HRI regulatory center

Regulatory and legislative updates and analysis


President Donald Trump: The latest healthcare developments

Comprehensive report: Health reform 2.0: A guide to developing resilience amid an uncertain future for the Affordable Care Act

President Donald Trump and Republican congressional leadership have promised to repeal and replace the Affordable Care Act (ACA). Just how that will happen remains unclear. For the nation’s healthcare providers, payers, pharmaceutical and life sciences companies, new entrants and employers, this uncertainty makes planning for the future a complicated matter. In this report, PwC’s Health Research Institute and the firm’s strategy practice, Strategy&, present a comprehensive analysis of scenarios for repealing and replacing the ACA, along with practical steps health organizations can take in this time of uncertainty. 

Read HRI and Strategy&'s report, Health reform: 2.0: A guide to developing resilience amid an uncertain future for the Affordable Care Act

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Trump administration weekly highlights

Highlights – April 24, 2017

Trump administration: President Trump calls for 15% corporate tax rate; no mention of border adjustment tax
The Trump administration announced this week that it wants to lower the business income tax rate to 15%, create a territorial tax system that “levels the playing field for American companies,” offer a one-time tax on assets held overseas and eliminate tax breaks for “special interests.” The administration also proposed reducing the number of tax brackets for individuals from seven to three, doubling the standard deduction, providing additional child care tax breaks, eliminating deductions except for mortgage interest and charitable giving and repealing the alternative minimum tax (AMT), the 3.8% Affordable Care Act (ACA) tax on some net investment income for high-earners and the estate tax. The one-page plan echoes proposals made by the president during the campaign. President Trump’s plan lacks further details. Notably, the plan does not include a border adjustment tax (BAT), a controversial provision opposed by an increasing number of US Senators and import-heavy industries. It also does not include estimates of its costs, if enacted. During a briefing this week, Treasury Secretary Steven Mnuchin offered scant details, saying the plan would “pay for itself with growth” and the “reduction of different deductions and closing loopholes.”

HRI impact analysis: American companies have been seeking comprehensive tax reform for decades. President Trump’s plan, while light on details, signals tax reform remains a priority for the White House. It also offers insight into the key principles guiding the administration – simplification, reduction in business and individual tax rates, repatriation of overseas assets and elimination of the AMT, the estate tax and the ACA tax on investment income. While there is no clear path forward for the controversial BAT provision, Speaker Paul Ryan (R-WI) and Secretary Mnuchin both acknowledged Wednesday that the BAT will need to be altered in order to work but neither offered specific revisions. The broad outlines proposed by the administration should be thought of as an opening bid for negotiations with Congress. Legislating will take considerable time, and any final bill likely will look very different from the plan proposed on Wednesday. The president’s budget is due in May, so legislative text on tax reform could be introduced before the Memorial Day recess.

Highlights – April 17, 2017

Trump administration: HHS finalizes ACA exchange stabilization rule
Last week the Trump administration finalized a rule for stabilizing the ACA’s health insurance exchanges in 2018. The rule sets the window to sign up for 2018 exchange coverage from Nov. 1 to Dec. 15, 2017, half as long as last year’s open enrollment period. It also tightens requirements for signing up outside the standard window—via a special enrollment period—including providing proof of eligibility based on events such as the loss of employer coverage or a child’s birth. The rule gives insurers more flexibility to design benefits, allowing them to offer lower-premium, higher-cost-sharing plans, and prohibits individuals from enrolling in new coverage until they have settled any outstanding premium payments from prior years. It also shifts authority to the states for evaluating whether insurers offer timely access to a sufficient number of healthcare providers. The rule, after eliciting more than 4,000 comments, was largely finalized as proposed.

HRI impact analysis: Health insurers have expressed support for the rule but remain concerned that it doesn’t go far enough to stabilize the ACA marketplaces. The rule doesn’t address two of the sector’s biggest concerns: the future of ACA subsidies that help cover costs for low-income consumers, and the administration’s intent regarding the law’s individual mandate. A Health Affairs analysis also found that a shortened enrollment window could limit sign-ups, particularly by “healthy procrastinators,” which could skew the exchanges’ risk pool and result in more expensive coverage. Insurers have until June 21 to decide whether to participate in the exchanges next year. Some already have said they will scale back their participation

Trump administration: Trump requests policy advice from industry leaders
More than 170 comments have been submitted in response to a March 7 Department of Commerce request for feedback on regulatory requirements the government could cut or streamline for American manufacturers, including healthcare product manufacturers. The Biosimilars Council and the Association for Accessible Medicines (AAM) made six requests, including eliminating proposed labeling changes for approved drugs and withdrawing quality metrics data requirements. The organizations said these changes will enable them to serve patients taking generic medications more cost-effectively. Three senior administration officials told The Washington Post this week that they expect the White House to accept “many” industry recommendations.

HRI impact analysis: The request for feedback further reflects the Trump administration’s interest in reducing federal regulation, and follows the executive order President Donald Trump signed in January requiring agencies to remove two regulations for every new regulation issued. A memorandum issued by the Office of Information and Regulatory Affairs this month clarified that the cost of new regulations would have to be completely offset by the savings from those eliminated. Companies should begin to identify which regulations are major barriers to doing business, determine the regulations’ financial impact, and relay their concerns to the government via Regulations.gov, senators and members of Congress.

