Monday Morning Recap: The Week (10.13.14-10.19.14) in Drug & Device Law & Policy

October 20, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3It’s Monday morning, time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. Making the news this week was a release by WikiLeaks of “a second updated version of the Trans-Pacific Partnership (TPP) Intellectual Property Rights Chapter[,]” which will have significant implications for access to medicines. Public Citizen has released a detailed analysis of the pharmaceutical issues that remain under negotiation, here. Public Citizen notes that the negotiating countries are still wide apart on some issues and are, for example, “debating a range of possible monopoly periods for biotech drugs, ranging from zero years to twelve.”

2. Ebola drug development continued to make the news this week. This article by Peter Loftus and Betsy McKay at the Wall Street Journal provides a very helpful overview. Loftus and McKay quote Food and Drug Administration Commissioner Margaret Hamburg who “said the agency has shifted more employees to help speed the development of drugs, vaccines and diagnostics. ‘We’ve been up in the middle of the night in order to make product available’ on an emergency basis to infected patients in the U.S., she said in an interview this week.

3. Turning now to diseases for which safe and effective vaccines have been developed and are widely available, this week Karen Kaplan at the LA Times analyzes new Centers for Disease Control data on vaccine coverage among children in kindergarten. Kaplan highlights the fact that, “[a]cross the country, the median rate of MMR vaccination for kindergartners in the 2013-2014 school year was 94.7% for the MMR vaccine[,]” with “seven states and the District of Columbia [reporting] rates below 90%. At those rates, some communities are in danger of losing herd immunity – having enough people vaccinated to protect the small number of those who can’t get shots for medical reasons.”

4. At Forbes John Osborne reported that “Chairman Fred Upton (R-Michigan) and some of his colleagues on the House Energy & Commerce Committee want to talk about the off label issue.” Osborne notes that Congress could “direct the FDA to establish a new pathway under which truthful information outside the scope of the approved label would be able to be discussed with physicians. … Congress also could simply declare that the FDA may not regulate the communication of truthful information, and that may (or may not) limit the Justice Department’s determination to apply the False Claims Act to cases where off label prescribing is prevalent.” Osborne writes that “Chairman Upton plans to introduce an omnibus reform bill in the new Congress. If the off label issue is addressed, it would represent a historic change in attitude and behavior within the United States government that would clearly have significant implications for the way in which the FDA regulates drug, biotechnology and device company communications.

5. Finally, not this week but still worth noting, earlier this month the Office of Inspector General of the Department of Health and Human Services published a proposed rule which “would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules under the authority of the Office of Inspector General (OIG).” The rule “would protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute[,]” “codify revisions to the definition of ‘remuneration,'” and “add a gainsharing CMP[.]“ This McDermott Will & Emery summary of the proposed rule provides helpful context. Comments on the rule are due December 2, 2014.


Experimenting with Transparency and Decision Support to Inform Health Plan Selection

Tara Ragone

Cross-Posted at HealthLawProf Blog

As we prepare for the second open enrollment period for the health insurance marketplaces to begin in just over one month, transparency offers a potential means of empowering consumers to make better decisions regarding the health plans they choose.

Some states are making strides in this area. The New Hampshire Insurance Department was an early leader on the transparency front, creating a website called NH HealthCost in 2005 to provide information on the costs of medical services based on claims data collected from the state’s insurers and stored as part of the Comprehensive Health Care Information System. Although the site was down for months earlier this year because of problems encountered when it changed vendors, it is back up and running and promises that “significant changes” are in store. Currently, however, it only offers data on the costs of a few dozen medical services, such as MRIs, CT scans, ultrasounds, X-rays, colonoscopies, and emergency room visits.

Beginning October 1, 2014, insurers in Massachusetts must provide information about the full-range of costs for medical care on their websites. As Martha Bebinger reported earlier this week, there are some limitations to the disclosures. For one, the prices are not standardized among carriers, and thus some reported prices include all charges related to a particular medical service whereas others exclude related costs, such as charges to read the test or facility fees. In addition, carriers sometimes use different terminology to refer to the same procedure. Such differences make it difficult for consumers to make meaningful comparisons. There also are few prices available for inpatient care, and there is limited information about the quality of care provided at different costs. Consumers will need to log into their account, and the program will calculate each consumer’s particular deductible, co-pay, and co-insurance amounts based on what claims they already submitted in a plan year.

