A federal court has sent back (vacated and remanded, in regulatory-speak) to the Bush administration a rule aimed to limit government reimbursement for Medicaid providers. The rule is one of several the administration is attempting to codify in an effort to undermine the entire Medicaid program.

The process by which the Centers for Medicare and Medicaid Services finalized the rule was particularly sneaky, even by Bush administration standards. A New York Times editorial explains:

In a decision issued last week, Judge James Robertson of the Federal District Court in Washington ruled that the administration had overstepped its authority last year with a maneuver "deliberately designed to outfox a clear directive of Congress." The administration was seeking to evade the annoying fact that Congress had enacted a one-year moratorium on the administration's efforts to alter — and in the process cut — Medicaid reimbursements to public hospitals and nursing homes.

Congress had already passed, but President Bush had not yet signed, a broad funding bill that included the moratorium when the secretary of the Department of Health and Human Services rushed through a typo-ridden rule for "emergency display" on May 25, 2007, the very day the moratorium took legal effect. The rule, which had been in preparation for some time, was officially published a few days later. That shifty maneuver was too much for Judge Robertson to swallow. He found ample reason to overturn the rushed-through rule as a violation of Congressional intent.

The ruling should serve as a reminder to Bush administration higher-ups that Congress, not the Executive Branch, is primarily responsible for crafting federal policy. The role of federal agencies is to faithfully enforce the law in the spirit Congress intended, not to undermine it based on personal views — in this case, an ideological aversion to government programs meant to help the needy.

In his opinion, Judge Robertson writes to that effect:

[T]he Secretary treated an act of Congress seeking to control the substantive rules of Medicaid reimbursement as an "emergency," and prioritized issuance of his own rule over Congress's plain intent to prohibit his actions ... Although administrative law has evolved to allow agencies significant leeway to fill in the interstices of broad congressional mandates … control over the substance of the rules that govern the nation has always remained with Congress first. The Executive must comply with the duly enacted commands of Congress.

Yesterday, Reg•Watch blogged about five environmental groups that are suing the Environmental Protection Agency over its new national air quality standards for ozone, or smog.

Turns out, pretty much everyone is happy with the new EPA rules. In addition to the environmental groups, 14 states announced they will sue EPA hoping for a standard even more protective of public health than the one EPA adopted.

One state, Mississippi, is also suing but is doing so in order to weaken the standard. A coalition of industry groups, including the National Association of Manufacturers, is also suing. According to BNA news service (subscription), "The Mississippi and industry lawsuits will likely challenge EPA's scientific underpinnings for setting the ozone standards, including how background ozone levels were modeled and how scientific studies were interpreted, one industry attorney familiar with the cases, but who asked not to be named, told BNA May 28 ."

Those suing in favor of a more protective standard will likely argue that the body of scientific evidence supports a stricter rule and will cite the Clean Air Act's clear directive that EPA protect the public within an "adequate margin of safety."

According to an EPA analysis, the new standard will prevent at least 260 premature deaths, 890 heart attacks, and 200,000 missed school days every year starting in 2020. Had EPA adopted a standard at the weakest end of the range recommended by its scientific advisors, an additional 300 premature deaths, 610 heart attacks, and 440,000 missed school days could be prevented every year.

The 14 states are New York, California, Connecticut, Delaware, Illinois, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania and Rhode Island. The city of New York and Washington D.C. also joined the suit.

Yesterday, five environmental groups announced they will file suit against the Environmental Protection Agency over its recent revision to the national air quality standard for ozone, or smog.

Although EPA tightened the public health standard, also known as the primary standard, for ozone to 0.075 parts per million (ppm), down from 0.084 ppm, the agency did not go as far as its scientific advisors had recommended. EPA's Clean Air Science Advisory Committee recommended the standard be set somewhere between 0.060 ppm and 0.070 ppm. Other advisory committees and countless independent scientists also recommended a standard lower than the one adopted.

Because the Clean Air Act requires EPA to set the standard for ozone based solely on the best scientific evidence available, the decision to set the standard outside the recommended range puts the standard on shaky legal footing.

The public welfare standard, also known as the secondary standard, is on even shakier footing. EPA decided to set the secondary standard identical to the primary standard, instead of adopting a separate standard tailored for the summer months when ozone levels are at their highest.

The problem is, both EPA scientists, policymakers, and administrator Stephen Johnson wanted the summer standard because science shows that sensitive trees and plants could benefit. The White House Office of Management and Budget disagreed, and President Bush was brought in to arbitrate the dispute. Bush ultimately came down on the side of OMB.

Bush and OMB paid no mind to the Clean Air Act, which requires EPA set a standard to protect public welfare if necessary and which invests in the EPA administrator, not the president, the power to make clean air decisions. (More on that here.)

If the courts tell EPA they need to set a separate secondary standard, the decision will be a stinging rebuke to Bush's intervention and a forewarning to future presidents. We don't know why the White House opposed a separate secondary standard. Maybe it was funneling the concerns of industry. Maybe it was exercising its ideological opposition to environmental regulation. Maybe neither. Maybe both.

Regardless of the rationale, a decision in favor of a separate standard will send a clear message for this and other rulemakings: A president's personal views do not trump the plain language of federal law.

The organizations filing the suit are the American Lung Association, Natural Resources Defense Council, Environmental Defense Fund, National Parks Conservation Association, and Appalachian Mountain Club. They will be represented by Earthjustice, a nonprofit, environmental law firm.

Last night, a federal court ruled the Bush administration must make a decision by May 15 on whether to list the polar bear under the Endangered Species Act. Three advocacy groups — the Center for Biological Diversity, the Natural Resources Defense Council, and Greenpeace — sued the Department of the Interior in order to force a decision after months of delay.

