapse in funding for federal surface transportation programs that were originally tacked onto the infrastructure bill. Lawmakers now have until Sunday, October 31 to iron out an agreement on a path forward for the Biden-endorsed infrastructure deal and the Build Back Better Act (BBBA) after Congress passed a monthlong funding measure to address the expired surface transportation funding. <\/p>\n\n\n\n\n\n\n\n

Negotiations on the size\nand scope of the reconciliation package will continue throughout the month as\nSpeaker Nancy Pelosi (D-CA) and Majority Leader Chuck Schumer (D-NY) look to\nget these key Biden agenda items back on track. However, it remains to be seen\nwhether centrist Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) will\ncoalesce behind filibuster-proof measure that falls in the price range of\n$1.9-$2.3 trillion \u2014 a figure that President Joe Biden floated to Democrats\nduring a caucus meeting last Friday. Leadership will also need to shore up\nprogressive support that could ultimately wane if reconciliation priorities on\nhealth care, climate change, and child care are pared back significantly during\nthe course of these intraparty talks. <\/p>\n\n\n\n

CMS Releases Second\nInterim Final Rule Regarding Surprise Medical Bills <\/strong><\/p>\n\n\n\n

On Thursday,\nthe Centers for Medicare & Medicaid Services (CMS) issued its second\ninterim final rule (IFR) (rule<\/a>; press release<\/a>; fact sheet<\/a>) to address large out-of-pocket costs to\nconsumers from \u201csurprise billing.\u201dThe IFR released last week\nis the second set of rulemaking issued by the Biden-Harris Administration\nto implement certain provisions of the No Surprises Act, which was included as\npart of the Consolidated Appropriations Act, 2021, that was signed into\nlaw last December. Part II of the rule announced last week aims to provide\nan avenue to settled out-of-network (OON) provider and payment rates and outlines\ncost estimates for the uninsured. Additionally, it addresses a\npathway for dispute resolution processes for the uninsured.   <\/p>\n\n\n\n

The IFR was\nreleased in conjunction with the Departments of Labor (DOL), Treasury, and\nthe Office of Personnel Management (OPM). However, the CMS rules only\napply to selected dispute resolution (SDR) entities, providers, facilities, and\nproviders of air ambulance services as depicted in Part I of the\nIFR.  The first rule in this two-part series, entitled \u201cRequirements\nRelated to Surprise Billing; Part I,\u201d (TRP analysis<\/a>; rule<\/a>; fact sheet<\/a>; press release<\/a>) banned “surprise billing” for\nemergency services and other out-of-network charges that applied to\nhealth care providers, facilities, and providers of air ambulance\nservices. The regulations announced in Parts I and II are applicable\nbeginning January 1, 2022.  <\/p>\n\n\n\n

The rule details\nthe long-anticipated federal independent resolution (IDR) process, which\nallows plans and insurers to determine OON rates for emergency\nservices after an unsuccessful open negotiation. The rule also\ndiscusses good faith estimates of health care items and services for\nuninsured or self-pay individuals and the associated patient-provider dispute\nresolution process. Additionally, the rule contains OPM\nclarifications regarding the No Surprises\nAct provisions that apply to health benefits plans offered by carriers\nunder the Federal Employees Health Benefits (FEHB) Act.  <\/p>\n\n\n\n

Notably, the rule\nstates that the Biden-Harris Administration is intending to issue further\nadditional regulations regarding surprise billing throughout several phases of\nthis year and into 2022. These future regulations would address: (1) patient\nprotections through transparency; (2) price comparison tools; and (3)\ntransparency provisions for insurance identification cards, continuity of\ncare, the accuracy of provider network directories, and the prohibition on gag\nclauses. <\/p>\n\n\n\n

Senate Considers Special\nProvisions for Small Biotech Companies in Reconciliation <\/strong><\/p>\n\n\n\n

As reported in STAT\nNews, Senate Finance Committee Chair Ron Wyden (D-OR) continues to juggle the\nprecarious reconciliation package \u2014 specifically, drug pricing provisions \u2014 as\nDemocrats work to unify and pass the legislation. One of the most recent\nefforts toward this goal includes a carve-out for small biotech firms. In its\ncurrent form, the reconciliation bill would institute Medicare price\nnegotiations for some of the U.S.\u2019s most expensive medications, effective\nimmediately. Under the new carve-out for small firms, small-firm drugs that\nqualify for Medicare negotiated prices would have the negotiated price phased\nin over several years. At this time, it is unclear if the phase-in policy would\nsunset. Wyden did not provide specific details about this plan when prompted\nlast Tuesday, but he confirmed that the committee is continuing to develop\npolicies that would protect smaller biotech firms.<\/p>\n\n\n\n

