Health Populi

MARCH 10, 2023

As our homes and health care services continue to converge, we can see signposts of direct-to-consumer strategies from the pillbox (where DTC is a mature thing) to clinical care in peoples’ hands (and on their preferred technology platforms). There’s more on Sequence here. This is a major focus of my work these days in the U.S.

Hospitals 62

Hospitals Telemedicine 62

Healthcare Law Blog

MARCH 20, 2023

Private payors may learn from the strategies of state and federal leaders in crafting frameworks to support patient populations both virtually and in-person, despite the growing provider shortage. 6] Increase provider reimbursement strategies. 6] Increase provider reimbursement strategies. Incentivizing provider participation.

Medicaid 52

Medicaid Medicaid Licensing ACA 52

MedTrainer

DECEMBER 5, 2023

The act defines personal data broadly and includes a category for “sensitive data.” Here are some key strategies to help healthcare organizations manage compliance effectively: Conduct State-Specific Training: Provide ongoing training and education to staff that is customized to your state’s regulations as well as your facility.

Compliance 52

Compliance Licensing Public Health Governance 52

Health Populi

MARCH 12, 2020

Staying healthy strategies among consumers, like buying out the shelves of Purell hand sanitizers and purchasing vitamins, minerals and supplements for immune support. Thinking beyond the bug at other categories of consumer purchases. Preparing the “pandemic pantry” for shelf-stable essential foods.

COVID-19 137

COVID-19 Telemedicine Hospitals Public Health 137

AIHC

AUGUST 30, 2023

What compliance issues need to be considered when drafting a marketing strategy? It is a strategy used to not only increase your patient based, but increase other incremental income as well. The bottom line is that this marketing strategy has the ultimate goal of increasing revenue. So, what is telemarketing in healthcare ?

Compliance 52

Compliance Fraud Medicare Medicare 52

Health Law Advisor

APRIL 4, 2023

This post uses topic modeling, a natural language processing algorithm I’ve used in previous blog posts, including here [1] and here [2] , to discern the major topics of these requests. There is no reason to believe that the categories would be obvious and completely distinct from one another. They don’t fall into cookie-cutter topics.

FDA 52

FDA 52

Health Populi

MAY 29, 2020

In the coronavirus-self-care moment, DIY hair color has been a winning category in fast-moving-consumer-goods (FMCG) at retail. That is the Question” in a CDC blog in 2017, well before the coronavirus raised its crowns in 2019. Can you see yourself? The Centers for Disease Control wondered, “To Beard or Not to Beard?

COVID-19 83

COVID-19 Public Health Doctors Hospitals 83

MedTrainer

NOVEMBER 29, 2023

The phased implementation of this requirement, which began in 2018, ensures that various categories of practitioners, including those in emergency departments and pain management clinics, integrate INSPECT checks into their prescribing practices. If using a learning management system, ensure the vendor offers Indiana -approved training.

Compliance 52

Compliance Licensing Governance Public Health 52

YouCompli

DECEMBER 14, 2022

Sharon Parsley, JD, MBA, CHC, CHRC contributes a monthly post on compliance officer effectiveness for the YouCompli blog. As much as possible, offer specific examples of what is ok, what is not, and the “why” behind each category. Many people in our discipline love the slogan “compliance is everybody’s business.” Sales and Marketing.

Compliance 52

Compliance Compliance Officers Nurses Overpayments 52

Hall Render

DECEMBER 4, 2023

CMS expects these rates will continue to fall into one of three categories: (1) standard dollar amount, (2) standard algorithm or percentage, or (3) hybrid where a standard dollar amount can be identified but the final allowed amount is dependent on additional variables. It does not replace the existing requirement.

Hospitals 52

Hospitals Compliance Patient Advocacy Medicare 52

Healthcare Law Blog

NOVEMBER 10, 2023

INTRODUCTION Recent developments at the Federal Circuit and the USPTO can inform evolving patent strategy on medical technology. Note: First published by ALM / Law.com in The Intellectual Property Strategist I. In one case, the Federal Circuit invalidated a patent relating to catheter insertion technology. While Junker v. The PTAB disagreed.

