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Ingrid A. Pelzer
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By Nancy A. Henshaw and Kristina C. Jordan The Governor of Florida recently signed legislation that will permit advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe, order, and administer controlled substances. These provisions will become effective on January 1, 2017. As to ARNPs, the Board of Nursing... Continue reading
Posted 4 days ago at Pharmaspective
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Porzio Life Sciences, LLC (PorzioLS), a wholly-owned subsidiary of the law firm of Porzio, Bromberg & Newman, P.C. (Porzio), is dedicated to helping pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment. In order to create a better understanding of the life sciences healthcare compliance environment and gain... Continue reading
Posted Apr 1, 2016 at Pharmaspective
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By Ingrid A. Pelzer The Governor of Massachusetts recently approved legislation that will require pharmaceutical product manufacturers that sell or distribute a covered drug to consumers in Massachusetts, whether through a wholesaler, retailer, or other agent, to: Finance and operate a drug stewardship program, either individually or jointly with other... Continue reading
Posted Mar 30, 2016 at Pharmaspective
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By Jennifer A. Romanski and Kim C. Capone The past two years have created a bit of uncertainty for life sciences promotional review professionals. With fewer enforcement letters, high-profile lawsuits, and a shift in marketing focus as a result of the Affordable Care Act, companies are struggling for a greater... Continue reading
Posted Mar 11, 2016 at Pharmaspective
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Porzio Life Sciences (PorzioLS) has been a leading resource for the life sciences industry for over 11 years. The 2014 Year-End Report was the first annual PorzioLS accounting of the headlines and emerging trends of the prior year. Continuing in this vein, we proudly offer the 2015 Year-End Report: Navigating... Continue reading
Posted Mar 10, 2016 at Pharmaspective
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By Ingrid A. Pelzer In March 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA). Among other things, the Act imposed an excise tax of 2.3% to the sale of any taxable medical device. The term "taxable medical device" includes an "instrument, apparatus, implement, machine, contrivance, implant,... Continue reading
Posted Jan 7, 2016 at Pharmaspective
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By Ingrid A. Pelzer Senator Charles Grassley has introduced legislation to amend the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.” Pursuant to the Sunshine Act, applicable manufacturers of covered drugs, devices,... Continue reading
Posted Oct 13, 2015 at Pharmaspective
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By Rena C. Bartel The U.S. Food and Drug Administration (FDA) has published on its website a searchable database of licensing information reported by wholesale distributors and third-party logistics providers (3PL) in accordance with the Drug Supply Chain and Security Act (DSCSA). As expressed in the DSCSA, beginning November 27,... Continue reading
Posted Oct 12, 2015 at Pharmaspective
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According to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report all ownership and... Continue reading
Posted Apr 1, 2015 at Pharmaspective
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By Ingrid A. Pelzer On March 24, 2015, the Governor of West Virginia approved Senate Bill 267 (SB 267), which will repeal the article in the Code of West Virginia that created the Governor's Office of Health Enhancement and Lifestyle Planning (GOHELP). Included in this repeal is §16-29H-8 of the... Continue reading
Posted Mar 27, 2015 at Pharmaspective
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By James Brenner and Richard Velardi On January 6, 2015, the U.S. House of Representatives introduced House Bill 160 (H.R. 160), also known as the Protect Medical Innovation Act. As introduced, H.R. 160 would repeal the 2.3% medical device excise tax, which was enacted in 2010 as part of the... Continue reading
Posted Jan 15, 2015 at Pharmaspective
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By Rena Bartel and Ingrid Pelzer On July 27, 2012, the Alameda County Board of Supervisors, located in Northern California, passed the Safe Drug Disposal Ordinance (Ordinance). The Ordinance, which was scheduled to go into effect on November 1, 2013, requires Producers to fund or operate “take-back” programs in Alameda... Continue reading
Posted Jan 14, 2015 at Pharmaspective
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By Ingrid Pelzer and Rakan Ghubej The Connecticut State Legislature was busy in 2014! Due to legislative updates, qualified advanced practice registered nurses ("APRNs") in Connecticut are permitted to practice and prescribe medication without having a collaborative relationship with a licensed physician. Previously, APRNs were required to practice, prescribe, dispense,... Continue reading
