Update on Federal Issues

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1 Update on Federal Issues HFMA Region 7 Conference September 28, 2018 South Bend, IN

2 Presentation Overview Congressional Action 2018 Election Regulatory Update Working with Congress

3 Fall Preview Unfinished Business Supreme Court & Other Nominations Appropriations FY 2018 funding expires September 30 OPPS rule Dear Colleague Opioids legislation 340B program

4 Congressional Schedule Both chambers in session House in session Senate in session Holiday September October Image November December

5 Legislative Activity Appropriations OPPS proposed rule Opioids 340B

6 FY 2019 Appropriations Trump Wants $5 Billion for Border Wall Amid Shutdown Threat - August 20, 2018 FY 2019 funding not complete House has passed 4 of 12 bills Senate has passed 9 of 12 bills Working on conference for minibus bills Address Homeland Security after midterm elections?

7 OPPS Proposed Rule: Congressional Response Dear Colleague Circulating Senators Rob Portman (R-OH) and Debbie Stabenow (D-MI) Representatives Peter Roskam (R-IL) and Mike Thompson (D-CA) Focus on site neutral payment policy changes and limitations on new services Please ask your House Members and Senators to sign on

8 Opioid Action in Senate Opioid Crisis Response Act of 2018 Increases funding and flexibility for existing SAMHSA grants to states Gives other federal agencies (CDC, FDA, NIH) more authority to address crisis Demo to promote follow-up to ED care of overdose patients Targets Medicare, Medicaid and CHIP programs ability to address crisis Conference with House: September or Lame Duck? AHA Priorities: Include 42 CFR and IMD in Conference Package

9 340B Program - Update Legal strategy Congressional activity Development of principles

10 Legal Fight Continues in Federal Court Court July 17 dismissed case on a procedural ground: failure of presentment Decision was NOT made on the merits of the case Appeal filed September 5

11 Another Lawsuit ACA provisions developed in response to OIG reports of drug company overcharges: Authorize HHS to issue regulations defining ceiling prices Direct that those prices be posted on the internet Require HHS to issue regulations to impose Civil Monetary Penalties for noncompliance in 180 days Regulations have been delayed 5 times, most recently on June 5 AHA, AAMC, 340B Health and AEH filed lawsuit early September challenging most recent delay as unreasonable and arbitrary and capricious

12 Congressional Update Senate HELP Committee Held several hearings Image House Energy and Commerce Committee Held multiple hearings Released reports Legislation considered to modify program Mark-up pending?

13 Key Messages The 340B program is working as intended. Any additional regulatory burden would do nothing to enhance access to care for communities and patients, but rather would reduce the size of the program, putting access to care at risk and more dollars in drug manufacturers pockets. The real transparency that is needed is on drug manufacturers, as required by the ACA but never implemented. The 340B savings are drug manufacturer dollars, not taxpayer dollars.

14 Engaging Members Development of Principles Board-level AHA Task Force on the 340B Drug Pricing Program Built on the work of informal AHA advisory group 340B hospital structure policies and practices to demonstrate commitment to: Communicate Value of the 340B Program Disclose 340B Estimated Savings Perform Rigorous Internal Review Member Webinar September 13

15 Pushing Back Developed advertising in favor of the CREATES Act, to stop drug companies from unfairly delaying drugs moving off-patent to less expensive generics Developed and updated policy proposals to reduce prices that are market-based and bipartisan Engaged with HHS Secretary Azar via letter and discussion to try to include these policies in the Administration s drug pricing strategies Supported language in Senate Labor-HHS bill to require "direct-to-consumer" advertising include the price of the medications

16 Pushing Back Nearly 1 in 5 Hospitals Marks Up Medicine Prices at Least 700 Percent A 700 Percent Markup Could Result in Patients Being Billed $1,050 for a $150 Medicine PhRMA September 5, 2018 ** A message from PhRMA: According to a new analysis, nearly one in five hospitals mark up medicine prices 700% or more. Even worse, 320 hospitals in the study marked up prices more than 1000%. These hospital markups lead to higher costs for everyone patients, employers and payers. **

