Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency, often described as the law that keeps citizens “in the know” about their government. Managed and overseen by the Office of Information Policy within the U.S. Department of Justice, Federal agencies are required to disclose any information requested under the FOIA, unless it falls under one of nine exemptions which protect interests, including personal privacy, national security, and law enforcement. The FOIA also requires agencies to proactively post online certain categories of information, including frequently requested records.
FOIA requests can be used to keep healthcare and life sciences industry stakeholders informed and can provide strategic advantages, even in the context of disputes between private parties. For example, a pharmacy that has been denied access into a network can use FOIA requests to not only understand why they have been denied network access, but also understand how many other pharmacies it has happened to. While private entities like Pharmacy Benefit Managers (PBMs) may not be willing to disclose this information, it may be easily and legally discernable through a FOIA request to CMS. This information can be used to help support legal claims against a PBM or insurer.
Though FOIA requests can be submitted by virtually anyone, it takes time and effort to submit and follow up on. Many FOIA requests can be rejected on the basis that the requested material is not correctly specified, so it is imperative that the request properly identify the specific information sought. If the request is filed properly and is successful, knowing what to do with this information is the most important part of the process.
Frier Levitt Government Affairs assists healthcare and life sciences industry stakeholders formulate FOIA requests and use the information to help maximize your business interests, including predicting trends and future threats to their bottom line. Contact us today to get started.
The end of summer is traditionally a slow time during the legislative calendar. Most of the state governments have adjourned and historically members of Congress escape the D.C heat to head back home to their districts. This time of year can be a great time for companies and organizations looking to get more involved with their legislators to contemplate a plan to introduce themselves to legislators in the district. Additionally, with the power in Congress potentially hanging in the balance due to the upcoming mid-term elections this coming November, opportunities abound for companies and organizations that are aggressive in proactive government affairs planning.
Seldom has there been a time of greater policy and regulatory change in healthcare. An active HHS Secretary has been pushing policies such as importation, greater Medicare negotiating power, which is being proposed through a possible merger of Medicare Parts B and D, utilization of step therapy protocols, investigation of Pharmacy Benefit Managers. In addition, an active FDA is pushing for greater generic utilization, challenges to drug pricing and friendlier biosimilar policies. The recent policy changes will have a lasting impact on the healthcare and life sciences industries, and typically state legislatures enact state laws that address the same topics and are often have substantial impact on Providers.
The last year has also witnessed CMS’ increasing reliance on issuing Requests For Information (RFIs). This rulemaking process involves a proposed rule from the agency outlining the regulation CMS is looking to either add or change. Proposed rule announcements are usually followed by a comment period, public workshops/hearings, a final comment period and then a final rule with effective date. The RFI process provides opportunities for the industry to comment on the technical aspects of a proposal. However, the Administration is using agencies like CMS to distribute RFIs as a way for the industry to guide the conversation on what should be included. This could provide your organization with another way to influence policy, giving you even more reasons to take this “quiet” time during the legislative calendar to contemplate strategy.
The end of summer should be used to evaluate every healthcare stakeholders’ priorities and to design a game plan for achieving government affairs strategies and results. Each company or organization should consider how it is positioned for the upcoming elections. Are you comfortable with how your state and federal government interests are being advocated? Is your company or association prepared for different policies if Democrats take control of a particular house of the legislature? Lastly, what has been your organization’s philosophy for government engagement? Have you let your industry competitors or trade associations take the lead? While you may indirectly benefit from these actions, you should consider how whether the discourse aligns with your interest. Consider getting more active with strategic consulting, lobbying, PAC formations or undergoing an aggressive issue management program.
Frier Levitt Government Affairs, LLC, works with all types of companies and organizations across the healthcare and life sciences spectrum to help them stay ahead of the market and avoid policy surprises on the state and federal level, ranging from issue management to active engagement such as RFIs. Contact us today to see how your company or organization can get started.