On August 4, 2009, the Senate Health, Education, Labor and Pensions Committee is holding a hearing “Protecting Patients from Defective Medical Devices.”
July 2009
Health Reform Update
By Debra A. McCurdy on
Congress returns next week from its August recess, starting a critical period for the fate of health reform legislation. After a turbulent summer of town hall meetings and public wrangling regarding the scope of reform, President Obama will address a joint session of Congress on September 9, 2009 to discuss in more detail his vision for…
Senate HELP Committee Approves Bill; Finance Committee Stalls
By Debra A. McCurdy on
On July 15, 2009, the Senate Committee on Health, Education, Labor, and Pensions (HELP) approved its health reform plan, the “Affordable Health Choices Act,” on a party-line 13-to-10 vote. The major features of the legislation are summarized in a previous posting. Note that the HELP Committee does not have jurisdiction over Medicare or Medicaid;…
Status of House Tri-Committee Bill
By Debra A. McCurdy on
As previously reported, on June 17, 2009, the chairmen of the three House committees that share jurisdiction over health policy released a “discussion draft” of their comprehensive health reform plan. A revised version of the bill, the America’s Affordable Health Choices Act of 2009 (H.R. 3200), was unveiled on July 14, 2009. In short, the…
House Approves HHS Appropriations Bill
By Debra A. McCurdy on
On July 24, 2009, the House of Representatives approved H.R. 3293, legislation to fund the Departments of Labor, Health and Human Services (HHS), and Education for fiscal year (FY) 2010. Among other things, the legislation would increase funding for: the HHS Health Care Fraud and Abuse Control Program; health professions training; NIH biomedical research…
Congressional Hearings/Markups
By Debra A. McCurdy on
A number of Congressional panels have held hearings recently on health policy issues, including the following:
- A Senate Commerce Subcommittee on Consumer Protection hearing on “Competition in the Health Care Marketplace.”
- A House Judiciary Subcommittee on Courts and Competition Policy hearing on “Biologics and Biosimilars: Balancing Incentives for Innovation.”
- A House Energy and Commerce Oversight
…
Improper Medicaid/CHIP Payments
By Debra A. McCurdy on
The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to implement provisions from the Children’s Health Insurance Program Reauthorization Act of 2009 with regard to the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs. The rule also would also codify several procedural aspects of the process for estimating improper …
PACE Proposal Solicitation
By Debra A. McCurdy on
CMS is soliciting proposals for private, for-profit Program of All-Inclusive Care for the Elderly (PACE) demonstration projects. The PACE program provides a comprehensive service delivery system and integrated Medicare and Medicaid financing targeting all services necessary for long-term care clients. Proposals must be submitted by July 26, 2010.
Hospital Quality Information
By Debra A. McCurdy on
CMS has expanded its Hospital Compare website to include updated information on 30-day mortality rates for patients with heart failure, acute myocardial infarction, and pneumonia, and to include new data on 30-day readmissions rates for patients originally admitted for one of these three conditions.
NDA Reporting Requirements
By Debra A. McCurdy on
On July 28, 2009, the FDA published a final rule requiring holders of new drug applications (NDAs) to submit certain information regarding authorized generic drugs in an annual report. The FDA is taking this action as part of its implementation of the Food and Drug Administration Amendments Act of 2007, which requires the FDA to…
FDA Guidance Documents & FAQs
By Debra A. McCurdy on
The FDA is accepting comments on the following new draft guidance documents for industry:
- Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting; to be considered in drafting the final guidance, comments must be received by October 13, 2009.
- Postmarketing Studies and Clinical Trials— Implementation of Section 505(o)
…
Power Wheelchair Claims
By Debra A. McCurdy on
The HHS Office of Inspector General (OIG) has issued a report entitled "Miscoded Claims for Power Wheelchairs in the Medicare Program." According to the OIG, 7% of Medicare standard rehabilitation power wheelchair claims and 23% of complex rehabilitation power wheelchair claims from the first half of 2007 were miscoded because the supplier used procedure …
Medicare Part B Billing for Ultrasound Services
By Debra A. McCurdy on
The OIG reports that 20 high-use counties with 6% of Medicare beneficiaries accounted for 16% of Part B spending on ultrasound services in 2007. In addition, the OIG believes that 3.2 million ultrasound claims (almost one in five nationwide) might be inappropriate. The OIG recommended that CMS monitor ultrasound claims data to detect and review questionable …
Part D Drug Information
By Debra A. McCurdy on
An OIG report on the Medicare Prescription Drug Plan Finder found that Plan Finder Part D drug price data frequently overestimate the charges to beneficiaries when they have their prescriptions filled at the pharmacy. Specifically, based on a review of 10 drugs commonly used by seniors, the Plan Finder drug prices were a median of 28% …
Clinical Laboratory Fee Schedule Payments
By Debra A. McCurdy on
The OIG has issued a report on “Variation in the Clinical Laboratory Fee Schedule,” in which the OIG recommends that CMS seek legislative authority to establish a new process for setting laboratory test payment rates. According to the OIG, 97% of lab tests had at least one carrier rate that varied from the …
FDA Medical Product Program Funding
By Debra A. McCurdy on
According to a recent Government Accountability Office (GAO) report, the FDA faces challenges fulfilling its growing medical product oversight responsibilities, particularly those not funded by industry user fees. While FDA reports that funding levels allow it to address the most urgent needs and priorities, the agency did not receive enough resources to meet some…
MedPAC Data Book
By Debra A. McCurdy on
The Medicare Payment Advisory Commission (MedPAC) has released its June 2009 Data Book on Healthcare Spending and the Medicare Program, which includes detailed data for various provider settings .
Hip & Knee Replacement Registry Solicitation
By Debra A. McCurdy on
The Agency for Healthcare Research and Quality (AHRQ) has announced the availability of funding for the development of a clinical registry of orthopedic devices, drugs, and procedures, with an initial focus on hip and knee replacements. The initiative seeks to enable comparative effectiveness and safety studies regarding various orthopedic procedures and devices.
FDA Workshop on Prescription Drug Risk Information
By Debra A. McCurdy on
On September 24-25, 2009, the FDA is holding a public workshop entitled “Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.” Comments on workshop documents (including a series of prototypes on different written approaches to conveying prescription drug information to consumers) will be accepted until November 25, 2009.
Preparing for DMEPOS Competitive Bidding
By Debra A. McCurdy on
CMS has released an educational article identifying steps suppliers should take in preparation for the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to ensure successful bidder registration.