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 16, 2017

Uncertain fate for bipartisan ACA stabilization deal

Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., announced this week they have reached a bipartisan deal to stabilize the Affordable Care Act (ACA) exchanges. The deal would continue funding cost-sharing reduction (CSR) payments for the next two years while providing states with more flexibility under the ACA’s Section 1332 waiver program. The deal would streamline the 1332 program application and approval process, making it easier for states to establish programs such as reinsurance funds. Finally, the deal would also expand access to catastrophic-only health plans to individuals over the age of 30. President Donald Trump has expressed ambivalence about the deal. Reaction from Senate and House Republicans and Democrats has been mixed. The deal comes after the Trump administration decided to end CSR payments to insurers two weeks before open enrollment starts. At the center of a lawsuit challenging the legality of how they’re funded, the payments’ fate has been uncertain for months, and states have adopted different ways to cope. In August, the Congressional Budget Office (CBO) estimated that gross premiums for silver ACA plans would increase by 20 percent in 2018 and 25 percent by 2020 if the CSRs were eliminated. Because taxpayers heavily subsidize many ACA shoppers’ premiums, the decision to abandon the payments could increase federal deficits by $200 billion from 2017 to 2026, according to the CBO analysis.

HRI impact analysis: With ACA open enrollment beginning Nov. 1, states are scrambling to tell insurers how to handle the CSR payments’ elimination. Some states already asked insurers selling ACA exchange plans this fall to assume the payments would end when calculating their rates. Others asked insurers to give two sets of rates, one with payments and one without. The payments’ end may affect some consumers who don’t receive tax credits to help pay for ACA plans. Subsidized consumers may find their tax credits’ value actually increases because the credits are pegged to the premium for the second-least expensive ACA silver plan available to them. As the premiums for these so-called “benchmark” plans rise, so do the tax credits. In some states, that means consumers may even be able to buy higher-value gold plans with their tax credits. As states and insurers adjust to the payments’ end, work continues on a congressional fix.

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 Vox.com

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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
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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
Tel: +1 (202) 414 4309
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