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Payers: Trump administration briefs

After President Donald Trump and Republican leaders canceled a vote on the American Health Care Act (AHCA), the world became more complicated for health industry leaders and their consumers. Amid the multiple unknowns, health leaders may be tempted to wait for clarity. But in this atmosphere, it is even more important for organizations to lean into the unknowns and build resiliency. Healthcare companies can make some “no regrets” moves to build resilience amid periods of change and uncertainty.

Read HRI’s spotlight, What’s next for health reform?

 

As they mull the ACA’s fate, Republican lawmakers are weighing four options to replace the individual mandate. Any replacement to the mandate would need to accomplish two goals: encourage sign-ups by healthy enrollees, and discourage voluntary coverage gaps.

Read HRI’s spotlight, Replacing the individual mandate

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Providers: Trump administration briefs

After President Donald Trump and Republican leaders canceled a vote on the American Health Care Act (AHCA), the world became more complicated for health industry leaders and their consumers. Amid the multiple unknowns, health leaders may be tempted to wait for clarity. But in this atmosphere, it is even more important for organizations to lean into the unknowns and build resiliency. Healthcare companies can make some “no regrets” moves to build resilience amid periods of change and uncertainty.

Read HRI’s spotlight, What’s next for health reform?

 

The American Health Care Act (AHCA) aims to partially repeal and replace the ACA, by phasing out the ACA’s Medicaid expansion and capping federal funding for the program, among other things. Under the AHCA’s Medicaid plans, healthcare providers could experience a gradual increase in uncompensated care, cuts in Medicaid reimbursement rates, or both.

Read HRI’s spotlight, Implications of phasing out Medicaid expansion


Republican lawmakers are promoting Medicaid block grants as a way to control federal healthcare spending. Providers can expect a shift from an entitlement to a free market Medicaid approach, along with a possible rise in the uninsured population or decrease in reimbursement.

Read HRI’s spotlight, Medicaid block grants and per capita funding

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Pharma and life sciences companies: Trump administration briefs

After President Donald Trump and Republican leaders canceled a vote on the American Health Care Act (AHCA), the world became more complicated for health industry leaders and their consumers. Amid the multiple unknowns, health leaders may be tempted to wait for clarity. But in this atmosphere, it is even more important for organizations to lean into the unknowns and build resiliency. Healthcare companies can make some “no regrets” moves to build resilience amid periods of change and uncertainty.

Read HRI’s spotlight, What’s next for health reform?

 

President Trump has consistently argued for lower prescription drug prices, but no specific plan has emerged from the White House. Pharmaceutical and life sciences companies are beginning to take steps to increase drug price transparency, limit price increases and explore novel approaches to demonstrate the pharmacoeconomic value of medicine, in light of pressure from all sides to justify pricing decisions.

Read HRI’s spotlight, Preparing for new drug-pricing risks


Tax proposals from the Trump administration could result in pharmaceutical, medical device and medical equipment companies restructuring their supply chains, repatriating overseas capital, and moving manufacturing back to the US. Such reforms, though, pose a sharp deviation from current global operational structures and thus could take years to be fully realized.

Read HRI’s spotlight, Tax reform proposals could impact pharma, medical device and equipment supply chains

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Health industry strategy: Trump administration briefs

Healthcare reform efforts by Congress will create challenges and opportunities that may require changes in operating models across the US healthcare industry. As the legislation undergoes debate and negotiation in Congress, healthcare organizations face considerable uncertainty. Organizations that have developed enterprise resilience—the ability to adapt the business model to change, anticipate disruption and recognize opportunities to generate a competitive advantage—may be best positioned to survive and thrive in these conditions.

Read HRI’s spotlight, Developing enterprise resilience in the face of health reform

 

The inaugural festivities are over, the revelers have gone home, and President Donald Trump has moved into the White House. With so much change in the air, what actions can health organizations take today?

Read HRI's spotlight, (Some) change is coming to healthcare

 

As the American Health Care Act (AHCA) bill makes its way through the legislative process, the nation’s healthcare industry is left to contend with considerable uncertainty. However, there are concrete steps healthcare stakeholders can take in the whirl of uncertainty to help build resilience no matter what specific policy provisions are enacted.

Read Strategy&’s article, Why Healthcare Companies Need to Focus on Enterprise Resilience

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2016 election insights and analysis

Like a chief executive hired to turn a failing company into a profitable one, president-elect Trump has said he will take an unflinching corporate approach to overhauling the US healthcare system. For an industry that prefers stability to surprises--and one that has worked to adapt to the Affordable Care Act—Trump’s “repeal and replace” agenda may create new uncertainty and opportunity for healthcare leaders.

Read HRI's report, President-elect Donald Trump: Turnaround time

 

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About the center

As the US healthcare system continues to undergo transformation, health industries are confronted with an evolving and complicated regulatory environment. With an eye towards how public policy impacts the business of healthcare, the HRI regulatory center serves as a vital resource for executive decision makers who must navigate the changes that lie ahead.

HRI's regulatory center is a group of seasoned professionals that analyze legislative and regulatory policy in Washington and in key states. The group, which focuses on all health sectors, publishes a weekly newsletter and more focused reports that detail the interconnection between Washington and healthcare. The HRI regulatory center calls upon key contacts in government and industry to develop a point of view that is both informative and actionable for health industry leaders.
 

Contact us

Benjamin Isgur
Health Research Institute leader
Tel: +1 (214) 754 5091
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Trine K. Tsouderos
HRI Regulatory Center Leader
Tel: +1 (312) 241 3824
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Alexander Gaffney
Senior Manager, PwC Health Research Institute, Washington
Tel: +1 (202) 414 4309
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