Despite these impending\nchanges to the reconciliation package, the biotech industry is not satisfied.\nThey continue to assert that targeting drug prices would stifle critical\ninvestments needed to keep small firms in business. Stakeholders argue that a\nphase-in would merely offer smaller companies a narrow window to rely on\nmarket-based pricing. Additionally, the policy would disincentivize product\nacquisition by large manufacturers \u2014 a practice that many small manufacturers\nrely on for revenue \u2014 since acquisition would nullify any benefits from the\ncarve-out. Moderate Democrats are sympathetic to these concerns, with Sens. Tom\nCarper (D-DE), Bob Menendez (D-NJ), and Kyrsten Sinema (D-AZ) continuing to\nraise concerns about the drug pricing legislation regardless of mitigation\npolicy to reduce the burden on small manufacturers. <\/p>\n\n\n\n

House Lawmakers Push\nBipartisan Mental Health Legislative Plan<\/strong><\/p>\n\n\n\n

Last Wednesday, the\nBipartisan Addiction and Mental Health Task Force, led by Reps. Annie Kuster\n(D-NH), Brian Fitzpatrick (R-PA), David Trone (D-MD), and Jaime Herrera Beutler\n(R-WA), unveiled their Task Force\u2019s 2021 Legislative\nAgenda<\/a>. The agenda includes 66\nbills that address opioid and suicide prevention, treatment, rural and\nunderserved communities, workforce development, first responders, drug\ntrafficking and interdiction, children and families, veterans, prescribing,\neducation and stigma reduction, and health care access and parity. The plan\ndropped amidst a worsening mental health and substance abuse disorder (SUD)\ncrisis instigated by the COVID-19 pandemic. <\/p>\n\n\n\n

The increase in these\ncases sheds light on health disparities that affect several American\ncommunities. Specifically, a National Institutes of Health (NIH) study<\/a> published in September found that opioid deaths\nincreased by 38 percent amongst Hispanic Black Americans. Analyzing trends\nthrough a state-by-state lens, the study also identified New York,\nMassachusetts, Kentucky, and Ohio as states where overdoses among other racial\nand ethnic groups maintained their previous rates or decreased. <\/p>\n\n\n\n

The House Majority\ncalendar has yet to schedule the package for consideration, though leaders\nagreed to support further work on mental health and addiction issues. All 66 of\nthe bills are bipartisan and are in different stages of the legislative\nprocess. Among the bills outlined in the report are the Suicide Training and\nAwareness Nationally Delivered for Universal Prevention (STANDUP) Act of 2021 (H.R. 586<\/a>) and the Pursuing Equity in Mental Health Act (H.R. 1475<\/a>), both of which have already passed the House\nand were referred to the Senate Health, Education, Labor, and Pensions (HELP)\nCommittee. The Improving Mental Health Access from the Emergency Department Act\nof 2021 (H.R. 1205<\/a>), Family Support Services for Addiction Act (H.R. 433<\/a>), and the Mental Health Services for Students\nAct of 2021 (H.R. 721<\/a>) also passed the House and fall under Senate\nHELP jurisdiction. The Senate Finance Committee is working on its own mental\nhealth package with the aim of developing the proposal by the end of 2021. <\/p>\n\n\n\n

MA Premiums Set to Drop\nin 2022, Though Plans Remain Skeptical<\/strong><\/p>\n\n\n\n

Last Wednesday, CMS\nannounced that Medicare Advantage (MA) premiums will drop to $19 per month in\n2022. This number is an average of about $2 less than the average 2021 premium.\nCMS reports that MA plans will increase by three million beneficiaries from\n2021 to 2022 as MA plans continue to consume larger percentages of Medicare\nbeneficiaries each year. The Kaiser Family Foundation found that bout 42\npercent of Medicare beneficiaries are enrolled in MA plans. Additionally, more\nthan 1,000 MA plans will participate in the Center for Medicare and Medicaid\nInnovation’s (CMMI’s) MA Value-Based Insurance Design (VBID) Model in 2022. The\nmodel will focus on customized health plans that factor in beneficiaries\u2019\ndisease and social determinants of health needs. <\/p>\n\n\n\n

Insurance stakeholders\nsupported the announcement, but they worried that a looming reconciliation bill\nwill cut MA payments to fund the package\u2019s proposed changes to original\nMedicare. Congressional Democrats aim to expand original Medicare to include\ndental, vision, and hearing coverage. Insurance stakeholders worry that\ncovering the costs of such an expansion could come from the MA program, most of\nwhich already cover dental, vision, and hearing. Some groups speculate that the\ncurrent MA risk adjustment could be pushed from its current 5.9 percent rate to\nanywhere from seven to nine percent. If this adjustment occurred, and MA\nplans maintained the same level of supplemental benefits, MA premiums could\nincrease by $9 to $25 per month. As a result of such a change, low premium\nplans would be more difficult to come by. If MA plans decided to decrease\nbenefits as risk-adjustment rates rose, plan values are projected to decrease\nby 35 to 57 percent.<\/p>\n\n\n\n

GAO Publishes Report on\nCCBHC Demonstrations<\/strong><\/p>\n\n\n\n

Last Monday, the U.S.\nGovernment Accountability Office (GAO) published its report<\/a> on certified community behavioral health clinic\n(CCBHC) demonstrations. Out of the eight states participating in the\ndemonstration, GAO found that five states increased their spending on\nbehavioral health services. GAO attributed the uptick in spending to an influx\nin beneficiary participation and an expansion of services offered. On the other\nhand, two states experienced a decrease in CCBHC spending due to the enhanced\nfederal funding to their states\u2019 Medicaid programs. Officials from the eighth\nstate, Pennsylvania, said that the budgetary effect of the demonstration\nprogram was unknown. <\/p>\n\n\n\n

