LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner
CMS formalizes its Medicare Part D Coverage Gap Discount Program rules as part of an omnibus Medicare Part C and Part D rulemaking.
Outside Publication | Article
Jacqueline Berman
Much remains to be seen.
Outside Publication | Article
Scott Memmott, Jennifer Clarke
An overview of the most important aspects of the proposed regulations.
LawFlash/Client Alert | Intellectual Property LawFlash
Robert Smyth, Ph.D.
Court ruling applies law of nature; impacts patents directed to personalized medicine.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Lee Rosebush, Michele Buenafe
DEA's recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, Phoebe Mounts, Alexis Miller, Kathleen Sanzo
Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner, Stephen Ruscus
The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.
Presentation | Webinar
Rebecca Osowski, Kathleen McDermott, Jonathan Havens
Morgan Lewis hosted a webinar focusing on the Centers for Medicare and Medicaid Services' (CMS) long-awaited proposed rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests." This webinar pr... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe
The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.
LawFlash/Client Alert | FDA and Healthcare LawFlash
Joyce Cowan
Healthcare industry clients should be prepared for possible cuts to the Medicaid program, Medicare provider and supplier reimbursement rates, Medicare Advantage, and Medicare Part D, and for increased fees for manufacturers.
Outside Publication | Article
Heather Deixler, W. Reece Hirsch
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
FDA & Healthcare, Life Sciences, and Employee Benefits Practices
On May 31, the U.S. Department of Health and Human Services (HHS) released a notice of proposed rulemaking (Proposed Rule) creating a new requirement that covered entities produce an "access report" informing individuals of all ... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe
The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender
The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more
Presentation | Webinar
Kathleen McDermott
Morgan Lewis partner Katie McDermott participated in AHLA's hosted webinar on "Medicare ACOs: Details From the Fraud and Abuse Perspective" on May 24, 2011. The much-anticipated proposed regulations regarding the Medicare Shared ... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Phoebe Mounts, Lee Rosebush, Stephen Mahinka
On May 10, the Food and Drug Administration (FDA) issued a Federal Register notice requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitt... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Phoebe Mounts, Jacqueline Berman
The Food and Drug Administration (FDA) has issued a proposed rule which, if finalized, will expand the scope and consequences of clinical investigator disqualifications. [1] Under the propose... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice
Following tremendous changes for healthcare in the 111th Congress, stakeholders can expect continued focus on healthcare reform in the 112th Congress. The Obama administration and Democrats will be defending the 2010 healthcare... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen Sanzo, Stephen Mahinka
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen Sanzo, Stephen Mahinka
Following final congressional passage on December 21, President Obama is expected to sign into law H.R. 2751, the Food and Drug Administration (FDA or the Agency) Food Safety Modernization Act (the Act). By amending the Fede... more
LawFlash/Client Alert | Cross-Practice Alert
Stephen Mahinka, Karen Butcher
After almost three years of review and analysis, the Federal Trade Commission (FTC) on October 6 released proposed revisions to its Guides for the Use of Environmental Marketing Claims, generally termed the "Green Guides" (the G... more
LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen Sanzo, Phoebe Mounts
The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), establishes an abbreviated licensure pathway for biosimilar biological p... more
LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen Sanzo
The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law, or Law), will have a number of direct and indirect effects on pharmaceuti... more
LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Kathleen McDermott
The Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law) provides for a number of new transparency requirements for several health ... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice
Background The Reportable Food Registry (RFR), released by the U.S. Food and Drug Administration (FDA) on September 8, is an electronic portal through which the food industry is to report when there is a reasonable probabil... more