POLICY & MEDICINE
Earlier this year, Patrizia Cavazzoni, MD, was named the Director of the United States Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The announcement was made via Dr. Janet Woodcock’s official twitter account, @DrWoodcockFDA. In the tweet, Dr. Woodcock STARK LAW FINAL RULE IS EFFECTIVE Readers may remember that just one day before President Joe Biden was inaugurated as the 46 th President of the United States, on January 19, 2021, a final rule issued by the Centers for Medicare and Medicaid Services (CMS) modernizing the physician self-referral law (the Stark Law) became effective.. Also effective on January 19, 2021, was a final rule issued by the United States THE IMPACT COVID-19 IS HAVING ON ACOS Recently, the National Association of Accountable Care Organizations (NAACOS) surveyed the Accountable Care Organization (ACO) community to gauge their experience in handling the COVID-19 pandemic. According to the results, more than half of the ACOs said they are likely to drop out of the program because they fear having to pay massive losses as a result of the pandemic. COURT RULES FDA EXCEEDED AUTHORITY WHEN IT REGULATED The US District Court for the District of Columbia recently ruled that the US Food and Drug Administration (“FDA”) exceeded its authority when it regulated a contrast agent as a drug instead of a medical device. In overturning the FDA’s decision, the court noted that the agency “does not have discretion to regulate all contrast agents uniformly, irrespective of their defining features HOW ARE INSURERS TREATING THE $2M DRUG, ZOLGENSMA For example, one of the nation’s largest private insurers, Anthem, sets out six months as the maximum age at treatment and stipulates covered infants must either show symptoms before then or have at most two copies of a related gene called SMN2, which produces a less effective, “back-up” form of SMN protein. Neither of those additional criteria are included in the FDA’s label. COMPLIANCE CHALLENGES WITHIN MEDICAL AFFAIRS Last week’s World Congress Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency highlighted compliance challenges facing medical affairs departments.. Continued regulatory pressure has shifted many “commercial” responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap PHYSICIAN PAYMENT SUNSHINE ACT FINAL RULE: RESEARCH Under the Physician Payment Sunshine Act Final Rule, certain research payments or other transfers of value made to a covered recipient by an applicable manufacturer under a product research or development agreement may be delayed from publication on the website. “This provision seeks to balance the need for confidentiality of proprietary information with the need for public transparency of “ACCELERATING MEDICINES PARTNERSHIP” AND OTHER AMP – Accelerating Medicines Partnership. In February, we wrote about the National Institutes of Health (NIH) announcement of a partnership with ten drug makers, as well as eight non-profit organizations, to accelerate the discovery of new therapies for Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, and lupus. Under the collaboration, termed the Accelerating Medicines MARKET RESEARCH AND THE PHYSICIAN PAYMENTS SUNSHINE ACTPHARMACEUTICAL SUNSHINE ACT REPORTING REQ… The market research space is an interesting one as far as Sunshine reporting is concerned because it implicates many of the same challenging “indirect payment” issues we have seen related to continuing medical education (CME). This article desc SUPREME COURT RULES IN FAVOR OF PROTECTING VACCINE MAKERS The United States Supreme Court reached a decision recently, concluding that federal law protects vaccine makers from product-liability lawsuits that are filed in state courts and seek damages for injuries or death attributed to a vaccine.In the 57-p POLICY & MEDICINE
