Compliancy Group

MARCH 19, 2024

In this blog, we’ll outline the fundamentals and importance of regulatory compliance in healthcare in the U.S. HITECH Act The Health Information Technology for Economic and Clinical Health (HITECH) Act promotes using electronic medical records (EMRs) in various medical settings. What Does Regulatory Compliance in Healthcare Involve?

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Regulatory Compliance Compliance US Department of Health and Human Services ACA 52

Hall Render

MAY 11, 2022

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). Hall Render blog posts and articles are intended for informational purposes only.

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Licensing FDA 40

Natalia Mazina

APRIL 10, 2022

It also has a few new points, as explained in this blog post. The DEA argued that the pharmacy repeatedly dispensed Trinity cocktail medications without any indication that its pharmacists addressed or resolved the fact that such prescriptions present a risk of abuse or diversion. Improper Dosing for Pain Management.

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Compliance 52

MedTrainer

NOVEMBER 29, 2023

For example, Indiana requires prescribing providers to use a prescription drug monitoring program (PDMP) and meet certain continuing education requirements to obtain a Controlled Substance Registration (CSR). The law is intended to encourage hospitals to focus more on retaining physicians and incentive providers by adjusting compensation.

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Compliance Licensing Governance Public Health 52

Hall Render

JUNE 15, 2022

The inquiry will investigate the impact of vertically integrated PBMs on the access and affordability of prescription drugs. This news comes at a time when PBM practices are under increased scrutiny by both federal and state actors, as the country tries to gain further control over the ever-increasing prices of prescription drugs.

Licensing 45

Licensing Health Insurance 45

Health Populi

MARCH 10, 2023

You know Best Buy for its consumer electronic retail chops, starting up Best Buy Health several years ago as a key pillar for the company’s strategic long term plans. Keep staying tuned to the Health Populi blog as I continue to grow and learn more in the field on our home as site of care. and Europe.

Hospitals 62

Hospitals Telemedicine 62

Hall Render

AUGUST 29, 2022

Maintaining labeled prescription bottles and other PHI in opaque bags in a secure area and using a disposal vendor as a business associate to pick up and shred or otherwise destroy the PHI. Procedures must also address removal of electronic PHI from electronic media before it is made available for re?use.

HIPAA 40

HIPAA Compliance 40

Health Blawg

DECEMBER 25, 2017

I first met Doc Rob through our involvement in the late lamented Grand Rounds (the notable medical blog carnival – you can find some editions here ). You should read his blog, Musings of a Distractible Mind , and perhaps you will be able to divine the origins or meaning of his deep interest in llamas.

Doctors 60

Doctors 60

Health Blawg

DECEMBER 25, 2017

I first met Doc Rob through our involvement in the late lamented Grand Rounds (the notable medical blog carnival – you can find some editions here ). You should read his blog, Musings of a Distractible Mind , and perhaps you will be able to divine the origins or meaning of his deep interest in llamas.

Doctors 60

Doctors 60

Health Blawg

DECEMBER 25, 2017

I first met Doc Rob through our involvement in the late lamented Grand Rounds (the notable medical blog carnival – you can find some editions here ). You should read his blog, Musings of a Distractible Mind , and perhaps you will be able to divine the origins or meaning of his deep interest in llamas.

Doctors 60

Doctors 60

Health Blawg

DECEMBER 25, 2017

I first met Doc Rob through our involvement in the late lamented Grand Rounds (the notable medical blog carnival – you can find some editions here ). You should read his blog, Musings of a Distractible Mind , and perhaps you will be able to divine the origins or meaning of his deep interest in llamas.

Doctors 60

Doctors 60

Provider Trust

JULY 25, 2022

The Special Advisory Bulletin states that “no Federal healthcare program payment may be made for any items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person.” Monitoring every provider in your health system can be a challenging task. Recent OIG Enforcement Actions.

Electronic Medical Records 52

Electronic Medical Records Licensing Medicare Medicare 52

Hall Render

AUGUST 3, 2023

If so, and if the resident has provided this information to the assisted living facility, the assisted living facility must provide a list of the resident’s prescription and over-the-counter medications, dosages and frequency of administration. Hall Render blog posts and articles are intended for informational purposes only.

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Hospitals Nurses HIPAA 40

Health Care Law Brief

APRIL 12, 2023

On April 5, the Centers for Medicare & Medicaid Services (“CMS”) released the 2024 Medicare Advantage and Prescription Drug Benefit Programs Final Rule (“Final Rule”), which will be codified at 42 C.F.R. We discuss the Supreme Court’s denial of writ of certiorari challenging the 60 Day Rule in a previous blog post.)

Medicare 52

Medicare Medicare Overpayments Overpayment 52

Healthcare IT Today

FEBRUARY 7, 2024

Congress this year are expected to boost e-prescriptions. State governments are also roped in thanks to their Prescription Drug Monitoring Programs (PDMPs). Drug abuse is clearly a leading social problem, and prescriptions notoriously play a large part. Two bills in U.S.

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Telemedicine Doctors COVID-19 Medicare 113

Health Populi

DECEMBER 27, 2021

I covered this announcement in the Health Populi blog at the time, and today want to double-down on the significance of Ford’s leading presence at #CES2022. . “This marks the first time in CES history that a healthcare company will take the mainstage for a keynote at the show,” CTA’s press release stated.

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COVID-19 FDA Health Outcomes Doctors 161

Healthcare Law Blog

OCTOBER 25, 2023

[iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. Violations of the educational requirements can be subject to fines $1,000 to $3000 per day of violation. [ix] ix] Nevada.

