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Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR
June 20, 2018 | Blog
Privacy and security compliance obligations for health care companies remain hot topics this spring. Health care companies must now contend with data breach laws in all 50 states as well as keeping on top of federal HIPAA developments.
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A Deeper Dive: What the Trump Administration Blueprint to Lower Drug Prices Might Mean for Medicaid
June 19, 2018 | Blog
It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.
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ML Strategies Health Care Preview - June 18th
June 18, 2018 | Blog
Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis.
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Appeals Court Rejects Insurers Risk Corridors Claims
June 14, 2018 | Blog | By Xavier Hardy
On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government. Inside contains more detailed information on the program.
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HIPAA Tips from the Trenches
June 14, 2018 | Blog
Earlier this week, I moderated a panel discussion at an event hosted by the New York chapter of the Health Information and Management Systems Society (HIMSS). The panel was comprised of private sector health information technology and security experts and was tasked with discussing challenges related to the interoperability and security of health information systems.
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Mintz’s Health Care Enforcement Defense Group Publishes Latest Qui Tam Update
June 12, 2018 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect.
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Decision Expected Soon in Ongoing Risk Corridors Litigation
June 12, 2018 | Blog | By Xavier Hardy
Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby Lobby. One of the more overlooked topics of litigation has been the ACA’s “Risk Corridors” program.
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ML Strategies Health Care Preview - June 11th
June 11, 2018 | Blog
This week the Senate Finance Committee will mark up its opioid package. Additionally, the HELP Committee will hear from Secretary Azar on the Administration's effort to lower prescription drug prices. For our complete review and what else to watch for this week.
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The Hazards of Prescription Auto-Refill Programs
June 6, 2018 | Blog | By Lauren Moldawer
States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, regulators argue that automatic refill programs result in waste to the system, stockpiling, and federal program payment for unneeded prescriptions.
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New Bill Would Expand the Sunshine Act to Cover Physician Assistants and Advance Practice Nurses
June 5, 2018 | Blog
Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to cover payments and other transfers of value made to advance practice nurses and physician assistants.
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ML Strategies Health Care Preview - June 4, 2018
June 4, 2018 | Blog
Congress is back in session for a four week work period. With the focus on opioids, there's the potential that meaningful legislation gets done. We will also continue monitoring state action as it relates to work requirements and other initiatives via 1115 waivers.
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A Rundown of Recent State Action Relating to Medicaid Expansion
June 4, 2018 | Blog
To date, 34 states (including D.C.) have adopted Medicaid expansion. Of the remaining 17 states, some are considering expanding Medicaid.
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OCR Highlights Importance of Physical Safeguards to Protect PHI
May 31, 2018 | Blog
The May 2018 cyber security newsletter from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) focused on a topic often overlooked by covered entities and their business associates: physical security.
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HHS Announces a "Settlement Express" Option for Medicare Appeals
May 29, 2018 | Blog | By Bridgette Keller
HHS's Office of Medicare Hearings and Appeals (OMHA) has long faced a backlog in Medicare appeals to Administrative Law Judges (ALJs). In an effort to address this backlog, OMHA established a Settlement Conference Facilitation (SCF) process.
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Ohio Submits 1115 Waiver on Work Requirements
May 23, 2018 | Blog
In a previous blog, we reviewed pending and approved 1115 waivers in 11 states. These reviews provide an overview of 1115 waiver applications, including a focus on work requirements, lock-outs, changes in coverage structures, repealing the Medicaid IMD exclusion, and other behavioral health initiatives.
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DOJ Continues Aggressive Enforcement Action Against Opioid Manufacturers
May 22, 2018 | Blog | By Benjamin Zegarelli
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.
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ML Strategies Health Care Preview - Week of May 21st
May 21, 2018 | Blog
This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week.
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Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices
May 21, 2018 | Blog
On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.
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The General Data Protection Regulation (GDPR) Goes Into Effect in Under 10 Days!
May 16, 2018 | Blog
In less than 10 days, the European Union will begin enforcing its General Data Protection Regulation (GDPR) which will apply to any company that collects, processes, or uses EU-origin personal data, regardless of where the company is located.
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ML Strategies Health Care Preview - May 14, 2018
May 15, 2018 | Blog
This week, the House Energy & Commerce Committee will hold its second round markup of opioid-related legislation. While they remain on pace for passage by Memorial Day, the timing will be determined by how smooth the markup this week goes.
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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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