January 2008

CMS has published a proposed rule that would allow Medicare Part D prescription drug plan (PDP) sponsors to offer a reduced drug plan premium amount for low-income subsidy (LIS) individuals, subject to certain conditions. The proposal would apply in regions where there otherwise would be fewer than five PDP sponsors with a “zero-premium” plan option

CMS has issued a proposed rule that would permit states to administer “self-directed personal assistance services” through their state Medicaid plans. Under this framework, states could provide Medicaid beneficiaries who need help with activities of daily living with a cash allowance to hire, direct, train, or fire their own personal care workers (including family members)

On January 18, CMS published another short-term extension of the revisit user fee program for Medicare survey and certification activities through December 21, 2007, in accordance with a temporary spending bill signed by President Bush in December. By way of background, CMS published a final rule in September 2007 to establish revisit user fees for

On January 16, the Food and Drug Administration (FDA) published a notice announcing that the voluntary direct-to-consumer (DTC) television advertisement user fee program authorized by the Food and Drug Administration Amendments Act of 2007 (FDAAA) will not be implemented at this time, since $11.25 million in user fees were not appropriated by Congress or promised

The FDA has published a proposed rule to codify the agency’s views on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the FDA’s review of the change. The rule would codify that a supplemental application is appropriate only to reflect newly-acquired information. It

On January 24, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a notice soliciting recommendations for potential revisions to the OIG’s compliance program guidance for nursing facilities, including changes to existing risk areas or suggestions for new risk areas. The comment deadline is February 25.

CMS has announced the second phase of Medicare competitive bidding for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). In this second round, competitive bidding will be implemented next year in 70 areas, including the nation’s largest cities. With very limited exception, only suppliers who are successful bidders in these regions and who meet program

CMS has posted the draft combined 2009 call letter for Part D PDPs and MA plan sponsors. Comments will be accepted until January 30. CMS also is accepting comments until February 11 on proposed revisions to the CY 2009 Plan Benefit Package and Formulary Submission for MA Plans and PDPs; and the CY 2009 Bid

There have been many Congressional health policy hearings recently, with more scheduled. Highlights include the following:

  • House Ways and Means Committee. Recent hearings have examined traditional Medicare’s benefit design and tax-related provisions in the ACA, and on March 15, the Health Subcommittee is holding a hearing on the Medicare Payment Advisory Commission’s annual March Report

On January 23, the House of Representatives again failed to override President Bush’s veto of another State Children’s Health Insurance Program (SCHIP) expansion bill (H.R. 3963).  Note that the SCHIP program has been funded through March 31, 2009 as part of the Medicare, Medicaid, and SCHIP Extension Act of 2007.

The Medicare Payment Advisory Commission (MedPAC) met January 10 – 11 to vote on Medicare payment policy recommendations that will be included in its annual report to Congress to be issued in March 2008. Among other things, the panel voted to recommend a freeze in Medicare skilled nursing facility, home health agency, and inpatient rehabilitation

The OIG has issued a report on Medicare Part D payments to community pharmacies. Among other things, the OIG found that Medicare Part D payments (excluding dispensing fees) exceeded the pharmacies’ drug acquisition costs by about 18.1 percent when drug wholesalers rebates to pharmacies were included. Excluding rebates, Part D payments exceeded drug acquisition costs

CMS has released detailed health care spending statistics for 2006. Health care spending growth in the United States increased 6.7 percent in 2006, reaching a total of $2.1 trillion, or $7,026 per person, and equaling 15 percent of the nation’s Gross Domestic Product. Medicare spending grew 18.7 percent in 2006, compared to 9.3 percent in 2005, fueled

The FDA Center for Biologics Evaluation and Research (CBER) is inviting biologics facilities to participate in its Regulatory Site Visit Training Program, which is intended to allow CBER staff to directly observe routine biologics manufacturing practices. Interested parties should contact CBER by February 21.

On January 28, President Bush is scheduled to deliver his State of the Union address to Congress. His speech will be followed by the release of the Administration’s proposed FY 2009 budget on February 4. The President is expected to include significant health care proposals, including a plan to address Medicare financing as a result