CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline

cdc_logo(3)Over the past year, the Centers for Disease Control and Prevention (CDC) has been drafting a Guideline for Prescribing Opioids for Chronic Pain in relative secrecy, relying upon the input of a hand-picked group of advisers and a limited number of stakeholders. Such a stealth approach drew criticism from numerous interested parties, including Washington Legal Foundation, which explained in a November 17, 2015 letter to CDC that the agency’s drafting process ran afoul of the Federal Advisory Committee Act (FACA).

This week, CDC took several unexpected steps towards greater transparency for its prescribing guideline project, implicitly conceding its prior FACA violations. The director of CDC’s National Center for Injury Prevention and Control informed WLF on December 14 of its about-face in a letter responding to our November 17 missive. That same day, CDC published a notice in the Federal Register that seeks comments on the draft guideline and also directs the public to numerous previously-unreleased documents. In addition, CDC announced that it will ask a federal advisory committee, its Board of Scientific Counselors, to review the draft guideline and public comments and make recommendations to the agency. Continue reading

Advisory Committee’s Violations of Federal Law Threaten Credibility of 2015 Dietary Guidelines

MyPlateIn introducing an October 7, 2015 oversight hearing on the forthcoming 2015 Dietary Guidelines for Americans (DGA), House Agriculture Committee Chairman Michael Conaway stated, “It is essential that the guidance that comes out of this process can be trusted by the American people.” Chairman Conaway framed that remark in the context of the scientific evidence the 2015 Dietary Guidelines Advisory Committee (DGAC) relied upon in its Scientific Report. Lawmakers should question the quality of the report’s science, but their probe of the DGAC and its work shouldn’t stop there. Another, perhaps greater, threat to the Dietary Guidelines’ credibility is the significant breaches of federal law that occurred in the creation of the DGAC. Violations of the Federal Advisory Committee Act (FACA) infect the entire Scientific Report and call into question its recommendations and any federal regulatory proposals that rely on the report or the resulting DGA. Continue reading

King v. Burwell’s Implications for Employer-Sponsored Health Plans

Guest Commentary

Kim Wilcoxon, Thompson Hine LLP

Three years ago, the Supreme Court of the United States announced its decision in NFIB v. Sebelius and upheld the individual mandate under the Patient Protection and Affordable Care Act (ACA). Last week, the Supreme Court announced its decision in King v. Burwell and upheld the Internal Revenue Service’s (IRS) interpretation that tax credits were available under the ACA for taxpayers in all states, whether or not a state’s exchange was established by the state government or the federal.

There are many similarities in how these decisions affect employer-sponsored health plans. It’s déjà vu all over again, so this post revisits questions addressed in this blog three years ago in light of King v. Burwell. Continue reading

The 2015 Dietary Guidelines: Another Federal Food Activism Vehicle?

MyPlateEvery five years, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) jointly issue the latest iteration of the federal government’s formal guidance on healthy eating, the Nutrition Guidelines. These Guidelines not only inform as to how government feeds its millions of employees (including the military) and those who eat in a government facility (i.e. public schools, prisons), but they also influence food-related laws and regulations.

A federal advisory committee is expected to report its recommended updates for the 2015 Guideline to HHS and USDA this month. If the committee’s proceedings and its December 15, 2014 interim report are any indication, the 2015 “My Plate” will feature supersized, empty-calorie portions of activism and food-nanny nagging.  We should expect to be lectured on the need to eat “sustainably,” the imperative for mandated “added sugars” food labeling, and the importance of imposing marketing restrictions on certain foods.

The advisory committee. None of this comes as a surprise, given the makeup of the Dietary Guidelines Advisory Committee (DGAC) and the motivations of the regulators at HHS and USDA who appointed its 15 members. Every single member hails from academia, and as one assessment of the DGAC and its work published by Capital Research Center noted,

There is not a single business owner, family physician, working nutritionist, food services executive, or federal nutrition program director in the mix.

Continue reading

Why “King v. Burwell” Obamacare Case Is Not “NFIB v. Sebelius” Redux

supreme courtThe Supreme Court’s decision to hear King v. Burwell means that the Court, for the second time in three years, will be deciding an issue that will have a major impact on the Obama Administration’s ability to implement the Affordable Care Act. The ACA’s requirement that individuals purchase health insurance or else pay a penalty barely survived a constitutional challenge in June 2012 when the Court voted 5-4 in NFIB v. Sebelius to uphold the mandate as a proper exercise of Congress’s power under the Taxing Clause. The claim raised in King—that individuals who purchase insurance on the federal government’s healthcare exchange are not entitled to the tax subsidies available to those purchasing on state exchanges—would, if accepted by the Court, have an impact on the ACA every bit as great as a decision striking down the individual mandate. That fact has caused some commentators to draw spurious parallels between the two cases. Many Obamacare partisans who dismissed the NFIB constitutional challenge as a “shameful” and hypocritical “solicitation of right-wing judicial activism,” are making the same accusation against the King challenge.

The accusations were inaccurate in NFIB; they are hopelessly wrong when applied to King. Before such unfounded criticism of King takes hold, it is important to emphasize major distinctions between the two cases. The petitioners in NFIB were asking the Court to take a decisive step: to strike down legislation adopted by Congress and signed by the President. Those petitioners, in my opinion, raised highly plausible (and indeed, partially successful) arguments in support of their constitutional claims. However, a majority of the justices—mindful of separation-of-powers concerns that arise whenever they are asked to override the will of Congress and the President—followed the Court’s long-held preference that, in the words of Chief Justice Roberts, “every reasonable construction must be resorted to, in order to save a statute from unconstitutionality.” Continue reading

A Trail To Data Insecurity: ObamaCare’s “Navigator” Program Lacks Privacy Protections

sextantCross-posted at WLF’s Forbes.com contributor page

With the October 1 date for open enrollment in ObamaCare health insurance exchanges rapidly approaching, the handful of states which agreed to run the exchanges are relying on everything from football teams to storied folk legends to spread the word. In the 36 other states that the federal government is in charge for now, outreach and education will be done by “Navigators,” a fancy term for taxpayer-funded community helpers. Though the Navigator program has yet to begin, many elected officials have raised serious concerns over whether it sufficiently prevents Navigators from helping themselves to sensitive consumer information. October 1 is just 26 days away, and those valid privacy concerns remain unaddressed.

$67 Million with Scant Privacy Strings Attached. The Department of Health and Human Services, which just two weeks ago doled out $67 million to 100 organizations for ObamaCare navigation, has ignored letters from congressional committee chairmen and state attorneys general criticizing the Navigator program’s severe privacy shortcomings. The rule governing the Navigator program, finalized just this past July, offers broad principles and platitudes about data quality and integrity, but few clear standards for ensuring the privacy of health records, social security numbers, and other patient information. It neither requires background checks nor dictates that any prior criminal act (such as, perhaps, identify theft) would per se disqualify a Navigator applicant. There are no licensing requirements, no obligations that Navigators or their employers carry liability insurance, and no provisions holding any entity, including HHS, responsible for data breaches. It’s not even clear whether HHS will assist an ObamaCare insurance exchange customer who is defrauded. Continue reading