I. Overview of Final Rule. On November 2nd, the Centers for Medicare & Medicaid Services (CMS) issued the final rule for the second year of the Quality Payment Program (QPP). The rule outlines the requirements for the 2018 Merit-Based Incentive P…
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In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback…
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Tags: Adherence, Anti-Kickback, Arthur Y. Tsien, Attorney, Drug, Health Care, Law Firm, Lawyer, Medication, Medication Therapy Management, P4HA, Patient, Pharma, Pharmacy, Prescriber, Prescription, Prescriptions for a Healthy America, Refill Reminder, White Paper
Kristen O’Brien serves as Counsel in OFW Law’s Health Industry Policy and Regulatory Practice, which represents clients in the health care delivery system and innovative life sciences areas. She is principally responsible for the group’s work w…
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Tags: Attorney, Biopharmaceutical, Health Care, Health Systems, Kristen O'Brien, Ladd Wiley, Law Firm, Lawyer, Medicaid, Medicare, OFW Law, Physician
In response to the tragic fallout from Hurricane Harvey, an unprecedented storm that decimated the city of Houston and a large swath of the Gulf Coast of Texas and Louisiana, the U.S. Department of Health and Human Services (HHS) declared a public he…
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Tags: Business Associate, Covered Entity, Emergency Preparedness, HHS, HIPAA, Hospital, Hurricane Harvey, Jonathan M. Weinrieb, Louisiana, Medical Privacy, OCR, Office for Civil Rights, Patient Authorization, Protected Health Information, Texas
OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice. The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery system…
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Tags: Attorney, Brett T. Schwemer, FDA, Health Care, Health Industry Policy and Regulatory Practice, HHS, Ladd Wiley, Law Firm, Life Sciences, Lobbyist, Medicare, OFW Law, Richard L. Frank
As federal policy rapidly develops under the Trump Administration, much of it reversing or seeking to reverse the Obama legacy, the world of medical privacy (at least that which is on the books for now) remains static – after all, privacy always ha…
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Tags: 21st Century Cures Act, Health and Human Services, Health Information, HHS, HIPAA, HITECH, J. Mason Weeda, Jonathan M. Weinrieb, Medical Privacy, OCR, Office for Civil Rights, President Trump, Roger Severino, Trump Administration
Happy 2017, everyone! 2016 has come and gone. Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!), ind…
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Tags: 2016, 21st Century Cures Act, Agriculture, Animal Drug, Arthur Y. Tsien, Bioengineered Food Disclosure Standard, Congress, Drug, Election Day, Feed, Feinstein Institute, Food, Food Drug and Cosmetic Act, FSIS, Genetically Engineered, Guidance, HIPAA, Law Firm, Lawyer, Mecadox, Medical Privacy, Misbranded Drug, Nutrition Facts, OFW Law, Park Doctrine, Rulemaking, Salmon, Sodium
Ever since the election we have been asked which Obama Administration regulations and executive actions are likely to be stricken by the new Trump Administration or the 115th Congress. Will the focus be on the rules issued since mid May of this year,…
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Tags: Agriculture, Appropriations, Congress, Continuing Resolution, Donald Trump, Farm Bill, FDA, Food, Freedom Caucus, Labeling, Regulation, Roger R. Szemraj, SNAP, Trump Administration, USDA
With President-Elect Donald Trump’s unlikely victory in Tuesday’s election, we begin to look ahead at what the Trump Administration will mean from a medical privacy perspective. Neither the media, nor Trump himself, made privacy, much less medica…
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Tags: Ben Carson, Cybersecurity, Donald Trump, HHS, HIPAA, HITECH, J. Mason Weeda, Jonathan M. Weinrieb, Law Firm, Lawyer, Medical Privacy, Newt Gingrich, Obamacare, OCR, President, Privacy, Regulation, Rich Bagger, Rick Scott, Treatment Communication, Trump Administration
As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assess…
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