October 2008

On December 18, 2008, CMS and the Centers for Disease Control and Prevention are holding a listening session to solicit informal comments on hospital-acquired conditions and hospital outpatient healthcare-associated conditions in preparation for the fiscal year 2010 inpatient prospective payment systems and calendar year 2010 OPPS rulemaking processes. Hospitals, hospital associations, representatives of consumer purchasers…

On October 28, 2008, the Food and Drug Administration (FDA) published a final rule requiring a statement to be included on certain human drug product labeling that provides a toll-free number for reporting side effects and specifies that the number is not intended to be used for medical advice. The rule, which confirms a January 3, …

On October 20, 2008, the Department of Health and Human Services (HHS), together with the Treasury and Labor Departments, published a final rule imposing requirements on group health plans and health insurance issuers concerning hospital lengths of stay for mothers and newborns following childbirth. The rule, which finalizes interim final rules published October 27, 1998 …

CMS has released updated final quality standards for Medicare suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The new version, dated October 2008, includes a number of changes from the August 14, 2006 version, including: requirements that the supplier furnish appropriate quality equipment and services; expanded documentation requirements; additional protections related to infection control; protections …

CMS has posted guidance for Medicare Part D prescription drug plan sponsors on compliance with its September 18, 2008 final rules updating Part D marketing regulations in conformance with the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

Medicaid spending is projected to total $339 billion in 2008, up 7.3% from 2007 levels, according to figures released by CMS October 17, 2008. Medicaid spending is expected to continue increasing by 7.9% on average over the next 10 years, reaching $674 billion by 2017, far exceeding the 4.8% projected growth rate for the general…

HHS announced it is preparing to open FDA offices in China, India, Europe, and Latin America before the end of 2008 to beef up efforts to ensure the safety of imported food and medical products. FDA personnel overseas will be tasked with providing technical advice to local authorities and industries, conducting additional inspections, and working…

The HHS Office for Human Research Protections has released its “Guidance on Engagement of Institutions in Human Subjects Research.” The guidance document describes whether certain scenarios would result in an institution being considered engaged in a human subjects research project, and addresses institutional review boards’ review considerations for cooperative research in which multiple institutions …

On November 6, 2008, CMS will host a Special Open Door Forum to discuss a Medicare Improvements for Patients and Providers Act provision that provides coverage for Kidney Disease Patient Education Services for individuals with Stage IV chronic kidney disease (CKD).  Among other things, CMS is seeking comments on: specific competencies for referring clinicians and the …

On December 8, 2008, the Practicing Physicians Advisory Council is holding its quarterly meeting to discuss Medicare policy changes related to physicians’ services. Agenda items include: Physician Fee Schedule Final Rule; Outpatient Prospective Payment System/Ambulatory Surgical Center Fee Schedule Final Rule; Stark Reform; Value Based Purchasing—Efficiency Measures; CMS-FDA Collaboration; and Medically Unlikely Edits Update. 

On October 22, 2008, the Government Accountability Office (GAO) issued a report entitled “Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA’s Foreign Drug Inspection Program.” Among other things, the GAO found that: FDA databases contain inaccurate information on foreign establishments subject to inspection; FDA inspects relatively few foreign establishments each…

On October 30, 2008, CMS is hosting a Special Open Door Forum to discuss the Quality Improvement Organization (QIO) Beneficiary Protection Program (BPP). The BPP incorporates several QIO functions, including quality of care reviews, reviews of beneficiary complaints, utilization reviews, EMTALA reviews, and appeals of discharges from various provider settings, among others. The purpose of…

On October 14, 2008, the Agency for Healthcare Research and Quality (AHRQ) and the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published a notice announcing the availability of an interim guidance document entitled “Implementing the Patient Safety and Quality Improvement Act of 2005, Including How to Become a…

On October 10, 2008, the Centers for Medicare & Medicaid Services (CMS) published a notice soliciting comments on the Medicare Part D/Medicare Advantage Calendar Year (CY) 2010 Bid Pricing Tool and the CY 2010 Plan Benefit Package software and formulary submission. CMS also has posted the forms and related documents regarding the information collections. CMS…