Numerof & Associates Releases Annual Report on Health Adoption
On April 10, 2018, Numerof & Associates released its third annual national study of population health adoption. The report provides a national in-depth look at the pace of transition from fee-for-service models to models that are based on fixed payments linked to outcomes. According to the report, a growing number of healthcare delivery organizations are failing to keep pace with their population health objectives and are actually continuing to fall further behind the industry leaders. The report surveys and summarizes responses from over 400 executives and decision makers in the healthcare industry. Unfortunately, p...
Source: Policy and Medicine - April 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition
  In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help. We have been covering for some time now the apparent war on patient assistance programs (“PAPs”) being waged by the Department of Health and Human Services Office of Inspector General (“OIG”). It seems that at the core its OIG is inherently suspicious of any PAPs that cover a patient’s insurance co-payment especially...
Source: Policy and Medicine - April 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Bernie Sanders Introduces Bill Imposing Jail Time for Pharma Execs
Vermont Senator and former Democratic presidential candidate Bernie Sanders introduced a bill into the United States Senate on April 17, 2018, that would impose jail time on pharmaceutical executives whose companies engage in manipulative practices when marketing opioids. The bill, the Opioid Crisis Accountability Act of 2018, prohibits illegal marketing and distribution of opioids, creates a criminal liability for top company executives, penalizes drug manufacturers who illegally advertise, market, or distribute an opioid product, and requires drug makers to reimburse the United States for “the negative economic impact...
Source: Policy and Medicine - April 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Escobar Hurdle – False Claims, Materiality, and Dismissal
U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court opted to vacate a nearly $350 Million FCA verdict involving a nursing home operator. The case is significant because it demonstrates the ongoing impact of a party’s failure to meet the Escobar materiality standard. For many months, we have followed the U.S. Supreme Court decision in case of Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”). Back in August 2016, we noted that it appeared neither side won a decisive victory, but time would tell. Starting with a...
Source: Policy and Medicine - April 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Physician Specialty Groups Caution Against Proposed Drug Pricing Changes
Nine of the nation’s leading physician groups – including the American College of Rheumatology, American Academy of Neurology, American Academy of Ophthalmology, and American Urological Association – joined together this week to urge the Trump Administration to reconsider some of the policy changes suggested in recent drug pricing proposals that would have negative effects on patient care. In a letter sent to U.S. Department of Health and Human Services Secretary Alex Azar, the groups cautioned that the Administration’s proposal to consolidate certain physician-administered drugs covered under Medicare...
Source: Policy and Medicine - April 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Insys Net Gets Wider
In mid-March 2018, five New York City doctors were arrested and charged with accepting bribes and kickbacks from Insys Therapeutics to prescribe high volumes of Subsys, a fentanyl-based cancer pain medicated spray. The five doctors – Gordon Freedman, 57, of Mount Kisco; Jeffrey Goldstein, 48, of New Rochelle; Todd Schlifstein, 49, of Manhattan; Dialecti Voudouris, 47, of Long Island City and Alexandru Burducea, 41, of Little Neck – all practiced in Manhattan and pled not guilty in federal court to an unsealed indictment charging them with several charges, including conspiracy. The five doctors allegedly collected tens...
Source: Policy and Medicine - April 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

It ’s Not All About the Money - Medtronic’s Infusion Multi-State Settlement Agreement
  In a closely watched matter culminating years of litigation, Medtronic on December 12, 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry. Within both the U.S. medical device manufacturing arena as well as the life science compliance communities, ...
Source: Policy and Medicine - April 18, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Gottlieb Discusses Opioids and Lays Out Vision
Conclusion Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions. Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic schedule...
Source: Policy and Medicine - April 18, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Nicodemo (Nico) Fiorentino Joins Life Science Compliance Update as Associate Editor
As Life Science Compliance Update enters its fourth year of publication, it is a great pleasure to announce that Nicodemo Fiorentino joins Thomas Sullivan, Publisher and Dr. Seth Whitelaw, Editor as a member of the Update’s editorial staff.  “Nico brings an outstanding mix of passion, scholarship and pure writing ability that will only enhance quality of the publication,” said Sullivan.  “It is aligned with our goal to create a single resource that allows busy compliance professionals and business executives to read less but become more attuned.” “It’s a sign that both the topics we cover and t...
Source: Policy and Medicine - April 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

State of Washington Enacts Statewide Drug Disposal Law
On March 22, 2018, the State of Washington officially enacted the first statewide drug take-back program in the country. Washington Governor Jay Inslee signed HB 1047 into law, which establishes a single, uniform, statewide system of regulation for safe and secure collection and disposal of medicines through a uniform drug "take-back" program operated and funded by drug manufacturers. The Act goes into effect on June 7, 2018, and requires “covered manufacturers” to submit their proposed programs by July 1, 2019. Also by July 2, 2019, Washington’s Department of Health (DOH) must determine its own costs for administra...
Source: Policy and Medicine - April 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept
For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to expand its efforts to use data analytics to detect Medicare fraud. While promising, it remains to be proven that the tool and techniques will be cost-effective in this context. The fiscal year 2017 was a big year for the Office of Inspector General of the Department of Health and Human Services (“OIG”). Among many important accomplishments, the OIG undertook “the largest healthcare fraud takedown in history,” involving more than 400 defendants and more than $1.3 billion in false billi...
Source: Policy and Medicine - April 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

House E & C Subcommittee on Health Reviews Dozens of Opioid Bills
Conclusion Chairman Burgess indicated that he is still deciding whether to combine numerous opioid-related bills into a single legislative package or try to move the bills through committee individually. Chairman Burgess noted that it is possible to put all of the legislation together in one package, but added that part of him “wants to consider them as individual bills so that, as we go through at least the subcommittee markup and the full committee markup, there will be ample opportunity for people’s ideas to be heard.”         (Source: Policy and Medicine)
Source: Policy and Medicine - April 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

OPDP Sends First Untitled Letter of 2018
Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has finally issued its first untitled letter of the year. The letter, sent to Collegium Pharmaceutical, dealt with an exhibit promoting the company’s opioid drug Xtampza ER (oxycodone). The exhibit in question was Collegium’s exhibit booth at the American Society of Health-System Pharmacists’ summer 2017 meeting. The exhibit promoted Xtampza ER, which is an opioid approved for managing "pain severe enough to require daily, around-the-clock, long-term opio...
Source: Policy and Medicine - April 13, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Coming into the Modern Era - CMS Creates Interagency Task Force to Examine Alternative Payment Mechanisms
To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) created some “value-based programs” (“VBPs”) which provide incentives for cost cutting while ensuring the quality of patient care. VBPs inherently rely on collaboration between referring physicians and other healthcare providers as well as share Electronic Health Record (“EHR”) systems, thereby conflicting with the old fee-for-service fraud protection provided by the Anti-Kickback Statute and the Stark Law. CMS Administrator...
Source: Policy and Medicine - April 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

How Can We Increase Value and Monitor / Lower Costs?
Conclusions Insurance plans should be mindful of the impact of cost-sharing because, as Baicker notes, "There is ample evidence that when patients have to pay more for care, they consume less of it.” This can, however, result in patients not paying for lower-value care and skimping on necessary services and treatments. Financial incentives on both sides of the equation may be the key to increasing value while monitoring increasing healthcare costs.       Related StoriesThe Day After Tomorrow – The Drug Pricing Transparency Chorus Grows LouderSenate Holds Hearing on 340B Drug Prici...
Source: Policy and Medicine - April 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs