New Postings on the Reed Smith Health Industry Washington Watch Blog
The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:
- Legislative Developments. President Obama has signed into law H.R. 4872, the Health Care and Education Reconciliation Act of 2010, completing a year-long effort to enact health insurance reforms and Medicare, Medicaid, and other health policy changes. A number of Congressional hearings have focused on health policy issues.
- Regulatory Developments. The Drug Enforcement Administration (DEA) has issued a rule allowing practitioners to write prescriptions for controlled substances electronically and permitting pharmacies to receive, dispense, and archive these electronic prescriptions. CMS has published a notice seeking nominations for the Advisory Panel on Ambulatory Payment Classification Groups. The FDA has issued rules regarding standards for direct-to-consumer advertisements, device registration and listing requirements, and the sale and distribution of cigarettes. HHS has published notices seeking collaboration on an HHS initiative to prevent healthcare-associated infections and announcing the establishment of the Presidential Commission for the Study of Bioethical Issues.
- Other CMS Developments. Congress has adjourned for a two-week recess without taking final action on legislation to avert the 21.2% cut in the Medicare physician fee schedule set to go into effect April 1, 2010. CMS has instructed its contractors to hold claims containing services paid under the MPFS for the first 10 business days of April to accommodate potential future Congressional action to restore payments. CMS has posted the Medicare ASPs in effect for the period of April 1, 2010 through June 30, 2010. At a recent Program Advisory and Oversight Committee (PAOC) meeting, CMS released its draft timetable for round two of the DMEPOS competitive bidding program. CMS also has issued guidance on reporting changes in DMEPOS supplier surety bonds, Medicare quality standards related to respiratory therapy equipment, power mobility devices, and other related DME, signature guidelines for medical review purposes, and use of technology in contractor program integrity efforts.
- Other FDA Developments. The FDA has announced a realignment of certain review divisions in the Center for Drug Evaluation and Research. The FDA also has issued guidance on drug pedigree issues and on the content and format of the dosage and administration section of drug labeling.
- OIG & GAO Reports. The OIG has issued a report on Medicaid rebates for brand-name drugs with multiple versions. The GAO has issued a report on FDA management challenges.
- Health Industry Events. MedPAC is meeting to discuss a number of Medicare policy issues. CMS is holding a series of meetings on HCPCS code applications. HHS is hosting a conference on HIPAA security issues. FDA is holding a meeting on reauthorization of the Prescription Drug User Fee Act (PDUFA).
