HRI regulatory center

Regulatory and legislative updates and analysis

President Donald Trump: The latest healthcare developments

Healthcare, hurricanes and disaster response

Months and even years after the winds subside and the floodwaters recede, hospitals and health systems in regions battered by a hurricane will still be dealing with the financial, physical and reputational wreckage caused the storm. Hospitals face closure, chaotic revenue cycle operations, disrupted supply chains, possible credit downgrades, destroyed and damaged physical assets and displaced workforces and patients. Partner institutions, such as long-term care facilities and retail pharmacies, may temporarily, or permanently, operate at diminished capacities. To survive such an event, hospitals and health systems should plan for the complex challenges left in the wake of a hurricane or other natural disaster.

Read HRI 's report, Hospitals and health systems feel the impact of hurricanes long after the floodwaters recede

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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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Weekly insights from Capitol Hill

Highlights – October 9, 2017

President Trump sets stage slimmer insurance plans

Insurers may be free to sell cheaper health plans that sidestep some Affordable Care Act (ACA) regulations thanks to an executive order President Donald Trump signed Thursday morning. The order asks the Treasury, Labor and HHS secretaries to consider ways to broaden access to two types of plans that do not have to comply with some ACA regulations - association health plans and short-term limited duration insurance. The order also directs the Treasury, Labor and HHS secretaries to expand the use and usability of health reimbursement arrangements, pre-tax dollars set aside by employers to pay for some employee medical expenses.

HRI impact analysis: President Trump’s executive order changes nothing now; it’s a directive asking Treasury, Labor and HHS to pursue his goals through the regular notice and comment rulemaking process. That would likely take months, with the potential for court challenges. Those who support President Trump’s goals, including Republican Sen. Rand Paul of Kentucky, say they will increase consumer choice by making cheaper plans available to some. Critics of these plans say they will draw healthy people away from ACA-compliant plans, driving up premiums and destabilizing those markets. They also point to problems with earlier, similar plans. (This 25-year-old General Accounting Office report, unearthed by The Washington Post, describes the “regulatory confusion,” “enforcement problems” and “in some cases, fraud” associated with the plans, known as multiple employer welfare arrangements, or MEWAs). Tennessee has allowed broad access to a non-ACA-compliant association health plan run by the Farm Bureau for some years, with mixed results, according to

Highlights – October 2, 2017

Congress moves to restore federal funding for Children’s Health Insurance Program

On Wednesday, the House Energy and Commerce Committee and the Senate Finance Committee passed bills to extend federal funding of Children’s Health Insurance Program (CHIP), which lapsed on Oct. 1, for five years. Both bills also propose rolling back the federal enhanced match rate for CHIP by 2021. The House bill would allocate $1 billion in additional Medicaid funding for storm-ravaged Puerto Rico and $30 million for the US Virgin Islands. The House bill also restores $2 billion in federal disproportionate share hospital (DSH) funding for fiscal year 2018 but adds $8 billion in DSH cuts for fiscal year 2026 and an additional $8 billion in cuts for fiscal year 2027.

While the Senate bill does not include details about how the CHIP reauthorization would be funded, the House bill proposes several offsets, including premium increases for higher-income Medicare recipients, changes to Medicaid rules that would make it easier for states to collect money from third-party insurers and a provision that would restrict lottery winners from receiving Medicaid for periods of time based on the size of their winnings. Without CHIP reauthorization, 10 states say they will run out of federal funds by the end of the year, and 28 states say they will use up their money by April, according to an analysis by the Kaiser Family Foundation. Several states have told the federal government they will have to scale back or shut down the program, if funding is not agreed to soon.

HRI impact analysis: While it appears very unlikely lawmakers will allow the popular program’s funding gap to continue very long, states are working to determine when funds will run out; how to cap enrollment, cut services or shift enrollees to other programs; and when to begin notifying beneficiaries of any changes. Recent natural disasters are expected to exacerbate the situation in Texas, Florida, and Puerto Rico, which already was facing significant issues with Medicaid funding. Even with reauthorization, states should prepare for a three-year phase-out of the 23 percent enhanced federal match for CHIP, which will hit rural and children’s hospitals particularly hard.

