Rules at Risk – POLITICO


Agency: Environmental Protection Agency

Status: Early litigation

Summary: A bizarre coalition of biofuels and oil refinery groups is attacking a Biden administration proposal to toughen carbon dioxide limits for new vehicles, attacking it as an unauthorized ‘transformation’ of the fuel industry. transport. The EPA, which says its limits would save 3 billion tons of greenhouse gases by 2050, has regulated tailpipe emissions under the Clean Air Act since the Obama administration. But the groups argue the new rule is an attempt to push people towards electric vehicles, which would crowd out those that burn petrol or diesel.

Topic: Protection of water and wetlands

Agency: APE

Status: Supreme Court arguments pending; unfinished ruler

Summary: The Supreme Court later this year take a deal in a long-running legal battle over waterways and wetlands eligible for federal protection. Conservative groups, including the Cato Institute and the Americans for Prosperity Foundation, argue that the EPA cannot resolve ambiguous water jurisdiction questions that Congress has refused to answer.

Topic: Greenhouse gases and federal lands

Agency: Land Management Office

Status: Rule not yet proposed

Summary: The Biden administration is trying to force operators of oil and gas wells on federal lands to capture most of their emissions of methane, a potent greenhouse gas, after a judge rejected a version of the law. Obama-era rule. The precise outlines of a future rule remain unclear, but any regulation that comes close to EPA authority under the Clean Air Act could result in a challenge accusing BLM of stepping out of its wheelhouse.

Topic: Disclosure of climate risks by public companies

Agency: Security and Exchange Commission

Status: Proposed rule

Summary: The SEC in March proposed a new disclosure regime requiring filing companies to tell investors about climate-related risks that could affect their business. Companies would also have to disclose their direct and indirect greenhouse gas emissions under the rule, which is much broader than an existing climate disclosure guideline the SEC issued in 2010.

The SEC justified the proposal on the grounds that investors want more climate-related disclosures, but legal challenges from the financial regulator’s authority to set climate-related policy are expected.

Technology

Topic: Net Neutrality

Agency: Federal Communications Commission

Status: Potential rule

Summary: The “major issues” doctrine is a potential threat to any new FCC rules requiring internet service providers to treat all web traffic the same. Such a rule no longer exists now, after the agency’s Trump-era leaders repealed an Obama-era version in 2017, but the agency’s current leadership is expected to launch new regulations – once the Senate confirms President Joe Biden’s nominee for an open seat on the commission.

Judge Brett Kavanaugh has previously weighed in on the rule, which has broad support among liberal activists but fierce opposition from cable and internet providers. As a federal appellate judge, Kavanaugh written in 2017 that Congress “did not clearly authorize the FCC to issue the net neutrality rule”.

Health care

Topic: Reduced Medicare payments for certain drugs

Agency: Department of Health and Social Services

Status: Awaiting Supreme Court decision

Summary: In 2018, HHS changed its calculations to reimburse hospitals that primarily treat low-income and underserved populations through a program known as 340B. The change effectively reduced government payments for drugs from around 106% of their cost to around 77% and was quickly challenged by provider organizations.

HHS says it was within legal limits to adjust the payment rate. The Supreme Court is expected to deliver its opinion this month.

Topic: New Drug Exclusivity

Agency: Food and drug administration

Status: Potential litigation

Summary: As part of its process for reviewing the safety and efficacy of a new drug, the FDA may grant certain protections that provide incentives for new drug development, such as years of market exclusivity for a new chemical entity. These exclusivity decisions can generate or reduce billions of dollars in drug-related revenue, meaning what is considered “new” can be a hotly contested arena, as legal experts recently wrote in the Institute of Food and Drug Lawthe newspaper.

Manufacturers rarely challenge FDA decisions — and when they do, they often lose. But that could change if changing the Supreme Court’s guidance on regulators’ legal powers opens the FDA up to challenges from drug developers arguing the agency is inconsistent.

Topic: Obamacare Subsidies for Insurance Coverage

Agency: HHS

Status: Potential litigation

Summary: In 2015, the Supreme Court upheld HHS’ authority to hand out grants to people using the Affordable Care Act market, a decision that has kept millions of people from paying hundreds of dollars a month for purchased insurance. on the market. HHS had estimated in the months before the court’s 6-3 ruling that more than 6 million people were receiving grants, a number that has exploded in recent years as enrollments have increased, especially during the pandemic. A record 14.5 million people signed up for Market Insurance last year.

The court’s decision in this case was based in part on a legal principle known as Chevron deference, or the assumption that HHS’s reading of the ACA’s expansive law was correct in this case. Holding the agencies to a higher standard could trigger a new round of lawsuits arguing that HHS overstepped its authority in already divisive health care law. Meanwhile, the Biden administration has sought to expand and formalize more subsidies that have kept costs low for millions of people during the Covid-19 crisis.

Topic: Access to contraception

Agency: HHS

Status: In front of a Texas District Court judge and is expected to head to the Supreme Court

Summary: The Affordable Care Act required insurers to cover preventive health care services such as vaccines and diagnostic screenings at no cost to patients. But some religious advocates have argued that payers should not be required to cover contraceptives and drugs that prevent HIV transmission without cost sharing.

If the Supreme Court decides Kelley v. Becerra that HHS interpreted the Congressional mandate too broadly to cover preventive services, insurers could impose new costs on contraceptives or limit access to them.

Topic: Civil rights and health equity

Agencies: Centers for Medicare & Medicaid Services and HHS Civil Rights Office

Status: Existing Policies and Proposed Rule

Summary: Various efforts by the federal Department of Health to address issues such as civil rights and religious freedoms could also be vulnerable to legal challenges.

For example, the CMS proposed this year to include equity measures in its hospital payment systems by asking providers to expand their data systems to include more indicators of health and socioeconomic status. But some Republicans in Congress have challenged the health agency’s authority to address inequities and racism in health care. representing Gary Palm (R-Ala.) in May introduced a bill this would prevent HHS from deploying “anti-racism” policies.

The health agency’s civil rights office has also been shaped by the priorities of various presidents — including the Biden administration’s announcement of a new environmental justice office that would work with civil rights leaders to fight against health disparities exacerbated by climate change and environmental policies. Congress did not mandate the move.

Last year, HHS Secretary Xavier Becerra rolled back a Trump-era regulation — through the same office — that allowed vendors to refuse care because of their religious beliefs. The Trump administration in 2018 also created a Conscience and Religious Liberty Division within the HHS Civil Rights Office, which health care advocates such as the National Women’s Law Center said overstated their mandate.

Topic: Drug price transparency

Agency: HHS

Status: Hit by federal court

Summary: As part of a wide-ranging effort to reduce drug costs, President Donald Trump in May 2019 ended a rule that would require pharmaceutical companies to list drug prices in their direct-to-consumer advertisements.

A DC District Court judge struck down the rule two months later, a day before it went into effect, saying HHS had clearly overstepped its authority. An appeals court upheld the ruling in 2020, adding that the rule was “largely independent of the actual administration of the Medicare or Medicaid programs.”

While the publicity battle is over for now, pharmaceutical groups and payers have continued to challenge CMS’s proposed rules that would change drug payment structures, questioning the government’s authority to manage drug pricing.

Katy O’Donnell and John Hendel contributed to this report.

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