Earlier this year, Patrizia Cavazzoni, MD, was named the Director of the United States Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The announcement was made via Dr. Janet Woodcock’s official twitter account, @DrWoodcockFDA. In the tweet, Dr. Woodcock STARK LAW FINAL RULE IS EFFECTIVE Readers may remember that just one day before President Joe Biden was inaugurated as the 46 th President of the United States, on January 19, 2021, a final rule issued by the Centers for Medicare and Medicaid Services (CMS) modernizing the physician self-referral law (the Stark Law) became effective.. Also effective on January 19, 2021, was a final rule issued by the United States THE IMPACT COVID-19 IS HAVING ON ACOS Recently, the National Association of Accountable Care Organizations (NAACOS) surveyed the Accountable Care Organization (ACO) community to gauge their experience in handling the COVID-19 pandemic. According to the results, more than half of the ACOs said they are likely to drop out of the program because they fear having to pay massive losses as a result of the pandemic. COURT RULES FDA EXCEEDED AUTHORITY WHEN IT REGULATED The US District Court for the District of Columbia recently ruled that the US Food and Drug Administration (“FDA”) exceeded its authority when it regulated a contrast agent as a drug instead of a medical device. In overturning the FDA’s decision, the court noted that the agency “does not have discretion to regulate all contrast agents uniformly, irrespective of their defining features HOW ARE INSURERS TREATING THE $2M DRUG, ZOLGENSMA For example, one of the nation’s largest private insurers, Anthem, sets out six months as the maximum age at treatment and stipulates covered infants must either show symptoms before then or have at most two copies of a related gene called SMN2, which produces a less effective, “back-up” form of SMN protein. Neither of those additional criteria are included in the FDA’s label. COMPLIANCE CHALLENGES WITHIN MEDICAL AFFAIRS Last week’s World Congress Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency highlighted compliance challenges facing medical affairs departments.. Continued regulatory pressure has shifted many “commercial” responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap PHYSICIAN PAYMENT SUNSHINE ACT FINAL RULE: RESEARCH Under the Physician Payment Sunshine Act Final Rule, certain research payments or other transfers of value made to a covered recipient by an applicable manufacturer under a product research or development agreement may be delayed from publication on the website. “This provision seeks to balance the need for confidentiality of proprietary information with the need for public transparency of “ACCELERATING MEDICINES PARTNERSHIP” AND OTHER AMP – Accelerating Medicines Partnership. In February, we wrote about the National Institutes of Health (NIH) announcement of a partnership with ten drug makers, as well as eight non-profit organizations, to accelerate the discovery of new therapies for Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, and lupus. Under the collaboration, termed the Accelerating Medicines MARKET RESEARCH AND THE PHYSICIAN PAYMENTS SUNSHINE ACTPHARMACEUTICAL SUNSHINE ACT REPORTING REQ… The market research space is an interesting one as far as Sunshine reporting is concerned because it implicates many of the same challenging “indirect payment” issues we have seen related to continuing medical education (CME). This article desc SUPREME COURT RULES IN FAVOR OF PROTECTING VACCINE MAKERS The United States Supreme Court reached a decision recently, concluding that federal law protects vaccine makers from product-liability lawsuits that are filed in state courts and seek damages for injuries or death attributed to a vaccine.In the 57-p POLICY & MEDICINE
