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

Health reform 3.0: Thriving in a permanent state of policy disruption

The death of health reform has been greatly exaggerated. Though Congress was unable to pass a comprehensive national health reform bill in 2017, many other reforms are playing out in Congress, regulatory agencies and state capitals that could profoundly impact the healthcare landscape over the next year and beyond. 

These changes include efforts by Congress to reform the federal tax code; by HHS to reshape how the Affordable Care Act (ACA) is administered and how government pays for value over volume; and by states to control Medicaid and drug spending. These efforts make it clear that this is no time for companies to take a relaxed or reactive posture. On the contrary, they should act now to anticipate which changes are most likely to occur and how those changes might affect their business operations, then decide what they’re going to do about it. 

Payers, providers, life sciences companies and employers no longer have just one high-profile reform effort to monitor, but dozens. There are several that require their immediate attention. 

Read HRI and Strategy&'s report, Health reform 3.0: Thriving in a permanent state of policy disruption

View more

Weekly insights from Capitol Hill

Highlights – February 12, 2018

President’s budget suggests state formularies, shared Medicare rebates

The president’s budget, released this week, proposed allowing some states to experiment with formularies and requiring Medicare drug plans to share rebate savings with members. The proposals follow President Donald Trump’s State of the Union address, in which he called drug pricing a top priority. The budget also suggests letting the FDA review generic drug applications more quickly. The drug pricing plans follow a recently published report by the White House Council of Economic Advisers that also outlined policy changes to reduce drug prices. The council recommended accelerating FDA approvals of second- and third-line drugs, which treat a disease or condition similarly to the way an already approved drug does. The council said it believes the additional branded competition could lead to lower prices. The report also calls for rethinking Medicaid and Medicare rebates and the 340B drug pricing program.

HRI impact analysis: Congress holds budgetary power, so the president’s budget is a largely symbolic document that outlines White House priorities and wishes. This year’s budget, like last year’s, called for cuts to social safety net programs and funding for the CDC and other health agencies. This year it also called for more funding to address the opioid epidemic and focused on specific drug pricing policies. Some of the drug pricing proposals in both the budget and council report are similar to ideas that have been floated before, including letting the FDA speed reviews of generic products. Others date back to promises made by then-candidate Trump on the campaign trail, such as the suggestion that some states be allowed to negotiate more forcefully with drug companies and use formularies. One state, Massachusetts, has proposed introducing a formulary program through an amendment to its Section 1115 demonstration waiver. If the federal government gives states greater power to address drug pricing, the pharmaceutical industry should be prepared for additional waiver applications that would add to an increasing amount of transparency and price control legislation

Medicare Advantage, Part D sponsors may see plan payment boost next year

CMS expects plan payments to Medicare Advantage and Part D plans will increase 1.84 percent in 2019 thanks to policy changes it is proposing to its risk adjustment model and an estimated effective growth rate of 4.35 percent. These increases would be partially offset by changes CMS wants to make in its star ratings program and use of encounter data. CMS wants to update its Medicare Advantage risk adjustment model to include considerations such as mental health, substance abuse disorders, chronic kidney disease conditions and comorbidities as required under the 21st Century Cures Act. The agency expects the new conditions will improve its ability to accurately model risk for Medicare Advantage beneficiaries. CMS also is proposing to expand supplemental benefits under Medicare Advantage plans to items or services that compensate for physical impairments, diminish the impact of injuries or health conditions, or reduce avoidable emergency visits. The proposals are open for public comment until March 5.

HRI impact analysis: CMS’ proposed risk score changes might ease some worries that hospitals could receive inaccurate risk scores under the system as it was originally proposed in 2016. And the proposed payment boost is more generous than in recent years. Medicare Advantage plans have been growing since 2003 and are increasingly attractive for payers seeking better rates than those of commercial individual markets. Approximately 20 million beneficiaries enrolled in Medicare Advantage plans in 2017, according to CMS.

Highlights – February 5, 2018

President signs budget deal

Early this morning, House and Senate lawmakers passed budget legislation to fund the government through March 23. President Donald Trump signed the bill into law a few hours later, ending a brief government shutdown. The bill gives lawmakers time to craft two-year appropriations legislation. The legislation and its related deal have many provisions related to healthcare, including funding for community health centers, additional years of funding for CHIP, more money for veterans health and the NIH and money to combat the opioid crisis. HRI as we see it will dig into the particulars of the legislation next week.

View more

Payers: Trump administration briefs

While the Obama administration championed value-based care, the Trump administration has taken a more measured approach, slowing or eliminating some programs while expanding and creating others. Value-based care will continue to drive provider and payer decision-making, though the pace of change is likely to be moderate. The Trump administration is likely to focus on reforms that prioritize voluntary participation and minimize reporting requirements.

Read HRI’s insight: The Trump administration’s slower, more voluntary value-based care (February 2018)

 

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

While the Obama administration championed value-based care, the Trump administration has taken a more measured approach, slowing or eliminating some programs while expanding and creating others. Value-based care will continue to drive provider and payer decision-making, though the pace of change is likely to be moderate. The Trump administration is likely to focus on reforms that prioritize voluntary participation and minimize reporting requirements.

Read HRI’s insight: The Trump administration’s slower, more voluntary value-based care (February 2018)

 

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

        

        


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
Email

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

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

Follow us