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Why regulators didn’t challenge Amazon-One Medical deal, despite data concerns

Health Care Dive

billion buy of primary care company One Medical closed last week without a challenge from the FTC, even as consumer protection groups and regulators aired worries about the tie-up The ecommerce giant's $3.9

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Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

Bill Of Health

The Truth Pill , authored by Dinesh Thakur and Prashant Reddy , is a monumental work that convincingly shows that drug regulation is but a myth in India. In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global.

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Zelis helps address new NSA and TiC regulations

Health Care Dive

Learn more about innovative solutions that can help you comply with new regulations

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A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

Bill Of Health

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. By Sarah Hashkes.

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CMS tackles provider availability, exchange regulations in proposed rule

Health Care Dive

The regulation comes as the ACA exchanges, spurred by financial incentives during the COVID-19 pandemic, reached record enrollment numbers

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The Biden Administration Should Resolve Cannabis Regulation Chaos

Bill Of Health

The Biden Administration has the opportunity to be the first administration to rid our legal system of cannabis regulation chaos. The DOJ’s authority to regulate cannabis stems from the Controlled Substances Act (CSA), passed by Congress in 1970. By Troy Sims.

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Zelis helps address new NSA and TiC regulations

Health Care Dive

Learn more about innovative solutions that can help you comply with new regulations

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Federal regulators nix contested language in surprise billing final rule

Health Care Dive

The final rule removes the earlier requirement that arbiters must first presume that the median in-network rate is the appropriate payment

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Healthcare Dealmakers—Elevance to acquire BCBSLA; Regulators' request for Sanford and Fairview and more

Fierce Healthcare

Healthcare Dealmakers—Elevance to acquire BCBSLA; Regulators' request for Sanford and Fairview and more dmuoio Wed, 02/01/2023 - 14:41

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Regulating Out of the Social Media Health Crisis

Bill Of Health

If something changes the pathways in our brains and damages our health — and if it does so to Americans on a vast scale — it should be regulated as a threat to public health. It’s time for our regulators to acknowledge that social media fits this description. By Bailey Kennedy.

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There’s More Than Rules in Regulating Concussions

Bill Of Health

This post considers the application of Lawrence Lessig’s New Chicago School approach to regulation to the prevention of concussions (and other types of brain damage generalized under the word “concussions” for simplicity) in football. By Jack Becker.

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Fall of SVB hits healthcare sector as federal regulators step in

Health Care Dive

The major healthcare and life sciences lender closed Friday in the culmination of a rapid four-day nosedive that left some healthcare companies temporarily locked out of funds

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Cerner to pay $1.9M to settle racial discrimination claims in deal with federal regulators

Fierce Healthcare

to settle racial discrimination claims in deal with federal regulators. Cerner to pay $1.9M hlandi. Thu, 08/11/2022 - 17:40

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Compliance with Oct. 6 data blocking regulations will suffer without more clarity, stakeholders tell HHS

Fierce Healthcare

6 data blocking regulations will suffer without more clarity, stakeholders tell HHS. Compliance with Oct. dmuoio. Mon, 08/22/2022 - 16:14

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Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

Bill Of Health

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). His teaching and research interests are in the areas of intellectual property, privacy, and the regulation of controlled substances.

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Industry Voices—With the healthcare sector under constant cyberattacks, are tighter regulations the answer?

Fierce Healthcare

Industry Voices—With the healthcare sector under constant cyberattacks, are tighter regulations the answer? hlandi. Wed, 08/24/2022 - 12:20

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Shaved Costs, High Risk, Maximum Profits: Regulators Worry About Florida’s Butt Lift Boom

KHN

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

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Should We Regulate Direct-to-Consumer Health Apps?

Bill Of Health

Of these, only a fraction are regulated by the U.S. Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA , should they undergo any kind of review, such as whether they are helpful for consumers?

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Mass General dinged for spending growth by state regulator

Health Care Dive

A key driver behind spending at the health system is prices, not increased utilization, according to the Health Policy Commission, which is charged with policing healthcare cost growth in the state

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Medical practices say regulations adding more red tape that hamstrings patient care

Fierce Healthcare

Medical practices say regulations adding more red tape that hamstrings patient care. dmuoio. Tue, 10/26/2021 - 12:00

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Antitrust regulators aim to revamp merger guidelines, signaling threat to health sector deals

Health Care Dive

The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for the healthcare sector for years to come

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Revamping of Cosmetics Regulation and Safety

Triage Health Law

The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. FDA Regulations

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Regulators propose outpatient pay increase, but hospitals say it's not enough

Health Care Dive

"A much higher update is warranted," the American Hospital Association said in a statement citing increased inflation

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Cybersecurity in a Highly Regulated Industry

Healthcare Leadership Council

The public is awaiting future regulations from CISA of how to proceed with that reporting process. The Problem with Breach Notifications As healthcare is a highly regulated industry, organizations who comply with one law run the risk of violating another law because the federal agencies and states have not adequately communicated with each other regarding the larger operational impact of what they are trying to accomplish.

