The Next 1361 Days — and How They Will Impact Clinical Pathways

Over the course of the Trump Administration’s first 100 days, the president and members of Congress have introduced health care reform legislation that aims to profoundly change the ways medicine is practiced—and paid for—in America. The American Health Care Act (AHCA) would largely undo many of the provisions enumerated within the Affordable Care Act (ACA), with skeptics claiming that the new legislation would result in higher consumer costs and fewer patient protections. Should President Trump and his administration succeed in rolling back many of the ACA’s key policies, clinical pathways will be needed to mitigate the costs borne by patients, providers, and payers, as health care delivery in the United States remains in flux. 

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If the first 100 days of the Trump Administration has your head spinning, imagine what the next 1361 days will bring. To date there are two pieces of legislation that paint the future for the rest of the Trump Administration: The AHCA1 and Improving Access to Affordable Prescription Drugs Act.2 These pieces of legislature could potentially impact clinical pathways, both in terms of their elements and their execution.

Our health care environment is increasingly being impacted by federal and state legislators and regulators, especially given the seismic shift of political control in Washington. The proposed repeal and replacement of the ACA3 via the AHCA is expected to increase the number of uninsured and underinsured, resulting in provider difficulty following through with recommended clinical pathways, due to patient affordability and treatment access. As estimated by the Congressional Budget Office (CBO),4 some 52 million Americans may be uninsured by 2026. A complete breakdown of where that population will come from, including those newly insured ACA individuals, is noted in Table 1.

changes in numbers

The CBO estimates that should the AHCA replace the existing health care laws, as many as 14 million currently insured individuals would lose their coverage as early as 2018, arising from a number of factors. The AHCA would remove the ACA’s individual mandate to purchase health insurance, and the CBO projects that many younger and healthier individuals would decline to purchase insurance if it were not federally mandated. Additionally, a percentage of individuals who want to purchase insurance likely would not be able to because of unaffordable premiums. Changes to Medicaid eligibility and the nongroup market would increase the ranks of the uninsured to 21 million by 2020 and 24 million by 2026, resulting in a total of 52 million uninsured individuals—28 million of whom currently carry insurance.

On the other side of this is legislation positioned to make pharmaceuticals more affordable. The Improving Access to Affordable Prescription Drugs Act aims to reduce prescription drug costs through reductions in both prices and utilization via government price controls, increasing competition and pressure on copayment coupons, and patient assistance programs.2 Although the most significant change would be the federal government negotiating prices for Medicare prescription drugs, other potential measures exist, such as increasing competition through the allowance of drug importation and generic drug availability (Table 2). Although it is unlikely that all these provisions will be passed and implemented, the direction in which our new government wants to take health care is clear. 

proposals

Several of the positions espoused within the Improving Access to Affordable Prescription Drugs Act could have direct or indirect effects on the development of clinical pathways. According to a summary of the bill published on the website of Sen Elizabeth Warren5, the bill aims to strengthen drug manufacturing reporting, in an attempt to increase transparency surrounding drug pricing; to allow Medicare to negotiate prescription drug prices, which it is currently prohibited from doing, in hopes that these negotiations would have a global impact on all prescription drug costs; and to make generic drugs more easily accessible by removing the current 180-day generic exclusivity period from generic companies engaging in pay-for-
delay strategies, as well as ending the practice by which manufacturers slightly alter existing drugs in order to extend their patents, which is commonly known as “product hopping.” The potential introduction of transparently and affordably priced medications could have a significant effect on value-based care, by driving down the costs of care without a concomitant reduction in quality. However, it is unlikely that this legislation—sponsored exclusively by Democratic senators and representatives—will gain the requisite bipartisan support to push through the Republican-controlled legislation.

It further remains to be seen how the current administration’s health care reform efforts might affect The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)6, which officially went into effect in January 2017. The bill—which enjoyed bipartisan support in Congress, passing the House of Representatives in a vote of 392 to 37—seeks to redesign payment models for clinicians caring for Medicare beneficiaries. MACRA introduces several methods by which to promote value-based care7, including the Merit Based Incentive Payment Systems, which ties reimbursement and providers’ compensation to performance and appropriate resource utilization; Alternative Payment Models, which introduces new compensation structures for physicians and providers; and the Advanced Alternative Payment Models, which will apply to providers who qualify for increased reimbursement levels based on performance. Due to MACRA’s bipartisan support, it stands to reason that this legislation is likely safe from the current attempts to restructure the health care delivery system.

On May 4, 2017, the House of Representatives narrowly passed a revised version of the AHCA, in a vote of 217 to 213.9 The bill will now go to the Senate, whose members have already indicated that it will be majorly overhauled prior to any further votes.10 It remains unclear which provisions enumerated by the new bill—which include the removal of an individual mandate to carry health insurance, the potential to charge higher premiums for patients with certain pre-existing conditions, and the possible reinstatement of lifetime caps on individual coverage—will be kept. What remains certain is that the health care debate will continue for some time. Clinical pathways will be more important than ever to ensure the consistency of care throughout the process.

As clinical pathway developers continue their work, careful consideration of these external factors from Washington will be critical, especially as they impact patient access to treatments. For providers tasked with implementing clinical pathways, appreciating needed adjustments to assure patients have access to recommendations will be a challenge for some, depending if they are on the winning (insured and enjoying legislated lower pharmaceutical costs) or losing (uninsured) ends of what is to come out of Washington over the next 1361 days. 

References

1.    HR 1628—American Health Care Act of 2017. United States Congress website. https://www.congress.gov/bill/115th-congress/house-bill/1628/text. Published March 20, 2017. Accessed May 1, 2017.

2.    HR 1776—Improving Access to Affordable Prescription Drugs Act. United States Congress website. https://www.congress.gov/bill/115th-congress/house-bill/1776. Published March 31, 2017. Accessed May 1, 2017.

3.    Compilation of Patient Protection and Affordable Care Act. Healthcare.gov website. http://housedocs.house.gov/energycommerce/ppacacon.pdf. Published May 1, 2010. Accessed May 2, 2017.

4.    American Health Care Act report. Congressional Budget Office website. https://www.cbo.gov/publication/52486. Published March 13, 2017. Accessed May 2, 2017.

5.    Summary of the Improving Access to Affordable Prescription Drugs Act. Senator Elizabeth Warren website. https://www.warren.senate.gov/files/documents/2017_3_29_Improving_Access_to_Affordable_Prescription_Drugs_Act_Summary.pdf. Accessed May 2, 2017.

6.    Quality Payment Program website. https://qpp.cms.gov/. Accessed May 2, 2017.

7.    What is MACRA? Network for Regional Healthcare Improvement website. http://www.nrhi.org/work/what-is-macra/what-is-macra/. Accessed May 2, 2017.

8.    2016 Biennial Health Insurance Survey. The Commonwealth Fund website. http://www.commonwealthfund.org/interactives-and-data/surveys/biennial-health-insurance-surveys/2017/2016-biennial-health-insurance-survey. Published February 1, 2017. Accessed May 2, 2017.

9.    Kaplan T, Pear R. House passes measure to repeal and replace the Affordable Care Act. The New York Times. May 4, 2017. https://www.nytimes.com/2017/05/04/us/politics/health-care-bill-vote.html. Accessed May 8, 2017.

10.    Fram A, Lardner R. House GOP health bill faces bumpy road in the Senate. Time. May 5, 2017. time.com/4769420/ahca-health-care-senate-vote/. Accessed May 8, 2017.