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Ingrid A. Pelzer
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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 5 days ago 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
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By Ingrid Pelzer (@IngridPelzer) As previously reported, the Centers for Medicare and Medicaid Services (CMS) has adopted a two-phased approach for registration and submission of Sunshine Act data for the 2013 reporting year. Phase 1 began on February 18, 2014, and concluded on March 31, 2014. Phase 2 began on... Continue reading
Posted Jul 1, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzer) The Centers for Medicare and Medicaid Services (CMS) has announced that Open Payments registration and detailed data submission for applicable manufacturers and group purchasing organizations (GPOs) will begin on June 1, 2014, and will be completed in two steps. CMS has released an instructions document... Continue reading
Posted May 27, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzer) The District of Columbia's (D.C.) Prescription Drug Marketing Cost Reporting Law (D.C. CODE § 48-833.01-09) requires manufacturers and labelers of prescription drugs dispensed in D.C. that employ, direct, or utilize marketing representatives in D.C. to submit an annual report disclosing certain prescription drug marketing costs.... Continue reading
Posted May 21, 2014 at Pharmaspective
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By Kim C. Capone In a notice published in the Federal Register on May 7, 2014, the federal Food and Drug Administration (FDA) is soliciting comments on a proposed study entitled "Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements." The FDA's Office of Prescription Drug Promotion (OPDP) will... Continue reading
Posted May 20, 2014 at Pharmaspective
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By Christina Codispoti On May 8, 2014, the Governor of Connecticut signed Senate Bill 36 (SB 36), which will amend the Connecticut Nursing Practice Act. Effective July 1, 2014, SB 36 will permit qualified advanced practice registered nurses (APRNs) to practice and prescribe medication without having a collaborative relationship with... Continue reading
Posted May 19, 2014 at Pharmaspective
By Ingrid A. Pelzer (@IngridPelzerPLS) As previously reported, the Centers for Medicare and Medicaid Services (CMS) has adopted a two-phased approach for registration and submission of Sunshine Act* data for the 2013 reporting year. Phase 1 of CMS' Open Payments registration and data submission for applicable manufacturers and applicable group... Continue reading
Posted May 9, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) The Centers for Medicare and Medicaid Services (CMS) has made updates to its data submission resources, which applicable manufacturers and applicable group purchasing organizations (GPOs) will use to submit data during Phase 2 of Open Payments registration and data submission. During Phase 2, which is... Continue reading
Posted May 8, 2014 at Pharmaspective
By Rakan Ghubej In July 2013, the Centers for Medicare and Medicaid Services (CMS) submitted an information collection request (ICR) to the Office of Management and Budget (OMB), and invited interested parties to submit comments regarding implementation of the Sunshine Act. Among other things, interested parties were asked to comment... Continue reading
Posted May 7, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the release of the final regulations implementing 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... Continue reading
Posted May 5, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) As previously reported, the Centers for Medicare and Medicaid Services (CMS) has adopted a two-phased approach for registration and submission of Sunshine Act data for the 2013 reporting year. Phase 1 of CMS' Open Payments registration and data submission process for applicable manufacturers and applicable... Continue reading
Posted May 2, 2014 at Pharmaspective
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By Kim C. Capone On May 11, 2010, the Division of Drug Marketing, Advertising, and Communications (DDMAC), now the Office of Prescription Drug Promotion (OPDP), announced the launch of the Bad Ad Program “to help health care professionals recognize misleading prescription drug promotion and provide them with an easy way... Continue reading
Posted Apr 30, 2014 at Pharmaspective
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By Albert E. Cuccinello On April 15th, April 16th, and April 22nd, the Centers for Medicare and Medicaid Services (CMS) will hold webinars to provide a regional-level overview of the final rules implementing the Sunshine Act, and the Open Payments program. The target audience for the webinars is association and... Continue reading
Posted Mar 27, 2014 at Pharmaspective
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By Kerry Miele Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01], manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must... Continue reading
Posted Mar 20, 2014 at Pharmaspective
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By Brianna Pirmann In an effort to assist reporting entities with Phase 1 registration and data submission, the Centers for Medicare and Medicaid Services (CMS) has posted on its Open Payments website a new table that provides a side-by-side comparison of Phases 1 and 2. Some of the topics covered... Continue reading
Posted Mar 18, 2014 at Pharmaspective
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By Nancy A. Henshaw In its continuing efforts to provide a "safe, convenient, and responsible means of disposing of prescription drugs," the federal Drug Enforcement Administration (DEA) has scheduled its eighth National Prescription Drug Take-Back Day for Saturday, April 26, 2014. The DEA held its first Prescription Drug Take-Back event... Continue reading
Posted Mar 10, 2014 at Pharmaspective
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By Natasha Bobo 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 this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved in the... Continue reading
Posted Mar 7, 2014 at Pharmaspective
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By Kim C. Capone The Office of Inspector General (OIG) has released its 2014 Work Plan. The Work Plan summarizes activities OIG plans to pursue with respect to the U.S. Department of Health and Human Services (HHS) programs and operations. The Work Plan can be an important resource for identifying... Continue reading
Posted Mar 6, 2014 at Pharmaspective
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By Kim C. Capone On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices." The draft guidance recommends practices for pharmaceutical and medical device manufacturers when disseminating scientific and medical literature... Continue reading
Posted Mar 5, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) The Centers for Medicare and Medicaid Services (CMS) has been busy this month. All in preparation for the first set of disclosure reports as required by the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care... Continue reading
Posted Feb 25, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) 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 this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved... Continue reading
Posted Feb 24, 2014 at Pharmaspective
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By Ingrid A. Pelzer The Vermont Attorney General's Office (AG's Office) is offering to accept a payment to the State in the amount of $10,000 per reporting period to settle failures to report under the Prescribed Products Gift Ban and Disclosure Law (Law) for prior reporting years. According to the... Continue reading
Posted Feb 21, 2014 at Pharmaspective