Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
On January 20, 2012, the Obama Administration posted its Fall 2011 Regulatory Agenda, outlining its planned regulatory initiatives in a number of policy areas. Priorities for the Department of Health and Human Services (HHS) include, among many others:
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The Centers for Medicare & Medicaid Services (CMS) has published a final rule that implements provisions regarding the reporting of gross covered retiree plan-related prescription drug costs and retained rebates by Retiree Drug Subsidy (RDS) sponsors. The rule, which was published January 12, 2012, also addresses the scope of CMS’s authority to waive requirements…
On January 10, 2012, HHS published an interim final rule with comment period that implements an ACA provision requiring the adoption of a standard for electronic funds transfers (EFTs). By streamlining standards for the format and data content of EFT transmissions, HHS estimates that health system administrative costs will be reduced by up to…
In August 2011, HHS published an interim final rule that requires most health plans to furnish certain preventive health services, including contraceptive services, for women without cost sharing under the ACA, effective for plan years beginning on or after August 1, 2012. The rule provided an exemption with regard to contraceptive services for certain religious…
As previously reported, the ACA modified the statutory federal upper limit (FUL) provisions for Medicaid reimbursement for multiple source drugs. While CMS has not yet promulgated regulations to implement this policy, the agency has issued several sets of draft FUL reimbursement files, including the draft methodology used to calculate the FULs in accordance with…
The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows: a February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act; on February 7, a Subcommittee hearing will…
On January 23, 2011, the ACA’s Patient-Centered Outcomes Research Institute (PCORI) released its first draft National Priorities for Research and Research Agenda, which will be used to guide funding announcements for comparative clinical effectiveness research. The proposed national priorities for research are as follows:
Comparative Assessments of Prevention, Diagnosis, and Treatment Options — determining which…
