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Mintz BNA Article Discusses Medicare Overpayment Rule’s Implications for Compliance and Enforcement

March 1, 2016 | Blog | By Brian Dunphy

Expanding on our recent discussion of CMS’s long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments (“Overpayment Rule"), my colleague Larry Freedman and I published an article in BNA’s Medicare Report entitled The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement.
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CMS Releases 2017 Advance Notice and Draft Call Letter

February 29, 2016 | Blog | By Bridgette Keller, Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017 Call Letter to be released April 4, 2015, CMS is providing interested stakeholders until this Friday, March 4th to provide comments.
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Opioids, FDA and Medicare Advantage Spending on the List for Congress

February 24, 2016 | Blog

As Congress is back to Washington for its next work period, ML Strategies has published an Advisory outlining health care issues on the radar for the upcoming weeks. Highlights include: legislative initiatives on opioid abuse, mental health access, chronic care and a group of innovation bills; the FDA Commissioner nomination; and Medicare Advantage (MA) lobbying efforts.
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Groundbreaking Multi-Payer Alignment on Core Measures for Quality-Based Payments

February 23, 2016 | Blog | By Bridgette Keller

For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense. 
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Provider Confusion and Interoperability Concerns Prompt OCR and ONC to Release Guidance on PHI Sharing

February 22, 2016 | Blog

Last Friday, the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT (“ONC”) and the Office for Civil Rights (“OCR”) released two fact sheets regarding permitted uses and disclosures of protected health information (“PHI”) among health care providers and other entities covered by HIPAA.
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Hollywood Presbyterian Concedes to Hacker’s Demands in Ransomware Attack

February 19, 2016 | Blog

In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack on the hospital’s computer systems.
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FTC Again Urges Consideration of Competitive Impact on State Regulation of APRNs

February 17, 2016 | Blog | By Dionne Lomax

The Federal Trade Commission (FTC) submitted written comments last week on the likely competitive impact of a legislative proposal in West Virginia to modify the supervision requirements imposed on Advanced Practice Registered Nurses (APRNs) for certain activities.
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Amidst the Raucous Debate in D.C., States Quietly Take Action on Rising Prescription Drug Prices

February 16, 2016 | Blog | By Carrie Roll, Theresa Carnegie

Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would repeal the government non-interference clause and allow the Centers for Medicare & Medicaid Services (CMS) to directly negotiate Medicare Part D drug prices with manufacturers.
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CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

February 16, 2016 | Blog | By Lauren Moldawer

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies. 
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The Final 60-Day Rule: the Good, the Bad, and the Ugly

February 12, 2016 | Blog | By Brian Dunphy, Laurence Freedman

As we announced yesterday, the Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments within 60 days (the “Final Rule”).
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What the Administration Actually Can Do on Drug Pricing

February 12, 2016 | Blog

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have virtually no chance of passing this year.
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The Final 60-Day Rule Is Finally Here!

February 11, 2016 | Blog | By Karen Lovitch

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule"). 
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Now Trending on Twitter: Will you be my #HealthPolicyValentines?

February 11, 2016 | Blog

In 2012, an HHS staffer named Emma Sandoe created the Twitter hashtag, #HealthPolicyValentines. It was a way for health policy geeks on Twitter to post clever Valentine’s wishes online. With a story appearing on Politico today, #HealthPolicyValentines Day immediately started trending on Twitter. Below you will find a few of my tweets and some other clever ones from today’s barrage.
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CMS Takes Action Against Network Transparency While New Jersey Legislation Hits a Snag

February 10, 2016 | Blog

Just as the Centers for Medicare & Medicaid Services (CMS) began holding federal health care plans accountable for their provider network transparency obligations, the New Jersey legislature stalled in its bid to pass a law that would require hospitals and physicians to disclose whether they are in or out-of-network with a patient’s insurance plan before providing treatment. 
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Positive FDA Advisory Committee Vote for First Monoclonal Antibody Biosimilar - But Will Patent Dispute Delay Launch?

February 10, 2016 | Blog | By Joanne Hawana

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech.
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OMB Finalizes Review of 60-Day Overpayment Rule

February 9, 2016 | Blog | By Brian Dunphy

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule”).  As a result, the final 60-day rule will likely be published soon.
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Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

February 4, 2016 | Blog

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing. 
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Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

February 3, 2016 | Blog | By Alexander Hecht

Today, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under Medicare.
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ICYMI: Biosimilars and FDA Regulatory Webinar

February 2, 2016 | Blog | By Joe Rutkowski

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation.
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FDA Releases Draft Guidance for Medical Device Cybersecurity

February 1, 2016 | Blog

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called "Internet of Things." Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked.
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