June 2010

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.

In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.

Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.
Continue Reading Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers

Under the ACA, certain group health plans and health insurance coverage existing as of March 23, 2010 (the date of enactment of the ACA), are considered “grandfathered” and excused from complying with some of the ACA’s health care improvement and market reform provisions. On June 17, 2010, the Department of Health and Human Services (HHS)

The ACA provides a tax-free, one-time $250 check for beneficiaries who reach the Part D coverage gap during 2010 and are not eligible for low-income subsidies. A June 10, 2010 CMS memo to Part D plan sponsors provides additional information on implementation of coverage gap rebate. The memo notes that prompt submission of prescription drug

On June 17, 2010, CMS published a notice correcting technical and typographical errors in its June 2, 2010 “supplementary” proposed rule updating the Medicare hospital inpatient prospective payment system (IPPS) and the long-term care hospital prospective payment system (LTCH) for 2011. CMS also corrected technical errors in its June 2, 2010 notice on IPPS and

CMS has published a notice announcing the procedures that will be used when certain hospitals (those that previously had been granted a waiver to work with an OPO other than the designated OPO for the hospital’s service area) seek to enter into an agreement with a different OPO. The process provides the public with

On June 11, 2010, CMS announced that Provider Enrollment, Chain and Ownership System (PECOS) records will be used to verify Medicare enrollment prior to making Medicare EHR incentive payments. While additional details on the EHR incentive program will be provided in an upcoming final rule, CMS is encouraging providers to act now to ensure that

CMS has issued a series of guidance documents on the Medicare Secondary Payer (MSP) mandatory reporting provisions in section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA). The new guidance documents address: risk management write-offs by providers, physicians, suppliers, and non-provider/supplier entities; reporting health reimbursement arrangements; what entities are MMSEA Section

This post was written by Paul Sheives. FDA has issued a guidance document entitled “Bioequivalence Recommendations for Specific Products,” which announces that FDA will make available recommendations on study design for particular products on the agency’s website. In the past, applicants of abbreviated new drug applications had to request this information; FDA

This post was written by Paul Sheives. FDA has issued a notice to stakeholders requesting that those parties intending to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA) notify the agency. The first meeting will occur July 1, 2010, and FDA requests that the notices of intent

This post was written by Paul Sheives.

FDA is requesting comments on a draft document entitled ‘‘CDER Data Standards Plan Version 1.0,” which outlines the agency’s approach to establishing a comprehensive data standards program within the Center for Drug Evaluation and Research (CDER). Outlined in the plan are key objectives for a data standards program,

This post was written by Paul Sheives. FDA will hold a 2-day public meeting on July 27 and 28, 2010 to address the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. The purpose of the meeting is to seek public input on various concerns that stakeholders have raised

This post was written by Paul Sheives. FDA and FCC will hold a joint public meeting to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices on July 26 and 27, 2010. The meeting is formally entitled: “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and

This post was written by Paul Sheives.

FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency’s plan to address them on the FDA website. Because evidence of some side effects arises following approval of the products, FDA is

The OIG released a report entitled "Medicare Part D – Prescription Drug Event Reconciliation Process." The OIG contracted with a certified public accounting firm to audit CMS’s Medicare Part D PDE reconciliation process. Under this process, CMS compares estimated subsidy payments made to plan sponsors throughout the year with the cost data submitted

The Government Accountability Office (GAO) has issued a report on “Home Infusion Therapy: Differences between Medicare and Private Insurers’ Coverage.” The report describes (1) coverage of home infusion therapy components under Medicare fee-for-service, (2) coverage and payment for home infusion therapy by other health insurers, and (3) the utilization and quality management practices