Washington Healthcare Update

September 25, 2017

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This Week: Republicans try repeal-replace again… Grassley asks about hospitalinspection records and opioids hearing planned.

1. Congress



2. Regulations Open for Comment

3. Administration

4. States

5. Reports

1. Congress


Lawmakers Urge FDA to Rewrite “Deemed to be a License” Biosimilar Guide

On Sept. 20, the Congressional Diabetes Caucus chairs Reps. Diana DeGette(D-CO) and Tom Reed (R-NY) sent a letter to FDA Commissioner Scott Gottliebon revising the guidance for the Biologics Price Competition and InnovationAct’s provisions. The letter summarizes their position that existing policydiscourages a lower price market for insulin products. In 2016, FDA laidout guidance that any biologic applications filed under the Food, Drug andCosmetic Act that are still pending by March 23, 2020, the date oftransition, will not receive approval and need to be resubmitted. Thecaucus chairs stated, “Insulins are the largest category of productsimpacted by the ‘deemed to be a license’ provision. The draft guidanceissued last year, however, unnecessarily delays market entry forcompetitive products that could help lower the cost of insulin.” Further,the letter states, “The FDA should amend the guidance to streamline thetransition…. We believe the draft guidance should be amended to streamlinethe transition to ensure patient access to more affordable biosimilartreatments, reflecting the Congressional intent of BPCIA.”


Graham-Cassidy Hearing and Maybe a Vote

Senate Finance Chair Orrin Hatch (R-UT) has called a committee hearing onthe health care bill by Sens. Bill Cassidy (R-LA) and Lindsey Graham (R-SC)for Sept. 25. In addition, Senator Ron Johnson (R-WI), who chairs theSenate Committee on Homeland Security, had announced a hearing for the billin his committee, but canceled his committee’s hearing once the FinanceCommittee hearing was scheduled.

The Congressional Budget Office announced it would release a “preliminary”analysis early this week that will only state whether the bill meetsreconciliation instructions. CBO has stated that it won’t be able to sayfor several weeks, however, how the bill would affect the deficit, coveragenumbers or cost of premiums. This means that Senate Majority Leader MitchMcConnell (R-KY) would have to bring it to the floor before senators knowthe projected impact if he wants to pass it through reconciliation. Thoseinstructions expire Sept. 30.

Because of the deadline of Sept. 30, the majority leader and others arepushing to try one last time to move legislation to repeal and replace theAffordable Care Act. Sen. Rand Paul (R-KY) has said he will not vote forthe bill. Pressure is being placed on Sens. John McCain (R-AZ), LisaMurkowski (R-AK) and Susan Collins (R-ME), who voted “no” on the previousefforts to repeal and replace when the Senate considered it prior to theAugust recess.

On Sept. 19, a bipartisan letter from 10 governors urged the Senate to notconsider the proposal. The letter was signed by Republican governors JohnKasich of Ohio, Brian Sandoval of Nevada, Charlie Baker of Massachusettsand Phil Scott of Vermont. Other signers included independent Bill Walkerof Alaska and Democratic governors John Hickenlooper of Colorado, Tom Wolfof Pennsylvania, John Bel Edwards of Louisiana, Terry McAuliffe of Virginiaand Steve Bullock of Montana. In addition, the Republican governors ofMaryland, New Jersey and New Mexico have stated their opposition to thelegislation.

Grassley Asks Hospital Inspection Records Be Made Public

On Sept. 18, Senate Judiciary Chairman Chuck Grassley publicly asked CMSAdministrator Seema Verma to release all hospital inspection records.According to recent news reported by the Wall Street Journal,hospitals have retained their accreditation regardless of violations thatwere deemed to cause serious injury or death. Specifically, Grassleystated, “The Joint Commission appears to be unable to aggressively enforcethe necessary standards on all facilities. Making facility inspectionsreports public may go a long way to providing the necessary additionalinformation for patients and their families to make informed decisionsabout where to seek care.” The Joint Commission is the accrediting agencyfor CMS.

To view the letter,click here.

HELP Hearing Oct. 5

The Health Education Labor and Pensions (HELP) Committee has announced ahearing for Oct. 5, “the Federal Response to the Opioid Crisis.” Witnesseswill be:

  • Elinore F. McCance-Katz, M.D., Ph.D., assistant secretary for Mental Health and Substance Use, SAMHSA
  • Brenda Fitzgerald, M.D., director, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry
  • Francis Collins, M.D., Ph.D., director, National Institutes of Health
  • Scott Gottlieb, M.D., commissioner, Food and Drug Administration

2. Regulations Open for Comment

CMS Proposes 2018 and 2019 Payment Changes for Medicare Home HealthAgencies

The Centers for Medicare & Medicaid Services (CMS) on July 25 issued aproposed rule that would update payment rates and the wage index for homehealth agencies (HHAs) serving Medicare beneficiaries in 2018; it alsoproposes a redesign of the payment system in 2019. Comments are due Sept.25, 2017.

