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Potential Election Year Shakeup: Regulatory Implications of the Congressional Review Act

The Congressional Review Act (CRA) empowers Congress to act to invalidate regulations issued by federal agencies. These regulations include final rules, interim final rules and guidance documents. The CRA is most practically used by a new Congress to invalidate regulations issued by a previous administration and received within 60 legislative days of the previous Congress’ adjournment.

Should Republicans gain control of both chambers of Congress and the presidency, the 119th Congress could use the CRA to nullify certain Biden administration regulations. With federal elections looming later this year, this article reviews the CRA and how it might impact the current administration’s regulatory agenda.

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Pharmacy Benefit Manager Reform: What’s on the Horizon?

The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government.

Pharmacy benefit managers (PBMs) are a key stakeholder in the drug supply chain, functioning as intermediaries between insurance providers and pharmaceutical manufacturers. PBMs administer prescription drug benefits and seek discounts for insurers as standalone plans, such as Medicare Part D plans, or as entities embedded in commercial insurance products, including Medicare Advantage, Medicaid Managed Care Organizations and employer-sponsored coverage.

PBMs are under increased scrutiny from policymakers due to the perceived opaqueness of their operations and their perceived role in increasing drug costs. As part of this scrutiny, Congress and other stakeholders are raising questions about PBMs’ impact on drug prices and out-of-pocket costs for patients. In the 118th Congress, several key committees have advanced legislation that would increase PBM transparency and reporting obligations and modify other business practices.

Read on for a side-by-side comparison of US House and US Senate PBM bills and our forecast of the possible effects of these proposed changes to PBM operations.




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Proposed Legislation Would Allow 403(b) Plans to Invest in Lower-Cost Collective Investment Trusts

A new bill introduced in Congress would allow 403(b) plans maintained by tax-exempt organizations to make use of collective investment trust (CIT) investments. CITs are an alternative to mutual funds that may provide significant cost savings for 403(b) plans and their participants. The SECURE 2.0 Act took the first steps along this path by making amendments to the Internal Revenue Code to permit 403(b) plans to invest in these vehicles; however, that legislation failed to include the necessary changes to securities laws. The Retirement Fairness for Charities and Educational Institutions Act of 2023 aims to take the next steps by amending the Securities Act and the Investment Company Act to allow 403(b) plans to make use of CITs.

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Drug Discount Plan Remains Target for Possible Legislation

Members of Congress could call for more transparency about how hospitals use their federal drug discount program savings. According to this Bloomberg Law article, a study found that the Health Resources and Services Administration’s oversight of the 340B program could be improved. McDermott Partner Emily Jane Cook said there is interest in Congress overseeing aspects of hospitals, including the 340B program.

“I wouldn’t be surprised to see a bill being introduced that imposes more explicit oversight requirements,” Cook said.

Access the article.

Reproduced with permission. Published May 15, 2023. Copyright 2023 by Bloomberg Industry Group, Inc. (800-372-1033) http://www.bloombergindustry.com




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Post-Election Committee Membership Tracker

This document serves as a tool to track key congressional positions, as well as potential and pending changes that are relevant to health policy on Capitol Hill. It covers US House of Representatives and US Senate leadership and membership of the healthcare committees of jurisdiction. This tracker will be updated after the election when Congress returns, to determine the answers to the speculation below.

Click here to view tracker.




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COVID-19 Response in Jeopardy amid Congressional Inaction

Congressional inaction may prevent a more robust federal government COVID-19 response, according to this Washington Post article. A $15 billion COVID-19 funding bill recently collapsed in Congress, potentially crippling testing, treatment and vaccine access. McDermott+Consulting’s Rodney Whitlock said not enough “spadework” was done to get compromises across the finish line.

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Staying Connected: An Update on Medicare Reimbursement for Telehealth Services After the PHE

In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.

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What You Need to Know About the PRO Act

The Protecting the Right to Organize Act (PRO Act) passed the US House of Representatives for a second time this March. If it’s signed into law, the legislation would eliminate state right-to-work laws, increase the number of workers eligible for collective bargaining and ban mandatory arbitration agreements.

In this video, McDermott partner Ron Holland breaks down the PRO Act’s most significant changes to employment law.

Visit McDermott’s resource center to learn more.




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The Challenges of the Trump Administration’s Vow to “Repeal and Replace” the Affordable Care Act

In the presentation “ACA Repeal/Replace Under the Trump Administration,” Susan Nash discusses the implications of President Trump and the GOP’s immediate vow to “repeal and replace” the Affordable Care Act (ACA), which was enacted in 2010 by the Obama Administration to reform the health care system in the US. A complete repeal is unlikely since many ACA changes will require a filibuster proof majority vote in the Senate. However, some changes can be made unilaterally through Executive action by Republicans through Budget Reconciliation, a special legislative process created by Congress to allow for expedited voting on bills that directly impact reviews and expenditures.

The presentation also highlights several proposals that the GOP has been working on to replace ACA, the non-enforcement of market reform requirements, the possible outcomes for the Trump Executive Order and the immediate ramifications for the insurance markets and millions of Americans.

View the presentation slides here.




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