In the wake of the resignation of former Secretary Tom Price, MD over concerns about his travel expenses, President Trump has named Don Wright, MD, MPH, as Acting Secretary of the Department of Health and Human Services (HHS). Wright previously served as Acting Assistant Secretary for Health. The Administration has not yet indicated who will
Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees
The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget blueprint,” dubbed “America First: A Budget Blueprint to Make America Great Again.” The blueprint…
Senate Confirms Verma as CMS Administrator; Trump Nominates Gottlieb for FDA, Hargan as Deputy HHS Secretary
The Senate has approved the nomination of Seema Verma to be CMS Administrator on a vote of 55 to 43. In other nomination news, President Trump has nominated Scott Gottlieb to be Commissioner of Food and Drugs. Dr. Gottlieb is a physician, resident fellow at the American Enterprise Institute, and venture capital firm partner who…
The Fine Print of the Trump Administration “2-for-1” Regulatory Reduction Executive Order
President Trump has signed an executive order entitled “Reducing Regulation and Controlling Regulatory Costs,” also known informally as the “2-for-1 Order,” that directs agencies to take a number of actions aimed at deregulating a variety of industries. The Order is considerably vague, relying instead on the Office of Management and Budget (OMB) to issue additional implementation guidance. As a result, it remains unclear how this new regulatory approach will operate in practice.
2-for-1 Regulatory Identification Process
The Executive Order, signed January 30, 2017, directs each department or agency to identify two regulations to be repealed any time it proposes or finalizes a new regulation. It is worth noting that the Executive Order never expressly requires these regulations to actually be repealed; rather, merely identified. Importantly, the Order provides that this 2-for-1 regulatory identification process need only be followed if it is permitted by law. That is, Congress often passes laws that require certain administrative agencies to promulgate implementing regulations. To this end, the Order cannot and does not block regulations required by statute. Instead, only discretionary regulations would be eligible for elimination.
Critics of the Executive Order view this 2-for-1 regulatory identification process as an illogical approach to industry deregulation, arguing that this approach demonstrates a dearth of understanding about how and why regulations are actually issued. For example, in its examination of costs, the Executive Order ignores expected long-term cost savings, and only focuses on annualized regulatory costs. Accordingly, agencies might be required to eliminate regulations whose benefits greatly outweigh their regulatory costs, simply to meet this arbitrary regulatory standard. Supporters contend, however, that a requirement to eliminate regulations in order to promulgate new ones forces agencies to review and update existing regulations. This perceived lack of periodic of review and update is something that has long troubled many in regulated industries.
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Senate Finance Committee to Vote on Price HHS Nomination
On January 31, 2017, the Senate Finance Committee is set to vote on the nomination of Rep. Thomas Price to be Secretary of Health and Human Services.
Trump Executive Order Directs Executive Agencies to Minimize “Unwarranted” ACA Economic and Regulatory Burdens
President Donald Trump’s first official act in office was to sign an executive order declaring it the policy of his Administration to seek prompt repeal of the Affordable Care Act (ACA) – but in the meantime, he calls for executive branch action “to minimize the unwarranted economic and regulatory burdens of the Act.” Specifically, Trump’s…
President Trump’s Regulatory Review to Impact Recent Health Rules
As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect. In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff…
Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives
Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues. Today President-elect Trump’s transition team released a one-page statement on health care policy, but many questions remain. Nevertheless, we offer below our initial observations and issues to watch in the months to come.
- Potential Sea Change. Uncertainty is, as some like to say, the “obvious comment” that characterizes the whole prospective Trump Administration. Other than an intended “repeal and replacement” of the Affordable Care Act (ACA), President-elect Trump has provided relatively few details on a proposed health care agenda. Until these policies are fleshed-out, expect an environment where some business decisions and investments may be delayed, with a resulting impact on merger and acquisition activity. That said, other transactions may become more likely, as the threat of new restrictions under a Clinton administration are removed, along with the prospect of potential regulatory relief under a Republican-controlled federal government.
- Affordable Care Act Repeal and Replacement. Trump has repeatedly indicated his desire to repeal and replace the ACA, including a vow to summon Congress into a special session for this task. If the law is repealed, however, what would take its place, and how would Congress address the roughly 20 million Americans currently covered in some way under the ACA (and the potential rise in uncompensated care costs that also would result)? Despite the call for repeal, certain parts of the law are popular. For instance, President-elect Trump noted on the campaign trail that he was in support of the ACA’s prohibition against the use of pre-existing health conditions to deny coverage (or as a basis for premium-setting). Other proposals offered by Trump as candidate include allowing for the sale of health insurance across state lines as long as plans comply with state requirements, various tax benefits, and more transparency in health care pricing. In today’s policy statement, President-elect Trump added support for high-risk pools, which he characterizes as “a proven approach to ensuring access to health insurance coverage for individuals who have significant medical expenses and who have not maintained continuous coverage.” Congressional Republicans have offered a number of alternatives that are likely to be a springboard for reform, most notably the “Better Way” plan proposed by House Speaker Paul Ryan. In fact, according to the Speaker’s office, “in the 114th Congress alone, House Republicans have introduced more than 400 individual bills that would improve our nation’s health care system” – demonstrating that Congress is not reticent about legislating on health care issues. The new Senate’s Republican majority will not have the 60 votes required to override a potential Democratic filibuster of legislation to fully repeal the law. While Congress could use budget reconciliation authority (which requires only 50 votes in the Senate) to make significant changes, the drawn-out pace of the budget process may not satisfy those who want quick action in this area. Regardless of the legislative vehicle, after years of calling for Obamacare repeal while President Obama was in office, the Republican Congress will be under tremendous pressure to act quickly – even if it is a “down-payment” on reform — now that Republicans will control the presidency and the Congress.
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