Earlier this year, Patrizia Cavazzoni, MD, was named the Director of the United States Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The announcement was made via Dr. Janet Woodcock’s official twitter account, @DrWoodcockFDA. In the tweet, Dr. Woodcock CAVAZZONI APPOINTED DIRECTOR OF CDER Earlier this year, Patrizia Cavazzoni, MD, was named the Director of the United States Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The announcement was made via Dr. Janet Woodcock’s official twitter account, JUNE 7, 2021
18 hours ago · Legal, Regulatory, and Compliance Issues. Recently, the Journal of the American Academy of Orthopaedic Surgeons published an article reviewing industry payments made to LAWMAKERS EXPRESS CONCERN OVER LACK OF TRANSPARENCY A bipartisan group of lawmakers raised concerns about the lack of compliance among hospitals to post prices for services online. A new rule requiring them to do so went into effect January 1 but compliance is spotty. The group called on HHS to step AAOS JOURNAL PUBLISHES ARTICLE ON INDUSTRY PAYMENTS TO From 2014 to 2019, the total amount paid increased each year, from $260,472,564.51 to $394,133,594.07. A net increase was also observed in the percent of the total payments made to the five highest-paid surgeons from 10.18% of total payments (2014) to 22.96% (2019). A NEW HURDLE FOR MENTAL HEALTH CARE PROVIDED VIA Over the last year, we have seen major changes happen to federal and state telemedicine and digital health laws, including expansions to telehealth coverage and reimbursement and exemptions of controlled substance prescribing rules. While most of the JUDGE BLOCKS 340B DISCOUNT PROGRAM RULE A federal judge blocked the Biden administration from implementing a controversial rule to handle disputes over the 340B drug discount program, handing drugmakers a major win in an escalating feud over the program. The opinion grants a preliminary injunction sought by Eli Lilly, which sued the feds over the rule. The ruling comes as Lilly and several other drugmakers restricted sales of drugs GOVERNMENT INTERVENES AGAINST DEVICE MANUFACTURER SPINE Earlier this year, the U.S. Department of Justice (DOJ) announced it had intervened in a False Claims Act case against a medical device manufacturer, SpineFrontier, Inc. and related entities, as well as three executives (collectively, the “Defendants”). According to United States’ complaint-in-intervention, the Defendants violated the Anti-Kickback Statute by using a third-party company NEW – PAGE 71 – POLICY & MEDICINE Legal, Regulatory, and Compliance Issues. On October 24, 2018, the SUPPORT for Patients and Communities Act became law after passing both the House and the Senate with TRICARE”) (10 U.S.C. §§ 1071-1110B), WHICH PROVIDES HEALTH Settlement Agreement Among USA, Medicrea, and Relator Frain 2 (“TRICARE”) (10 U.S.C. §§ 1071-1110b), which provides health insurance for
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HEALTH CANADA SEEKS FEEDBACK ON GUIDANCE REGARDING NON-PROMOTIONAL MESSAGES
_ Thomas Sullivan _ Aug 9, 2019 __ 0
Health Canada recently published a draft guidance document, “The Distinction Between Promotion and Non-Promotional Messages and Activities for Health Products.” The draft guidance represents the first substantive update to Health Canada’s policy on health product communications since it was originally published in 1996 and relates to promotion of… Read More... THE YEAR OF THE STATE _ Thomas Sullivan _ Aug 23, 2018 __ 0
STATE LAWS HAVE TEETH _ Thomas Sullivan _ Aug 21, 2018 __ 0
NEVADA DHHS RELEASES UPDATED TRANSPARENCY DRAFT REPORTING… _ Thomas Sullivan _ Aug 5, 2019 __ 0
SENATORS GRASSLEY AND WYDEN EXPAND THEIR OPIOID INVESTIGATION TO… _ Thomas Sullivan _ Jul 11, 2019 __ 0
CMS TURNS FOCUS TO TRANSPARENCY _ Thomas Sullivan _ Apr 12, 2019 __ 0
RHODE ISLAND HOLDS HEARING ON PRESCRIPTION DRUG REPRESENTATIVE… _ Thomas Sullivan _ Mar 29, 2019 __ 0
ILLINOIS GIFT BAN BILL AMENDED TO MIRROR HHS OIG AND PHRMA… _ Thomas Sullivan _ Mar 27, 2019 __ 0
HEALTH CANADA BEGINS TO RELEASE CLINICAL DATA ON DRUGS AND… _ Thomas Sullivan _ Mar 20, 2019 __ 0
IFPMA NEW CODE OF PRACTICE EMBRACED BY BIOPHARMACEUTICAL R&D… _ Thomas Sullivan _ Jan 23, 2019 __ 0
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HEALTH CANADA SEEKS FEEDBACK ON GUIDANCE REGARDING… FDA REPORT SHOWS NDA AND BLA FILINGS ON THE RISE IN THE FIRST… HHS OIG PUBLISHES SEMIANNUAL REPORT TO CONGRESS DETAILING… NECC CONSPIRACY CONVICTIONS OVERTURNED ON LEGAL IMPOSSIBILITY… FTC REPORT FINDS FEWER ANTICOMPETITIVE REVERSE PAYMENT DEALS IN… NEVADA DHHS RELEASES UPDATED TRANSPARENCY DRAFT REPORTING… FDA ISSUES ENFORCEMENT LETTER REGARDING ESKATA RISKS OMITTED… HHS AND FDA OFFER TWO PATHWAYS TO DRUG IMPORTATION CMS 2020 PROPOSED PHYSICIAN FEE SCHEDULE INCLUDES CHANGES TO THE… CMS PROPOSED RULE WOULD EXPEDITE PART D PRIOR AUTHORIZATION… DOJ BRINGS ENFORCEMENT ACTIONS AGAINST HOSPITALS FOR KICKBACKS… CMS PRIMARY CARE FIRST MODEL TO LAUNCH EARLY 2020 PHARMACEUTICAL AND DEVICE International
HEALTH CANADA SEEKS FEEDBACK ON GUIDANCE REGARDING NON-PROMOTIONAL MESSAGES
_ Thomas Sullivan _ __ 0 Conflict of Interest GSK MODIFIES ETHICS-BASED REPRESENTATIVE COMPENSATION _ Thomas Sullivan _ __ 0 Congress
IS DIVIDED GOVERNMENT BAD FOR PHARMA? _ Thomas Sullivan _ __ 0 Pharmaceutical and Device ACPE ANNOUNCES THE RETIREMENT OF EXECUTIVE DIRECTOR _ Thomas Sullivan _ __ 0 FDA
FDA REPORT SHOWS NDA AND BLA FILINGS ON THE RISE IN THE FIRST QUARTER…
_ Thomas Sullivan _ Aug 8, 2019
NECC CONSPIRACY CONVICTIONS OVERTURNED ON LEGAL IMPOSSIBILITY THEORY Aug 6, 2019
FDA ISSUES ENFORCEMENT LETTER REGARDING ESKATA RISKS OMITTED FROM DTC ADVERTISING
Aug 2, 2019
HHS AND FDA OFFER TWO PATHWAYS TO DRUG IMPORTATION Aug 1, 2019
NEW FDA DRAFT GUIDANCE ON OPIOID BENEFIT-RISK ASSESSMENT INCLUDES COMPARATIVE…
Jul 16, 2019
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CME
CMS 2020 PROPOSED PHYSICIAN FEE SCHEDULE INCLUDES CHANGES TO THE OPEN…
_ Thomas Sullivan _ Jul 31, 2019
STUDY DEMONSTRATES IMPACT OF CME ACTIVITIES ON CLINICIAN AWARENESS OF BIOSIMILARS
Jun 22, 2019
ROCKPOINTE STUDY QUANTIFIES IMPACT OF CME ON AFIB TREATMENT, PROMPTS NEW WORKSHOP
Jun 16, 2019
ACCME PUBLISHES RESPONSES TO ITS JANUARY 2019 CALL FOR FEEDBACK Jun 10, 2019
ROCKPOINTE LAUNCHES NEW OBESITY CME PROGRAM ON AMAZON ALEXA-ENABLED PLATFORMS
May 22, 2019
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CMS
CMS 2020 PROPOSED PHYSICIAN FEE SCHEDULE INCLUDES CHANGES TO THE OPEN…
_ Thomas Sullivan _ Jul 31, 2019
CMS PROPOSED RULE WOULD EXPEDITE PART D PRIOR AUTHORIZATION REQUIREMENTS
Jul 30, 2019
CMS PRIMARY CARE FIRST MODEL TO LAUNCH EARLY 2020 Jul 26, 2019
CMS SEEKS PATIENT INPUT OVER PAPERWORK INITIATIVE Jul 22, 2019
THREE PHARMA COMPANIES SUE HHS, JUDGE RULES IN THEIR FAVOR Jul 18, 2019
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GSK MODIFIES ETHICS-BASED REPRESENTATIVE COMPENSATION IS DIVIDED GOVERNMENT BAD FOR PHARMA? ACPE ANNOUNCES THE RETIREMENT OF EXECUTIVE DIRECTOR Recent Posts
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