A U.S. Department of Health and Human Services unit sent highly anticipated privacy and data breach changes to the Health Insurance Portability and Accountability Act to the White House on Saturday, bringing the rules closer to fruition.
New York legislative leaders reached a deal Tuesday on a $132.6 billion state budget that aspires to boost infrastructure fixes and private investment in energy projects but has no room for a health insurance exchange, which will be created by executive order, or a study on environmental risks of hydraulic fracturing.
House Democrats said Monday that their proposed 2013 federal budget — to be released this week — would guarantee Medicare coverage for low-income senior citizens, countering Republican proposals that would give seniors subsidies to buy private health insurance.
Budget legislation proposed by New York's Republican-controlled Senate over the weekend did not include a health insurance exchange, leading to renewed criticism Monday from Democrats and business interests.
Nearly all states have developed effective strategies to implement new insurance standards set by the 2010 health care overhaul, but questions linger about whether states properly can enforce more complex mandates that take effect in 2014, according to Commonwealth Fund report published Thursday.
As the Obama administration's health reform law celebrates its second anniversary, it also faces its greatest challenge as Supreme Court oral arguments examining the constitutionality of the mandate start Monday.
The Democratic ranking member of the U.S. House Committee on Ways and Means introduced a bill on Thursday he says would help end overpayments to private insurers in the Medicare Advantage program, saving taxpayers $20 billion over the next 10 years.
Two insurance companies have raised their premiums an “unreasonable” amount on individual and small group policyholders in nine states, the U.S. Department of Health and Human Services said Thursday, and called on the companies to rescind their rate hikes.
The U.S. House of Representatives on Thursday passed a bill that would quash the health care law's Medicare cost-cutting board, as well as set certain limits on medical malpractice suits, a move that was expected but without the bipartisan support the bill once had.
Two Washington state agencies announced Wednesday that they have asked the Ninth Circuit to overturn a state court ruling that repealed regulations requiring pharmacists to carry emergency contraceptives like Plan B, saying they crafted the rules to protect all patients' access to medication.
Alabama Republican Sen. Jeff Sessions on Wednesday blocked a bipartisan attempt to pass a bill that would force the U.S. Supreme Court to televise oral arguments, essentially ensuring that the bill will not pass in time for next week's arguments in the Patient Protection and Affordable Care Act.
Medical technology company Stryker Corp.’s Wingspan stent used to prevent strokes may come with increased stroke risks that outweigh their potential benefits, the U.S. Food and Drug Administration said Wednesday.
Oral arguments scheduled for Tuesday in the Supreme Court on the health reform law's individual mandate, which requires most individuals to have health insurance, will be the first indicator of how the justices view the constitutional debate over the mandate that has raged since before the law was signed two years ago.
U.S. congressional leaders on Wednesday sent information-seeking letters to licensed pharmacies they claim are buying up drugs in short supply and reselling them on a gray market at marked-up prices, as part of an ongoing probe of secondary suppliers that sell marked-up drugs amid shortages.
In a two-day meeting starting Thursday, the U.S. Food and Drug Administration will hear public input, much of it from the pharmacy and pharmaceutical industries, on a proposal to make more drugs available without prescriptions, including those that treat high blood pressure and asthma.
Republican lawmakers took a nuts-and-bolts approach to attacking the president's health care reform law Wednesday in a hearing where they grilled the director of the agency charged with implementing many of the law's provisions.
The D.C. Circuit on Wednesday affirmed a lower court's decision that ViroPharma Inc. lacked standing to challenge a U.S. Food and Drug Administration ruling on generic drugs that allegedly set a precedent affecting the pharmaceutical company's business.
With the public comment period on the U.S. Department of Labor's proposal to extend minimum wage and overtime protections to in-home care providers drawing to a close, lawmakers sparred Tuesday over whether the changes would safeguard vulnerable workers or just drive up costs for seniors.
