Monday Morning Recap: The Week (3.31.14-4.6.14) in Drug & Device Law & Policy

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. This week the New York Times published the seventh part  of Elisabeth Rosenthal’s gripping series Paying Till It Hurts, this one on the increasingly-costly drugs and devices relied on by Type I diabetics.

2. At The Atlantic, Clara Ritger summarizes “[a] new report from the Centers for Disease Control and Prevention find[ing] that states don’t offer many of the Health and Human Services Department’s recommended [tobacco cessation] treatments, and the services they do cover come with co-pays, limits on the duration of use, and other barriers to access for Medicaid patients.” Ritger explains that “[a]lthough more states increased the number of [tobacco cessation] treatments covered between 2008 and 2014, more states also added barriers to accessing those treatments. That trend can be attributed, in part, to the Affordable Care Act’s requirement that state Medicaid programs cover all FDA-approved tobacco cessation medications by January 2014. Not all states used to offer that benefit, so as some added it, they also added it with restrictions.”

3. The Philadelphia Inquirer ran a story about a campaign by Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Amy Reed, an anesthesiologist, to end the use of electric tissue-cutting morcellators in gynecologic surgery. ”Power morcellation, introduced in 1993, enables tissue removal through tiny abdominal incisions, but in rare cases it can also spread a hidden uterine cancer called leiomyosarcoma. Reed, a mother of six, has become the poster woman for that awful scenario. During a minimally invasive hysterectomy in October at Brigham and Women’s Hospital in Boston, the morcellator hurled uterine tumor fragments that were implanted in her abdominal cavity. She now has stage-four leiomyosarcoma, and the hospital acknowledges the procedure likely worsened her prognosis.”

4. Sachin Jain, Michael Rosenblatt, and Jon Duke published a piece in JAMA about a partnership between the Indiana University School of Medicine’s Regenstrief Institute and Merck to conduct research on electronic clinical data from the Indiana Network for Patient Care (INPC), a health information exchange. The authors write: “Neither industry nor academia can navigate this terrain alone—nor should they. Working together, governments, health plans, academic delivery systems, electronic medical record vendors, and private sector companies have the potential to analyze data to improve care and enhance the sophistication of this research.” That said, “[r]igorous controls on how the data are used and by whom, careful and considered alignment of interests, and focused investments in long-term capability-building are important starting points for this new and expanding frontier of collaboration.”

5. Finally, at the FCPA Professor Mike Koehler discusses the Foreign Corrupt Practices Act in light of the Supreme Court’s recent campaign finance decision, McCutcheon v. FEC.  He writes: “In the end, the double standard between the meaning of corruption as it relates to ‘foreign officials’ vs. U.S. ‘officials’ matters as it undermines the legitimacy and moral authority on which the U.S. government acts.”

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Commonwealth Study Finds Access to Health Care for Low-Income Populations Varies by State

September 26, 2013 by · Leave a Comment
Filed under: Disparities, Health Reform, Medicaid 

Doctor's OfficeThe Commonwealth Fund (“Commonwealth”) has recently released its first-ever Scorecard, which provides a state-by-state comparison of the health care experiences of the 39 percent of Americans with incomes less than 200 percent of the federal poverty level. The report, titled Health Care in the Two Americas: Findings from the Scorecard on State Health System Performance for Low-Income Populations, finds striking disparities by income within and among states, and many news sources have quickly made these findings known to the public.

The purpose of the study was to identify opportunities for states to improve how their health systems serve their low-income populations and to provide benchmarks of achievement tied to the top-performing states. The report is based on thirty indicators of access, prevention and quality, potentially avoidable hospital use, and health outcomes, but does not analyze the potential effect of the 2010 healthcare law, the Patient Protection and Affordable Care Act (“ACA”). This law was designed, in part, to guarantee healthcare access for all Americans no matter where they live and the study’s lead author and Commonwealth’s senior vice president Cathy Schoen has suggested that “[w]e ought to be able to close the geographic divide … There is potential for a real leap forward.”

More specifically, the study finds that the poor in the highest-ranking states are more likely to be covered by health insurance, to have a regular source of medical care, and to get recommended preventative care. Health system performance for low-income populations in leading states is often better than the national average and better than it is for high-income populations in other states. Several news articles have pointed out that Texas is the state with the largest rate—55 percent—of uninsured low-income adults. Nine of the ten states at the bottom were in the South–other states at the bottom include Alaska, Florida, Georgia, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Virginia and Wyoming, all of which have refused to expand their Medicaid programs. New Jersey is ranked number 26. It is also among the states that will participate in the Affordable Care Act’s Medicaid expansion.

Significantly, Commonwealth notes that having low income does not have to mean below-average access, quality, or health outcomes. Further, the Scorecard finds much less state-to-state variation in health and health care experiences among people with higher incomes.

As the ACA continues to take effect, the report is optimistic that the Act “represents a historic opportunity for states to provide better health care to economically vulnerable people by providing resources to overcome the geographic and income divide—especially for states with high rates of poverty.” In light of the Senate’s recent 100-0 vote to avert government shutdown, the date on which health care exchanges set up under the Affordable Care Act will go into effect, October 1, looms ahead.

Photo, of a doctor’s office in New Orleans, courtesy of Bart Everson.

