Health Policy Update

The Health Policy Update is a bi-weekly newsletter from McKesson Specialty Health with legislative updates and resources to help community providers advocate for their practices and patients.

********* Embedded Contact Object*******

Health Policy Update – February 12, 2020 (PDF, 127 KB)

  • President Renews Call for Drug Pricing Reform, Highlights Other Healthcare Issues in State of The Union
  • Administration Unveils 2021 Budget Proposal
  • Lawmakers Introduce Bill to Increase CMMI Transparency
  • Ways and Means Health Subcommittee Holds Hearing on Drug Pricing
  • CMS Clarifies Use of Copay Accumulators
  • CMS Enables States to Restructure Medicaid Program Benefits
  • FDA, FTC Outline Steps to Deter Anticompetitive Practices in Biosimilar/Biologic Advertising
  • CMS Expands Coverage of Next Generation Sequencing Diagnostic Tests
  • Insurer Groups, CMS Announce Efforts Aimed at Improving Prior Authorization

Health Policy Update – January 28, 2020 (PDF, 106 KB)

  • Hospital Groups Sue Over 2020 Site Neutral Payment Cuts
  • Supreme Court Will Weigh Validity of State Laws Regulating PBMs
  • Report Finds Significant Variability in Oncology Drug Costs Across Sites of Service
  • GAO Report Faults HRSA for Lapses in 340B Program Oversight
  • MedPAC Issues Payment Recommendations, 340B Study Following January Meeting

Health Policy Update – January 14, 2020 (PDF, 106 KB)

  • The US Oncology Network Responds to Cures 2.0 RFI
  • President Signs End of Year Spending Deal; Tees Up Health Legislation in Spring
  • Brad Smith Named New Head of CMMI
  • Avalere Releases Analysis on Part D Formularies
  • Study Finds 340B Hospitals Reimbursed at a Significantly Higher Rate Than What They Pay for Drugs
  • Study Finds Increase in Hospital Mergers Has Not Led to Improvements in Quality

Health Policy Update – December 19, 2019 (PDF, 115 KB)

  • House Passes Drug Pricing Legislation, Republicans Introduce Alternative
  • CMS to Repay 2019 Site Neutral Payment Cuts; Continue Cuts for 2020
  • Hospital Groups Oppose 340B Survey
  • Hospitals Sue HHS Over Price Transparency Rule, Insurers Ask for Delay
  • Two Committees Reach Agreement on Legislation to Lower Health Care Costs
  • Senate Unveils Updated Drug Pricing Bill with White House Support
  • Senate Confirms FDA Nominee Dr. Hahn

Health Policy Update – November 19, 2019 (PDF, 110 KB)

  • Medicare Part B Premiums to Increase in 2020
  • CMMI Extends Oncology Care First Model Comment Deadline to December 13
  • HHS Defends 340B Payment Cuts in Court
  • MedPAC Highlights Hospital Consolidation In New Analysis
  • HHS Releases Price Transparency Rules
  • Op-ed: Reforming CMMI is Not a Partisan Issue
  • Stephen Hahn Nominated to FDA Commissioner

Health Policy Update – November 5, 2019 (PDF, 122 KB)

  • Michigan State Legislature Rejects Proposed CAR-T Regulation
  • CMMI Releases Informal RFI on Oncology Care First Model
  • House Passes Two PBM Transparency Bills
  • Floor Vote on House Drug Pricing Bill Postponed
  • HHS Delays Primary Care First Model to 2021
  • Representative Greg Walden, Ranking Member of House E&C Committee, Announces Retirement
  • New Report Finds Hospital Consolidation Raises Prices; UnitedHealthcare Implements Site of Service Medical Necessity Reviews for HOPDs
  • FDA Releases New Report on Drug Shortages

Health Policy Update – September 17, 2019 (PDF, 207 KB)

  • Pelosi Drug Pricing Plan Revealed, Talks Continue on Senate Finance Bill
  • Dr. Stephen Hahn Top Contender to Lead FDA, Brad Smith Leading Candidate for CMMI
  • House Small Business Committee Holds Hearing on Prior Authorization Burden
  • Coalition of Patient and Employer Groups Urge HHS to End Part B Cost Sharing for Biosimilars
  • Hospital Groups Double Down on Claim that Mergers Lower Costs, Experts Disagree
  • Study Finds Administering Specialty Drugs Outside Hospitals Could Save $4 Billion Annually
  • HHS Announces $1.8 Billion in State Grants to Combat Opioid Crisis