In 2016, the U.S.\nDepartment of Health and Human Services (HHS) selected eight states \u2014\nMinnesota, Missouri, Nevada, New Jersey, New York, Oklahoma, Oregon, and\nPennsylvania \u2014 to participate in a CCBHC demonstration program, resulting in 66\nCCHBC facilities. The goal of the demonstration is to improve patient access to\ncommunity-based mental health services. States participating in CCBHC\ndemonstration programs are required to provide a minimum threshold of\nbehavioral health services and, in return, they receive enhanced federal\nfunding for their Medicaid programs. The Coronavirus Aid, Relief, and Economic\nSecurity (CARES) Act commissioned a GAO report on the status of the CCBHC\ndemonstrations, including state experiences with the program, impact on state\nspending, and Centers for Medicare & Medicaid Services (CMS) payment\nguidance. <\/p>\n\n\n\n

Four states assessed\ncost savings resulting from the CCBHC program. Three of the states found\nthat diverting care from more expensive settings, such as hospital emergency\ndepartments, yielded cost savings. Missouri officials identified a 70 percent\ndecrease in emergency room visits and hospitalizations after six months for\nbeneficiaries who engaged in their CCBHC Emergency Room Enhancement program. In\nNew York, CCBHC programs reported that hospitalization and emergency room costs\ndecreased by over 25 percent in the first year, aggregating over $1 million and\n$100,000 in savings per month from decreased hospitalizations and emergency\nroom visits. Oklahoma saw similar trends, reporting annual savings of over $2\nmillion compared to Community Mental Health Centers (CMHCs). Beginning in\nOctober of 2021 and 2022, Michigan and Kentucky will join the CCBHC\ndemonstration program. <\/p>\n\n\n\n

While the report sheds\nan overall positive light on CCBHC demonstrations, GAO took issue with CMS\u2019\nrole in facilitating the program. Upon examining CMS guidance for aligning the\ncost of care with CCBHCs payment rates, GAO concluded that \u201cthe guidance lacked\nclear and consistent information.\u201d GAO also asserted in its report that CMS\nguidance was insufficient at preventing duplicative payments. Specifically, CMS\nguidance gives states the option to rebase their initial payment rates after\nthe first year of the demonstration to ease states\u2019 reliance on anticipated\ncosts. While CMS expected states to rebase, the agency did not provide rebasing\ninstructions and states did not heavily utilize this option. Additionally, GAO\nfound that CMS provided conflicting guidance regarding overlap between CCBHCs\nand Federally Qualified Health Centers (FQHCs), possibly leading to duplicative\npayments. <\/p>\n\n\n\n

Based on these concerns,\nGAO outlined two recommendations to CMS: (1) CMS should issue \u201cclear and\nconsistent written guidance\u201d that encourages rebasing CCBHC payments, including\na more detailed explanation of how and when states should rebase; and (2) CMS\nshould issue \u201cclear and consistent written guidance\u201d on ways to avoid\nduplicative payments between the CCBHC payments and other Medicaid program\npayments. <\/p>\n\n\n\n

FDA Issues Draft Guidance Regarding Drug Regulation Process <\/strong><\/p>\n\n\n\n

On Wednesday, the Food and Drug Administration (FDA) released draft guidance<\/a> informing drug companies that should they wish to use real-world evidence \u2014 such as electronic health records (EHRs) \u2014 in their drug approval applications, they should clear questions with identified endpoints. The FDA guidance also suggests that companies utilize standardized records that include patients\u2019 demographic, comorbidity, and mortality information. It is important to note that EHRs and medical claims contain information that is not available from clinical trials. Over the last several years, Congress and industry stakeholders have encouraged FDA to embrace the inclusion of real-world information in the approval process. Specifically, the 21st<\/sup>\u00a0Century Cures Act required FDA to look into requiring real-world data in its evaluation of potential new therapies. The most recent rendition of the Prescription Drug User Fee Act (PDUFA) also encouraged FDA to release guidance on the subject. <\/p>\n","protected":false},"excerpt":{"rendered":"

Capitol Hill Update Democratic leadership has brokered a new deadline for action on both the bipartisan infrastructure deal and the fiscal year (FY) 2022 reconciliation package amid lingering disagreements between progressives and moderates. Progressive Members pushed back against a vote on the Senate-passed infrastructure legislation due to a lack of progress on reconciliation, derailing last […]<\/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 (10\/4) - 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-10-4\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Policy Report (10\/4) - thornrun\" \/>\n<meta property=\"og:description\" content=\"Capitol Hill Update Democratic leadership has brokered a new deadline for action on both the bipartisan infrastructure deal and the fiscal year (FY) 2022 reconciliation package amid lingering disagreements between progressives and moderates. 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