Health policy issues are high on the agenda of the new Congress. The stated priorities for Speaker of the House Nancy Pelosi (D-Calif) and the new House majority include:
- reducing drug prices;
- defending the Affordable Care Act;
- addressing the opioid abuse crisis; and
- investigating the pharmaceutical industry.
There is the potential for at least some bipartisan cooperation on each of these priorities, which means that stakeholders in the healthcare industry should be prepared for legislative and regulatory opportunities and challenges.
Democrats and Republicans could find common ground by trying to lower prescription drug costs and increase transparency. In particular, several Democrats and Republicans have signalled interest in working with the White House on some of the drug pricing initiatives, including proposals mentioned in the American Patients First Blueprint.(1) Notably, President Donald Trump and House Democrats have expressed their support for giving the secretary of health and human services the authority to negotiate the price of drugs covered by the Medicare Part D programme. House Democratic committee leaders with jurisdiction over Medicare have made it clear that approving this policy is a top priority.
In addition, Senator Charles Grassley (R-Iowa), the new chair of the Senate Finance Committee (he previously chaired the committee in 2001 and again from 2003 to 2007), has expressed an interest in bipartisan efforts relating to lowering drug pricing and increasing pricing transparency. He recently stated that he will "continue working across the aisle to lower drug prices, restore competition and increase transparency in the pharmaceutical industry" and welcomed "the incoming Democratic House Majority to join our efforts on behalf of the American taxpayers and consumers".
Thus, pharmaceutical companies must be prepared for a continued focus on drug pricing and transparency issues, including new Department of Health and Human Services proposals and potential reforms to existing laws, as well as in-depth investigative hearings. Any such hearings are likely to analyse pricing decisions, raise questions regarding the use of taxpayer money for drug research and explore how companies can help to offer more affordable medications to consumers.
Democratic committee chairs conducting investigations will have virtually unchecked power to issue subpoenas, demand documents, call hearings and require witnesses to testify.(2) In the House, one of the most significant powers that comes with a majority is the ability of a committee chairs to issue subpoenas unilaterally (in the Senate, the rules require a committee's chair and ranking member to authorise subpoenas together).
Senate Republicans will likely join House Democrats in conducting drug-related investigations. Senators Grassley and Susan Collins (R-Maine) have spearheaded past investigations into the healthcare industry and are expected to work closely with Senate Democrats on these types of investigations.
Drug and biologics manufacturers should consider preparing for inquiries and investigations now by evaluating the risk of an inquiry or investigation, weighing strategic options, understanding company policies and procedures, assessing potential vulnerabilities and documenting the rationale for company decisions.
Protecting the Affordable Care Act was a cornerstone of many successful Democratic campaigns, and the recent decision nullifying the law in Texas v United States heightens the Democratic sense of urgency in defending it.(3) While many observers expect that the decision will be reversed on appeal, congressional Democrats have forcefully pledged to take action in the interim to protect the law at the beginning of the new Congress. In recently adopted House rules, Democrats included a section authorising the speaker, on behalf of the House, to intervene, otherwise appear or take any steps in Texas v United States, in any appellate proceedings arising from the case or in any other cases involving the Affordable Care Act. On the opening day of the Congress, the Energy and Commerce Committee Chair Frank Pallone (D-NJ), announced that the second hearing he will hold will examine the impact of the decision.
Importantly, Republicans will be interested in protecting certain provisions of the Affordable Care Act. The Ways and Means Committee ranking member Kevin Brady (R-Texas) said:
Should the courts ultimately uphold this decision, both parties should start over, working together to make healthcare truly affordable, making sure patients can see local doctors and be treated at local hospitals, and ensuring that patient protections like pre-existing conditions, no lifetime limits and allowing children to stay on their parents plans until age 26 are preserved.
This potential for bipartisan agreement on at least certain provisions of the Affordable Care Act can present important strategic opportunities for stakeholders to engage with policy makers on Affordable Care Act matters.
Even with the recently enacted bipartisan Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), many in Congress have stated that they believe more is needed to combat the national opioid abuse epidemic. Democrats criticised the SUPPORT Act because they said it did not provide adequate resources or expand Medicaid enough to address the problem. As the opioid abuse crisis was seen as one of voters' top priorities in the 2018 midterm elections, Congress is expected to take further steps to address the abuse epidemic.
Given the significant bipartisan interest in advancing health policy initiatives and investigations, industry participants should consider both ways to share their views with policy makers in Congress and ways to prepare for possible inquiries and investigations. Stakeholders may increase their chances for positive outcomes by engaging with and educating policy makers before legislative or investigative actions are taken.
Endnotes
(1) "HHS Secretary Azar announces DTC drug price transparency proposal, foreshadows additional regulatory action to address drug prices", 16 October 2018.
(2) "US election results 2018: preliminary considerations for the energy industry", 27 November 2018.
(3) Texas v United States, 4:18-cv-00167-O (ND Texas 2018).
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.