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With Cerebral in the spotlight, DOJ, regulators to ramp up scrutiny of telehealth startups, former prosecutor says

Fierce Healthcare

With Cerebral in the spotlight, DOJ, regulators to ramp up scrutiny of telehealth startups, former prosecutor says. hlandi. Tue, 07/05/2022 - 06:56

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From 340B to short-term health plans: Here are the top 4 regulations to watch for in 2022

Fierce Healthcare

From 340B to short-term health plans: Here are the top 4 regulations to watch for in 2022. rking. Fri, 12/10/2021 - 16:44

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Health cost regulator tells Mass General Brigham to clamp down on spending, critiques $2B expansion plan

Fierce Healthcare

Health cost regulator tells Mass General Brigham to clamp down on spending, critiques $2B expansion plan. dmuoio. Wed, 01/26/2022 - 15:23

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AHA moves to shift cost blame to health plans in letter to antitrust regulators

Health Care Dive

The letter included an updated AHA-funded study on the benefits of hospital mergers, which was previously criticized by outside experts for cherry-picked data, among other methodological weaknesses

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Limiting hospital price regulation to concentrated markets would miss the worst offenders

Fierce Healthcare

Limiting hospital price regulation to concentrated markets would miss the worst offenders. dmuoio. Mon, 09/13/2021 - 12:28

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

The Food & Drug Administration’s new over-the-counter (OTC) hearing aid regulations are now in effect and health plans are starting to explore what it means for them. Health plans should be on the alert for potential pitfalls arising from the new regulations.

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Public Health Emergency (PHE) COVID-19 Regulations

Briggs Healthcare

Mary Madison, RN, RAC-CT, CDP Clinical Consultant – Briggs Healthcare. The Iowa Department of Human Services issued IL 2315-MC-FFS-CVD on Sunday, February 20, 2022. The Informational Letter is directed to Iowa Medicaid Providers, but it contains a message that I thought was worth sharing.

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Health Apps: Good, Bad, and Regulation?

Healthcare Leadership

In healthcare we need more _ apps and we need less _ apps” T4 Should health/healthcare apps be regulated like medical devices are?

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What was the impact of regulating markups for US health insurance?

Healthcare ECONOMIST

This is exactly what a paper by Cicala, Lieber and Marone (2019) find: We show that minimum MLR regulations are predicted to curtail cost-reducing effort and increase medical claims, while the impact on premiums is ambiguous (and depends on the relative curvatures of the demand and cost-reducing effort functions). Addendum : Note that prior to the ACA, some states (n=29) did have MLR regulations in place.

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Zelis Helps Address New NSA and TiC Regulations

Fierce Healthcare

Zelis Helps Address New NSA and TiC Regulations. admin. Thu, 09/23/2021 - 15:54

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FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

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Reimagining The Future of Pharmacovigilance (PV): Regulations, Tech, Public Perceptions

HIT Consultant

This will ensure that both regulators and software users can validate AI algorithms and their outputs – a critical step for applying to artificial intelligence the same rigor of reproducibility that we’ve come to expect from clinical trials.

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HHCN+ Report: The Pros and Cons of Certificate of Need Regulations in Home Health Care

Home Health Care

But, again, each state has different regulations. Either way, CON regulations have – and will continue to – shape the home health sector for years to come. I think in certain markets, [CON regulations] make sense,” Dordick said. “I’m

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Changes Coming to How FDA Regulates Cosmetics

HKLaw

Michael J. Werner, Sara M. Klock

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Brain and Machine Confluence Requires Multi-Sectoral Regulation To Maximize Gains

The Rand Blog

As the commercialization of brain-computer interface technology expands, it would be prudent for international policymakers to consider how this technology should be regulated, in order to reap its benefits and minimize its risks

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‘It’s Now for the Wealthy’: Regulation Creating Cost Barriers for Live-In Home Care Services

Home Health Care

Mostly, though, the Obama-era regulation has ended up decreasing the amount of live-in care that home care agencies provide. But instead of improving the situation, industry regulation has just decreased the amount of paid people in the profession. “I

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CMS Releases Emergency Regulation Requiring COVID-19 Vaccinations for Medicare, Medicaid Providers

Home Health Care

The agency released its interim emergency regulation on Thursday morning. The CMS emergency regulation affects all health care organizations that participate in the Medicare and Medicaid programs, including home health agencies and home- and community-based services (HCBS) providers.

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Truth Decay, School Lunch Nutrition, Regulating Space: RAND Weekly Recap

The Rand Blog

This weekly recap focuses on tackling Truth Decay, how tech experts view the military's use of artificial intelligence, a new approach to regulating outer space, and more

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State-Only Webinar: The Impact of Rutledge on?State?PBM Regulation?and Beyond 

NASHP

The ruling affirmed that states can regulate pharmacy benefit managers (PBMs) despite PCMA’s assertion that?the?federal?Employee preempted such regulation.?The? PBM regulation is already the most common form of drug pricing-related legislation in state legislatures, and the?