17 2018 Election: Overview Charlie Cook s things to watch this year Generic ballot polling Direction of country polling Trump approval ratings Trump approval by intensity Consumer confidence Unemployment rate Policy polling: tax reform vs. ACA

18 2018 Election: Generic Ballot Democrats hold about a 10-point lead in generic ballot polling

19 2018 Election: Consumer Confidence Consumer confidence has declined slightly in recent months

20 2018 Election: Unemployment Rate The unemployment rate is at an almost historic low of 4%

21 2018 Election: Polling on Taxes and ACA The Affordable Care Act outperforms the Tax Cuts & Jobs Act in opinion polls

22 2018 Election: Medicare for All What does it mean? Single-payer, government-sponsored coverage Public option Nearly all Democratic senators potentially running for president in 2020 have endorsed Touted by Democrats in some House races Majority of public supports concept until you mention raising taxes

23 Medicare for All: Potential Dem Allies Five Senate Dem bills to expand Medicare/Medicaid for all 13 Dem Senators (excluding leadership) have not cosponsored any of them: Cantwell, Carper, Coons, Donnelly, Hassan, Heitkamp, Jones, King, Manchin, McCaskill, Nelson, Tester and Warner House Moderates: Blue Dogs Kurt Schrader (OR-05) Dan Lipinski (IL-03) Collin Peterson (MN-07) House Moderates: New Dems Ron Kind (WI-03) Derek Kilmer (WA-06) Brad Schneider (IL-10)

24 2018 Election: Democratic Candidates National Journal June 21, 2018

25 2018 Election: Republican Candidates National Journal June 21, 2018

26 2018 Election: Predictions

27 2018 Election: Predictions The next Congress will have to focus on deficits and entitlements National debt at highest level since after WWII Interest rates Social Security spending Medicare spending Revenues

28 Regulatory Update

29 Regulatory Activity IPPS final rule OPPS proposed rule Physician payment proposed rule Insurance market update Reducing regulatory burden Social determinants of health

30 Inpatient PPS Final Rule and Hospital Star Ratings IPPS Final Rule Payment for new technologies (CAR T) Wage index Meaningful measures Delay in Release of Star Ratings Hospital association request Expert meeting Upcoming listening sessions

31 Hospital Outpatient Proposed Rule Site-neutral payment expanded for grandfathered sites Clinic visit services New families of services 340B Reduced payment for non-grandfathered sites

32 Physician Fee Schedule Proposed Rule Proposed collapse of E/M payment rates for Levels 2-5 visits Add-on codes, separate podiatry codes also proposed Corollary proposal: Default to Level 2 documentation requirements Proposed MIPS changes Appropriate use criteria

33 Individual Market Developments Expanded access to association health plans 11 states and DC suing the Administration over this rule Expanded availability of short-term, limited-duration health plans Consumers will now be able to renew short-term coverage for up to three years States retain authority to regulate (and even ban) these plans Decreased funding for the navigator program for the second year Texas lawsuit against the ACA continues A coalition of state attorneys general are defending the law Amicus brief filed by AHA and other national hospital associations Oral arguments: September 5

34 Promoting Interoperability Programs (aka Meaningful Use) Image Greater flexibility in requirements Better alignment across hospitals and physicians Continued emphasis on sharing health information with patients and other providers 2015 Edition Certified EHR Enabling use of apps RFI on Conditions of Participation Forthcoming actions from ONC on a Trusted Exchange Framework and information blocking

35 Progress on Measures that Matter AHA influenced CMS s Meaningful Measures 16 out of 19 CMS meaningful measure areas align with AHA measure priority list (other 3 reflect AHA cross-org priorities) FY / CY 2019 CMS policies by the numbers: 29 percent reduction in inpatient hospital measures 28 percent reduction in inpatient psychiatric measures 55 percent reduction in outpatient hospital measures (proposed) 34 measures removed from MIPS (proposed) 10 measures removed from various post-acute care programs (final) AHA-facilitated collaborative effort for public / private measure alignment underway