Licensing 52

Licensing Compliance FDA Public Health 52

Hall Render

SEPTEMBER 2, 2022

Therefore, CMS proposed a new exception to protect referrals by physician owners to an REH for designated health services, namely, radiology and certain imaging services, clinical laboratory services and outpatient prescription drugs. Hall Render blog posts and articles are intended for informational purposes only.

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Payment Systems Hospitals Medicare Medicare 40

Provider Trust

JULY 26, 2022

Attorney’s Office press release , during her time at the practice, Pickering allegedly posed as a licensed physician’s assistant and issued prescriptions for controlled substances, “in the name of Doctor 1, a physician contracted by the practice, without Doctor 1’s permission.” Further, Ms.

Licensing 52

Licensing Fraud Compliance Nurses 52

SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. Semaglutide and liraglutide are prescription-only medicines. None were seized prior to January 2023.

FDA 52

FDA Compliance COVID-19 Public Health 52

Verisys

FEBRUARY 14, 2024

Example: A clinic identifies a risk of medication errors due to miscommunication between its electronic health record (EHR) system and the pharmacy’s system. To mitigate this risk, the clinic implements a new protocol for medication orders that includes double-checking all prescriptions before they are sent to the pharmacy.

Governance 52

Governance Compliance Regulatory Compliance Compliance Framework 52

Hall Render

MARCH 28, 2023

CMS waived the prescriptive requirements for the placement of alcohol-based hand rub dispensers for use by staff and others due to the need for the increased use of ABHR in infection control. Hall Render blog posts and articles are intended for informational purposes only. Alcohol-Based Hand-Rub (“ABHR”) Dispensers.

Public Health 40

Public Health Nurses Nursing Homes COVID-19 40

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. The electronic certificate and the paper version are equally authentic.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Hall Render

FEBRUARY 4, 2022

Hall Render blog posts and articles are intended for informational purposes only. ” Medicare Part C. Your primary Hall Render contact. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

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Fraud Governance Medicare Medicare 40

Hall Render

MAY 2, 2023

In 2020, CMS issued an interim final regulation to require SNFs to electronically report to the CDC information about COVID in each SNF in a form specified by CMS through the National Healthcare Safety Network. Hall Render blog posts and articles are intended for informational purposes only. COVID Reporting Requirements.

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Nursing Homes Public Health Nurses COVID-19 40

Hall Render

JANUARY 11, 2023

ONC’s Information Blocking Regulations – If an app developer certifies its technology through the ONC’s Health IT Certification Program, the app is subject to the ONC’s information blocking rules which prohibit “practices likely to interfere with access, exchange, or use of electronic health information” unless an exception applies.

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Compliance HIPAA FDA Due Diligence 40

YouCompli

MAY 24, 2023

million to settle allegations of accepting kickbacks for writing prescriptions for compounded drugs. A vendor may offer to provide free electronics or gifts. After the physician started receiving these benefits, he quickly became the largest prescriber in the country for the particular drug. In a different example, a doctor paid $3.1

Compliance Officers 52

Compliance Officers Compliance Doctors Due Diligence 52

SQA

SEPTEMBER 2, 2022

Drug Supply Chain Security Act (DSCSA) Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished, Prescription Drugs, Draft Guidance for Industry, July 2022. United States Food and Drug Administration (FDA) – Recalls.

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FDA COVID-19 Nursing Homes Compliance 91

Healthcare Law Blog

FEBRUARY 16, 2022

In our November 9, 2021, blog post on the No Surprises Act (“NSA”), we discussed new consumer protections against surprise out-of-network bills. The GFE must be provided in written form either on paper or electronically. If a GFE is requested by a self-pay patient (i.e.,

Health Insurance 52

Health Insurance Licensing Hospitals Medical Billing 52

Healthcare Law Blog

MAY 16, 2022

On April 29, 2022 , the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”).

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

OCTOBER 18, 2022

The seized products include seven that are labeled to contain prescription drugs and may pose serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives, or contaminants that may or may not be listed on the label. Prescription drugs can only be legally sold with a prescription.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

SQA

AUGUST 8, 2023

The products were seized because they are unauthorized and labelled to contain prescription drug ingredients and may pose serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives, or contaminants that may or may not be listed on the label. as the drug manufacturer.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

FEBRUARY 22, 2021

CMDE Announcement Addresses UDI-DI Electronic Submission, 29 December 2020. is expanding its recall for its prescription anti-gingivitis oral rinse, GUM Paroex, to all lots on the Canadian market. The Center for Medical Device Evaluation (CMDE) issued its Announcement No. Sunstar Americas Inc.

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COVID-19 Compliance Licensing Governance 52

Healthcare Law Blog

JANUARY 6, 2023

The Act, however, does not extend the waiver of the Ryan Haight Act’s requirement for an in-person exam for the prescription of controlled substances. Due to the COVID-19 pandemic, authorized prescription oral antiviral drugs will be covered as a Part D drug through the end of 2024. [22] Definition of “Originating Site”.

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COVID-19 Medicaid Medicaid Medicare 52

Healthcare Law Blog

JANUARY 10, 2022

On January 6, 2022 , the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Please contact Medicare.gov or 1-800-MEDICARE to get information on all of your options.”

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Medicare Medicare COVID-19 Medicaid 98

SQA

MAY 24, 2023

Last year also saw China’s first regulation permitting online sales of prescription drugs nationwide. It replaces the Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials. In addition, a new expression is defined: ALCOA+.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

The following is a summary of a Canadian case report that was evaluated by Health Canada, describing an error associated with confusion about the labelled strength of a mineral supplement: In this case, the prescription was dispensed by the pharmacy using a product labelled as “Calcium Carbonate 500 mg”. When to make the submissions.

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FDA Compliance Licensing World Health 40