Health Policy Update – August 20, 2019 (PDF, 182 KB)

  • CMS Issues National Coverage Determination for CAR-T Therapy
  • ASP Coalition Commends Senate Finance Committee Members for Opposing IPI
  • John O’Brien, Senior Advisory to the Secretary on Drug Pricing Reform, to Leave HHS
  • GAO Report Finds Part D Drug Rebates Growing Fast; PBMs Give Nearly All Rebates To Plan Sponsors
  • UnitedHealth Group Analysis on Rising Cost of Hospital Care

Health Policy Update – August 6, 2019 (PDF, 206 KB)

  • HHS Announces New Plan to Import Prescription Drugs
  • Legislation to Reduce Prior Authorization Barriers Introduced in House
  • CMS Issues 2020 Physician Fee Schedule Proposed Rule
  • CMS Issues 2020 Outpatient Prospective Payment System Proposed Rule
  • Congressional Action to Lower Drug Prices
  • Budget Deal Will Extend Medicare Sequestration To 2029
  • Site Neutral Payment Update

Health Policy Update – July 24, 2019 (PDF, 197 KB)

  • Senate Finance Committee Releases Drug Pricing Package
  • CMS Proposes Mandatory Radiation Oncology Bundled Payment Model as Head of CMMI Announces Departure
  • Judge Blocks HHS Rule Requiring Drug Companies to List Prices in TV Ads
  • Administration Abandons Proposal to Eliminate Certain Drug Rebates
  • HHS Secretary Azar Shifts Position on Drug Importation
  • CMS Releases Quality Payment Program Results
  • Federal Appeals Court Hears Arguments on the Constitutionality of the Affordable Care Act

Health Policy Update – July 11, 2019 (PDF, 118 KB)

  • CMS Announces Radiation Oncology (RO) Model Proposed Rule

Health Policy Update – July 9, 2019 (PDF, 141 KB)

  • Ben Jones: Oncologists Still Face Challenges When Trying to Extract Data From EHRs
  • House GOP Doctors Caucus Sends Letter to HHS Secretary Over Step Therapy Concerns Ads
  • President Trump Issues Executive Order on Pricing Transparency
  • CAP Study Confirms High Price of Hospital Care
  • Lower Health Care Costs Act Passes HELP Committee
  • Senate Judiciary Committee Advances Prescription Drug Pricing Legislation

Health Policy Update – May 21, 2019 (PDF, 144 KB)

  • FDA Issues Final Rule on Biosimilars
  • CMS Finalizes Rule Requiring Drug Prices in Direct-to-Consumer Ads
  • New Court Ruling Orders CMS to Quickly Rectify 340B Pay Cuts
  • House Lawmakers Launch Effort to Block Site Neutral Payments
  • Forty-Four States Sue Generic Drug Makers, Allege Price-Fixing
  • Senate Judiciary Committee Examines Drug Patents
  • Energy & Commerce Subcommittee on Health Holds Hearing on Drug Supply Chain
  • Senator Elizabeth Warren, Representative Elijah Cummings Introduce Comprehensive Opioid Legislation

Health Policy Update – May 17, 2019 (PDF, 92 KB)

  • CMS Release 2020 Medicare Advantage and Part D Drug Pricing Final Rule

Health Policy Update – May 7, 2019 (PDF, 153 KB)

  • Physician Groups Oppose Repeal of the Stark Law’s In-Office Ancillary Services Exception
  • ASTRO Survey of Radiation Oncologists Finds Prior Authorization Unnecessarily Delays Patient Access to Care Senators Question PBM Executives at Finance Committee Hearing
  • CMMI Unveils Primary Care Pilot Programs to Reform Payment to Providers
  • House Rules Committee Holds Hearing, CBO Releases Report on Medicare for All
  • House Energy and Commerce Holds Hearing on Prescription Drug Pricing in the Medicare Program
  • House Judiciary Committee Marks-Up Drug Pricing Bills