36 Reg Relief Ask Stark Exception for Value-Based Payment Arrangements Readmission Adjustment for SES Hospital-based Physician Reporting in MIPS Employ Risk Adjustment Rigorously, including SES Adjustment in MIPs Align Hospitals and Physician EHR Reporting Requirements for MIPS with Hospital Requirements for MU Increase the Number of Alternative Payment Models that Qualify under MACRA Use Only Measure that Truly Matter Flexibility for Shared Treatment Space to Address Gaps in Patient Access to Care Cancel Stage 3 of the "Meaningful Use" Program Clarify Medicaid Payment Policies Regarding Justice-involved Individuals Receiving Inpatient Care Delay Payment Impact and Reduce Burden of Appropriate Use Criteria (AUC) Eliminate Regulatory Barriers for and Alternative Payment Models (APMs) Eliminate Second Important Message from Medicare Eliminate the Observation Hours Carve-out Policy End Onerous Home Health Ageny Pre-claim Review Demonstration Examine IRF '60% Rule' Halt use of Encounter Data to Formulate MA Risk Scores Improve Consistency and Accuracy of IRF 'Three-hour Rule' Enforement Issue a Permanent Enforcement Mortorium on Direct Supervision Requirements Issue a Permanent Enforcement Mortorium on the '96-hour' Rule Make Future Bundled Payment Programs Voluntary Modify CoPs to Allow Hospitals to Recommend Post-acute Care Providers Permanently Eliminate Unfair Long-term Care Hospital (LTCH) Regulation Postpone and Re-evaluate Post-acute Care Quality Measure Requirements Preserve Medicaid Supplemental Payments in Managed Care Promote Transparency/Timeliness for Development and Release of Interpretive Guidance Reduce Burden Associated with Validation Surveys Remove Faulty Hospital Quality Measures Remove the Mandatory Free-text Field from the Medicare Outpatient Observation Require Formal Reciprocity Arrangements for Medicaid Provider Enrollment and Screening Rescind "JW Modifier" Requirement for Certain Drug Claims Restore Compliant Codes for Inpatient Rehabilitation Facility (IRF) 60% Rule Revise the RAC Contracts to Incorporate a Financial Penalty for Poor Performance Stop Federal Agency Intrusion in Private-sector Acreditation Standards Suspend Electronic Clinical Quality Meansures (ecqm) Reporting Requirements Suspend Hospital Star Ratings Undo Agency Over-reach on So-called "Information Blocking" Withdraw Final rule on Medicaid DSH Third-Party Payments Withdraw Proposed Mandatory Part B Drug Demonstration Expand Medicare Coverage of Telehealth Services Status: Dec Status: Dec Status: Sept Progress on Regulatory Relief 2018 Movement on: Stark exception for VBP arrangements Elimination of 25% rule Removing faulty hospital quality measures Aligning physician and hospital EHR reporting requirements with greater flexibility Allowing treating providers to access patients substance abuse disorder treatment records (Congressional)

37 Reducing Burden: Potential Progress CMS Rule to Reduce Regulatory Burden Awaiting publication Will amend certain COP requirements to reduce compliance burden CMS RFI on Stark and HHS OIG RFI on Anti- Kickback Statute (AKS) Stark RFI released June 25; comment period closed Aug. 24 AKS RFI released Aug. 24; comments due Oct. 26 CMS working on guidance --- Expected September Ligature risk Co-location EMTALA issues

38 New Effort to Address Social Determinants of Health Multi-stakeholder coalition BCBSA, Humana, Optum, Solera, United Healthcare, among others Develop pilot program(s) to align federal rules & funding across 30+ social service programs

39 Working with Congress Introduce yourself and your organization Raise one or two issues Keep in touch

40 Update on Federal Issues HFMA Region 7 Conference Kim Byas, Sr., PhD, MPH, FACHE kbyas@aha.org

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