Regulatory Compliance 52

Regulatory Compliance Compliance 52

Healthcare Law Blog

JANUARY 10, 2024

So, the butterfly wings that beat strongly during the health plan’s benefit design decision making during its Medicare Advantage bid process in the June of the preceding year to shift plan offerings to a PPO design caused the unexpected result of unforeseen jumps in medical spending for certain categories of disease over a year later.

Medicare 52

Medicare Medicare Hospitals 52

Provider Trust

JUNE 1, 2022

One suggested strategy to manage the complexities that come with the nurse staffing crisis and the credentialing process is to better connect and foster the relationship between HR and Compliance departments. As the largest category of licensed caregivers, nurses are the most commonly excluded discipline.

Licensing 52

Licensing Nurses COVID-19 Compliance 52

Healthcare Law Blog

MARCH 17, 2022

The Therapy is available only for clinical use under an FDA-approved, Category B Investigational Device Exemption (“IDE”) ( see 42 CFR 405.211(b)-(c) ). The Category B IDE allows Medicare to make payment for the device and related services furnished in a clinical study, provided the study meets ten enumerated criteria ( see 42 CFR 405.212 ).

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

Med Com Blog

NOVEMBER 30, 2021

physicians routinely are seeing their higher-cost claims down coded by insurers, a strategy a family physician in Cincinnati called a revenue grab, according to Medscape. E/M coding represents the largest category of codes submitted by most providers and monitoring for compliance with billing remains an ongoing effort for Anthem.

Compliance 40

Compliance 40

AIHC

AUGUST 8, 2023

Analyze them for repeat offenders which appear consistently not only within categories but between categories. Written by: Carl Byron , CCS, CHA, CIFHA, CMDP, CPC, ICDCT-CM/PCS, OHCC This article follows The Cobra Effect articles Part 1 and Part 2 also written by Carl Byron. Great auditors know this and live by it.

Compliance 52

Compliance Fraud Medicaid Medicaid 52

Provider Trust

AUGUST 16, 2023

While medical providers comprise a large percentage of healthcare vendors, other facility staff members also fall under this category. Strategies for Effective Vendor Exclusion Monitoring Effective vendor exclusion monitoring is crucial for healthcare organizations to maintain compliance with federal and state regulations.

Fraud 52

Fraud Compliance Licensing Compliance Officers 52

SQA

FEBRUARY 22, 2021

The principal focus of the Plan is to introduce a management model that is more agile, dynamic, adaptable, and transparent, with the aim of better aligning the execution of strategy at all levels of the organization. By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates. SQA Regulatory Surveillance Summary, #1 2021.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

Healthcare Law Blog

FEBRUARY 1, 2023

This does not come as a surprise, as most startups in the healthcare technology space have been active in developing attractive strategies. As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health.

Electronic Medical Records 52

Electronic Medical Records Medicare Medicare Health Outcomes 52

Bill of Health

OCTOBER 11, 2022

Their responses fall into three broad categories. Others consider the limited legal strategies available to plaintiffs. Legal limitations and strategies. Since the first days of the COVID-19 pandemic, employers, businesses, and other entities have anticipated litigation around tort claims associated with the novel coronavirus.

COVID-19 348

COVID-19 COVID-19 Vaccine Public Health Governance 348

SQA

FEBRUARY 15, 2023

Where electronic certificates produced and issued by the provincial application system are used, the provincial drug regulatory department shall clarify the relevant guidelines to enterprises within its administrative region and provide guidance and services.

US Department of Health and Human Services 40

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

Hall Render

NOVEMBER 30, 2023

Phased Enforcement Strategy : The FDA delineates a detailed five-stage plan to transition from a policy of enforcement discretion to full regulation of LDTs as medical devices by 2028. Part 820 ), unless they fall under an exemption. At the end of this four-year period, most LDTs will be subject to all applicable medical device regulations.

