Webinar: Delay, Deregulate, Derail — Health Care Roiled by Actions of Trump and Congress

Since January, both President Trump and Republican leaders in Congress have talked about a three-step process for repealing and replacing the Patient Protection and Affordable Care Act (ACA). While the first six months of the Trump administration has seen mixed results, its efforts to reign in or hold back regulations, combined with its delay in filling lower-level agency roles, has impacted regulatory review and issuance of new regulations. So, despite Congress’ inability to pass legislation to change parts of the ACA, there is still plenty for providers to be concerned about.

Join Associate Managing Editor Kathryn Beard, JD, on Wednesday, August 2, for this half-hour live webinar covering attempts by the Trump Administration and Congress to delay, deregulate, and derail significant parts of federal health policy. She will discuss the two “repeal and replace” bills, FDARA, and significant executive and regulatory actions taken by the Trump administration which directly impact ACA provisions.

Registration Link:

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

Related Links

http://www.wolterskluwerlr.com

Are employer wellness programs under attack by the EEOC?

Many employers or their group health insurance plans offer wellness programs to promote healthier lifestyles for their employees. These employer wellness programs (EWPs) often involve medical questionnaires, health risk assessments (HRAs), and weight, cholesterol, glucose and blood pressure screenings. Some employer and group health insurance plans offer financial and other types of incentives to participating employees or to those who achieve certain targeted health outcomes.

Until 2014, it seems to have been clear sailing for employers on the EWP front as long as they complied with certain federal nondiscrimination provisions. In 2014, however, the U.S. Equal Employment Opportunity Commission (EEOC) starting filing lawsuits against employers alleging that their EWPs were not voluntary as required by Title I of the Americans with Disabilities Act (ADA). While the courts have uniformly ruled in favor of the employers in these cases, the EEOC, nevertheless, proceeded to propose new regulations under the ADA and Title II of the Genetic Information Nondiscrimination Act (GINA) that imposed new standards and ignored an existing ADA “safe harbor” provision for bona fide employer benefit plans. Despite both Congressional concerns and numerous industry comments asking the EEOC to align its new ADA and GINA final rules with the requirements of the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) and the HIPAA privacy and security breach notification requirements, with which employers had worked so hard to comply, the final rules made no concessions to these concerns.

This White Paper first examines the federal law applicable to EWPs, the recent court challenges by the EEOC, the new ADA and GINA final rules, and the status of proposed legislation to void the rules. It closes by providing the results of a Q&A session with industry experts and advice on what employers should do to ensure that their EWPs pass muster with the new EEOC rules, both applicable on January 1, 2017.

Read further, “Are employer wellness plans under attack by the EEOC?

An impossible course: navigating the generic drug label delay

In May 2016, the FDA put off until 2017 a decision about a Final rule that would allow generic drug companies to update their labels with new safety information similar to their reference product counterparts. This marks the third time since the FDA proposed the rule that it has been shelved in the face of opposition from the pharmaceutical industry and some lawmakers. The delay, with major ramifications for consumers and industry alike, was initially discovered in an update to a timetable for the rule and officially appeared in a Federal Register Notice in mid-June. The development dismayed consumer groups and representatives for trial lawyers, who had urged the agency to close a legal loophole that prevents patients harmed by generic drugs from suing manufacturers.

Unlike brand-name drug makers, generic drug makers are not permitted to make changes to a drug’s label without the FDA’s approval unless the brand name drug maker makes the label change first. Instead, generic drug makers must wait for the FDA to order them to change their label. Since the passage of the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417) in 1984, known as the Hatch-Waxman Act, the FDA has approved over 8,000 generic drugs. The Hatch-Waxman Act provides an expedited approval process for generic drugs that have an identical reference listed drug (RLD). As a result, nearly nine in 10 prescriptions filled today in the U.S. are for generic drugs, yet only account for 28 percent of drug expenditures.

Two Supreme Court decisions have helped to establish the conflicting division faced by patients and drug makers regarding drug label. Under the federal Food, Drug, and Cosmetic Act (FDC Act) and the subsequent Hatch-Waxman Act amendments, a generic drug company “may not unilaterally change its labeling or change its design or formulation and cannot be required to exit the market or accept state tort liability.” Consequently, a state law is preempted in the event a generic drug manufacturer must take one of the aforementioned actions to comply with a state law duty. Thus, patients taking a generic prescription drug are unable to recover for alleged injuries from either the brand name or generic drug maker. The brand name drug maker is not liable because it did not sell the drug directly to the patient and the generic drug maker faces the “impossibility” of providing updates to the drug label without direction from the brand name drug maker.

This White Paper provides an overview of the laws and regulations establishing the foundation of drug labels. The White Paper will also discuss the impact of the Supreme Court decisions on consumers’ ability to sue a drug maker for its drug labels. Finally, this White Paper examines whether industry pressure or consumer sentiment will carry the day. As the public service announcement from the FDA attests, it may be difficult to get generic drug approval, but as follows in this White Paper, generic drug makers are also harder to sue.

Read further: “An impossible course: navigating the generic drug label delay.”