Regulatory/Legislative Update

Transcription

1 Regulatory/Legislative Update Gain Real-Time Updates on State and Federal Legislative Advancements May 23, 2017

2 Panelists Nicole Russell Manager, Government Affairs NCPDP Michele V. Davidson, R.Ph. Senior Manager, Pharmacy Technical Standards, Development & Policy, Government Relations Walgreen Co Perry Lewis VP, Industry Relations CoverMyMeds Joel White Founder and President Horizon Government Affairs

3 NCPDP Overview

4 NCPDP Multi-stakeholder, Problem-solving Forum for Healthcare Standards for Electronic Exchange of Information Telecommunication Standard eprescribing Standard (SCRIPT) Best Practices for Patient Safety Health Literacy, REMS, Safe Use of Acetaminophen, ml Dosing, PDMP Advisor to Policy Makers ONC, FDA, CMS, NCVHS

5 Best Practices NCPDP s Process Obligation to be non-biased Credibility among members, public sector and government Getting the right people in the room, engendering trust Bottom-up commitment to a solution created by consensus Driven by clinical need, business need, patient safety Workflow-enabled solutions

6 Forum for Healthcare & Patient Safety Solutions Examples: Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen; Recommendations for Dose Accumulation Monitoring in the Inpatient Setting: Acetaminophen Case Model; Recommendations and Guidance for Standardizing the Dosing Designations on Prescription Container Labels of Oral Liquid Medications; Risk Evaluation & Mitigation Strategies (REMS) The PROTECT Initiative brought these issues to NCPDP based on its success in addressing and mobilizing the industry to take action on other patient safety issues, and are looking forward to seeing this NCPDP white paper catalyze patient safety oriented standardization industry wide. Dr. Daniel Budnitz Director, Medication Safety Program Centers for Disease Control and Prevention & Leader of the CDC PROTECT Initiative

7 NCPDP s epa Transactions Electronic Prior Authorization (epa) Transactions available in SCRIPT Standard Significant Efficiency Gains - Leverage existing eprescribing technology; access info within current workflow; save time with automated epa process, cost savings Customized Electronic Exchange - Question sets based on specific patient health plan criteria; Dynamic communication no more forms! Better Clinical Care & Satisfaction - Higher quality and consistency of information in less time; Faster patient access to needed treatment improved compliance; Improved reputation and perceived value of prescribers, EHR systems, PBMs and pharmacies

8 NCVHS Recommends prompt industry implementation of NCPDP s PA Transactions

9 Why Electronic Prior Authorizations?

10 The Traditional PA Process Approximately 40% of prior authorizations are manually processed today. Inefficient process, not in workflow PA Increasing due to formulary management issues Specialty medications often require PA and are more complicated to resolve

11 Impact on Patient Source: Improving Patient Medication Adherence: A $290 Billion Opportunity

12 What is epa? Prior authorization (PA) is a requirement where your physician obtains approval from your health insurance plan to prescribe a specific medication for you. It is a technique for minimizing costs, wherein benefits are only paid if the medical care has been pre-approved by the insurance company. PA is typically required due to quantity limits, step therapy, non-formulary medications and expensive specialty drugs.

13 NCPDP SCRIPT Standard

14 epa Workflow: Retrospective Initiates Request Call CP!Completes Request Electronic Connection Pharmacy Prescriber or Staff Plan/PBM

15 epa Workflow: Prospective Initiates and Submits Request at Point of Prescribing Call CP! Electronic Connection Prescriber or Staff Plan/PBM Pharmacy

16 Five Benefits of New Standards for Prospective epa 1. Leverage eligibility and formulary data to notify providers of medication prior authorization requirements before E-prescribing 2. Instead of faxing forms, specific prior authorization questions are sent to the EHR based on patient, health plan and medication 3. Pre-population of required patient information adds efficiency and accuracy to administrative tasks 4. Real-time communication with PBMs to complete PA review before sending E-Prescription 5. Pre-approved E-Prescriptions routed to pharmacy won t be subjected to PA block

17 epa Legislation (NCPDP Standard) 16 states call for the use of an electronic method for submitting medication prior authorization in compliance with the NCPDP SCRIPT Standard.

18 epa Legislation (No Standard) 9 states call for the use of an electronic method for submitting medication prior authorization, but do not name a standard.

19 Standard Form 3 states call for the use of a universal or standard form for medication prior authorization approved by the state s Department of Insurance.

20 epa Legislation and Standard Form 17 states call for the use of a universal or standard form as well as the use of an electronic method for submitting medication prior authorization.

21 Legislation Key Takeaway Twenty-eight states have legislation pertaining to prior authorization, with pending legislation in West Virginia, Washington and New Jersey. Many states still requiring the use of a standard, universal form for PA. While this is a step in the right direction, this legislation merely replaces existing forms, rather than improving the paper process. More states should consider implementing legislation that favors the use of an electronic standard, with particular emphasis on the existing NCPDP SCRIPT Standard.

22 Next Steps Continue with epa Legislation Increase EHR adoption of the NCPDP epa transactions Pharmacies and payers are already committed

23 Adoption The technology for epa solution will continue to grow and change with the industry. API support will make it easier for technology teams at EHR, payer and pharmacy systems to quickly implement new and optimized epa solutions. Documented, standards-based epa APIs will be a key to driving adoption in the market.

24 What s on the Horizon?

25 Political Change from 2012

26 2017 Political Outlook Topline 2018 and 2020 elections shaping both parties actions Uncertain political environment generating uncertain policy outcomes Congress Key for Republicans: Manage expectations and deliver Key for Democrats: Party unity, develop agenda, exploit political gaffs Administration Early missteps and unforced errors complicate efforts on key priorities Public opinion is very important Focus on demonstrating action and results

27 Outlook for Legislation and Regulation Q2 ACA Repeal/Replace - House CR Medicare Extenders/CHRONIC UFA Hearings/Drug Pricing MACRA Rule Q4 21 st Century Cures Regs Medicare Extenders Unfinished Business End of Year Funding Bills Q1 Budget Q3 ACA Repeal/Replace Senate/Conference Finish UFAs Debt Limit CHIP Authorization Fiscal Year Ends Medicare Extenders/CHRONIC

28 Legislative Outlook ACA Repeal/Replace 1. Passed the House on May 4, 2017, , but faces total overhaul in the Senate. 2. Issues: Narrative Process mistakes/senate Process Policy Medicare Extenders and New Policies 1. Several Medicare provisions expire this year and need to be extended 2. Congressional interest in new policies may get bundled into extenders package CHRONIC Care package includes medication adherence/pharmacy changes epa? EPCS?

29 Health IT Regulation in a New Political World Medicare/Medicaid MACRA and Meaningful Use Medicare extenders and new policies, CHRONIC Care Act ONC Should ONC persist? What is their mission in a MACRA world? How effective are they? OPIOIDS White House Task Force/HHS Listening Sessions CARA Implementation/preference for interoperable, real time systems State PDMP activities Other Issues Implementation of 21 st Century Cures (FDA and Interoperability) American Council on Innovation

30 Overview: 21st Century Cures Prime Motivators 7,000 diseases with 500 treatments drove 300+ groups to support Vehicle for issues that otherwise wouldn t move Bipartisanship and legacy Right thing to do/white Hat issues Clear deck for UFAs Implementation 25 titles of the law to be implemented by regulations Congressional authors will continue to have and drive input into regulatory development Two years of hearings, meetings and discussions led to enactment of P.L , the 21 st Century Cures Act, whose goal was to modernize the discovery, development and delivery of cures. Key Issues for Regulators Definitions of Interoperability and information blocking Contracts may requite common, trusted exchange framework Implement digital provider directory Open APIs Testing and Certification

31 So What Will Happen? Medicare Changes and MACRA Implementation Despite some opposition, progress is likely to continue 21 st Century Cures Not a question of if but what and when Repeal and Replace Leaders are committed to signature issue, but party unity frayed UFAs, CHIP and Debt Limit Must pass legislation by September 30, 2017 contains broader opportunities

32 Thank you! Nicole Russell Manager, Government Affairs NCPDP Office: ext. 149 Michele V. Davidson, R.Ph. Senior Manager, Pharmacy Technical Standards, Development & Policy, Government Relations Walgreen Co Office: Perry Lewis VP, Industry Relations CoverMyMeds Office: Joel White Founder and President Horizon Government Affairs Office: