Verisys

NOVEMBER 30, 2022

organizations that receive any funds from Medicare, Medicaid, TRICARE, or other federal programs cannot afford to employ individuals or entities excluded from even one program. OIG, SAM DEA, GSA, FDA. Medicare opt out. Medicare and Medicaid Opt-Outs. Medicare and Medicaid Opt-Outs. FBI, PHS, ORI, DOJ, TRICARE.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

CMS.gov

OCTOBER 2, 2018

Modernizing Medicare to Take Advantage of the Latest Technologies. Administrator, Centers for Medicare & Medicaid Services. Modernizing Medicare to Take Advantage of the Latest Technologies. However, while medical technology is developing at a rapid pace, Medicare’s payment systems haven’t always been as quick to change.

Medicare 44

Medicare Medicare Payment Systems FDA 44

HIPAA Journal

DECEMBER 8, 2022

However, they need support from the federal government as the field continues to face targets from sophisticated cyber adversaries and nation-states.”. Greater support is required from the federal government for victims of cyberattacks. The FDA should also make it clear that security updates are required, not optional.

HIPAA 104

HIPAA FDA Governance Hospitals 104

Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] The introduction of the metaverse will likely exacerbate these interoperability issues. Medical Device Regulations. 1, 2021).

FDA 90

FDA HIPAA Medicare Medicare 90

HIT Consultant

DECEMBER 14, 2021

They are focused on expanding the number of providers who can prescribe the treatment (it requires a special waiver from the federal government) and training more clinicians to provide support needed for the treatment to be successful. government agencies to develop OUD treatment protocols for decades.

Licensing 98

Licensing Governance FDA Telemedicine 98

Healthcare IT Today

MAY 5, 2023

The following is a guest article by Erin Rutzler, Vice President of Fraud, Waste, and Abuse at Cotiviti In Delaware, more than 250 Medicare patients underwent unnecessary genetic testing based on telehealth consultations that often lasted less than two minutes— costing Medicare thousands of dollars per patient.

Fraud 62

Fraud Medicare Medicare Overpayments 62

HIT Consultant

MAY 24, 2023

With an anticipated dramatic rise of Americans diagnosed with AD approaching, broad changes to Medicare are needed. While Medicare and other sources of financial assistance may cover some of these costs, they won’t cover it all, leaving individuals with AD or other dementias and their families with high out-of-pocket costs.

Medicare 97

Medicare Medicare FDA Governance 97

Healthcare IT Today

AUGUST 28, 2023

Regarding medication, several new psychiatric treatments have been approved by the FDA, including Auvelity for major depressive disorder, the SAINT transcranial magnetic stimulation protocol for treatment-resistant depression, and Zurzuvae for postpartum depression.

US Department of Health and Human Services 111

US Department of Health and Human Services Telemedicine Hospitals Compliance 111

Verisys

DECEMBER 1, 2022

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. FACIS Level 3 background screening of federal sources. SAM ( including SDN ). State Dept.

Medicaid 52

Medicaid Medicaid Fraud Governance 52

HIT Consultant

JANUARY 9, 2023

The Star Rating system, which measures the quality of care and member satisfaction in privately managed Medicare plans, helps consumers compare the benefits and costs of different plans. It also impacts government payment rates. Take, for example, the smartphone camera-based ACR test recently cleared by the FDA – Minuteful Kidney™.

Medicare 52

Medicare Medicare FDA COVID-19 52

Healthcare Law Blog

MARCH 17, 2022

22-05 , relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). 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) ).

US Department of Health and Human Services 52

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

Redox

OCTOBER 12, 2023

The FDA has approved more than 500 AI and machine learning models for medical use—most of which are in radiology. In 2022, the FDA announced that some types of risk-scoring tools were to be regulated as medical devices. However, regulations exist to validate that AI algorithms are clinically robust and safe to use.

FDA 69

FDA Hospitals Medicare Medicare 69

HIT Consultant

APRIL 4, 2023

In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health. In alignment with PHE’s conclusion, other government bodies are rolling back pandemic-era measures.

FDA 52

FDA Medicaid Medicaid COVID-19 52

HIPAA Journal

NOVEMBER 4, 2022

Warner suggests the only way to improve healthcare cybersecurity rapidly is through a collaborative effort involving the public and private sectors, with the federal government providing overall leadership. The program would standardize coverage elements and provide incentives for insurance companies to adopt them.

HIPAA 114

HIPAA Governance FDA Medicaid 114

Compliance Now

AUGUST 1, 2022

Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above. To this end, they indicate that the Medicare Part D Coverage Determination Request Form would be a good model for this purpose. Imposing an age limit on contraceptive coverage.

FDA 100

FDA Medicare Medicare Governance 100

Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. It is critical for hospitals and health systems to know that everyone on the staff is compliant and in good standing at all times.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Healthcare Law Today

JANUARY 20, 2022

However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to such tests, including the Clinical Laboratory Improvement Amendments (CLIA), which govern most laboratory testing and the operations of clinical laboratories.

COVID-19 52

COVID-19 FDA Licensing Medicaid 52

Health Care Law Brief

JUNE 2, 2022

Therefore, a telehealth platform operating in all 50 states will, for example, need to comport with the laws governing corporate formation, provider licensure, scope of practice, and telehealth encounters in all 50 states. What type of telehealth encounters will take place on the platform? How is this disclosed to consumers?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

As telehealth in general, including telepsychiatry, has become more commonly used, there has been pressure on Medicaid, Medicare and private insurance companies to develop standards for coding and billing for telehealth services. There continue to be updated guidelines to help clinicians use appropriate codes for billing.

COVID-19 133

COVID-19 Public Health Licensing FDA 133

Pharmacy Law Blog

MARCH 13, 2018

The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

Fraud 52

Fraud Governance Licensing FDA 52

The Digital Health Corner

OCTOBER 28, 2016

The Physician Quality Reporting System (PQRS) has been used since 2015 as a metric to determine negative Medicare payment adjustments to providers who do not meet quality standards. The FDA has chimed in with a Guidance on the Use of Real-World Data to Support Regulatory Decision-Making for Medical Devices.

FDA 60

FDA Medicare Medicare Governance 60

Verisys

JANUARY 18, 2022

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Food and Drug Administration (FDA). System for Award Management (SAM). Specially Designated Nationals (SDN).

Licensing 52

Licensing Medicaid Medicaid Governance 52

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Notably, ketamine infusions or prescriptions for behavioral health matters are generally not reimbursable by Medicare or other federal health care programs.

Licensing 40

Licensing Telemedicine COVID-19 FDA 40

Hall Render

FEBRUARY 23, 2024

biotech pins hopes on 3 drug approvals as battles with FDA continue Luxury senior living facility coming to D.C. CT’s Medicaid reimbursement rates lower than peer states: report Better safety training, reporting, escorts for CT home health care workers focus of new legislation D.C.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Healthcare Law Blog

AUGUST 3, 2022

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”.

Governance 52

Governance FDA Medicare Medicare 52

Hall Render

MAY 10, 2024

Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M million expansion ‘Very, very unusual.’ Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M million expansion ‘Very, very unusual.’ million expansion ‘Very, very unusual.’

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Jane Sarashon

JULY 29, 2022

” It turns out that if Medicare Part D paid for the 184 most common generic medications for enrollees based on Costco’s cash-prices for the same products, the U.S. government would have saved $2.6 billion in 2018. Costco isn’t only beloved for the $1.50

COVID-19 67

COVID-19 Health Insurance Telemedicine Doctors 67

Healthcare IT Today

JANUARY 6, 2023

The Leidos-Milken partnership in spring 2021 launched a collaborative initiative aimed at bringing together leaders in the private, government, academic, and nonprofit sectors to address the national opioid epidemic and mental health crisis. Wayne Johnson, Vice President of Special Operations at Sunwave Health.

US Department of Health and Human Services 104

US Department of Health and Human Services Doctors Telemedicine Public Health 104

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

COVID-19 207

COVID-19 Hospitals Doctors Health Insurance 207

Health Law Advisor

MARCH 7, 2023

The proposed rules also clarify that a telemedicine encounter that results in a controlled substance prescription requires the health care professional treating the patient to use an interactive telecommunications system, and directly refers to the Medicare definition of that term at 42 C.F.R. 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

The Digital Health Corner

JUNE 14, 2017

The hesitation of many entrepreneurs to embrace the intuitive adoption requirement of proof of claim (which needs to be said should not differ from the adoption of product in any field of endeavor making claims) is the misconception that time-consuming large costly randomized clinical trials are what I am referring to.

Patient Satisfaction 87

Patient Satisfaction Hospitals FDA Governance 87

Healthcare IT Today

SEPTEMBER 12, 2023

A major justification for President Biden’s tax hike proposal is to shore up the tenuous finances of Medicare whose trust fund is forecasted to be depleted by 2028. Historically, it is the most prolific driver of family bankruptcy, and now it is on its way to bankrupting our country collectively.

Nurses 66

Nurses Doctors Medicare Medicare 66

Hall Render

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Troubled NC nursing home set to lose nearly all its government funding — and patients. Government watchdog: Health care giants improperly denied Medicare benefits. Kim Schrier, Health initiatives, Inflation & Medicare. HHS awards $16.3M

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

The Digital Health Corner

NOVEMBER 28, 2016

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

Public Health 68

Public Health Health Services Administration Patient Advocacy Governance 68

Health Populi

AUGUST 16, 2019

Employers’ most daunting challenge and uncertainty when it comes to dealing with pharmacy spending is the specialty drug impact — specifically, new million-dollar therapies getting approved by the FDA. Federal government Blueprint for reducing prescription drug costs. Across party identification, U.S.

Governance 74

Governance Health Care Reform FDA ACA 74

Healthcare IT News - Telehealth

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. Fortunately, government, investors and startups are working together to close some of these care gaps.

Medicaid 198

Medicaid Medicaid COVID-19 Telemedicine 198

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98