Wolters Kluwer Announces White Paper Series on Healthcare Legislation

As federal lawmakers grapple with sweeping healthcare reform, Wolters Kluwer provides resources to help professionals stay ahead of reimbursement and compliance requirements

Wolters Kluwer Legal & Regulatory U.S. today announced the launch of an authoritative and timely white paper series to track updates and provide analysis on the American Health Care Act (AHCA) and Better Care Reconciliation Act (BCRA), the proposed replacements for the Affordable Care Act (ACA) under consideration in Congress.

The AHCA passed in the House of Representatives by a slim majority in May. A discussion draft of the BCRA was released in late June but the Senate has delayed any votes on the legislation until July. The first white paper in the series, entitled “How the AHCA Directly Impact Significant Parts of the ACA,” identifies and explains aspects of the ACA that are directly impacted by the AHCA. Wolters Kluwer’s white paper series will track the legislation as new versions of the bill become available.

“Considering the impending changes proposed by lawmakers, healthcare, legal and compliance professionals need to understand the evolving regulatory landscape,” said Paul Clark, Health Law Analyst for Wolters Kluwer’s Healthcare group. “Our series of white papers will help healthcare professionals to track changes in the legislation as they occur, measure the impacts, and manage compliance and reimbursement practices more efficiently.”

Download a free electronic copy of “How the AHCA Directly Impact Significant Parts of the ACA”

For those interested in daily, comprehensive coverage of the latest health law developments, Wolters Kluwer offers Health Law Daily providing in-depth analysis on new developments delivered directly to users’ device of choice every day. To learn more visit The Health Law Daily.

About Wolters Kluwer Legal & Regulatory U.S.

Wolters Kluwer Legal & Regulatory U.S. is part of Wolters Kluwer N.V. (AEX: WKL), a global leader in information services and solutions for professionals in the health, tax and accounting, risk and compliance, finance and legal sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.

Wolters Kluwer reported 2016 annual revenues of €4.3 billion. The company, headquartered in Alphen aan den Rijn, the Netherlands, serves customers in over 180 countries, maintains operations in over 40 countries and employs 19,000 people worldwide.

For more information about Wolters Kluwer Legal & Regulatory U.S., visit www.WoltersKluwerLR.com, follow us on FacebookTwitterand LinkedIn.

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Linda Gharib
Director, Communications
Wolters Kluwer Legal & Regulatory U.S.
Tel: +1 (646) 887-7962
Email: linda.gharib@wolterskluwer.com

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Average drug spending dropped for consumers with employer-sponsored coverage

Although average annual drug spending for those with employer-provided health coverage dropped $23 between 2009 and 2014, more people are spending over $1,000 a year on prescription drugs. The Kaiser Family Foundation (KFF) believes that the drop in spending first occurred to due generic substitution and then from the Patient Protection and Affordable Care Act’s (ACA) (P.L. 111-148) contraceptive mandate (section 2713).
Employer-based plans. Recent surveys have shown that a growing amount of those taking prescription drugs find it difficult to afford their medication. The KFF also noted that government and insurer studies blame specialty drugs and price increases for name brand drugs as the reason for the more rapid drug spending growth in recent years. A comparison revealed that drug spending trends in employer coverage generally match national patterns, such as a large spending spike in 2014.

Trends

Average drug spending in employer plans stayed within a small range when adjusted for inflation for almost a decade, at $909 in 2004 to $947 in 2013. In 2014, it grew by 13 percent to $1,053. At the same time, the share of people with drug spending exceeding $5,000 (both out of pocket and paid by insurance) grew from 1.6 percent in 2004 to 3.9 percent in 2014. Those with diagnosed endocrine disorders, circulatory diseases, cancers, and blood diseases are more likely to have high drug spending. The share of those with employer coverage that spent over $1,000 per year on retail prescription drugs nearly tripled. Although this group represents only 3 percent of all people with large employer coverage, their spending accounts for one-third of aggregate out of pocket spending.

Despite this growth, those with large employer coverage spent less on average in 2014 ($144) than they did in 2009 ($167, or $185 in 2014 dollars). During this time, some popular drugs lost patent protection and patients began taking the generic option. In addition, the contraception mandate may have been responsible for causing women to see the sharpest drop in out-of-pocket spending. Oral contraceptives make up 63 percent of drop in average out-of-pocket spending on retail drugs after 2012.

Mylan calculated profitability using 37.5% tax it doesn’t pay

Mylan is being met with yet more derision after a profitability analysis released by the company to the Securities and Exchange Commission (SEC) revealed that its profits are calculated after factoring in a U.S. tax rate that is much higher than the actual rate—which the Washington Post reports is nearly nothing.

When Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform to address the pen’s price increases, she claimed that the company receives about $100 of profit from each sale of the $608 EpiPen® 2-Pak (see Mylan CEO highlights EpiPen® access improvement efforts before House committee, Health Law Daily September 22, 2016). The SEC’s profitability analysis revealed that Mylan includes a 37.5-percent tax rate when calculating its net product profitability.

According to the Washington Post, Mylan relocated its headquarters to the Netherlands, which reduced its tax rate. In 2015, the company’s overall tax rate was 7 percent in 2015, but an independent tax expert reported that the U.S. tax rate is actually close to zero. Mylan argued that standard profitability analyses include tax for the jurisdiction reviewed. Representative Elijah Cummings (D-Md) expressed Congress’s skepticism over the numbers provided, and noted that Mylan has until Friday, September 30, 2016, to give Congress files that will allow the government to determine the company’s actual profits.

Next abortion legislation arguments will use mixed evidence on fetal pain

Reproductive health issues have long been controversial, and one law professor believes that the next wave of abortion restriction legislation and court cases will take a new approach by discussing the effects of abortion on the fetus. In an article published in the New England Journal of Medicine, Professor R. Alta Charo projects that, because the recent arguments supporting abortion restrictions focusing on women’s safety were shot down due to medical evidence, the focus will turn to the effects on the fetus.

New focus on evidence

The recent U.S. Supreme Court decision Whole Woman’s Health v. Hellerstedt shot down a Texas law requiring physicians performing abortions to have admitting privileges at local hospitals while reasoning that the procedures have become so safe that such a requirement is not necessary. This reasoning signals a shift in court thinking and a new willingness to dive into the medical evidence surrounding the issue rather than defer to the legislature on factual issues. Charo pointed out that in 2007, when the Supreme Court upheld a statute banning dilation and extraction based on the legislature’s findings that such a procedure is not necessary to protect a woman’s health, the Gonzales v. Carhart opinion accepted the legislature’s factual findings because of mixed evidence. Even so, the opinion indicated that the court had a duty to review the facts underlying decisions involving constitutional rights.

Next steps

Charo believes that a shift will occur because medical evidence does not support the argument that abortion is unsafe and presents significant health risks to women. This shift will involve claims that a fetus can feel pain about 20 weeks after conception, based on fetal movement and hormonal activity in response to stimuli and stress. Charo observed that there are growing efforts to require fetal anesthesia, outlaw second-trimester use of dilation and evacuation, and prevent abortion starting at 20 weeks following conception. The opportunity arises for a legislature to state that medical opinion is mixed in light of studies showing that a fetus cannot feel pain due to the development timeline until almost 30 weeks. Charo believes that the Gonzales decision prioritized fetal concerns over women’s health and that that the opportunity may arise again. However, Whole Woman’s Health presents the possibility that the court will consider further evidence rather than deferring to the legislature’s fact finding.