In December 2018, Dr. Christopher Duntsch lost his appeal and the court upheld his life sentence. The name may not sound familiar, but to the medical community in Dallas, Texas, Christopher Duntsch represents what happens when every part of the medical regulatory system fails to protect patients. Christopher Duntsch was given the nickname “Dr. Death” in November 2016 when the DMagazine ran a cover story on him and his victims. In 2018, Wondery produced a six-part podcast series named “Dr. Death” detailing Duntsch’s educational and medical history and the acts that led him to incarceration.
A pair of injunctions in the Northern District of California on January 13, and the Eastern District of Pennsylvania on January 14, halted the implementation of amendments to a religious exemption to the so-called contraception “mandate” of the Affordable Care Act, also known as Obamacare. The “mandate” requires most employers to include contraception coverage in the insurance plans they offer to employees. While Obama administrative agencies contemplated religious exemptions early on, contentious litigation and political transition expanded the scope of the exemption until these latest developments.
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
On October 24, President Trump signed a new bill aimed at combatting issues arising from the opioid epidemic. This bill, entitled the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT” Act) is a combination of seventy bills that effect the healthcare industry. This act includes new and revised Medicaid and Medicare laws that relate to the opioid crisis through the expansion of substance use disorder services. However, this bill, primarily aimed to combat the opioid epidemic, contains key provisions that will affect healthcare providers. Healthcare providers should be especially mindful of this new Act, as there are new anti-kickback provisions that require compliance officers and departments to ensure that their healthcare entities are in compliance with this new law.
The Mental Health Parity and Addiction Equity Act (“the Parity Act”) is a federal civil rights and consumer protection law. The Parity Act prohibits most public and private insurance plans from imposing more restrictive standards on mental health (“MH”) and substance use disorder (“SUD”) benefits than they impose on similar medical/surgical benefits. However, ten years since its passage, states have failed to appropriately enforce the Parity Act.
Protected Health Information is seeing a surge of breaches on the cyber security front due to contractor error. It’s also impacting the most consumers in comparison to other data breaches and, in some cases, has the power to cause chaos in national infrastructure. Advances in technology and compliance measures can stem the tide and protect the most valuable information in consumers lives.
Before the Affordable Care Act (“ACA”) was passed, critics exclaimed that the government had no right to interfere in a citizen’s healthcare. When it was passed, the requirement that every American purchase health insurance caused America to scramble to comply. However, in a year all the critics might be silenced. Recently, Congress repealed the individual mandate’s tax penalty. How will Americans comply with the new act?
Across the United States more and more women are choosing to give birth outside of hospitals. Currently, in Illinois, Certified Professional Midwives are not licensed to provide home birth services. However, over the last decade, advocates in Illinois have urged lawmakers to reconsider this restriction. The most recent attempt in 2017 was unsuccessful once again. While opponents argue that individuals with this level of training should not be providing care to women during delivery, the choice for women who are committed to home birth is not between home and the hospital. It is between home and an illegal or unassisted delivery.
Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute.
In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.