Although these efforts to make the cost of healthcare more transparent are important, consumers already tend to over-focus on cost when choosing health insurance. A Kaiser Family Foundation survey, for example, found that twenty-seven percent of consumers who purchased non-group coverage for 2014 identified cost as the most important factor in choosing a plan. In contrast, only eleven percent identified choice of doctors or providers as the most important factor.

Recent articles about out of network bills by Elisabeth Rosenthal and others are important reminders of how important it is for consumers to balance cost with access to needed providers, among other salient factors. Yet surveys by McKinsey & Co. and the Commonwealth Fund similarly found that roughly a quarter of consumers who enrolled in exchange plans did not know whether they had chosen a broad or narrow network plan, and McKinsey found that this number increased to forty-two percent for consumers who previously were not insured. The Commonwealth Fund survey further found that thirty-nine percent of adults who enrolled in an exchange plan or Medicaid through the marketplace did not know which doctors were included in their plan.

An August 2014 report of physician network transparency by the Urban Institute highlighted Massachusetts’ Health Connector as a model of transparency in many respects. For one, it includes a dedicated “provider network disclosure” section for each plan that makes plain whether the plan has a general or limited provider network and identifies in red lettering under each plan name if the plan includes a narrow network of providers. It also embeds provider directories for all plans in its state marketplace with full search functionality, which helps “alleviate the complexity and confusion around network-based plan choice.”

Although received praise in the report for displaying plan type directly beneath each plan’s name and including a hover definition, it was criticized for not embedding provider directories. And as Margot Sanger-Katz reported earlier this week, still will not have the capacity to permit consumers to identify which doctors and hospitals are participating with particular plans or to compare networks among different plan options in the fall 2014 open enrollment period. Consumers in the twenty-seven FFM states instead must navigate insurers’ external websites, which have varied greatly in terms of content and user-friendliness. For example, as the Urban Institute report noted, “[m]ost Marketplace websites link to carrier pages where it is difficult to associate a directory with a particular Marketplace plan because network names do not always match Marketplace plan names, and a single insurer can have different networks that apply to different plans.”

Although an FFM state cannot change, it can make information available to consumers to aid consumer choice, either by directly providing this information to consumers or by regulating carriers offering plans in its state.

The Pacific Business Group on Health’s Helping Vulnerable Consumers in the Exchange Project offers a number of transparency resources for states with and without exchanges to use as they build, or require insurers to build, consumer choice decision support. It is important to proceed thoughtfully because behavioral economists have found that too much information is not necessarily good. The jackpot question is how to improve transparency on multiple fronts without overwhelming consumers with too much information.

Alternatively, states may look to use decision support resources developed by others. A team of business, law, health care management, and technology professors at the University of Pennsylvania partnered with a veteran insurance company executive to launch Picwell in September 2014, which uses predictive analytics to offer personalized recommendation and decision-support technology to healthcare consumers. As its site explains:

The first technology of its kind, Picwell marries Big Data, predictive analytics, behavioral economics, and machine learning with consumer friendly user interfaces and engagement tools that integrate directly into healthcare exchanges and benefits platforms. The end result enables exchanges to quickly and seamlessly organize and analyze more than 900,000 variables that affect plan selection and present the highest recommended plans to participants based on their individual needs.

It was announced this week that Picwell will use its predictive recommendation engine to analyze the plan choices consumers made during the 2014 open enrollment period using deidentified data from state exchanges, beginning with Minnesota’s insurance exchange, MNsure.

The Robert Wood Johnson Foundation also is sponsoring the Plan Choice Challenge, which offers cash prizes to developers who design an “an app that will help consumers compare health plan cost sharing features and choose the best plan.” RWJF narrowed the field to six finalists in late September 2014 and plans to announce a winner in February 2015, following submission of Phase II plans in January 2015.

