Regulatory Issues

CDC: No Change in Level of Uninsured in U.S. in 2017

CDC: No Change in Level of Uninsured in U.S. in 2017

Overall, 9.1 percent of individuals in the United States were uninsured in 2017, which was not significantly different from the level in 2016.

Nonprofit Manufacturer Could Keep Generic Drug Costs Down

Nonprofit Manufacturer Could Keep Generic Drug Costs Down

Researchers discuss generic drug market failure, whereby a generic drug manufacturer increases the drug price, which can compromise care.

Making Alternative Payment Plans Mandatory: Inherent Risks and Pitfalls in Reducing Healthcare Costs

Making Alternative Payment Plans Mandatory: Inherent Risks and Pitfalls in Reducing Healthcare Costs

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The Center for Medicare and Medicaid Innovation (CMMI) program was created by the Affordable Care Act to identify and test new strategies for reimbursement in an effort to reduce growing healthcare costs.

Medical Marijuana Users More Likely to Use Prescription Drugs for Medical, Nonmedical Purposes

Medical Marijuana Users More Likely to Use Prescription Drugs for Medical, Nonmedical Purposes

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Patients who use medical marijuana may be more likely to use prescription drugs for both medical and nonmedical purposes.

White House Unveils Plan to Lower Cost of Prescription Drugs

White House Unveils Plan to Lower Cost of Prescription Drugs

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FDA Commissioner, Scott Gottlieb MD, said, "The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs."

Regulatory Requirements Drive Dissatisfaction With EHRs

Regulatory Requirements Drive Dissatisfaction With EHRs

Regulatory requirements are likely to be an important aspect of physician dissatisfaction with electronic health records that is driving burnout.

Many Organizations Not Meeting Trial Reporting Requirements

Many Organizations Not Meeting Trial Reporting Requirements

Only 19 percent of organizations use computer software to monitor compliance with Final Rule.

Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

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The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4-17 years of age.

Medicine and Conscience Intersect at the Department of Health and Human Services

Medicine and Conscience Intersect at the Department of Health and Human Services

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The Department of Health and Human Services has announced the creation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights.

Anesthesiologists Report Drug Shortages Affecting Patient Care

Anesthesiologists Report Drug Shortages Affecting Patient Care

Survey finds that 98 percent of respondents report experiencing drug shortages on a consistent basis.

Medicare Requiring Hospitals to Post Prices Online

Medicare Requiring Hospitals to Post Prices Online

U.S. hospitals will have to post their standard prices online and make it easier for patients to access their electronic medical records, Medicare officials said.

Scale of Online Marketplace for Marijuana Increasing

Scale of Online Marketplace for Marijuana Increasing

Researchers examined the scale and growth trajectory of the online marketplace for marijuana by analyzing aggregate internet searches and the links searchers typically found.

ACP: Position Paper Shares Top Principles of Volunteer Medical Experiences

ACP: Position Paper Shares Top Principles of Volunteer Medical Experiences

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The position paper focuses on the 4 accepted principles of healthcare: beneficence, nonmaleficence, justice, and respect for autonomy.

Individual Consent for Health Research: Ethical Obligations vs Public Good

Individual Consent for Health Research: Ethical Obligations vs Public Good

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A recent paper examines the circumstances in which public good outweighs the requirement that researchers receive individual consent to use a person's data.

Kratom-Containing Dietary Supplements Recalled

Kratom-Containing Dietary Supplements Recalled

The FDA said it wants all companies making kratom products to take them off the market, and urged all consumers who have kratom-containing products to stop using them and throw them away.

ACA Coverage Expansion Places Spending Burden on Low- to Middle-Income Households

ACA Coverage Expansion Places Spending Burden on Low- to Middle-Income Households

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Although the Affordable Care Act's coverage expansions have reduced out-of-pocket spending for low- and middle-income individuals, these patients continue to experience a high burden of premium and out-of-pocket spending.

Evaluating the Consequences of the Federal Right-to-Try Legislation

Evaluating the Consequences of the Federal Right-to-Try Legislation

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Federal "right-to-try" legislation will restrict the FDA's oversight of access to investigational drugs for patients with life-threatening illnesses and diminish the FDA's public health mission

Congress Urged to Reverse CMS Policy That Could Affect Specialists, Patients

Congress Urged to Reverse CMS Policy That Could Affect Specialists, Patients

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Many healthcare organizations are calling on Congress to reverse the new Centers for Medicare & Medicaid Services policy that has the potential to jeopardize patient access to Part B drug therapies.

Seven Potential Harmful Consequences of the CDC's Banned Words List

Seven Potential Harmful Consequences of the CDC's Banned Words List

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Experts advise that should the CDC be banned from using certain words, it could give rise to at least 7 harmful consequences.

FDA Accepts New Drug Application for Postoperative Ocular Pain, Inflammation

FDA Accepts New Drug Application for Postoperative Ocular Pain, Inflammation

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The FDA has accepted a New Drug Application for an investigational topical twice-a-day product for the treatment of inflammation and pain in patients who have undergone ocular surgery.

What Does the CVS/Aetna Merger Mean for Primary Care?

What Does the CVS/Aetna Merger Mean for Primary Care?

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Aetna will have access to data on pharmaceutical usage patterns that will give the company the opportunity to figure out who is willing to pay more for healthcare. What does this mean for patients?

Trump Administration Hands CDC a List of "Forbidden Words"

Trump Administration Hands CDC a List of "Forbidden Words"

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Policy analysts at the Centers for Disease Control and Prevention have been informed to stop using certain terms in documents to be used in next year's budget.

Climate Change: Effects on the Incidence and Distribution of Infectious Diseases

Climate Change: Effects on the Incidence and Distribution of Infectious Diseases

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Scientists warn that unless there is an adequate response and proactive measures are taken, society will soon have to deal with direct and indirect effects of the changing climate on human health.

AHA Voices Concerns Over Tax Reform Bill

AHA Voices Concerns Over Tax Reform Bill

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After the Republicans passed their tax reform bill in the Senate over the weekend, the American Heart Association released a statement detailing their concerns about the legislation.

FDA Expresses Safety Concern Over Kratom

FDA Expresses Safety Concern Over Kratom

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The Food and Drug Administration's Commissioner Scott Gottlieb, MD, has issued a statement regarding the deadly risks associated with the botanical substance, kratom.

Pharma Companies Overemphasizing Flaws With Medicaid's "Best-Price" Rule

Pharma Companies Overemphasizing Flaws With Medicaid's "Best-Price" Rule

Medicaid's best-price rule is not as serious a problem as drug manufacturers imply, although it may affect novel pricing arrangements.

MACRA: Five Things You Should Know

MACRA: Five Things You Should Know

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Here are five potentially pivotal MACRA issues that you should know about.

Medical Schools' Social Mission Critical for Societal Health Equity

Medical Schools' Social Mission Critical for Societal Health Equity

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Enhancing health equity and addressing societal healthcare disparities is dependent on American medical schools committing to a social mission.

Generic Drugs Price Changes Raise Market Competition Levels

Generic Drugs Price Changes Raise Market Competition Levels

Market competition levels are associated with changes in the price of generic drugs.

Device-Specific ICD Codes Needed According to Researchers

Device-Specific ICD Codes Needed According to Researchers

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Researchers are urging legislators to assign ICD codes to all medical devices, which could help identify device-related adverse effects more accurately.

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