Secretary’s resignation raises questions about direction of HHS

HHS Deputy Assistant Secretary Don J. Wright began serving as acting secretary of HHS after Tom Price’s resignation last week amid criticism of his use of expensive, publicly-funded chartered and military jets. A family medicine physician and public health expert, Wright has served in the US government for more than 12 years. Price’s resignation came a few days after HHS released its draft strategic plan for fiscal years 2018-2022. Developed under Price, the plan emphasizes modernizing the nation’s healthcare system, improving public health outcomes, and updating the agency’s workforce and infrastructure. As HHS secretary, Price also championed an initiative to “reimagine” HHS through a broad reorganization that focuses on data mining, streamlining processes and personnel, and “restoring market forces” to the agency’s practices. Price’s departure leaves the future of these changes in question. Any nominee for a permanent successor to Price will need Senate confirmation.

HRI impact analysis: Despite leadership turnover at HHS, the agency’s draft strategic plan does provide a roadmap for the agency for now. Notably, the plan suggests that the agency continue to decrease efforts to support the ACA by shortening open enrollment for the exchanges, cutting the marketing and advertising budget by 90 percent, and announcing that will be closed for 12 hours on most open enrollment Sundays for maintenance. By contrast, the agency’s strategic plan for fiscal years 2014-2018 heavily emphasized insurance reforms, Medicaid expansion, and ACA marketplace support. The new draft plan also contains few references to value-based care, a key agency initiative under President Barack Obama. While much of the plan is uncontroversial, emphasizing access to affordable health care and boosting medical research, it makes significantly more references to faith-based care than previous plans.

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Payers: Trump administration briefs

As the debate over repealing and replacing the Affordable Care Act (ACA) moves to the US Senate, generating considerable uncertainty about the law’s future, health insurers face looming deadlines to participate in the ACA exchanges this fall. Several insurers already have announced they will drop or reduce participation, raising questions about the ACA nongroup market’s health as open enrollment begins Nov. 1.

Read HRI’s spotlight, Trump policy agenda – Exchange participation


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

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is transforming the way physicians are paid for Medicare services. But the law also could have profound effects on hospitals and health systems, potentially hitting their bottom lines, changing the way they evaluate consolidation and how they design provider networks. For hospitals and health systems, MACRA is a strategic puzzle to solve, requiring greater enterprise resilience in these times of change and uncertainty.

Read HRI’s spotlight, MACRA is a strategic puzzle that requires greater resilience (September 2017)


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 (March 2017)

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 (February 2017)

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Pharma and life sciences companies: Trump administration briefs

The pharmaceutical industry is facing a growing threat from safety data on the drugs it produces. The FDA has fostered unprecedented transparency on drug safety data, forcing companies to manage novel challenges from parties already busy mining those data: regulators, the public and data analytics firms. In this climate, pharmaceutical companies have the opportunity to find ways to mitigate risks, unlock savings, make new discoveries and create competitive advantages.

Read HRI’s spotlight: Pharmaceutical companies face the changing future of pharmacovigilance (September 2017)

The FDA’s new commissioner, Dr. Scott Gottlieb, has extensively argued that the agency is in need of regulatory reform meant to get critical medical products to patients more quickly and efficiently. Gottlieb’s previous statements signal a greater likelihood of significant change at the FDA, which has been given new authority – both statutory and executive – by legislators and President Donald Trump to streamline and accelerate the way it regulates. As change takes place, life science companies may benefit and find reasons to celebrate – but so, too, will their competitors. 

Read HRI's spotlight, The FDA leans forward: Dr. Scott Gottlieb’s opportunity to reshape the agency

As the US tax and trade reform debate continues, pharmaceutical and life sciences companies should waste no time in evaluating how different provisions would affect their business operations. Companies should model possible changes could affect manufacturing and supply chains, locations of intellectual property (IP) holdings, unremitted earnings held overseas and planned capital expenditures. Updated August 2017.

Read HRI’s spotlight, Creating a pharmaceutical supply chain and business strategy amid tax and trade reform uncertainties (Updated August 2017)

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?

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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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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

Trine K. Tsouderos
HRI Regulatory Center Leader
Tel: +1 (312) 241 3824

Alexander Gaffney
Senior Manager, PwC Health Research Institute
Tel: +1 (202) 414 4309

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