On May 28, 2009, the HHS Office of the National Coordinator for Health Information Technology (ONC) published a notice announcing a draft description of a program establishing regional extension centers to assist providers seeking to adopt and become meaningful users of health information technology, as required under the American Recovery and Reinvestment Act of 2009
May 2009
CMS Announces General Timeline for DMEPOS Competitive Bidding Program
Today CMS announced the general timeline for the next round of DMEPOS competitive bidding program:
Spring 2009
- CMS Begins a Pre-Bidding Supplier Awareness Campaign
- Program Advisory And Oversight Committee (PAOC) Meeting on June 4, 2009
Summer 2009
- CMS Announces the Bidding Schedule and the Schedule of Supplier Education Events
- CMS Begins Bidder Education Campaign
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Generic Drug Patent Settlement Delays — Hearing on June 3, 2009
On June 3, 2009, the House Judiciary Courts and Competition Policy Subcommittee is holding a hearing on “Pay to Delay: Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?”
HHS Semiannual Regulatory Agenda
On May 11, 2009, the Department of Health and Human Services (HHS) published its semiannual regulatory agenda, outlining planned regulatory initiatives in a number of health policy areas. The notice points out that due to the timing of the release of the agenda, it does “not necessarily reflect the policy perspectives of the Obama Administration,” …
FDA Seeks Comments on Presenting Risk Information in Drug and Device Promotion
On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The draft guidance proposes to use a “reasonable consumer” standard, similar to the Federal Trade Commission’s standard, for assessing whether advertisements are misleading, a…
OPPS for TRICARE Program
The Department of Defense (DoD) has published a notice that it is proceeding with implementation of its December 10, 2008 final rule establishing a prospective payment system (PPS) for TRICARE hospital outpatient services, similar to the Medicare hospital outpatient PPS (OPPS). The effective date had been extended from February 9, 2009 until May 1,…
HHS/DOJ Health Fraud Initiative
On May 20, 2009, Attorney General Holder and HHS Secretary Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat Medicare fraud. The HEAT team will include senior officials from Department of Justice (DOJ) and HHS who will build upon existing programs to combat…
DMEPOS Accreditation/Avoiding Exclusion
On May 20, 2009, CMS issued an updated educational article on DMEPOS supplier accreditation requirements to provide information for suppliers who choose not to become accredited. CMS notes that a DMEPOS supplier’s Medicare Part B billing privileges will be revoked on or after October 1, 2009 if the supplier fails to obtain accreditation or a…
Comment Opportunity on Comparative Effectiveness Definition/Prioritization Criteria
On May 26, 2009, the Federal Comparative Effectiveness Research Coordination Council announced that it is seeking comment on its draft definition of comparative effectiveness research and its draft prioritization criteria for comparative effectiveness research and investments. With regard to prioritization, the Council proposes to use the following criteria for determining “scientifically meritorious research and investments” …
Draft MDS 3.0 Item Set
CMS has released a draft version of the Minimum Data Set (MDS) 3.0 resident assessment instrument item set for nursing home residents. The final version is scheduled for publication in October 2009. In the May 12, 2009 proposed skilled nursing facility prospective payment rule, CMS has proposed requiring Medicare skilled nursing facilities and Medicaid nursing…
FDA Guidance on FDA-Industry Meetings
The FDA has issued final guidance regarding formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (note that the guidance does not apply to abbreviated new drug applications). …
FDA Small Entity Guide on Drug Labeling
The FDA has released a compliance guidance entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” The document, which finalizes draft guidance published in December 2004, is intended to help small businesses better understand and comply with the agency’s over- the-counter (OTC) labeling requirements and to prepare new labeling.
Federal False Claims Act Legislation Enacted
On May 20, 2009, the President signed into law the Fraud Enforcement and Recovery Act of 2009, which includes significant changes to the federal False Claims Act (FCA). Among other things, the new law expands the scope of FCA liability, provide for new investigative tools, and make it easier for qui tam relators to bring…
FDA Commissioner Hamburg Confirmed by Senate
On May 18, 2009, the Senate unanimously confirmed Dr. Margaret "Peggy" Hamburg as FDA Commissioner. Dr. Hamburg was sworn in as the FDA Commissioner by HHS Secretary Kathleen Sebelius on May 22, 2009.
Tobacco Regulation
On May 20, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee approved an amended version of S. 982, the "Family Smoking Prevention and Tobacco Control Act,” which would provide the FDA with certain authority to regulate tobacco products.
Congressional Hearings
A number of Congressional panels have held hearings recently on health policy issues, including the following:
- A Senate Judiciary Crime Subcommittee hearing on “Criminal Prosecution as a Deterrent to Health Care Fraud.”
- A HELP Committee hearing on “Delivery Reform: The Roles of Primary and Specialty Care in Innovative New Delivery Models.”
- A House
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Medicare Trustees’ Report
On May 12, 2009, the Social Security and Medicare Boards of Trustees released their annual assessment of the financial condition of the Social Security and Medicare trust funds. According to the report, Medicare’s Hospital Insurance (HI) Trust Fund is expected to pay out more in benefits and other expenditures this year than it receives in…
Inappropriate Medicare Payments for Chiropractic Services
The HHS Office of Inspector General (OIG) reports that in 2006, Medicare inappropriately paid a total net $178 million (out of $466 million) for chiropractic services that reviewers determined to be maintenance therapy, miscoded, or undocumented. The OIG recommends that CMS take a number of steps to address continuing vulnerabilities in this area, including implementing a …
ESRD Bundled Payment System
The Government Accountability Office (GAO) has issued a report entitled “End-Stage Renal Disease: CMS Should Monitor Effect of Bundled Payment on Home Dialysis Utilization Rates.” According to the GAO, the Medicare bundled payment system for ESRD services, which must be implemented by January 1, 2011 under the Medicare Improvements for Patients and Providers…
CMS HIPAA Version 5010 Conference Call (June 9, 2009)
On June 9, 2009, CMS is holding a conference call entitled“HIPAA Version 5010 – What you need to know.” This is the first in a series of national provider training calls on the transition to HIPAA Version 5010. Space is limited and preregistration is required.