The last time we heard from officials in Interior's Fish and Wildlife Service (FWS), they promised a decision by July. However, FWS has failed to keep its word a number of times already, giving the public no reason to believe the agency would make its decision this summer, if ever.

Meanwhile, another agency within the Interior Department (the Minerals Management Service) has been working hastily to hand out permits to oil and gas companies to drill in areas in Alaska where the polar bear lives. Because FWS has yet to list the polar bear under the Endangered Species Act, the companies do not legally have to take into consideration the effects of their operations on the bears' habitats.

The melting ice caused by global warming is the primary threat to the polar bear's existence, which means climate change skeptics are also opposed to listing the animal under the Endangered Species Act.

But environmental advocates are hopeful that, with this court decision in place, the administration will make the correct decision. Kassie Siegel of the Center for Biological Diversity said in a statement, "By May 15th the polar bear should receive the protections it deserves under the Endangered Species Act, which is the first step toward saving the polar bear and the entire Arctic ecosystem from global warming."

Reg•Watch in Review is a biweekly email update of recent news from the regulatory world. Reg•Watch in Review highlights regulatory process issues and stories about environmental, product safety, workplace safety, and scientific integrity policy.

Preview today's edition here, or sign up below.

In a MarketWatch article published today, reporter Ruth Mantell discusses how agencies are rarely held accountable when they miss statutory deadlines for writing regulations. In one particularly onerous example, EPA has missed a Congressional deadline — by more than 11 years — for a rule that would limit exposure to lead paint during home renovation.

The nonprofit group Public Employees for Environmental Responsibility (PEER) has sued EPA, a tactic that too often must be used to prod agency action, as Mantell points out:

Repercussions are typically light, if they are any at all, for a federal agency or other governmental body that's been late or slow in complying with a mandate, consumer advocates say. In response, a cottage industry in scheduling lawsuits, such as PEER's against EPA, has bloomed, looking to make sure that obligations are met.

Congress sometimes exerts its powers of oversight to push agencies along. However, oversight falls short when considering the scope of the federal bureaucracy (about 2.5 million civilian employees and half-a-trillion dollars in non-defense, discretionary spending) and the decades-worth of federal legislation agencies are responsible for enforcing.

As for the lead renovation rule, EPA plans to finalize the standard in March; but before EPA can do that, the rule has one more major hurdle to clear. The White House is currently reviewing the rule under Executive Order 12866. White House review — one of the many across-the-board government requirements agencies must abide by — certainly does not help agencies move more quickly.

This week, the White House Office of Information and Regulatory Affairs held a closed door meeting to discuss the rule with officials from EPA and representatives of the National Association of Home Builders — an outspoken opponent of the rule.

Yesterday, 16 states sued the U.S. Environmental Protection Agency (EPA) over its refusal to allow California to implement a program for reducing greenhouse gas emissions from vehicles. Had EPA granted California permission, the other 15 states in the suit would have adopted the California program.

EPA administrator Stephen Johnson denied California's request on Dec. 19. Johnson claimed California's proposed program is unnecessary in light of a recent federal law which would tighten the national fuel economy standard and that a federal regulation is preferable to a "confusing patchwork of state rules."

Johnson's argument is bogus. Had EPA approved California's request, other states could have adopted California's program (not created their own willy-nilly). The presence of two policies is neither confusing nor a patchwork. Furthermore, the Clean Air Act (not to mention the Constitution) contains provisions affording states the opportunity to enact their own regulatory schemes even if they are stricter than federal standards.

EPA insiders have acknowledged Johnson's decision does not hold water and will likely be overturned in court. But, since federal lawsuits take months or years, the Bush administration will still achieve its goal: delaying any meaningful action on climate change for eight long years.

Some progress may occur in the short term if Congress moves swiftly with focused oversight hearings. Rep. Henry Waxman (D-CA), chairman of the House Oversight and Government Reform Committee, and Sen. Barbara Boxer (D-CA), chairwoman of the Senate Environment and Public Works Committee, have both requested EPA documents and communications related to Johnson's decision. EPA's general counsel has instructed agency personnel to provide said material, including any evidence of communications with the White House, according to the Associated Press.

Although congressional attention will alter policy, identifying who is responsible for the denial of the California's request will allow the public to hold the culprits accountable.

The New York Times has a recap of the oral arguments heard yesterday by the Supreme Court in Riegel v. Medtronic. As Reg•Watch blogged yesterday, the issue is whether federal regulation preempts state common law claims against medical device manufacturers.

A case being argued before the Supreme Court today could affect the way consumers seek redress from companies when harmed by faulty drugs or medical devices. The case, Riegel v. Medtronic, "was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries," according to The Los Angeles Times.

Medtronic is arguing federal regulations serve as a shield which protects it from tort claims. Since FDA approved the medical device, Medtronic believes it bears no responsibility for injuries caused by its use.

As the LA Times reports, the case has broad ramifications: "The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976."

In fact, Congress did legislate a regulatory system in which state regulations cannot supersede federal ones. Congress recognized 50 different sets of rules would be a nightmare for pharmaceutical and device companies seeking approval and would put consumers at greater risk.

But Medtronic is trying to compare apples and oranges. The positive law enacted by the U.S. Congress and state legislatures is different than the common law created by the courts in tort claims like this one.

The Bush administration has also been conflating these two types of law in its war on torts. A series of federal regulations have included language that preempts tort claims against companies in compliance with federal regulations. More on that here.

Update: The New York Times recaps oral arguments (12/05/2007)

Posted by Matt Madia, 10:28:54 AM

Wednesday, November 21, 2007

Friday, November 09, 2007

Thursday, October 11, 2007

Wednesday, September 26, 2007

Wednesday, August 22, 2007

Wednesday, April 25, 2007