Posted Jan 8, 2015 at Pharmaspective
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By Ingrid A. Pelzer According to the Drug Supply Chain Security Act ("DSCSA"), effective January 1, 2015, manufacturers and wholesale distributors that transfer ownership of a product will be required to provide the subsequent owner with transaction history, transaction information, and a transaction statement in a single document in paper... Continue reading
Posted Dec 29, 2014 at Pharmaspective
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By Kerry M. Miele On June 20, 2013, the Board of Health (Board) in King County, Washington passed the Secure Medicine Return Regulations (Regulations), establishing a program to collect and properly dispose of unwanted medicines from local residents. According to the Regulations, the program will be funded and operated by... Continue reading
Posted Nov 11, 2014 at Pharmaspective
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By Ingrid A. Pelzer, Laura C. Conway, and Christine Bradshaw In July 2014, the Centers for Medicare and Medicaid Services (CMS) published proposed amendments to its rules implementing the Sunshine Act. Among other things, CMS proposed to remove section 403.904(g)(1), which previously stated that applicable manufacturers were not required to... Continue reading
Posted Nov 6, 2014 at Pharmaspective
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By Ingrid A. Pelzer and Christine N. Bradshaw The Centers for Medicare and Medicaid Services (CMS) has released the first round of Sunshine Act data on its freshly-updated Open Payments website. The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain... Continue reading
Posted Oct 2, 2014 at Pharmaspective
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By Rachael Garrison and Ingrid Pelzer In November 2013, several members of Congress submitted a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS), urging that the distribution of textbooks and scientific peer-reviewed medical journal materials be excluded from the reporting requirements under the Sunshine... Continue reading
Posted Sep 29, 2014 at Pharmaspective
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By Ingrid A. Pelzer On Friday, August 15, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that it had reopened the Open Payments system for physicians, teaching hospitals, and authorized representatives to register and review data. CMS had previously taken the system offline to investigate a report of... Continue reading
Posted Aug 18, 2014 at Pharmaspective
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By Rena Bartel On Thursday, August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system was taken offline temporarily in order to investigate an issue. Reportedly, a physician complained to CMS when, upon logging into the CMS Open Payments portal to view the... Continue reading
Posted Aug 11, 2014 at Pharmaspective
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By Rena Bartel and Ingrid Pelzer On November 27, 2013, President Obama signed into law the "Drug Quality and Security Act," which amends the Federal Food, Drug, and Cosmetic Act. Title II of the Act, also known as the "Drug Supply Chain Security Act” (DSCSA), establishes a timeline for entities... Continue reading
Posted Aug 4, 2014 at Pharmaspective
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By Danielle Burke In addition to imposing payment and physician ownership disclosure requirements, the federal Patient Protection and Affordable Care Act (Act) also requires manufacturers and authorized distributors of record (ADRs) to disclose information related to drug sample requests and distributions. Specifically, the Act states that beginning April 1, 2012,... Continue reading
Posted Jul 21, 2014 at Pharmaspective
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By Ingrid A. Pelzer According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations (GPOs), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to the data submitted pursuant to the Sunshine Act. This review and correction period... Continue reading
Posted Jul 14, 2014 at Pharmaspective
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By Ingrid A. Pelzer and Kiaema R. Reid On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) published proposed amendments to its rules implementing the Sunshine Act. Among other things, the proposed amendments would remove section 403.904(g)(1), which currently excludes the reporting of payments associated with certain... Continue reading
Posted Jul 8, 2014 at Pharmaspective
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By Grant Ostlund and Nicole Morris On July 2, 2014, the federal Drug Enforcement Administration (DEA) published a Final Rule in the Federal Register to place Tramadol into Schedule IV of the Controlled Substances Act (CSA). The DEA began its consideration to schedule Tramadol after a recommendation from the Assistant... Continue reading
Posted Jul 3, 2014 at Pharmaspective