HRI regulatory center

Regulatory and legislative updates and analysis

President Donald Trump: The latest healthcare developments

HRI Trump administration spotlight: House Republicans release bill to partially repeal/replace ACA

HRI Trump administration spotlight: House Republicans release bill to partially repeal/replace ACA

On March 6, House Republicans unveiled legislation, the American Health Care Act (AHCA), aimed at repealing and replacing provisions of the Affordable Care Act (ACA). Although the bill may change significantly, uncertainty and risk will continue for the next few years. Organizations can survive and thrive by taking steps to build resilience, scenario plan and identify potential opportunities in light of this legislation.

Read HRI’s spotlight, House Republicans release bill to partially repeal and replace the Affordable Care Act

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HRI Trump administration spotlight: Policy impacts on payers

HRI Trump administration spotlight: Policy impacts on payers

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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HRI Trump administration spotlight: Policy impacts on providers

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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HRI Trump administration spotlight: Policy impacts on pharma and life sciences

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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HRI Trump administration spotlight: (Some) change is coming to healthcare

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

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HRI's analysis of the 2016 presidential election results

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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Trump administration highlights – March 13, 2017

Trump administration: CBO says repeal/replace bill increases uninsured by 24 million, cuts Medicaid by $880 billion by 2026

The Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) released their much-anticipated scoring of the House GOP’s American Health Care Act (AHCA) on Monday. The analysis concluded that by 2018, 14 million more people would be uninsured than would be under the Affordable Care Act (ACA), largely because the ACA’s individual mandate would be eliminated. That number is expected to climb to 24 million by 2026 because of changes to Medicaid and premium tax credits, and the elimination of subsidies to help low-income Americans pay the out-of-pocket costs associated with their plan, such as deductibles and co-payments. The report estimates that federal funding for Medicaid would drop $880 billion between 2017 and 2026 — a 25 percent reduction — and that by 2026, 14 million fewer people would be enrolled in Medicaid. Federal deficits are expected to be $337 billion lower by 2026. (For more detail on the AHCA and the CBO/JCT report, please see HRI’s spotlight.) 

HRI impact analysis: Released just days before the House Budget Committee was scheduled to consider the bill, the CBO/JCT report triggered heated reactions. Senate Minority Leader Chuck Schumer, D-N.Y., called the report a “knockout blow” for congressional Republicans. House Speaker Paul Ryan, R-Wis., said he was encouraged by the report, as the analysis indicated long-term individual market stability and a drop in premiums. HHS Secretary Tom Price said the administration “strenuously disagrees” with the CBO’s assessment. Speaking at a rally in Nashville on Wednesday, President Donald Trump said, “We’re going to all get together; we’re going to get something done.”

The CBO/JCT’s estimates for the rise in the uninsured — which would result in 52 million total uninsured Americans by 2026 — have received the most attention from the media and federal legislators. But healthcare providers and state lawmakers may be more interested in another figure: the $880 billion drop in federal Medicaid funding by 2026, achieved by rolling back the ACA Medicaid expansion and capping expenditures. The reduction would force states to make up the difference, cut benefits and/or cut enrollees. The bill “would make the country worse off than we were before the ACA,” Bruce Siegel, CEO of America’s Essential Hospitals, told Politico. Under the AHCA, the fate of some healthcare providers heavily dependent on Medicaid — such as safety-net hospitals and long-term care facilities — could hinge on state and local lawmakers, each state’s financial health, and residents’ priorities. Consolidation among providers could accelerate in states with dramatic Medicaid funding reductions as hospitals seek scale, more varied payer mixes and financial safety.

Trump administration: Repeal/replace bill would drop ACA public health fund

The AHCA would eliminate the ACA’s Prevention and Public Health Fund, which has distributed nearly $1 billion since 2010. Most of that money has funded work at the Centers for Disease Control and Prevention (CDC), making up about 12 percent of its annual budget. The fund supported work on infectious disease surveillance, preventing hospital-acquired infections, immunization, and disease prevention and awareness. Republican lawmakers have remained critical of the fund, with Rep. Andy Harris, R-Md. — who sits on the House appropriations health subcommittee — labeling it a “slush fund” that has “been used by the secretary [of health and human services] for whatever the secretary wants.” 

HRI impact analysis: Public health spending sits below prerecession levels despite new concerns, such as the opioid epidemic. Reducing this funding could shift costs to providers and insurers, which could see increased demand from patients, such as opioid abusers, for long-term inpatient and outpatient treatment plans. As demand increases, patients could wait longer for care, become sicker, depend more on emergency rooms, and require more costly care.

Trump administration: President Trump nominates familiar face as FDA commissioner

President Trump nominated Dr. Scott Gottlieb last week as FDA commissioner. Gottlieb is well known in the pharmaceutical and life sciences industry; he works at the American Enterprise Institute, a conservative-leaning think tank, and New Enterprise Associates, a venture capital firm. He holds director positions on several pharmaceutical companies’ boards, including those of Glytec and American Pathology Partners, and is a member of the Federal Health IT Policy Committee. Gottlieb also has experience in the public sector; he was the FDA’s deputy commissioner of medical and scientific affairs under President George W. Bush. His nomination must be confirmed by the Senate.

