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|FDA Implements Expedited Review of ANDA Submissions for "Sole-source" Drug Products|
Duane Morris LLP;
July 23, 2016, previously published on March 31, 2016The U.S. Food and Drug Administration (FDA) recently updated its Manual of Policies and Procedures (MAPP) 5240.3 on Prioritization of the Review of Original ANDAs, Amendments and Supplements to Revision 2, adding a new category of expedited review of abbreviated new drug application (ANDA)...
|States Step Up Efforts on Drug Pricing Initiatives|
Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 22, 2016, previously published on June 6, 2016A few months ago, we noted that states were jumping into the drug pricing fray largely driven by a lack of federal action and a rising tide of public discontent. State legislation has taken various forms but most of the proposals reflect industry arguments that rising prices reflect rising R&D...
|Tackling the Dragon of Hospital Price Disparity: Massachusetts’s On-Going Efforts to Address Price Equity|
Eric R. Blythe, Stephen M. Weiner; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 22, 2016, previously published on June 8, 2016Price disparities among hospitals pose one of the more intractable issues for policy makers, regulators and the government. That they exist is indisputable. Why they exist is a source of much contention. And the issue creates great disunity within the hospital world, causing fissures especially...
|Navigating Pennsylvania's New Medical Marijuana Act: What Employers Need to Know|
Duane Morris LLP;
July 22, 2016, previously published on May 17, 2016On April 17, 2016, Pennsylvania Governor Tom Wolf signed the Medical Marijuana Act (“the Act”) into law. The Act, which takes effect on May 17, 2016, legalizes the use and possession of medical marijuana under specified circumstances and provides for a comprehensive program of...
|FDA Clarifies Its Position on Several Compounding Issues in New Draft Guidance Documents|
Duane Morris LLP;
July 22, 2016, previously published on May 12, 2016On April 15, 2016, the U.S. Food and Drug Administration (FDA) announced the release of three new draft guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act (FDCA). These draft guidance documents cover:
|Pay Attention to Business Associate Agreements!|
Cynthia J. Larose; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 22, 2016, previously published on March 22, 2016For our HIPAA-covered entity readers, we have asked these questions before: Have you taken a business associate inventory ? Have you undertaken a comprehensive risk assessment as required by HIPAA?
|Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs|
Eli Greenspan, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 21, 2016, previously published on June 30, 2016We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although Congress has not been sitting on the sidelines of the drug pricing debate -...
|Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief|
Helen J. Kim, Dionne C. Lomax, Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 21, 2016, previously published on June 30, 2016On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying...
|DOJ Announces Dramatic Increase in False Claims Act Penalties|
Laurence J. Freedman, Samantha P. Kingsbury; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 21, 2016, previously published on June 30, 2016On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA. After...
|At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes|
Karen S. Lovitch, Kate F. Stewart; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 20, 2016, previously published on June 20, 2016Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the rate-setting process under the Medicare Clinical Laboratory Fee Schedule...