Health Policy Update – April 25, 2019 (PDF, 160 KB)

  • Bipartisan Bill to Limit Step Therapy Introduced
  • Site Neutral Payments Lawsuit: Hospitals Argue CMS Can't Ignore Statute
  • Senators Question PBM Executives at Finance Committee Hearing
  • Drug Price Transparency Bill Passes House Ways and Means Committee
  • Medicare Expected to Announce CAR-T Coverage Decision Soon
  • CMS Announces ACO Application Timeline to Begin in 2020
  • Sanders Reintroduces Medicare for All Bill in the Senate

Health Policy Update – April 4, 2019 (PDF, 154 KB)

  • Azar to Reconsider IPI Drug Pricing Model
  • Alliance for Site Neutral Payment Reform Hosts Capitol Hill Briefing
  • McKesson's Ben Jones Discusses Cancer Care Policies with AJMC
  • Department of Justice Argues Court Should Strike Down Entire ACA
  • Federal Court Strikes Down Association Health Plan Rule
  • House Energy & Commerce Committee Advances Drug Pricing Bills
  • Energy & Commerce Subcommittee Chair: No Plans for 340B Oversight Hearings

Health Policy Update – March 25, 2019 (PDF, 156 KB)

  • Administration Releases 2020 Budget Proposal
  • Alex Azar Testifies Before Congressional Committees
  • MedPAC Releases March 2019 Report to Congress
  • Ned Sharpless Appointed Acting FDA Commissioner
  • Bipartisan Lawmakers Urge HHS to Maintain Protected Drug Classes
  • CMS Releases Updated Drug Pricing Data

Health Policy Update – March 15, 2019 (PDF, 56 KB)

  • Administration Releases 2020 Budget

Health Policy Update – February 22, 2019 (PDF, 140 KB)

  • New Bills Aim to Address Drug Prices, PBM Transparency
  • House Ways & Means Committee Holds Hearing on Drug Pricing
  • Hospital Groups Ask Court to Require CMS Recalculate 340B Payments
  • CMS Issues National Coverage Decision for CAR-T Cell Therapies

Health Policy Update – February 8, 2019 (PDF, 103 KB)

  • Healthcare, Drug Prices Featured in State of the Union Address
  • HHS Moves to Address Drug Rebates in Medicare Part D
  • House, Senate Committees Hold Hearings on Drug Prices
  • Hospital Groups Sue HHS Over Site Neutral Payment Policy
  • Study: Hospital Price Growth is Major Driver of U.S. Healthcare Spending

Health Policy Update – January 25, 2019 (PDF, 369 KB)

  • Trump Administration Proposals Could Increase Out-of-Pocket Costs for Consumers
  • CMS Unveils New Part D Payment Model
  • CMS Offers New Flexibility for MA Plans in Expanded Value-Based Insurance Design (VBID) Model
  • Chairman and Ranking Members Announced for Key Healthcare Committees
  • MedPAC Holds January Meeting
  • Azar Meets with Senate Finance Members to Defend HHS' Drug Pricing Proposals
  • Patient and Provider Groups Express Concerns about Shutdown Impact on FDA

Health Policy Update – January 10, 2019 (PDF, 366 KB)

  • Healthcare Stakeholders Submit Comments on IPI Model
  • MedPAC Releases Comments on Proposed IP Model
  • Pelosi Sworn in as Speaker of the House
  • Federal Court Strikes Down CMS 340B Drug Cuts
  • House Ways & Means Committee Leadership Urges Greater Transparency in CMMI Reform
  • Senators Urge CMS to Establish Guardrails for Step Therapy Policy
  • Government Shutdown Impacts & Updates
  • Texas ACA Case Under Appeal
  • Senate Confirms New Science Advisor and Drug Czar

Health Policy Update – November 26, 2018 (PDF, 330 KB)

  • CMS Releases 2020 Medicare Advantage and Part D Drug Pricing Proposed Rule
  • Providing Plan Flexibility to Manage Protected Classes
  • Medicare Advantage and Step Therapy for Part B Drugs
  • Requiring Part D Plans to Increase Transparency
  • Prohibition Against Gag Clauses in Pharmacy Contracts

Health Policy Update Archive – November 20, 2018 (PDF, 200 KB)

  • House E&C Republican Pushes Back on International Price Index Model, Opposes Price Fixing
  • CMS Administrator Seema Verma Discusses International Price Index Model
  • AMA Resolutions Support Site Neutral Payments, Call for More 340B Program Transparency
  • Senator Chuck Grassley to Chair Senate Finance Committee

Health Policy Update Archive – November 8, 2018 (PDF, 209 KB)

  • 2018 Midterm Election Results
  • The US Oncology Network Responds to International Pricing Index Model for Medicare Part B Drugs Site Neutral Provisions Included in Final OPPS Rule
  • CMS Releases Physician Fee Schedule Final Rule; Delays Payment Changes to E/M Visits
  • In Letter to CMS, Congressman Holding Expresses Concern about Step Therapy in MA Plans
  • After Legal Challenge, HHS Accelerates Implementation of 340B Rule

Health Policy Update Archive – November 2, 2018 (PDF, 195 KB)

Final Rule Expands Site Neutral Payments and Furthers Reduction to 340B Reimbursement:

  • Payment Policy Changes
  • Increasing Choices and Encouraging Site Neutrality
  • Application of 340B Drug Payment Policy to All Off-Campus Provider-Based Departments (PBDs)
  • Payment Policy for Biosimilar Biological Products without Pass-Through Status Acquired under the 340B Program

Health Policy Update Archive – November 1, 2018 (PDF, 214 KB)

CMS Releases Final Medicare Payment Rules for 2019

  • Payment Policy Changes
  • Streamlining Evaluation and Management Payment and Reducing Clinical Burden
  • Reduction to Add-on Amount for WAC-Based Payment for Part B Drugs
  • Practice Expense (PE): Market-Based Supply and Equipment Pricing Update
  • Medicare Physician Payment by Recognizing Communication Technology-Based Services
  • Payment Rates for Non-Excepted Off-campus Provider-Based Hospital Departments Paid Under the PFS
  • Clinical Laboratory Fee Schedule
  • Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
  • Final Changes to the Quality Payment Program Year 3
  • Key Changes to QPP under the Bipartisan Budget Act of 2018

Health Policy Update – October 26, 2018 (PDF, 268 KB)

  • Lawmakers, Stakeholders Call on Administration to Rescind Step Therapy Proposal
  • CMS Announces International Pricing Index (IPI) Model for Medicare Part B Drugs
  • President Trump Signs Package of Legislation to Combat Opioid Crisis
  • Trump Administration Issues New Requirements for Drug Advertising
  • Bipartisan Group of Lawmakers Urges CMS to Issue Guidance on Prior Authorization
  • Mississippi and Colorado Medicaid Programs Require Hospitals to Provide More Information on 340B Drugs
  • Senate, House Party Control Up for Grabs in Looming Midterm Election

Health Policy Update – Oct. 12, 2018 (PDF, 229 KB)

  • Senate Passes Historic Opioid Legislation Sending Final Bill to President Trump
  • House Passes $854B Spending Bill
  • CMS Announces Participants in New Value-Based Bundled Payment Model
  • CMS to Strengthen Oversight of Medicare’s Accreditation Organizations
  • Hospitals Urge Lawmakers to Protect 340B Drug Discount Program
  • CMMI Chief Adam Boehler Comments on ACO Participation
  • CMS Updates Local Coverage Determination (LCD) Process
  • OIG Report: Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials

Health Policy Update – Oct. 1, 2018 (PDF, 236 KB)

  • ASP Coalition Hosts Hill Briefing on Step Therapy Challenges
  • Alliance for Site Neutral Payment Reform Submits Comments on OPPS Rule
  • Congress Reaches Deal on Opioids Package
  • American Hospital Association Unveils 340B Good Stewardship Principles
  • Congresswoman DelBene Circulates Letter Urging CMS to Expand MIPS Low-Volume Threshold
  • Bills Banning PBM “Gag Clauses” Headed for President’s Signature

Health Policy Update – Sept. 14, 2018 (PDF, 221 KB)

  • 240 Stakeholder Groups Call on Congress to Ask CMS to Reverse Step Therapy Proposal
  • CMS to Allow Indication-Based Formulary Design for Part D Plans
  • Hospital Groups Refile Lawsuit to Challenge 340B Cuts, Force Implementation of Ceiling Pricing Rule
  • PhRMA Report Finds Hospitals Mark-up Prescription Drugs by up to 500 Percent
  • E&C Leaders Seek More Information on Role of PBMs in Impacting Drug Prices
  • House E&C Committee Advances PBM Gag Clause Ban
  • E&C Committee Leaders Ask MedPAC to Study Hospital Consolidation

Health Policy Update – August 30, 2018 (PDF, 215 KB)

  • CMS Releases New Guidance on Indication-Based Formulary Design for Medicare Part D Plans

Health Policy Update – August 13, 2018 (PDF, 84 KB)

  • CMS Releases New Step Therapy Guidance for Medicare Advantage Plans

Health Policy Update – July 18, 2018 (PDF, 199 KB)

  • CMS Releases Proposed Medicare Payment Rules for 2019
  • Groups Submit Comments to Trump Administration on Drug Pricing Plan
  • President Trump Nominates Brett Kavanaugh to the Supreme Court
  • House Energy and Commerce Subcommittee on Health Examines 340B Program  
  • Alex Azar Delivers Remarks at 340B Conference  
  • Appeals Court Denies Hospital Groups’ Challenge to 340B Cuts
  • CMS Announces Demonstration Program that Would Exempt Doctors in At-Risk Medicare Advantage Programs from MIPS Participation
  • FDA Administrator Gottlieb Delivers Remarks at National Comprehensive Cancer Network Policy Summit

Health Policy Update – June 21, 2018 (PDF, 147 KB)

  • Secretary Azar Discusses Administration’s Drug Pricing Blueprint Before Senate HELP Committee
  • Congresswoman Matsui Introduces Bill to Reverse 340B Cuts
  • Senate HELP Committee Holds Hearing on 340B Drug Discount Program
  • Administration Declines to Defend ACA’s Pre-existing Condition Ban in Federal Court
  • Administration Issues Association Health Plan Final Rule
  • House Passes Dozens of Bills to Address Opioid Crisis
  • NIH Leaders Outline Plan to Fight Opioid Epidemic

Health Policy Update – June 7, 2018 (PDF, 168 KB)

  • Community Oncology Alliance Sues HHS for Applying Sequestration to Part B Drug
  • HRSA Officially Delays 340B Penalties Rule
  • Senate HELP Committee to Hold Hearing on 340B Drug Discount Program
  • Bipartisan Bill to Lower Part D Drug Prices Introduced in the House
  • CBO Report Finds President’s FY 2019 Budget Would Reduce Federal Health Care Spending by $1.3 Trillion
  • Senator Bill Cassidy Presents Health Care Reform Ideas in White Paper
  • Report Finds Drug Spending Doubled in the Past Five Years, Expected to Double Again in the Next Five Years
  • Senate Judiciary Committee Approves Five Bipartisan Opioid Bills

Health Policy Update – May 24, 2018 (PDF, 179 KB)

  • Administration Releases Drug Pricing Proposal
  • CMS Releases Updated Drug Spending Dashboard
  • CMS Urges Medicare Part D Plans to Stop Using Pharmacy Gag Orders
  • COA Survey Highlights Physician Concerns with Part B Reform Proposals
  • House Passes Right to Try Bill, Sending it to President Trump’s Desk
  • House Energy & Commerce, Ways & Means Committees Advance Additional Bills to Combat Opioid Abuse
  • Senate HELP Committee Hearing Examines Oversight of the 340B Drug Discount Program

Health Policy Update – May 10, 2018 (PDF, 176 KB)

  • McKesson Chairman Testifies at House Energy and Commerce Subcommittee Hearing
  • President Trump to Deliver Speech on Drug Pricing This Friday
  • HHS Secretary Azar, CMS Administrator Verma Deliver Remarks Before the American Hospital Association
  • Alliance for Site Neutral Payment Reform Applauds Republican Study Committee Budget
  • HRSA Delays 340B Rule for a Second Time
  • Federal Appeals Court Hears Oral Arguments in 340B Cuts Lawsuit
  • Survey Reveals ACOs Have Significant Concerns About Risk, Would Prefer to Stay in Track 1

