As you may have read, President Obama plans to nominate Dr. Donald Berwick to head the Centers for Medicare & Medicaid Services at HHS. We thought you might be interested in seeing an interview (.PDF) that Reed Smith partner Elizabeth Carder-Thompson conducted with Dr. Berwick several months ago, for the American Health Lawyers Association. The interview was published in the November 2009 edition of AHLA Connections.
This post was written by Michael J. Wynne.
Last week, in Provena Covenant Medical Center v. Department of Revenue, the Illinois Supreme Court issued a decision in which it denied a property tax exemption for a Catholic hospital. The Court denied the exemption, in part, because the amount of charity care provided by the hospital was insufficient. However, the chilling national repercussions some portend for the Provena Covenant decision, with its inquiry into how much charity is enough to justify a property tax exemption, may ultimately be dwarfed by the repercussions of the new federal health care legislation. By 2014, under the new federal legislation, the extended coverage offered under Medicaid and the insurance exchanges will displace much of the charitable patient care that hospitals have traditionally dispensed. As hospital charitable patient care ebbs, so too may ebb the state and local grants of exemption for hospital properties.
To learn more about property tax implications of the Provena Covenant decision and the new federal health care legislation, read our full alert.
The Health Information Privacy page of the U.S. Department of Health and Human Services (HHS) website has formally announced that regulations implementing the privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act will soon be published (along with a comment period) relating to (1) business associate liability; (2) new limitations on the sale of protected health information, marketing and fundraising communications; and (3) stronger individual rights to access electronic medical records and restrict the disclosure of certain information. Although this posting is certainly welcome news, from a timing perspective the announcement only indicates that "OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions."
Providing further evidence that the HITECH Act provisions relative to covered entities and business associates will not be enforced until after these forthcoming regulations have been finalized, HHS stated that "[a]lthough the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements." The HITECH Act, however, is currently effective, and questions about the effective date for enforcement of the Act's privacy and security requirements may remain until published regulations specifically postpone enforcement. Additionally, HHS reminds us that the Breach Notification Rule and the revised Enforcement Rule are currently in effect, and that covered entities and business associates must comply now with breach notification obligations for breaches that are discovered on or after September 23, 2009.
China's long-awaited Tort Liability Law, passed on December 26, 2009 by the Standing Committee of the National People’s Congress of China, will take effect on July 1, 2010. The law, which serves to provide a stronger basis for the development of tort law and practice in China, offers standard guidance on issues ranging from product liability, environmental pollution, medical malpractice to employee-related liabilities. For example, prior to the enactment of the law, defective product recall obligations were only applied to a limited number of products, including medicine, food, toys and automotive products. The new law, however, expands the recall system to cover all products manufactured or sold in China.
Reed Smith Beijing Counsel Mao Rong and Michael H. Dardzinski and Consultant Joyce Sun recently drafted a brief summary of China's new tort law provisions regarding product liability, medical-related damages and environmental pollution. Read the full summary here.
This post was written by Elizabeth O’Brien and Joseph W. Metro.
On March 5, 2010, the Office of Pharmacy Affairs published a Final Notice allowing covered entities to use multiple contract pharmacies in order to supplement “in-house” pharmacy services or to increase patient access to 340B drugs. This Final Notice replaces “Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services (61 Fed. Reg. 43,549) and all other previous 340B Program guidance regarding non-network contract pharmacy services.
Under the Public Health Service Act’s Section 340B drug pricing program, manufacturers who sell covered outpatient drugs to specific federal grantees, federally-qualified health center look-alikes and qualified disproportionate share hospitals (“covered entities”) must agree to charge less than the statutorily-prescribed maximum price for those drugs, which results in significant savings on drugs for the covered entities. Previously, the Health Resources and Services Administration ("HRSA") Office of Pharmacy Affairs had specified procedures under which discounts could be made available to covered entities engaging a single contract pharmacy, and had conducted an Alternative Methods Demonstration Project program in which HRSA approved a limited number of covered entities using multiple contract pharmacies.
Effective April 5, 2010, the Final Notice permits all covered entities to use multiple contract pharmacies. The guidelines in the Final Notice give covered entities and contract pharmacies a great deal of freedom in structuring their contract pharmacy services agreements, so long as they implement and maintain mechanisms to ensure compliance with 340B Program rules, especially against diversion of drugs. To learn more about the Final Notice, including compliance guidelines, potential alternatives to the single location/single pharmacy model and suggested contract provisions, read the full alert.
As reported by our sister site, Health Industry Washington Watch, on Wednesday the House Energy and Commerce Health Subcommittee will hold a hearing entitled, "Drug Safety: An Update from the FDA." At the hearing, the FDA will detail its current challenges and successes in the area of drug safety. Joshua M. Sharfstein, M.D., FDA Principal Deputy Commissioner, is slated to testify.
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