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2.
J Leg Med ; 40(3-4): 391-419, 2020.
Article in English | MEDLINE | ID: mdl-33797330

ABSTRACT

Georgia's Section 1115 waiver application, titled "Georgia Pathways to Coverage," seeks to simultaneously expand the state's Medicaid program and condition eligibility on work requirements. Though Section 1115 waivers have become a common vehicle for state Medicaid expansion, the imposition of work requirements is a novel departure. This article explores whether approval of Georgia Pathways to Coverage by the U.S. Department of Health and Human Services can withstand judicial review. Recent precedent, beginning with the seminal Stewart v. Azar case, strongly suggests that a legal challenge would be successful on the merits. The features and justifications of Georgia Pathways to Coverage, examined in light of current data on work requirements in entitlement programs, make it likely that approval of the program would be found arbitrary and capricious under the Administrative Procedure Act. However, unique aspects of Georgia Pathways to Coverage, as compared with similar state waivers, raise significant hurdles related to constitutional standing requirements and the appropriate judicial remedy.


Subject(s)
Eligibility Determination/legislation & jurisprudence , Medicaid/legislation & jurisprudence , State Government , Georgia , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
3.
AMA J Ethics ; 21(7): E603-610, 2019 07 01.
Article in English | MEDLINE | ID: mdl-31333177

ABSTRACT

Current policies and ongoing border crossings have increased the number of unaccompanied minors and the length of time they spend in detention. The US Department of Health and Human Services Office of Refugee Resettlement and its detention facilities currently determine what constitutes appropriate medical care for unaccompanied minors in immigration detention. This care might not be in a child's best interest. In contrast, juvenile detention and human subject research regulations rely on child advocates and court orders to protect children from coercion and safeguard a child's best interest. It is urgent that the medical community advocate for these same safeguards to be put in place for the unaccompanied minors in immigration detention.


Subject(s)
Clinical Decision-Making/ethics , Coercion , Delivery of Health Care/ethics , Emigrants and Immigrants/legislation & jurisprudence , Minors/legislation & jurisprudence , Refugees/classification , Adolescent , Child , Child Advocacy , Child, Institutionalized/legislation & jurisprudence , Humans , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
4.
Hastings Cent Rep ; 49(2): 4-5, 2019 03.
Article in English | MEDLINE | ID: mdl-30998273

ABSTRACT

In January 2018, the Trump administration established the Conscience and Religious Freedom Division within the Department of Health and Human Services' Office of Civil Rights with the explicit goal of intensifying legal protection of religious and conscience objections in health care. The establishment of OCR's new division illustrates the significant powers of administrative agencies to mold the substance of law without seeking legislative action. The mere formation of a division dedicated to protecting conscience rights is already having a significant impact; it is causing health care entities, including hospitals, research organizations, and clinics, to change policies and practices to comply with the declared enforcement strategy. Administrative agencies also shape the law in what they decide not to pursue. For example, OCR has suspended enforcement of the Affordable Care Act prohibition against gender-identity discrimination.


Subject(s)
Civil Rights/legislation & jurisprudence , Conscience , Freedom , Refusal to Treat/legislation & jurisprudence , Religion and Medicine , Humans , Patient Protection and Affordable Care Act , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
5.
Ethics Hum Res ; 41(2): 22-28, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30895751

ABSTRACT

Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.


Subject(s)
Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Mental Competency , Specimen Handling/ethics , Costs and Cost Analysis , Data Anonymization , Electronic Health Records/ethics , Electronic Health Records/legislation & jurisprudence , Humans , Informed Consent/ethics , Risk Assessment , Selection Bias , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
11.
SMU Law Rev ; 71(2): 391-444, 2018.
Article in English | MEDLINE | ID: mdl-30028114

ABSTRACT

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public's health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response--demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may or may not be ill, raising serious questions about federal commitment to due process protections as well as the scope of statutory authority to impose quarantine. As the Supreme Court has stated in United States v. Salerno, "liberty is the norm, and detention prior to trial or without trial is the carefully limited exception." Unconstrained use of quarantines undermines both the rule of law and public confidence in government decisions in times of crisis. This article analyzes the regulations and argues for a rights-based approach to infectious disease control that also protects public health. By respecting constitutional rights, the federal government can encourage public trust and cooperation and minimize harm, both essential requirements for controlling an epidemic.


Subject(s)
Centers for Disease Control and Prevention, U.S./legislation & jurisprudence , Civil Rights , Communicable Disease Control/legislation & jurisprudence , Disease Outbreaks/legislation & jurisprudence , Disease Outbreaks/prevention & control , Federal Government , Quarantine/legislation & jurisprudence , United States Dept. of Health and Human Services/legislation & jurisprudence , Communicable Diseases/transmission , Government Regulation , Hemorrhagic Fever, Ebola/epidemiology , Hemorrhagic Fever, Ebola/prevention & control , Humans , United States/epidemiology
13.
Fed Regist ; 83(236): 63419-28, 2018 Dec 10.
Article in English | MEDLINE | ID: mdl-30525339

ABSTRACT

This final rule adopts the HHS-operated risk adjustment methodology for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. Following review of all submitted comments to the proposed rule, HHS is adopting for the 2018 benefit year an HHS-operated risk adjustment methodology that utilizes the statewide average premium and is operated in a budget-neutral manner, as established in the final rules published in the March 23, 2012 and the December 22, 2016 editions of the Federal Register.


Subject(s)
Insurance Carriers/legislation & jurisprudence , Insurance, Health/legislation & jurisprudence , Patient Protection and Affordable Care Act/legislation & jurisprudence , Risk Adjustment/legislation & jurisprudence , Humans , Insurance Pools/legislation & jurisprudence , Risk Adjustment/methods , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
16.
Fed Regist ; 82(179): 43459-70, 2017 09 18.
Article in English | MEDLINE | ID: mdl-28920639

ABSTRACT

On January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Product Safety Commission (CPSC or Commission) adopts the Common Rule.


Subject(s)
Research Subjects/legislation & jurisprudence , Research/legislation & jurisprudence , Safety/legislation & jurisprudence , Consumer Product Safety/legislation & jurisprudence , Humans , Privacy/legislation & jurisprudence , United States , United States Dept. of Health and Human Services/legislation & jurisprudence
19.
Cancer Discov ; 7(4): 346, 2017 04.
Article in English | MEDLINE | ID: mdl-28270385

ABSTRACT

The U.S. Department of Health and Human Services has revised the Common Rule governing the protection of patients who donate biospecimens for research. The final rule eliminates a controversial proposal that would have required researchers to obtain renewed consent for use of donated samples beyond their original purpose.


Subject(s)
Research/legislation & jurisprudence , Specimen Handling , United States Dept. of Health and Human Services/legislation & jurisprudence , Humans , United States
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