Trump administration health care policy

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Our ML Strategies colleagues have published a preview for another big week in health care. The American Health Care Act (AHCA) continues to be a big story as the Senate works on its version. This week we watch for updates on these items and how they might impact AHCA discussions:

  1. Cost-sharing reductions (CSRs) litigation on Monday
  2. President Trump’s anticipated budget proposal on Tuesday
  3. The Congressional Budget Office (CBO) score on the House AHCA on Wednesday
  4. Scheduled hearings in the House and Senate on Tuesday (Zika response), Wednesday (FY 2018 budget) and Thursday (budget proposals for Treasury and Tax Reform)

Despite reports last Friday that President Trump may seek to stop the CSRs paid to insurers, on Monday the Administration requested another 90 day extension in the House v. Price case. In a joint filing, the House and the Department of Justice requested the extension as they consider measures that might remove the need for the payments, including legislation to repeal the Affordable Care Act.

On Tuesday, President Trump’s budget proposal will be released. We anticipate major cuts to Medicaid, and to supplemental income and nutritional assistance programs. Then on Wednesday, the CBO will release its score of the AHCA. We don’t anticipate major changes from the original results, but stay tuned for updates.

We will continue to monitor each of these items. Stay tuned for additional coverage on this blog at https://www.healthlawpolicymatters.com/

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.

The ACA created CMMI to test innovative payment and service delivery models to reduce program expenditures and improve care.  To carry out this goal, the ACA allows CMMI to waive any Medicare provision of the Social Security Act, as well as select Medicaid provisions, that may be necessary to carry out and evaluate demonstration policies.  If the demonstrations prove effective, CMS may implement the program nationally.

Over the past few years, CMS has implemented numerous demonstration projects under CMMI’s authority.  These include delivery reform demonstrations such as the Medicare Shared Savings Program and Pioneer ACO program, as well as the Financial Alignment Initiative, which integrates care for dual-eligible individuals in select states. Demonstrations such as the Medicare Advantage Value-Based Insurance Design Model have focused on encouraging the use of high-value clinical services, while others, such as the Diabetes Prevention Program, have focused on preventive service models.  In July of this year, CMS proposed expanding the Diabetes Prevention Program nationally.

While there have been successes, CMS’s use of this authority has not been without controversy and criticism.  Continue Reading Will Republicans Embrace CMMI’s Authority?

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act.  Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.  In doing so, Republicans must consider three important factors as they look at policy.  The first two, talking with insurers and avoiding coverage disruption, were discussed in our prior blogs.  The third is making hard choices. 

The economist Thomas Sowell is often credited with this quote “There are no solutions, only tradeoffs.”  In 2009, the Democrats made tradeoffs in constructing the Affordable Care Act.  Now it will be the Republicans’ turn to make tradeoffs as they move to transition away from the Affordable Care Act.  Republicans will consult stakeholders and experts and will engage the Congressional Budget Office, especially around coverage and costs.  Republicans will then have to make hard choices based on the information they receive.

One specific example will involve Medicaid.  Will Republicans reduce the special matching rate states receive to cover those who are newly eligible under the Affordable Care Act?  They are certain to be told that drastically reducing the matching rate will cost millions of Americans their Medicaid coverage.  States have made the decision to cover these low-income individuals, but if the payment is reduced, it is highly likely that state budgetary pressures will force many states to make the difficult decision of reducing or eliminating coverage.

Republicans are going to receive information about the coverage and cost consequence of their policy choices.  They are going to be told things they may not have expected or wanted to hear.  They will then have to decide if they want to reconsider or proceed and face the consequences. 

In the end, Republicans are about to be able to engage in health care policy making in a way they weren’t in 2009.  Republicans want to show they have a better way (the title of the House Republican platform).  Their policies will produce coverage and cost numbers.  They must decide then how they will proceed.  Decisions will have consequences, and they will own those consequences. 

In the coming days, we’ll be continuing to cover health care reform in the 115th Congress with a focus on specific health care programs.  Stay tuned! 

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act.  Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.  In doing so, Republicans must consider three important factors as they look at policy. The first, talking with the insurers, was discussed in a previous post.  The second is avoiding coverage disruption.  As Republicans begin the process of transition, they must avoid policies that will cause severe coverage disruption.

For example, Republicans strongly oppose the individual mandate in the Affordable Care Act.  The incoming Administration could order the IRS to create a number of “carve outs” for the individual mandate that would render it ineffective.  While that is a policy choice, the consequence likely would be insurers exiting the marketplace.  Without a mechanism to cause participation, the risk of adverse selection becomes unacceptably high—especially given the experience to date with the Affordable Care Act population.

Republicans do not want to cause millions of people to lose coverage, but, at the same time, they want to make significant changes in the policies of the Affordable Care Act.  Republicans are going to have to make structured policy decisions to minimize coverage disruptions.  After years of holding the Democrats responsible for their policy decisions, Republicans will now have to own the consequences of their policy decisions.

This post is the third in a series, with the first being published on Monday and the second being published on Tuesday.  In the posts that follow, we will describe additional critical issues that Republicans must tackle as they transition the Affordable Care Act and the impact of the new Congress and new administration on certain hot topics in health reform.

Today, our colleagues at ML Strategies released their first look at what the results of Tuesday’s election mean for health care.  The client alert addresses both the lame duck session and what to expect in 2017 and beyond.  Key issues areas include the future of the Affordable Care Act, MACRA, drug pricing, and FDA User Fee Act reauthorization.

In the coming days, ML Strategies will be sharing further insight into what the election means for health care and what to expect from the new administration and Congress.