The final question the Supreme Court will consider in the health reform case — whether the federal government is forcing the states to expand Medicaid by threatening to take away funding for the program if they don’t — has the potential to fundamentally change the way Congress doles out money to the states, experts say.
The Rules Committee of the U.S. House on Tuesday advanced a bill that would eliminate the Independent Payment Advisory Board, a key facet of President Barack Obama's health care reform law, although a section establishing medical malpractice caps could eventually doom the bill.
Health care industry participants are starting to grapple with the governance issues that may arise in structuring accountable care organizations, says Robert L. Schuchard of Davis Wright Tremaine LLP.
While the U.S. Food and Drug Administration has laid the groundwork for guidance on Internet promotion of medical products to patients, physicians should still bear the primary responsibility to determine which medications or devices are appropriate, says Stacey L. Drentlaw of Oppenheimer Wolff & Donnelly LLP.
The district court opinion in Federal Trade Commission v. Lundbeck may be used in support of arguments that products that appear very similar may, in fact, not compete significantly against each other, say Jon B. Dubrow, Rachael Lewis and David Marx Jr. of McDermott Will & Emery.
Courts are taking destruction of evidence seriously and, in one recent case, the judge found a defendant in contempt of court for spoliation and sentenced him to up to two years in prison unless he paid the plaintiff's costs. There are a number of ways to avoid these sanctions, say Seth D. Rothman, Mira Vayda Edelman and Kelsey A. Schaefer, Hughes Hubbard & Reed LLP.
Maintaining a comprehensive framework to prevent, detect and correct potential violations of the Federal Food Drug and Cosmetic Act and other federal health care laws may not only help mitigate enforcement risks, but also may assist medical product manufacturers in their defense of private litigation, which may accompany a settlement with the government, say Daniel A. Kracov, Jeffrey L. Handwerker, Allison W. Shuren, Kirk Ogrosky and Mahnu V. Davar of Arnold & Porter LLP.
The authors of a recent guest article — The Curious Case of Pharma Sales Reps and the FLSA — complain that the Second Circuit’s decision in In re Novartis Wage and Hour Litigation shifts the "outside sales" paradigm. The offending “shift” appears to have been that the court declined to adopt a more flexible industry-specific approach to what it means to make a sale that would allow the pharmaceutical industry square peg to fit in the outside sales exemption round hole, says Kenneth J. Sugarman of Rudy Exelrod Zieff & Lowe LLP.
Haro v. Sebelius may have a significant effect on Medicare's recovery practices and the ability of beneficiaries to challenge repayment demands. Defendants, insurers and attorneys involved in personal-injury litigation with Medicare beneficiaries may want to follow developments in this case, especially if the district court grants the plaintiffs' motion for class certification, say Sharon L. Caffrey, Kenneth M. Argentieri, Christopher L. Crosswhite and Philip R. Matthews of Duane Morris LLP.
The Centers for Medicare and Medicaid Services and the U.S. Food and Drug Administration are considering parallel reviews of medical products. This unprecedented interagency coordination could, theoretically, shorten total time required between FDA marketing approval or clearance decisions and CMS coverage determinations, say Ralph F. Hall, Vincent J. Ventimiglia Jr. and Elizabeth A. Spurgin of Baker & Daniels LLP.
Whether in accounting, architecture, health care or law, professional services are provided by ever-larger entities — often comprised of individuals with purported ownership interests. One lesson EEOC v. Kelley Drye & Warren LLP teaches is that it is risky to remove an employer from your employer ranks and permit him or her to remain in an arguable employee status, says Martin J. Saunders of Jackson Lewis LLP.
United States of America v. Stricker is one of the first cases to provide insight into Medicare’s recovery practices under the Secondary Payer Statute, and the case's dismissal may deter the government from pursuing Medicare claims against old payments and settlements, say Sharon L. Caffrey, Philip R. Matthews, Kenneth M. Argentieri, Christopher L. Crosswhite and John M. Lyons of Duane Morris LLP.