Health Care Law Brief

APRIL 11, 2022

When there is the potential for patients to receive items and services payable by Federal health care programs (FHCPs), CM incentives are subject to scrutiny under the Federal anti-kickback statute (AKS) and the Beneficiary Inducements CMP.

Fraud 52

Fraud Medicare Medicare Compliance 52

Health Law Gurus

FEBRUARY 14, 2020

In an age of ever-increasing consolidation in the health care services market, this change would allow more plaintiffs than ever to file in Philadelphia, where medical malpractice plaintiffs have a much higher rate of success. The next steps in the rule change process are uncertain.

Malpractice 52

Malpractice Malpractice Attorneys Governance Hospitals 52

Healthcare Law Blog

NOVEMBER 21, 2022

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. OIG appears to want to have its cake and eat it, too.

Medicare 52

Medicare Medicare Governance Medicaid 52

SQA

FEBRUARY 22, 2021

The driving principles of the ANVISA Annual Management Plan (PGA) are to increase efficiency, improve the quality of service, focus on results, and guarantee better transparency. Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

HIT Consultant

JUNE 29, 2023

In the December 2002 GAO report, the organization looked at common practices at centers showing positive diversity results. About Kartina Rice Katrina Rice is the Chief Delivery Officer at Biometrics Services at eClinical Solutions.

FDA 98

FDA Governance 98

Health Populi

NOVEMBER 22, 2019

also has the lowest level of universal coverage for a core set of health care services compared with the 35 other OECD countries. That core set of services covers consultations with doctors, tests and examinations, along with inpatient hospital care. In addition to a relatively high level of avoidable mortality in America, the U.S.

Health Insurance 96

Health Insurance Doctors Governance Hospitals 96

SQA

MAY 24, 2023

The company’s written procedures and implantation of processes for storage, distribution, delivery, handling, installing, and/or servicing of medical devices were inadequate. The government is aiming for the revised framework to now apply from July 2025. The company could not provide a complete record of complaints.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. 15] Medical Device User Fee and Modernization Act of 2002, Report 107-728 (Oct. 7, 2002), at 21. [16] 8637, 8645 (Feb.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. United States Department of Health and Human Services (HHS) – Laws, Regulations, and Guidances. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

HIPAA Journal

MARCH 30, 2022

As the industry had evolved, many jurisdictions had interpreted the provision of indirect access to healthcare service as the “ unlicensed practice of medicine ”. However, when HIPAA was passed, the standards governing health care data, patients´ rights, and the flow of information were still several years away.

HIPAA 119

HIPAA Fraud Health Insurance Health Care Reform 119

Bill of Health

MAY 10, 2022

Bush, a Republican, anti-abortion supporter of government funded faith-based social services. Further, coercion, domestic violence, a lack of social services, inadequate social support, and other circumstances that devalue women’s agency to make decisions about mothering must be considered when evaluating safe haven advocacy.

Governance 301

Governance Public Health 301

Bill of Health

NOVEMBER 20, 2023

A long-running practice, with presidential endorsement in 2017 While the practice may have begun earlier, the legal framework for school expulsion of pregnant adolescents is typically traced to Education Act regulations adopted in 2002. These include when a student has committed an “offence against morality” or “entered into wedlock.”

Governance 144

Governance Hospitals Public Health 144

Healthcare Law Blog

MAY 25, 2022

She filed suit under Section 504 of the Rehabilitation Act (“Rehab Act”) and Section 1557 of the Affordable Care Act (“ACA”), two federal statutes that prohibit recipients of federal funding from discriminating in the delivery of services based on disability. 181, 185, 187 (2002). [6] MRI Radiology Network, P.A., 3d 1173 (11th Cir.

ACA 52

ACA Governance Medicaid Medicaid 52

SQA

FEBRUARY 26, 2024

The products found, subject to retention and seizure, were retained by the Federal Revenue Service. Health Canada is also working with the Canada Border Services Agency to help prevent importation of these unauthorized health products. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JULY 31, 2023

Courts are unanimous in refusing to categorize commercially-provided services as products.” Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 19, comment d. 19, comment f. at 1291-93 (construing 19 U.S.C. at 1291-92. at 1293-94. Aleynikov , 676 F.3d

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 1, 2023

Alaska “adopted the position that the trial court is the ‘gatekeeper’ responsible for keeping out ‘junk science.’” John’s Heating Service v. 3d 1024, 1033-34 (Alaska 2002) (quoting Coon ) (footnotes omitted). of Health & Social Services, 461 P.3d 2002) (citations and quotation marks omitted). Lamb , 46 P.3d

Governance 59

Governance Hospitals 59

Drug & Device Law

JANUARY 30, 2023

Charter Advanced Services (MN), LLC , 205 L. Davidowitz , 312 U.S. American Honda Motor Co. , Moran , 536 U.S. Moran , 536 U.S. United States , 567 U.S. Learjet, Inc. , Liberty Mutual Insurance Co. , Liberty Mutual Insurance Co. ,

FDA 72

FDA Fraud Governance Medicare 72