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Adventures in Health Care Cost Cutting

March 17, 2013 by · Leave a Comment
Filed under: Health Reform, Medicaid 

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Expect to keep hearing more talk about health care cost cutting, despite charts like this. It’s an idee fixe of the Wall Street/Washington corridor, and will only be implemented more vigorously over time.  So perhaps we should take stock of a few cost cutting initiatives. Medicare Part D, it seems, is coming way under its projected budget.  But maybe that’s because of ”a sharp fall in the number of breakthrough drugs,” a sign that innovation in pharma is stalling.  Cost cutting triumph, or logical outgrowth of a system that fails to reward actual contributions to health?

There’s also been a lot of pressure on skilled nursing facilities to hold the line on costs.  What are we getting in return? Here’s a summary from OIG:

Skilled nursing facilities (SNF) are required to develop a care plan for each beneficiary and provide services in accordance with the care plan, as well as to plan for each beneficiary’s discharge. . . For 37 percent of stays, SNFs did not develop care plans that met requirements or did not provide services in accordance with care plans. For 31 percent of stays, SNFs did not meet discharge planning requirements. . . . [R]eviewers found examples of poor quality care related to wound care, medication management, and therapy. These findings raise concerns about what Medicare is paying for. They also demonstrate that SNF oversight needs to be strengthened to ensure that SNFs perform appropriate care planning and discharge planning.

I’m sure the health care cost cutters will use this evidence to demand the SNFs be paid even less–rather than, say, investing real funding in proper training and pay in this vital service sector.  At some point, though, costs get cut so much that Medicaid will become little more than a meaningless plastic card, and “SNF” will stand for “Scarce Nursing Forever.”

This post first appeared on HealthLawProf Blog.
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Tara Ragone in Modern Healthcare on potential impact of U.S. Supreme Court hospital antitrust decision

March 5, 2013 by · Leave a Comment
Filed under: Antitrust, Health Law 

tara-ragoneResearch Fellow & Lecturer in Law Tara Ragone appeared in Modern Healthcare on the potential impact of a recent U.S. Supreme Court decision which found a hospital not exempt from antitrust scrutiny, despite its claim to be protected from such through “state action immunity doctrine,” which, according to Modern Healthcare, “gives states wide latitude to regulate competition.”

The Court’s decision was unanimous, citing the fact that although the hospital system in question, Phoebe Putney Health System, “operates public hospitals under a $1-a-year lease from the Albany-Dougherty Hospital Authority,” it did not dispute that its latest hospital acquisition would give it “control of 86% of  a six county market after the sale.” The Court, according to Modern Healthcare, ruled that Phoebe Putney’s financial relationship with the state was not sufficient to render its state action immunity defense tenable, and that “states must expressly grant antitrust immunity to local entities.”

The Modern Healthcare article notes, however, that the decision may also have impact on Medicaid ACOs under the ACA.

Modern Healthcare writes:

And it also could affect Medicaid ACOs. “The state action doctrine has been expanded, expanded, expanded to essentially immunize them,” [Matthew] Cantor said. “The Supreme Court is going to look a bit wary about stark anti-competitive behavior.”

But Tara Adams Ragone, a research fellow and lecturer at Seton Hall University School of Law who has written about how to structure Medicaid ACOs to avoid antitrust scrutiny, noted that the laws in New Jersey, New York, Oregon and Washington do state that they intend to authorize anti-competitive behavior.

“It doesn’t change things from my analysis,” she said about the Phoebe Putney decision. Yet she added that states may have to review statutes that don’t contain that explicit language.

The Phoebe Putney decision also doesn’t address the second prong of the state action doctrine, which requires states to actively oversee the anti-competitive behavior. “That’s where there’s a lot of work to be done,” she said.

Ragone and Cantor pointed out that it’s still unclear whether the FTC and U.S. Justice Department even intend to challenge ACOs as anti-competitive. A classic antitrust case involves entities colluding to fix prices—but the whole goal of an ACO is to reduce costs.

Read the full Modern Healthcare article, “Phoebe Putney dealt legal blow by Supreme Court.”

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Professor John Jacobi in The Record on ‘How Medicaid expansion will help New Jerseyans’

jacobi_johnProfessor John Jacobi published a feature Op-ed in The Record, New Jersey’s most awarded newspaper, on the impact Governor Chris Christie’s decision to expand Medicaid under the ACA will have.

Professor Jacobi writes:

GOVERNOR CHRISTIE’S decision to expand Medicaid coverage to more residents will improve the health of many low-income New Jerseyans, and save the lives of some. In addition, the expansion dovetails with other reform efforts in the state, furthering implementation of innovative programs for the poor and vulnerable.

The governor’s announcement is great news for low-income individuals. The Rutgers Center for State Health Policy estimates that the expansion will lead to an enrollment increase of about 234,000 in NJ FamilyCare, which combines New Jersey’s Medicaid and Children’s Health Insurance Program.

The expansion addresses gaps in the current Medicaid system, under which many poor people were ineligible even if they had absolutely no income or assets.

The expansion will plug those gaps, allowing people to enroll so long as they are lawful residents with an income of no more than about $15,414 per year, which is about the gross income of a full-time minimum wage worker.

Health insurance coverage is important to personal health, and it is simply not true that all Americans have meaningful access to health care. As the Institute of Medicine of the National Academy of Sciences has found, people who have health insurance — including Medicaid — have better access to a regular source of health care. Those with no coverage, in contrast, are more likely to do without medically necessary care, particularly for chronic conditions, and to not fill prescriptions due to cost.

As a consequence, the uninsured are more likely to be in “fair” or “poor” health — and to die before their time. Medicaid expansion will keep people healthy and even save lives.

 

Read the full feature, “How Medicaid expansion will help New Jerseyans

 

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