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ACO Model Expansion Hinges on Increasing Medicare Program Flexibility
May 28, 2015 | Blog
Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM).
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FDA Makes More Electronic Submissions Mandatory
May 22, 2015 | Blog | By Joanne Hawana
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry to the Agency.
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ML Strategies: 21st Century Cures and Other Health Legislation Markup
May 20, 2015 | Blog | By Bridgette Keller
Earlier this week, ML Strategies posted its weekly Health Care Update which provided timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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21st Century Cures Legislation “Punts” on Telemedicine
May 18, 2015 | Blog | By Carrie Roll
On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation.
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ML Strategies: 340B Discount Drug Program Guidance Submitted to OMB
May 15, 2015 | Blog | By Samantha Kingsbury
Earlier this week, ML Strategies (MLS) posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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More Biosimilar Q&A’s Released by FDA
May 14, 2015 | Blog | By Joanne Hawana
After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.”
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CMS Changes Medicare Prescriber Enrollment Requirements
May 14, 2015 | Blog | By Tara E. Dwyer
On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date, provisional supplies, and “other authorized prescribers” (a newly defined term).
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Is Your Pharmacy Ready for Drug Supply Chain Integrity?
May 13, 2015 | Blog | By Joanne Hawana
Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers.
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ML Strategies: 21st Century Cures Initiative and Pioneer ACO Expansion
May 7, 2015 | Blog
ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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ONC Releases Privacy and Security Guidance Geared Toward Small Providers
May 7, 2015 | Blog | By Ryan Cuthbertson
The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information.
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Medicare Part D Data Release Continues Transparency Trend
May 6, 2015 | Blog | By Brian Dunphy
The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers prescribed in 2013 under the Medicare Part D Prescription Drug Program.
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GAO Report Analyzes Options for Medicare Card Technology
May 5, 2015 | Blog
Historically, the Center for Medicare and Medicaid Services ("CMS") issues all Medicare beneficiaries a paper card that includes the beneficiary's name, Medicare number and eligibility status.
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New York Medicaid Redesign Program May Be Anticompetitive
May 5, 2015 | Blog | By Dionne Lomax
In an April 22, 2015 letter to the New York State Department of Health, the Federal Trade Commission (FTC) cautioned that part of the state’s Medicaid reform program may sanction anticompetitive behavior.
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Proposed GME Legislation Looks to Increase Residency Slots
May 4, 2015 | Blog
Last week, new bi-partisan legislation was introduced to increase the number of graduate medical education (GME) slots over the next five years at teaching hospitals and academic medical centers.
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FDA Finalizes Key Guidance Documents on Biosimilars
April 30, 2015 | Blog | By Joanne Hawana
On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA).
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Data Breach Nightmare Scenario: News Affiliate Reports Improper Disposal of Patient Information
April 29, 2015 | Blog
A tip from a local Denver news outlet lead to a compliance review, investigation and ultimately a resolution agreement between the Department of Health and Human Services' Office for Civil Rights ("OCR") and Denver-based Cornell Prescription Pharmacy ("CPP").
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States Move to Impose Limits on Biosimilar Drug Substitution
April 27, 2015 | Blog | By Joanne Hawana
In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed biological product.
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MACRA’s Advancement of EHR Interoperability and Telehealth
April 24, 2015 | Blog | By Dianne Bourque, Ellen Janos
This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post, payment provisions and offsets in our April 21st post, and provisions relating to program integrity and fraud and abuse in our April 23rd post.
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MACRA: Program Integrity and Fraud and Abuse Provisions
April 23, 2015 | Blog | By Samantha Kingsbury
On Thursday April 16th, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). Pub.L. 114-10. In two previous posts, we discussed MACRA’s repeal of the Sustainable Growth Rate formula (the “SGR”) and physician payment reform, and the payment provisions and offsets established by MACRA.
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5 Takeaways from the HHS OIG's Guidance for Health Care Governing Boards
April 22, 2015 | Blog | By Karen Lovitch, Ryan Cuthbertson
Yesterday the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled Practical Guidance for Health Care Governing Boards on Compliance Oversight (the Guidance).
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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