Many questions remain, including how to standardize available information so that consumers may make apples to apples comparisons, how to educate consumers about how to use these resources, and how to monitor these tools for accuracy and to ensure they are not subject to manipulation or industry capture. There is much work to be done, but I hope the experimentation continues.


Seton Hall Law’s Sentinel Project in the News

October 15, 2014 by · Leave a Comment
Filed under: Uncategorized 

site3Journalist Beth Fitzgerald wrote an article about Seton Hall Law’s Sentinel Project that ran in yesterday’s NJ Biz. Fitzgerald writes:

Seton Hall Law School professor John Jacobi said the project is looking at ‘the extent to which people who get health insurance are actually successful in getting the care they need.’ He noted that ‘Health coverage is not the same as access, and we are hoping to learn how the insurance plans offering care in the individual and small group markets are doing when it comes to connecting people to appropriate care.’

He said the project began earlier this year and will continue through 2015. Tuesday, the Sentinel Project began publicizing its website and encouraging individuals and employers who have encountered problems with health care access to contact them.

Jacobi said that, so far, ‘The areas of concerns raised most often have to do with access to behavioral health services and to services for people with developmental disabilities.’ He said work on these areas is ongoing and ‘We are following up and hoping we get to the point where we understand where the problems are.’

Read the entire article here.


Seton Hall Law’s Sentinel Project: Help Us Help New Jerseyans with Insurance Issues

October 14, 2014 by · Leave a Comment
Filed under: Seton Hall Law 

Sentinel Project mailer v5


Monday Morning Recap: The Week (10.6.14-10.12.14) in Drug & Device Law & Policy

October 13, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3It’s Monday morning, time for what Ed Silverman calls a  “ritual cup of stimulation,” and time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. At USA Today, Peter Eisler and Christopher Schnaars report that “[t]wo years after contaminated drugs linked to a compounding pharmacy in Massachusetts killed 64 and sickened more than 750 with fungal meningitis, the industry still struggles with serious safety problems affecting thousands of patients … A regulatory crackdown by the U.S. Food and Drug Administration since the outbreak in October 2012 has led to an unprecedented spate of drug recalls by compounding pharmacies — and scores of citations for bad practices.

2. At the Food and Drug Administration’s FDAVoice blog, Jean Hu-Primmer discusses a new joint effort between FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the United States Critical Illness and Injury Trials Group (USCIITG) “to gather important information about medical countermeasures used during public health emergencies.” Among other things, the project will work to “address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making. … USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.”

3. At Bloomberg BNA’s Health Care blog, Alex Ruoff reports that “[n]early 60 health information technology groups and various industry associations are circulating a letter among member of Congress asking for legislation that clarifies the Food and Drug Administration’s authority to regulate health IT products. The letter was also sent to Health and Human Services Secretary Sylvia Mathews Burwell and called on lawmakers to pass legislation reflecting health IT oversight recommendations made earlier this year by three federal agencies, including the FDA and the Office of the National Coordinator for Health IT. The proposed legislation would ‘provide much needed statutory clarity and a stable foundation for continued innovation in health IT’ by establishing parameters, defined by the framework, for the FDA to oversee health IT products, the letter said.”

4. And at Bloomberg BNA’s Life Sciences Law & Industry Report, Nicole Ostrow summarizes the results of an analysis in the Annals of Internal Medicine that found that “[researchers] with financial ties to flu drug companies more often reported positive findings in their studies of the treatments… Christine Laine, editor in chief of the Annals and a senior vice president at the American College of Physicians in Philadelphia, said there’s a lot of confusion for doctors because of the conflicting findings among the studies of the flu medicines. Today’s results provide some insight into why the literature on this topic has been ‘inconsistent.’

5. Finally, I can’t recommend it yet, because I it hasn’t climbed to the top of the pile yet, but I am looking forward to reading this month’s Health Affairs, on Specialty Pharmaceutical Spending & Policy, cover to cover. (I did sneak a peak at the Narrative Matters piece, by Leana Wen, in which “[a] doctor who stutters confronts the stigma against patients—and providers—with disabilities.” It’s off the topic of drug and device law and policy, but of general interest and very thought-provoking.)


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