Health Policy Update – April 26, 2018 (PDF, 253 KB)

  • The US Oncology Network Attends 2018 Community Oncology Alliance Annual Conference
  • CSRO Developing an APM to Cut PBMs Out of the Drug Channel
  • Key Committees Continue Work to Address Opioid Epidemic
  • CMS Releases FY2019 Inpatient Prospective Payment System Proposed Rule
  • House Ways and Means Committee Holds Hearing on Innovation in Healthcare
  • Poll Finds Over Half of Americans Support Single Payer Healthcare

Health Policy Update – April 12, 2018 (PDF, 160 KB)

  • House Speaker Paul Ryan Announces Retirement at End of Term
  • HHS Announces Adam Boehler as Director of CMMI
  • MedPAC Recommends Update to Physician Fee-for-Service Payment Rates
  • 340B Update: CMS to Allow Medicare Advantage Plans That Contract with Hospitals to Negotiate 340B Rates, Delays Rule to Set New Drug Ceiling Prices
  • Key Congressional Committees Hold Hearings on Opioid Legislation
  • Nearly 12 Million People Signed up for Health Insurance on the Federal Exchange
  • Presidents of the ACR, AAN Release Joint Op-ed Criticizing Trump Administration’s Drug Pricing Proposals

Congress Passes FY19 Omnibus (PDF, 83 KB)

This week, Congress passed legislation to fund the federal government for the remainder of Fiscal Year 2018, at the levels agreed upon in the two-year budget agreement passed in February. The $1.3 trillion bill will fund the government through September 30, 2018.

Health Policy Update – March 16, 2018 (PDF, 260 KB)

  • House Fails to Pass Right to Try Legislation
  • Senate HELP Committee Hearing Examines 340B Program
  • House, Senate Committees to Hold Hearings on Opioid Crisis
  • FDA Administrator Criticizes PBMs in Recent Remarks
  • HHS Secretary Azar Discusses Value-Based Care, Drug Pricing Transparency
  • CMS Rejects Idaho’s Plan to Sell Non-ACA Compliant Insurance Plans

Health Policy Update – March 1, 2018 (PDF, 250 KB)

  • HHS Releases Short-Term, Limited Duration Health Plans Proposed Rule
  • CMS to Study Impact of MIPS on Clinicians
  • Bipartisan Group of Governors Unveil Health Reform Blueprint
  • Administration Announces New Policies to Address the Opioid Crisis
  • Congress Holds Hearings on the Opioid Crisis, Bipartisan Treatment Bill Introduced in the Senate
  • New Study Examines Hospital Impact on Chemotherapy Spending

Administration Releases Budget Proposal for Fiscal Year 2019 (PDF, 161 KB)

The budget details legislative and regulatory priorities for next year including policies under the Department of Health and Human Services (HHS) designed to reduce the cost of prescription drugs, lower Medicare spending, address the opioid epidemic and increase funding for The National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

Health Policy Update – February 2, 2018 (PDF, 144 KB)

  • President Trump Delivers State of the Union Address
  • Alex Azar Sworn In as HHS Secretary
  • Congress Passes CR That Funds CHIP For 6 Years, Delays ACA Taxes
  • Avalere Releases Report on Impact of 340B Cuts

Health Policy Update – January 19, 2018 (PDF, 166 KB)

  • MSH Urges Congress to Exclude Part B Drugs from MIPS Payment Adjustments
  • Senate Finance Committee Advances Alex Azar's Nomination
  • Hospitals Groups to Appeal 340B Lawsuit Dismissal
  • House Energy & Commerce Committee Releases Recommendations to Reform 340B Drug Discount Program
  • CMS Introduces New Bundled Payment Model

Health Policy Update – January 8, 2018 (PDF, 152 KB)

  • Bipartisan Bill to Increase 340B Program Transparency Introduced in the House
  • HHS Seeks Input from Stakeholders on How to Increase Competition, Expand Patient Choice in the Healthcare Marketplace
  • President Trump Signs Tax Reform Legislation
  • Congress Passes Short-Term Funding Package to Avert an End-of-Year Government Shutdown
  • Senate Finance Committee Schedules Alex Azar's Confirmation Hearing
  • Senate Finance Committee Chair Orrin Hatch Announces Retirement