March 21, 2019

March 21, 2019

Subscribe to Latest Legal News and Analysis

March 20, 2019

Subscribe to Latest Legal News and Analysis

March 19, 2019

Subscribe to Latest Legal News and Analysis

March 18, 2019

Subscribe to Latest Legal News and Analysis

ML Strategies Health Care Preview Week of October 15

Last week concluded the Senate’s time in Washington prior to the lame duck session. With both the House and the Senate back home and focused on campaigning, we turn our attention to action from the Administration. As of October 15, 2018 there are 21 pending Health and Human Services regulations pending approval from the Office of Management and Budget (OMB). We are watching as regulation move onto and off of the OMB radar and how each regulation can affect the health care system. The regulation to watch this week focuses on drug pricing transparency

Drug Pricing Transparency Regulation

On August 21, 2018 the proposed rule “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency” was published to the Office of Information and Regulatory Affairs’ website. (As we have previously discussed, the OIRA website lists all regulations pending OMB review.) Although the actual text of the regulation is not published, it is expected that this regulation will require pharmaceutical manufacturers to include prescription drug list prices in direct-to-consumer advertisements. Does that mean the list price will be included in the fine print or auctioneer like talking at the end of prescription drugs advertisements? Details should be out soon.

However, this is not the first or only time we have heard of this concept. In August, Senators Grassley (R-IA) and Durbin (D-IL) had introduced legislation to require pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements. It passed the Senate as an amendment to the Defense-Labor-HHS-Education appropriations “minibus” package. However, this provision was ultimately removed during the joint conference committee of the House and Senate when finalizing the appropriation package.

The constitutionality of a regulation like this will most certainly be questioned. And the effects of the suggested regulation is already in question. Critics of the regulation note that most people do not pay the list price of drugs and this could confuse patients. However, proponents argue it will that promote transparency and lead to lower prescription drug costs.

As of today, the United States and New Zealand are the only countries allowing direct to consumer advertising of prescriptions drugs. With drug pricing continuing as a top political issue, the role advertising plays in utilization and pricing will continue to come under increased scrutiny.

©1994-2019 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.


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...