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

View more

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

View more

Trump administration weekly highlights

Highlights – September 11, 2017

Senators on right and left introduce new repeal/replace efforts; others shift focus to stabilizing ACA markets

On Wednesday, four senators introduced legislation that would give Republican lawmakers another chance to repeal and replace portions of the Affordable Care Act (ACA) after several attempts narrowly failed in July. The legislation—introduced by Senators. Bill Cassidy, R-La., Lindsey Graham, R-S.C., Dean Heller, R-Nev., and Ron Johnson, R-Wis.—would grant states more authority to oversee healthcare within their borders by providing block grants in lieu of federal dollars provided now under the ACA. The block grants’ sizes would be determined through a complex formula that likely would reduce federal funding to more urban states, such as California and Massachusetts, and increase funding to more rural states, such as South Carolina and Alabama. The plan, referred to as the Graham-Cassidy-Heller-Johnson (GCHJ) proposal, has not been scored by the Congressional Budget Office (CBO) and so far has received tepid support from the Trump administration and other Republican lawmakers. Senator Bernie Sanders, I-Vt., and more than a dozen Democratic co-sponsors also introduced what can be called repeal/replace legislation, advocating a Medicare-for-all proposal that would phase in Medicare for Americans over four years. The CBO has not scored Sanders’ bill either, and the proposal has no political path forward at this time. Meanwhile, a bipartisan group of senators is shifting attention toward stabilizing the ACA’s individual exchanges. The Senate Health, Education, Labor and Pensions (HELP) Committee began holding hearings last week on stabilizing premiums and finding bipartisan solutions to the healthcare industry’s problems. The committee has heard testimony from state insurance commissioners, governors and other industry stakeholders, many of whom called for Congress to fund cost-sharing reduction payments for low-income enrollees.

HRI impact analysis: Republican lawmakers face an uphill battle to pass their bill before its Sept. 30 expiration date. Other legislative priorities—such as tax reform—are competing for lawmakers’ time. It remains to be seen what solutions the bipartisan HELP Committee will propose after wrapping up its hearings this week. Even if the lawmakers craft solutions, it will likely be too late to affect the fall enrollment period, which begins Nov. 1, as many insurers have already decided whether to participate in the exchanges in 2018. Stakeholders outside of Capitol Hill are increasing pressure on lawmakers to explore bipartisan solutions to healthcare reform. A bipartisan group of governors led by Republican John Kasich of Ohio and Democrat John Hickenlooper of Colorado is urging congressional lawmakers to act immediately to stabilize the individual markets, noting that uncertainty in Washington has played a role in rising premiums. Some insurers say they have raised premiums by as much as 23 percent due to uncertainty about healthcare regulations—and whether the Trump administration will enforce them, according to The New York Times. Solutions outlined in the governors’ proposal include permanently funding cost-sharing reduction payments, creating a temporary “stability” fund to establish state reinsurance programs, and encouraging insurer participation by exempting insurance companies offering plans to underserved counties from the federal health insurance tax.

Senate committee announces agreement to reauthorize children’s health insurance program

Senate Finance Committee Chairman Orrin Hatch, R-Utah, and Ranking Member Ron Wyden, D-Ore., announced an agreement to extend Children’s Health Insurance Program (CHIP) funding for five years. The agreement would keep the ACA’s 23 percent increase in federal matching dollars through 2019, reduce the rate to 11.5 percent in 2020, and end it in 2021. The committee had not released final language for the deal as of Thursday. CHIP funding expires Sept. 30. Without reauthorization, states will begin to run out of money by the end of 2017.

HRI impact analysis: CHIP provides health insurance at a reduced cost to nearly 9 million children in families that don’t qualify for Medicaid. The 20-year-old program is credited with reducing the number of uninsured children from 13.9 percent when it was enacted to 4.5 percent in 2015. The ACA gave the program a temporary boost in federal funding in 2010. The Senate Finance Committee agreement would eventually roll back that boost. Time is tight for the reauthorization, which still must be passed by both houses of Congress and signed by President Donald Trump.

Highlights – September 5, 2017

Trump administration: Pennsylvania congressman nominated as ‘drug czar’
On Tuesday President Donald Trump nominated Rep. Tom Marino, R-Pa., to direct the Office of National Drug Control Policy (ONDCP), a position known as “drug czar.” In that position Marino would oversee anti-drug efforts such as the president’s drug addiction task force, which was established in March. Marino is a former US attorney known, in part, for advocating a forced drug rehab—or “hospital-slash-prison,” in his words—system of incarcerating nonviolent, nondealer drug offenders. The ONDCP develops the nation’s drug control strategy and coordinates related initiatives by working with law enforcement and public health entities. The ONDCP also allocates millions of dollars in federal grants to support anti-drug efforts and develops the federal drug control budget and other agencies’ budgets. The Senate must confirm Marino. No date has been set yet for a hearings, as of Thursday.

HRI impact analysis: Marino’s law enforcement and congressional voting record may color his approach to the nation’s ongoing opioid epidemic; it suggests he views the epidemic as a criminal justice issue more than a public health issue. His advocacy for forced rehab has been controversial. As yet, the opioid epidemic has resulted in relatively low numbers of arrests, according to statistics from the FBI’s Uniform Crime Reporting Program. As director of the ONDCP, Marino likely will have limited impact on policies affecting drug companies. He mainly will serve as an adviser to President Trump on drug control efforts and oversee the national drug control budget.

Trump administration: States act in wake of ACA ad budget cut
On the eve of this fall’s Affordable Care Act (ACA) open enrollment, some states are changing rules and spending millions of additional dollars on advertising in support of the law after CMS announced plans to cut the ACA’s promotional budget by $90 million—or 90 percent—of last year’s budget. California announced it would increase promotional spending for Medi-Cal to more than $111 million. Other states, including Colorado, Minnesota and Washington, have lengthened enrollment periods in the wake of the Trump administration’s decision to cut the enrollment period by 45 days.

HRI impact analysis: CMS’ advertising cuts coupled with the shorter enrollment period could result in fewer people purchasing plans on the ACA exchanges for 2018. Marketing is considered a critical factor in reminding people to buy plans. A study conducted by The Commonwealth Fund found that nearly 40 percent of uninsured American adults are unaware of health insurance marketplaces. In the last week of signups for the 2017 season, the Trump administration cut advertising. In 2016, nearly 700,000 people purchased plans in the last week of enrollment, a time when the Obama administration did a lot of advertising, according to Health Affairs. In 2017, about 370,000 people bought plans in the last two weeks, according to the report. States and insurers should expect fewer enrollees, of whom a higher percentage likely will be sicker and thus more likely to continue or seek enrollment despite reduced advertising and shorter enrollment windows. 

View more

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

View more

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)

View more

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?

View more

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

View more

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


View more



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

Follow us