2015 - Health Care Compliance Brief

What is a HIPAA Violation?

HIPAA Journal

DECEMBER 31, 2022

Since its passage, Standards have been introduced to improve patients´ rights and safeguard Protected Health Information (PHI). Unauthorized release of PHI to individuals not authorized to receive the information. HIPAA Violation Categories. There are four HIPAA violation categories. Mishandling and mis-mailing PHI.

HIPAA

HIPAA Due Diligence Compliance Fraud

Medicaid and Health Equity: CalAIM’s Bold Experiment

Healthcare Law Blog

MAY 16, 2022

It envisions enhanced coordination, integration, and information exchange among managed care plans (MCPs); physical, behavioral, community-based, and social service providers; and county agencies. In 2015, DHCS launched the WPC Pilots as part of its Medi-Cal 2020 Section 1115 Demonstration.

Medicaid

Medicaid Medicaid Nurses Health Care Access

Bonus Features – November 20, 2022 – 90% of healthcare buyers prioritize virtual care but want a clear roadmap, wearable data helped predict COVID-19 infections 12 days before the CDC, and more

Healthcare IT Today

NOVEMBER 20, 2022

Because there’s so much happening out there in healthcare IT we aren’t able to cover in our full articles, we still want to make sure you’re informed of all the latest news, announcements, and stories happening to help you better do your job. News and Studies. Specifically, certified health IT developers have a Dec.

COVID-19

COVID-19 Telemedicine Hospitals Nurses

How HHS-OIG, Regulators Enforce Vendor Compliance

Provider Trust

MAY 18, 2022

If the answer is yes, then the best mechanism for limiting CMP liability is to screen all persons that perform under that contract or that are in that job category. In January 2015, the OIG settled for $96,259 with a Minnesota Pharmacist, Joseph C. at a provider that furnishes items or services payable by Federal health care programs.

Compliance

Compliance Due Diligence Medicaid Medicaid

Medicare Advantage 2024 Rate Announcement – Further Impacts to Risk Adjustment

Health Care Law Brief

APRIL 3, 2023

health condition, age, gender, dual eligibility status, and demographics information) based off a risk score from CMS’s hierarchical condition category (HCC). All ICD codes are grouped into diagnostic groups with similar medical conditions and then condition categories based on clinical profiles and expected costs (e.g.,

Medicare

Medicare Medicare Overpayments Overpayment

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services

US Department of Health and Human Services FDA COVID-19 World Health

OIG Issues Information Blocking Penalties Final Rule: Health IT Developers and Health Information Exchanges/Networks Have a Million Reasons to Care

Health Law RX

JULY 18, 2023

On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023.

Fraud

Fraud Compliance Medicaid Medicaid

Gearing up for Immunizations

Redox

DECEMBER 4, 2020

Those challenges can be broken down into two general categories: How do we get it to everyone? Lisa Bari (she/her/hers) @lisabariMore accurate information about the number of distinct IIS in the US: Kate Ricker-Kiefert @k8kiefert@lisabari 64 IIS is for 50 states, 1 district, 8 territories, and 5 city local IIdNovember 17th 2020 2 Likes.

Public Health

Public Health Governance Doctors Medicare

Should You Worry About Data From Your Period-Tracking App Being Used Against You?

Kaiser Health News

MAY 13, 2022

They were expressing concerns about the privacy of this information — especially for people who live in states with strict limits on abortion — and how it might be used against them. Some period-tracking apps, which often ask for health information besides menstrual cycle details, take part in the broader internet data economy, too.

US Department of Health and Human Services

US Department of Health and Human Services HIPAA Governance Health Insurance

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 135 (Winter 2015) (citation and quotation marks omitted). 1145, 1165 n.135

Governance

Governance Payment Systems Hospitals Licensing

A Painful Preemption Decision

Drug & Device Law

JANUARY 9, 2023

Under Albrecht , these regulations and “final” monographs are the applicable “law” that requires preemption: [T]he only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’s congressionally delegated authority. 2022 WL 17348351, at *4. at 1682 (Thomas, J.

FDA

FDA Governance Nurses

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Mensing , 564 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA

FDA Fraud Governance Medicare

FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

NOVEMBER 9, 2023

The FDA’s chief concern about off-label communications from manufacturers has less to do with the safety of such uses − many of which are medical standard of care and Medicare reimbursable − than with the agency’s own bureaucratic imperative. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. Caronia , 703 F.3d

FDA

FDA Health Insurance Nurses Medicare

Health Care Compliance Brief

What is a HIPAA Violation?

Medicaid and Health Equity: CalAIM’s Bold Experiment

Trending Sources

Bonus Features – November 20, 2022 – 90% of healthcare buyers prioritize virtual care but want a clear roadmap, wearable data helped predict COVID-19 infections 12 days before the CDC, and more

How HHS-OIG, Regulators Enforce Vendor Compliance

Medicare Advantage 2024 Rate Announcement – Further Impacts to Risk Adjustment

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

OIG Issues Information Blocking Penalties Final Rule: Health IT Developers and Health Information Exchanges/Networks Have a Million Reasons to Care

Gearing up for Immunizations

Should You Worry About Data From Your Period-Tracking App Being Used Against You?

How the Fifty States View Electronic Data as a “Product”

A Painful Preemption Decision

Logical Contradiction Doctrine: Buckman for Textualists

FDA and Off-Label Communication – Getting Closer to Truth

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