February 19, 2019

February 18, 2019

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ML Strategies Health Care Preview - Week of October 9, 2018

While the House is out on recess, the Senate continues to be in session. This week the Senate has some non-health care related hearings scheduled as well as nomination hearings. We are looking for signals for a deal to finish work and send vulnerable Senators home to campaign.  


 The Office of Information and Regulatory Affairs (OIRA) is a part of the Office of Management and Budget (OMB) that reviews draft and proposed final regulatory actions. OIRA also publishes a list of all pending regulations. On the OIRA dashboard you can find if a pending regulation is economically significant, when it was received, and its title. However, the actual text of the regulation is not available until it clears review.  

Currently, there are 16 Health and Human Services (HHS) regulations pending review. There is no timeline for review, so these regulations can clear OIRA review at any time. So although legislative action may begin to cool down, regulatory activity at OIRA could be heating up. Below are the 16 pending regulations and their received date.

HHS Regulations Pending at OIRA

  • Nondiscrimination in Health Programs and Activities (04/13/2018)

  • Medical Device De Novo Classification Process (05/09/2018)

  • Exchange Program Integrity (06/05/2018)

  • Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (07/18/2018) 

  • Medicaid and CHIP Managed Care and Medicaid Provider Enrollment and Terminations (08/03/2018)

  • Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs (08/06/2018)

  • Proficiency Testing Regulations Related to Analytes and Acceptable Performance (08/09/2018)

  • Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency (08/21/2018)

  • Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier (08/31/2018)

  • Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2020 (09/11/2018)

  • Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph (09/13/2018)

  • 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (9/17/2018)

  • Interoperability and Patient Access (09/21/2018)

  • CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B and the Quality Payment Program (09/28/2018)

  • CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Value-Based Purchasing Model; Quality Reporting Requirements (10/05/2018) 

  • Format and Content of Reports Intended to Demonstrate Substantial Equivalence (10/05/2018)

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About this Author

Rodney L. Whitlock, Mintz Levin, ML Startegies, Health Policy Advisor, Washington DC
ML Strategies - Vice President

Rodney is a veteran health care policy professional with more than 20 years of experience working with the US Congress, where he served as health policy advisor and as Acting Health Policy Director for Finance Committee Chairman Chuck Grassley of Iowa and, earlier, on the staff of former US Representative Charlie Norwood of Georgia.

During his years with Representative Norwood, Rodney managed the Patients’ Bill of Rights, which passed the House in 1999 and 2001. In February 2005, Rodney left the office of Congressman Norwood to join the Finance...

Alexander Hecht, Vice President of Government Relations, Mintz Levin law Firm
Vice President of Government Relations

Alex is Deputy Director of the Mintz Levin Center for Health Law & Policy. He is an attorney with more than 10 years of senior-level experience in Congress and trade associations.

Alex assists clients with their legislative and regulatory needs on a wide range of issues. Prior to joining ML Strategies, Alex served for over six years as chief counsel for Senator Olympia J. Snowe (R-ME) on the US Senate Committee on Small Business & Entrepreneurship. He was the lead policy counsel for Senator Snowe on health insurance market reform, individual and employer-based insurance, ERISA, COBRA, HIPAA, and health care tax incentives. He worked on numerous bills, including the Patient Protection and Affordable Care Act of 2009, Health Care and Education Reconciliation Act of 2010, Small Business Health Fairness Act, and Small Business Health Options Program (SHOP) Act. He advocated for health care legislative and regulatory issues before Senate Finance, HELP, Commerce, and Homeland Security Committees, as well as the US Department of Health and Human Services and Department of Labor. Along with health care policy, he advised Senator Snowe on energy, financial services,  innovation, and technology matters.

Alex is also an adjunct assistant professor of Health Policy at the George Washington University School of Public Health & Health Services, and teaches courses on Basics of Legislation and Regulation and the Data Quality Act and Public Health.

Alex is regarded as one of the leading congressional staff specialists on the regulatory process and how federal agencies promulgate rules and regulations. He has developed numerous bills and amendments reducing the regulatory compliance burden of business.

Katie Weider, Mintz Levin Law Firm, New York, Health Care Policy Director
Director of Health Policy

Katie provides advice and guidance on issues relating to Medicaid, Medicare, and the Marketplace.

Prior to joining ML Strategies, Katie was a senior analyst with the Medicaid and CHIP Payment and Access Commission (MACPAC), a nonpartisan agency that provides Congress, the Secretary of the U.S. Department of Health and Human Services, and states with analysis and recommendations on issues affecting Medicaid and the State Children’s Health Insurance Program (CHIP). There Katie researched, developed, and prepared Medicaid policy recommendations;...

Manager of Government Relations

Prior to joining ML Strategies, Eli was a legislative correspondent for US Senator Martin Heinrich (D-NM), where his experience included health care, education, child welfare, social security, food assistance, and poverty issues specifically as they relate to the Affordable Care Act, Medicare, and Social Security. Previously, Eli served as a legislative intern with Senator Heinrich. He also served as a legislative intern with Senator Dick Durbin (D-IL), where he worked on issues related to education, health, and commerce. Eli has also served as an intern at a political...