FDA 40

FDA Public Health Compliance Hospitals 40

AIHC

FEBRUARY 16, 2024

The “Cobra” - In the late 1800s-early 1900s when India was ruled by the British government, there was a problem with venomous cobras invading major cities. The British government decided to take action and offered citizens a bounty to redeem for dead cobras. While this was an effective short-term solution it eventually failed.

Compliance 52

Compliance US Department of Health and Human Services COVID-19 Hospitals 52

AIHC

FEBRUARY 16, 2024

The “Cobra” - In the late 1800s-early 1900s when India was ruled by the British government, there was a problem with venomous cobras invading major cities. The British government decided to take action and offered citizens a bounty to redeem for dead cobras. While this was an effective short-term solution it eventually failed.

Compliance 52

Compliance US Department of Health and Human Services COVID-19 Hospitals 52

Health Populi

JULY 1, 2019

Get a cup of coffee and sit back, because this is a long one – not the usual short and sweet entry that each of us endeavors to craft on our respective blogs. By Susannah Fox, Jane Sarasohn-Kahn and Lisa Suennen. I’ve lived long enough to have learned. The closer you get to the fire the more you get burned. But the U.S.

Health Insurance 86

Health Insurance Pharmaceutical Industry HIPAA Bioethics 86

Healthcare Law Blog

JANUARY 11, 2023

This higher burden of illness is determined by providers coding their patients for both current and past disease history (using the Hierarchical Condition Categories codes and Risk Adjustment Factor approach, or HCC-RAF), based upon the provider interaction and as documented in the medical record. And…it’s even worse at the provider level.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

C&M Health Law

FEBRUARY 16, 2021

The following blog post presents a brief summary of the final rule’s key changes. The Mega Reg required states to develop and certify as actuarially sound each individual rate paid for each enrollee category (i.e., Standard Contract Requirements/Coordination of Benefits. Actuarial Soundness. Risk-sharing Mechanisms.

Medicaid 40

Medicaid Medicaid Medicare Medicare 40

SQA

DECEMBER 16, 2022

The CMDE published additional documents (link in Chinese) that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. One of the important questions addressed is: How can batch reproducibility be demonstrated? CMDE Announcement No. 21 Medical Software.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

APRIL 30, 2021

While updating the IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients, the team developed a strategy with the following rationale for determining when a term/definition should be included in the IPEC Glossary: The following types of terms/definitions should be included in the IPEC Glossary: Specific to excipients.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Healthcare Law Blog

NOVEMBER 13, 2023

As part of its Behavioral Health Strategy , CMS aims to improve access and quality of mental health care and services, such as substance use disorder prevention and treatment services. Please refer to our January 5, 2023 , November 4, 2022 and May 16, 2022 blog posts for more information.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

SQA

OCTOBER 18, 2022

Healthful Plus’s website has been removed, and the company appears to no longer be in operation. COVID-19 rapid antigen tests are an essential tool in helping to detect infection and slow the spread of the disease. Health Canada recognizes that it is vital that Canadians can trust that the test kits that they rely on are authentic.

US Department of Health and Human Services 40

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

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

FDA 52

FDA Compliance COVID-19 Public Health 52

Healthcare Law Blog

JANUARY 5, 2023

Please refer to our blog posts of November 4, 2022 , October 31, 2022 , and May 16, 2022. A health equity index is an index that summarizes contract performance among those with specified SRFs across multiple measures into a single score. That is, the HEI is specifically designed to create an incentive to reduce disparities in care.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Jane Sarashon

DECEMBER 20, 2023

At the end of each year since I launched the Health Populi blog, I have put my best forecasting hat on to focus on the next year in health and health care. Professor Galloway pointed out in his 2024 predictions the sheer scale that this new drug category could have on over 100 million Americans alone.

Prescription Drug Pricing 67

Prescription Drug Pricing Medical Billing Health Insurance Public Health 67

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. Today’s post is a little different in its format from what our readers are used to. The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC.

FDA 72

FDA Fraud Governance Medicare 72