CMS is planning a slight pay cut for home health agencies in 2018, byreducing Medicare payments to the agencies by 0.4 percent next year, savingthe federal government an estimated $80 million. That change is driven inpart by CMS’s planned phase out of a provision boosting pay rates forcertain home health services delivered to rural patients. The agency isalso floating a series of changes to the payment methodology beginning in2019, which could result in a pay cut of up to 4.3 percent. That wouldtranslate to as much as $950 million in reduced Medicare payments to homehealth agencies.

Under the proposed rule, the home health payment update percentage for HHAsthat submit the required quality data for the Home Health Quality ReportingProgram would be 1 percent in 2018. The proposed rule also includesproposals to refine the HH PPS case-mix adjustment methodology, including achange in the unit of payment from 60-day episodes of care to 30-dayperiods of care, to be implemented for periods of care beginning on orafter Jan. 1, 2019. Additionally, the proposed rule includes proposals forthe Home Health Value-Based Purchasing Model and the Home Health QualityReporting Program.

To view the proposed rule,click here.

For more information on the Home Health Prospective Payment System,click here.

3. Administration

CMS: Home Health Agencies: Quality of Patient Care Star RatingAlgorithm Call

During this call, CMS will talk about modifications and proposed changes tothe way the Quality of Patient Care star rating is calculated, includingthe removal of the influenza measure. CMS presents the rationale, proposedtiming and impact of the changes. A question-and-answer session follows thepresentation.

The call is scheduled for Tuesday, Oct. 10 from 2-3 p.m. ET.

To register for the call, click here.

CMS Innovation Center New Direction RFI: Submit Comments by Nov. 20

On Sept. 20, the CMS Innovation Center issued a request for information,seeking information on a new methodology to develop patient-centered careand also to experiment with market-driven reforms that empowerbeneficiaries as consumers, to provide more choice and transparency.

Comments can be submitted by clicking here.

4. States

New Jersey: Christie-led Opioid Commission Announces Public-PrivatePartnership With Pharma

On Sept. 18, New Jersey Republican Gov. Chris Christie announced apartnership between the NIH and the pharmaceutical industry in order tofast track a pain medication without opioids and treatment options. Thepress conference, held in Trenton, was a part of the president’s commissionon opioid addiction, chaired by the New Jersey governor. Kellyanne Conway,NIH representatives, FDA representatives and PhRMA were all in attendance.Prior to the conference, 14 pharmaceutical companies met, several of whichhave been a part of state-based lawsuits over deceptive marketing tacticsrelated to opioid use. The third meeting of the President’s Commission onCombating Drug Addiction and the Opioid Crisis will be held on Wednesday,Sept. 27 in Washington.

For more information on the President’s Commission on Combating DrugAddiction and the Opioid Crisis,click here.

5. Reports

Graham-Cassidy: Kaiser and Averlere Analysis Reports States Would LoseBillions

An analysis from the Kaiser Family Foundation, released Sept. 19, estimatesthat states would lose $160 billion over a decade if Graham-Cassidy wereenacted. Those cuts come largely from states that expanded Medicaid, likeCalifornia, which stands to lose $56 billion. In all, 35 states would seereduced federal support. The bill wouldn’t spare all nonexpansion states.Florida stands to lose $9.7 billion over a decade. Kaiser’s analysis alsohighlights a relatively overlooked implication of Graham-Cassidy: Theplan’s restrictions would go beyond Obamacare by cutting funding for nearlyevery state’s traditional Medicaid program. The bill imposes a cap onfederal funding for the program, resulting in a $15 billion reduction in2027 alone. Only Montana and Alaska would be spared from traditionalMedicaid cuts through a carve-out included in the bill.

To view the report, clickhere.

In addition, a new analysis from Avalere finds that the Graham-Cassidyproposal to repeal and replace the Affordable Care Act (ACA) would lead toa reduction in federal funding to states by $215 billion through 2026 andmore than $4 trillion over a 20-year period.

To view the report, clickhere.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

StephanieKennan, Senior Vice President
Anne Starke, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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