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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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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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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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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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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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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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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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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

February 10, 2016 | Advisory | By Theresa Carnegie, Lauren Moldawer

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).
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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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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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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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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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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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The Challenge of Non-Interference

January 29, 2016 | Blog

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example.  Acme Drug Company brings a drug to the market as a single source innovator. 
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This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today to more than 80 million by 2036.
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The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings.
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In 2012 Massachusetts adopted the most recent in a series of comprehensive legislative approaches to health care reform, Chapter 224 of the Acts of 2012 (Chapter 224), which focused especially on addressing the drivers of health care costs in the Commonwealth. 
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