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 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. 

Highlights – April 10, 2017

Trump administration: Industry pleads for clarity on ACA cost-sharing subsidies 
A group of health industry players sent letters to President Donald Trump and Congress this week asking them to clarify the fate of the ACA’s cost-sharing subsidies, billions of dollars in payments to insurers to cover costs for low-income consumers who purchase certain plans on the ACA exchanges. The cost-sharing subsidies have been tied up by a lawsuit filed by House Republicans during the Obama administration. The White House and HHS have not clearly stated whether these payments will continue as the lawsuit works its way through the courts, even as a crucial deadline for ACA exchange participation approaches. Under the Obama administration, the payments flowed despite the litigation. “The most critical action to help stabilize the individual market for 2017 and 2018 is to remove uncertainty about continued funding for cost sharing reductions,” say the letters, which were signed by the American Medical Association, America’s Health Insurance Plans, Blue Cross Blue Shield Association, the American Academy of Family Physicians, the US Chamber of Commerce, the American Hospital Association, the Federation of American Hospitals and the American Benefits Council. The groups also warned that if the subsidies aren’t provided, consumers will be left with higher premiums and fewer- or no - choices on the ACA exchanges. They also warned that many will go uninsured, driving up uncompensated care for providers.

HRI impact analysis: Insurers must decide whether they will offer plans on the ACA exchanges by June 21, the deadline for providing qualified health plan rate tables to CMS. Insurers are making crucial decisions about participation and pricing now, but with the cost-sharing subsidies’ fate uncertain, the insurers face many unknowns. The fact that stakeholders from across the industry signed these letters is a reminder that uncertainty about the ACA is pervasive. The next status hearing for the cost-sharing subsidies lawsuit, originally filed as House v. Burwell but now called House v. Price, is May 22.

Trump administration: Key regulatory positions may go to experts from Antonin Scalia Law School, Health Care Cost Institute
Last week President Trump announced his intent to nominate Neomi Rao, a law professor at the Antonin Scalia Law School at George Mason University, to serve as administrator of the Office of Information and Regulatory Affairs. The office maintains a low public profile but is extremely influential, serving as gatekeeper and overseer of regulatory activity in the executive branch. It also has the power to alter regulations under development. The Trump administration also announced that it plans to nominate Steven Parente, the Health Care Cost Institute’s governing head, to be HHS assistant secretary for planning and evaluation. If confirmed, Parente would lead a team that oversees HHS strategic planning and develops health policy positions on access, coverage, outcomes, regulation and financing.

HRI impact analysis: The Trump administration has nominated or appointed a small number of the top healthcare jobs in Washington, including the heads of HHS, CMS and FDA. Positions that oversee agencies such as the CDC and US Agency for International Development, and dozens of sub-cabinet-level posts have yet to be filled, according to a database maintained by The Washington Post and the nonpartisan, nonprofit Partnership for Public Service. Filling those posts will require time and Senate confirmation. Less visible positions will nevertheless powerfully affect regulatory development and implementation. New faces likely will bring new perspectives on how regulations and policy should be approached, developed, implemented or eliminated.

Trump administration: More clarity on regulatory reform executive order
Agencies planning to issue a new regulation before Sept. 30 will have to identify two to cut and must ensure that the new regulation’s cost is completely offset by the savings from the eliminated regulations, according to a new memorandum put out by the Office of Information and Regulatory Affairs. The memorandum clarifies an earlier executive order signed by President Trump. The memorandum explains how agency leaders should assess the cost of regulatory actions covered by the executive order; only final rules and “significant” guidance documents estimated to have a $100 million or more impact on the economy are covered. Agencies that remove more than the required two regulations, or exceed the required cost offset for enacting a new regulation, may “bank” these deregulatory actions or cost reductions for use in future rule-making. Beginning in fiscal year 2018, the Office of Management and Budget (OMB) will cap total incremental costs for each agency; exceeding the cap will require special permission from OMB Director Mick Mulvaney.

HRI impact analysis: Federal spending regulatory actions, or “transfers” that establish fees or implement programs such as Medicare or Pell Grants, are not covered by the executive order, according to the memorandum. Existing statutes that prohibit considering cost as a factor in taking regulatory action also will not be affected. The memorandum directs readers to the OMB Circular A4 document for additional information. Those wondering what kinds of regulations are being targeted can examine a list released in January by House Freedom Caucus members of more than 50 HHS regulations that they would like to see removed. They include patient record confidentiality requirements, Medicare and Medicaid hospital discharge and critical access requirements, and FDA food labeling regulations. Healthcare industry members should consider modeling how deregulation may affect their businesses. Companies should express support for regulations they deem beneficial, and provide justification to agency regulators for keeping specific regulations in place while removing others.

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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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