HRI impact analysis: Gottlieb could profoundly affect the life sciences industry. He would enter the FDA just as the 21st Century Cures Act ramps up and as the agency prepares to complete several user fee agreements. President Trump has spoken repeatedly about streamlining the regulatory process for evaluating drugs and devices. Gottlieb, a frequent commentator on FDA regulatory issues, has written and spoken about lower drug prices, generic drug labeling, stem cell regulation, complex generic drug regulation, drug shortages and more. His philosophy is that regulatory barriers should be simplified, reduced or eliminated to help promote innovation.

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Trump administration highlights – March 6, 2017

Trump administration: House GOP unveils partial repeal/replace bill

On Monday, House Republicans released draft legislation to partially repeal and replace the Affordable Care Act (ACA) through the budget reconciliation process. The “American Health Care Act” (AHCA), released by the House Ways and Means Committee and the House Energy and Commerce Committee, would repeal most of the ACA’s taxes and fees, phase out the ACA’s Medicaid expansion, cap federal Medicaid funding and replace the ACA’s income-based premium tax credits with age-based ones. Most changes would go into effect after 2019. Republican lawmakers are using the budget reconciliation process, which generally allows only changes related to revenues and outlays and only requires a simple majority vote in the Senate, which means Republicans will not need any Democrats’ support. By Thursday afternoon, the bill had passed both committees.

HRI impact analysis: As of March 9, House lawmakers had not released a Congressional Budget Office score for the bill, so its costs and effects on coverage remain unclear. In a series of analyses released on March 7, The Joint Committee on Taxation estimated that the bill would cut taxes by $594 billion through 2026. The bill likely will change during the legislative process. By midweek, the American Medical AssociationAmerican Hospital AssociationAARP and other organizations had issued critical statements about the bill. Healthcare organizations, especially providers, likely will be most concerned about the proposed Medicaid changes, including an expansion rollback and federal spending cap. Insurers may support provisions that would make the exchanges more attractive, such as one allowing them to charge older enrollees five times what they charge younger ones, instead of three times. Branded pharmaceutical companies and makers of nonretail medical devices may support AHCA’s ending of taxes that affect them (For a more detailed AHCA analysis, please see HRI’s Spotlightwhich will post later today).

Trump administration: New immigration and travel executive order will impact health industry

After courts stayed President Donald Trump’s Jan. 27 executive order on immigration and travel, he issued a new one Monday that — like the previous one — will affect the US health industry, parts of which rely heavily on foreign-born clinicians, scientists, students and patients. The new order, which is to take effect March 16, delays issuance of new visas for residents of six countries — Iran, Libya, Somalia, Sudan, Syria and Yemen — for 90 days, suspends the refugee admissions program for 120 days and reduces the number of refugees that will be permitted to enter the US to 50,000 from 100,000 in fiscal year 2017. The new order removes Iraq from the list and does not apply to certain groups, including lawful permanent US residents. The order also asks the secretary of homeland security, in consultation with the secretary of state and the director of national intelligence, to conduct a country-by-country assessment of whether more information is needed to admit their residents.

HRI impact analysis: The new order will have some ramifications for the US health industry. Hospitals, physician groupshealth tech companies and other organizations expressed concern about how the original order’s restrictions might disrupt their operations. In response to uncertainty generated by the first executive order, some hospitals weren’t sure they should accept medical school graduates from restricted countries for residency programs on Match Day, March 17. While the new order drops Iraq from its list, it likely will continue to produce uncertainty amid new rounds of legal challenges. A team of researchers from Harvard University and Massachusetts Institute of Technology concluded that physicians from the six countries named in the new executive order provided 14 million doctor’s appointments a year. These physicians tend to work in rural and underserved areas, particularly in Ohio, Michigan, West Virginia, Indiana and Kentucky, the researchers found.

Trump administration: Executive order places regulation reform officers in agencies

President Trump issued an executive order Feb. 24 directing each federal agency to designate a regulatory reform officer (RRO) to oversee regulatory reform policies. The RROs also will sit on each agency’s Regulatory Reform Task Force, which will identify regulations to change or repeal. The task forces will consider regulations that “eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies.” Also targeted are regulations that grew out of previous executive orders that are no longer in effect or have become moot.

HRI impact analysis: This executive order advances the Trump administration’s ongoing efforts to reduce regulation, which it sees as a barrier to job creation and economic growth. The order follows a Jan. 30 executive order requiring each agency to identify two regulations to eliminate before introducing a new one. The healthcare industry should closely track which regulations are slated for removal or modification, and consider which would be good to keep, change or cut. Federal agencies and industry will need to carefully examine each regulation’s complex interdependencies to understand how it may affect all related parties.

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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 Tsouderos
Health Research Institute director
Tel: +1 (312) 241 3824

Alexander Gaffney
Health Research Institute, senior manager, Pharma/New entrants
Tel: +1 (202) 414 4309

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