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Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law \u2014 say, in drugs that treat rare diseases or health care for seniors \u2014 decide how to translate Congress\u2019 words into action with input from industry, advocates, and the public.<\/p>\n
Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements \u2014 meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.<\/p>\n
One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.<\/p>\n
\u201cYou could have eight or nine of 11 different views of the courts,\u201d said William Buzbee, a professor at Georgetown Law.<\/p>\n
A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.<\/p>\n
In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.<\/p>\n
Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare \u2014 a key cog in President Joe Biden\u2019s effort to lower drug prices and control health care costs.<\/p>\n
Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren\u2019t written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.<\/p>\n
And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court\u2019s ruling is expected to spur more litigation over its implementation.<\/p>\n
\u201cThis really is going to create a tectonic change in the administrative regulatory landscape,\u201d Twinamatsiko said. \u201cThe approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.\u201d<\/p>\n
Industry groups, including the American Hospital Association and AHIP, an insurers\u2019 trade group, declined to comment.<\/p>\n
Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.<\/p>\n
\u201cThe legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,\u201d he said.<\/p>\n
In fact, FDA Commissioner Robert Califf said in an episode of the \u201cHealthcare Unfiltered\u201d podcast last year that he was \u201cvery worried\u201d about the disruption from judges overruling his agency\u2019s scientific decisions.<\/p>\n
The high court\u2019s ruling will be especially significant for the nation\u2019s federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.<\/p>\n
Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.<\/p>\n
\u201cA whole host of existing regulations could be vulnerable,\u201d said Larry Levitt, executive vice president for health policy at KFF.<\/p>\n
Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges \u2014 an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.<\/p>\n
Agencies are expected to be far more cautious in writing regulations to be sure they don\u2019t go beyond the contours of the law.<\/p>\n
The Supreme Court\u2019s 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council<\/em>, which held that courts should generally back a federal agency\u2019s statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don\u2019t overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.<\/p>\n