CMS has issued guidance to State Medicaid Directors on the Medicaid prescription drug rebate provisions of the Patient Protection and Affordable Care Act (PPACA). Specifically, the letter addresses the increased rebate percentages for covered outpatient drugs dispensed to Medicaid patients, the extension of prescription drug rebates to covered outpatient drugs dispensed to enrollees of
April 2010
States Take Steps to Begin Implementing Health Reform
By Debra A. McCurdy on
As focus shifts away from Congressional health reform activity, states are gearing up to act on the many PPACA provisions requiring their attention. Among other things, states will be looking to implement insurance market reforms; establish insurance exchanges; comply with new Medicaid eligibility, benefits, reimbursement and other policy revisions; and pursue funding opportunities under a…
CMS Issues Proposed FY 2011 IPPS/LTCH Rule
By Debra A. McCurdy on
CMS has released its proposed rule to update Medicare inpatient prospective payment system (IPPS) hospital and LTCH payment and other policies for FY 2011, which will be published in the Federal Register on May 4, 2010. Overall, CMS estimates that payments to general acute care hospitals for operating expenses under the proposed rule will…
Inpatient Psychiatric Facilities PPS Proposed Rule
By Debra A. McCurdy on
On April 30, 2010, CMS published a notice on that updates Medicare prospective payment system (PPS) payment rates for inpatient psychiatric hospital services provided by inpatient psychiatric facilities (IPFs) for discharges occurring during the rate year beginning July 1, 2010 through June 30, 2011. CMS estimates that the rule will increase Medicare payments by $91…
Medicaid Benefit Package Flexibility
By Debra A. McCurdy on
On April 30, 2010 CMS published a final rule providing states with increased flexibility to define the scope of covered Medicaid services by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid-eligible individuals. The rule is effective July 1, 2010.
CMS Proposed Rule on ASC Condition of Coverage/Patients’ Rights
By Debra A. McCurdy on
On April 23, 2010, CMS published a proposed rule that would revise the Medicare ambulatory surgical center (ASC) patients rights condition for coverage (CfC) that currently requires certain patient’s rights information to be provided to patients in advance of the date of the procedure. CMS observes that the current requirement has been problematic for ASCs…
Waiver of Disapproval of SNF/NF Nurse Aide Training Programs
By Debra A. McCurdy on
On April 23, 2010, CMS published a final rule that will permit CMS to waive the disapproval of a nursing facility’s or skilled nursing facility’s nurse aide training program if the facility has been assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. CMS did…
Federal Medicaid DSH, Part B Qualifying Individual Allotments
By Debra A. McCurdy on
CMS published a notice April 23, 2010 announcing the final FY 2008 and the preliminary FY 2010 federal share disproportionate share hospital (DSH) allotments and limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, the notice includes the revised preliminary federal share DSH…
HHS Semiannual Regulatory Agenda
By Debra A. McCurdy on
On April 26, 2010, HHS published its semiannual regulatory agenda outlining its planned regulatory initiatives in a number of health policy areas. Among other things, the agenda includes listings for Office of the Secretary health information technology rules, a variety of Food and Drug Administration (FDA) regulatory actions involving prescription drugs, and CMS regulations updating Medicare …
Upcoming Hearing on Health Care Pricing Transparency (May 6)
By Debra A. McCurdy on
On May 6, 2010, the House Energy and Commerce Health Subcommittee has scheduled a hearing on health care pricing transparency legislation, focusing on H.R. 4700, the "Transparency In All Health Care Pricing Act of 2010"; H.R. 2249, the "Health Care Price Transparency Promotion Act Of 2009"; and H.R. 4803, the "Patient’s Right To Know…
FDA Draft Guidance on Financial Information for Advisory Committee Members
By Debra A. McCurdy on
This post was written by Paul Sheives. FDA has issued a draft guidance document entitled “Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers.” The document highlights FDA procedures regarding the public nature of financial interests of advisory committee members and waivers granted by FDA to allow committee members to participate. FDA is…
FDA Announces New Procedures for CDRH Advisory Committees
By Debra A. McCurdy on
This post was written by Paul Sheives.
FDA has announced changes in the procedures for advisory committees considering medical devices under review for premarket approval, effective May 1, 2010. The changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion. Among other things, rather than focusing on whether…
FDA Draft Guidance on 513(g) Requests for Medical Devices
By Debra A. McCurdy on
This post was written by Paul Sheives. FDA has published two draft guidance documents relating to requests under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which provides a means to obtain the FDA’s views about the classification and regulatory requirements that may apply to a particular device. In the first draft guidance,…
Town Hall Discussion with FDA CDRH’s Director (May 18)
By Debra A. McCurdy on
This post was written by Paul Sheives.
FDA is hosting a public meeting on May 18, 2010 entitled “Town Hall Discussion With the Director of the Center for Devices and Radiological Health (CDRH) and Other Senior Center Management.” At the meeting, which will be held in Bloomington, MN, CDRH Director Jeffrey Shuren, MD,…
FDA Public Workshop on Home Use of Medical Devices (May 24)
By Debra A. McCurdy on
This post was written by Paul Sheives. FDA is holding a public workshop entitled “Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device Technology Migrating into the Home,” on May 24, 2010 in Silver Spring, MD. The purpose of the workshop is to seek input…
Berwick Nominated to be CMS Administrator
By Debra A. McCurdy on
President Obama has nominated Dr. Donald Berwick to be CMS Administrator. Dr. Berwick currently serves as President and CEO of the Institute for Healthcare Improvement, and is a professor at Harvard Medical School and the Harvard School of Public Health. Among many other appointments, Dr. Berwick has served as Chair of the National Advisory Council…
OIG Report Compares ASPs, AMPs
By Debra A. McCurdy on
The HHS Office of Inspector General (OIG) has released another in its series of reports comparing Medicare average sales prices (ASPs) for Part B drugs with average manufacturer prices (AMPs). In this latest report, the OIG identified 26 drug HCPCS codes with ASP that exceeded AMP by at least 5% in the third quarter of …
GAO Report on Special Focus Facilities
By Debra A. McCurdy on
The Government Accountability Office (GAO) has issued a report entitled “Poorly Performing Nursing Homes: Special Focus Facilities Are Often Improving, but CMS’s Program Could Be Strengthened.” In this report, the GAO reviewed the factors states consider in selecting facilities for the Special Focus Facility (SFF) program, which targets nursing homes with severe and…
GAO Report on Medicare Contracting Reform
By Debra A. McCurdy on
The GAO has issued a report entitled “Medicare Contracting Reform: Agency Has Made Progress with Implementation, but Contractors Have Not Met All Performance Standards.” The report discusses CMS’s transition of claims administration from carriers and fiscal intermediaries to 19 new Medicare Administrative Contractors (MAC), 15 of which will process both Part A and…
FDA Confirms Focus on Enforcement and Initiative to Bring Criminal Prosecutions of Company Executives
By Debra A. McCurdy on
This post was written by Areta L. Kupchyk. On April 22, 2010, at the Food and Drug Law Institute (FDLI) Annual Conference in Washington, D.C., FDA’s Deputy Chief Counsel for Litigation, Eric Blumberg, confirmed the Agency’s re-energized commitment to bring appropriate enforcement actions against companies and products that are in violation of the Federal…