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.

Media

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

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FDA relaxes guidelines for abortion-inducing drug, flames abortion controversy

The FDA announced a labeling change for the drug Mifeprex®, which, when used together with another drug called misoprostol, will terminate a pregnancy in the early stages. The labeling change will relax certain guidelines in prescribing practices and expand the time in which women can take this drug in order to induce an abortion. This change comes at a controversial time as the Supreme Court just heard oral arguments, and oddly asked parties for additional briefing, in a challenge to the contraception mandate under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). At the same time, anti-abortion candidates in the race to the White House have recently fueled the fire with inflammatory remarks while some pro-life proponents are framing the FDA’s change as a political move.

Labeling changes

While the FDA first approved Mifeprex in 2000, the latest announcement outlines a new approved regimen which was found to be safe and effective after a supplement application was submitted by the manufacturer. The FDA stated that the drug may be appropriately used to end a pregnancy through 70 days of gestation and through the following procedure:

  • The ingestion of 200g of Mifeprex on day one;
  • The ingestion of 800mcg of misoprostol 24 to 48 hours after taking the Mifeprex; and
  • A follow-up with a health care provider seven to 14 days after taking the Mifeprex.

The FDA also outlined an appropriate risk evaluation and mitigation strategy (REMS) for Mifeprex, as follows: (1) that it must be ordered, prescribed, and dispensed under the supervision of a health care provider with certain qualifications; (2) that those health care providers must complete a Prescriber Agreement Form before prescribing; (3) that it only may be dispensed in clinics, medical offices, and hospitals; and (4) the provider must obtain a Patient Agreement Form before dispensing it.

Effect

Other than extending the time in which this medication can be prescribed from seven weeks to 10 weeks, the new labeling reflects a change in dosage and procedure that, according to some sources, was adopted by physicians that prescribed Mifeprex off-label long ago. “The change brings the direction for taking the drug . . . in line with what has become standard medical practice in most states: reducing the dosage to 200 milligrams from 600 milligrams, decreasing the number of visits a woman must make to the doctor to two from three, and extending the period when she can take the pill to 10 weeks of pregnancy from seven weeks,” according to the New York Times. There is also evidence that fewer side effects accompany the lower dosage. The same article notes that while the new labeling might be applicable to all states at the moment, at least one state is already working to pass a law that would hold provider’s to the stricter standards imposed in the past.

Context

This FDA approval came at an interesting time for the abortion and contraceptive coverage controversy as, the day before this announcement, the Supreme Court issued an order asking for supplemental briefing in a case on which it had heard oral arguments the previous week and which challenged the contraception coverage mandate of the ACA. Some experts see this as the eight-Justice Court potentially looking for an avenue to strike a compromise on an issue and avoid a 4-4 vote, which would effectively result in the continuation of a circuit split and different laws applying in different jurisdictions on this issue. In this context, pro-life proponents argued that the FDA announcement is a politically fueled move to satisfy the “abortion industry” and pro-choice groups. Others defended it as unrelated to election year politics and as simply part of the FDA’s regulatory responsibility in the face of a supplement drug application.

TPP: years in the making, years to go

The Trans-Pacific Partnership (TPP) was signed by the trade ministers of 12 nations on February 4, 2016, in New Zealand, and thus, the world’s largest trade deal is now waiting for ratification of the treaty’s text in each nation. Here in the United States, President Obama has called upon Congress to vote on and pass the TPP before he leaves office in early 2017. In 2009, the U.S. began negotiating the TPP, seeking to boost U.S. economic growth with Canada, Mexico, and several Asian and Pacific countries considered key destinations for U.S. manufactured goods, agricultural products, and services suppliers. As a group, the TPP countries are the largest goods and services export market of the U.S., accounting for $698 billion in 2013, or 44 percent of total U.S. goods exports. U.S. exports of agricultural products to TPP countries totaled $58.8 billion in 2013, 85 percent of total U.S. agricultural exports. The TPP seeks to slash tariffs and trade barriers in this region, but pointedly does not include China.

At the core of the debate over the TPP, concerns have been raised about its application and impact on countries’ regulations—in particular the TPP’s key feature of regulatory coherence for the promotion of trade. For the pharmaceutical industry, issues concerning intellectual property (IP) protection in the TPP have focused primarily on patents, but there are concerns that the patent protection schema is not as effective for some classes of drugs such as biosimilars because these products do not require exact identity with the reference product. The Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established a pathway for biologics that employs a 12-year exclusivity period, which is in stark contrast to the five years for generic small-molecule drugs.

A difficult question to answer is whether an inventor of a new drug measures the cost of invention against the revenue that might be made in the “poor” world in calculating whether to undertake the research and development of the drug. Supporters of the TPP argue that the greater cost and difficulties involved in research and development of biologics required a longer exclusivity period as incentive for innovation. Critics look at the TPP as an attempt to use trade law and treaties to extend the “rich” world IP protections to the “poor” world.

In addition, there is strong opposition from many congressional Democrats and some Republicans, which could mean a vote on the TPP is unlikely before President Obama leaves office. These concerns and a myriad of others will still require years of tough negotiations before the TPP becomes a reality.

CMS clarifies user fee adjustment mechanism for contraception accommodation

Third-party administrators (TPAs) must submit the Notice of Intent Disclosure Form to CMS stating their intention to seek a user fee adjustment even though the original deadline has passed. CMS has issued answers to frequently asked questions for TPAs, pharmacy benefit managers (PBMs), and federally-facilitated marketplace (FFM) issuers who are seeking reimbursement for contraceptive services. The information that these parties must submit will allow CMS to determine the discount to be applied to the user fee paid for participation on the FFM (CMS FAQ, November 9, 2015).

User fee discount

The government has provided an accommodation for self-insured nonprofit religious organizations that object to the contraceptive coverage mandate found in sections 1001 and 1004 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). Under the accommodation, the nonprofit or their TPA notifies HHS of the objection. The TPA will cover the contraceptive services and will contract with an FFM issuer. The FFM reduces the issuer’s marketplace user fee to account for the payment made to the TPA to cover the services. In order to receive this discount, FFM issuers and TPAs must submit certain information to CMS.

FAQs

TPAs and PBMs must submit the notice of intent form by November 13, 2015, via email. FFM issuers seeking the 2014 benefit year adjustment should submit their spreadsheets by December 11, 2015. CMS will provide webinar training on completing the forms. The document contains instructions regarding recipient email address, subject lines, and attachments.

CMS clarifies that PBMs can enter in the same arrangements as TPAs to provide contraceptive services. PBMs must follow the requirements imposed on TPAs. However, if the TPA or PBM and the FFM issuer are part of the same entity or parent company, only the FFM should submit its spreadsheet. If the entities are separate, the TPA must submit its form indicating the total value of eligible paid claims.

The user fee discount is limited to the dollar amount of contraceptive claims. CMS intends to deduct the appropriate amount from the issuer’s monthly obligation at the end of the 2015 calendar year. The FFM issuer is also eligible for an additional 15 percent payment for administrative costs. Although CMS has not established reimbursement for TPA or PBM administrative costs, these groups may require that the FFM share part of its administrative payment.