Category:

Regulation

The Changing Face of Charity Care Determinations

Since the enactment of the Affordable Care Act, hospitals have faced strict and substantial regulations regarding the provision of financial assistance to patients in the form of “charity care.” An essential element in a hospital’s ability to maintain tax-exempt status and financial solvency, charity care has worked to serve uninsured and indigent patients while helping charitable hospitals serve their mission and retain the benefits that come with it. The state of Pennsylvania recently passed legislation requiring more explicit and affirmative acts to provide charity care to more eligible patients. The change is unprecedented, and other states look to be slowly responding in their own ways. Compliance with these changes is most beneficial with proactive measures and risk assessments even before change comes through the doors.

You’ve Heard About the GDPR, but What About the CaCPA?

On June 28, 2018 California took a page out of the European Union’s (EU) book and signed the California Consumer Privacy Act (CaCPA) into law. The CaCPA is a landmark privacy bill that will come into effect on January 1st, 2020 and it is being closely compared to the General Data Protection Act (GDPR).

What does this mean for California businesses and residents? In short, more privacy and more control over data. Key aspects include allowing consumers to request what data an organization has collected about them, allowing consumers the right to fully erase data, protecting children’s data, and making verification processes more stringent for businesses.

Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments

The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules.  The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework.  The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).

FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences

The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.

Regulatory Rollbacks: Changing the Career Education System

In a world where students are swimming in debt, the Education Department has made an effort to regulate career education and ensure students receive a quality education. During the Obama Administration, rules were implemented that require educational institutions to prove they are preparing graduates for gainful employment. In addition, the borrower defense rule allows for federal student loan forgiveness when the student can prove their institution misled them relating to the loan or education services provided. With so many students in debt, what is the appropriate standard of review to apply when determining these regulations?

Black Market Midwifery: Lack of Regulation Compromises the Safety of Women Who are Committed to Giving Birth Outside the Hospital Setting

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.

FDA Declares War on Flavored E-Cigarette

In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.

DeVos’ Deregulation Attempt Fails as Judge Upholds Borrower Defense Rules

A new set of student loan forgiveness regulations introduced earlier this year aimed to hack away at “borrower-defense” protections which shielded students from predatory loan practices by for-profit universities. Under Education Secretary Betsy DeVos, the Department of Education crafted new, more restrictive borrower-defense regulations after blocking an Obama Administration regulation from going into effect last year. U.S. District Court Judge Randolph Moss sided with consumer rights activists who argued against the Secretary of Education, alleging the Department of Education violated federal law and procedure by repealing the Borrower Defense to Repayment rule. The Trump Administration requested another opportunity to delay the regulations from taking effect, but Judge Moss has not yet ruled on their request. 

A Way Around HHS 340B Program Delays

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. 

Election Assistance Commission Releases Funds to Help States Prepare for 2018 Elections

The U.S. Election Assistance Commission has released over $300 million in Help America Vote Act funds to 48 states and territories intended to improve election security and administration. This comes after the Consolidated Appropriations Act of 2018 appropriated $380 million into the Help America Vote Election Security Fund in March of this year.