Regulatory Issues

What Does the Cigna-Express Scripts Merger Mean for the Future of Health Care?

What Does the Cigna-Express Scripts Merger Mean for the Future of Health Care?

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The $67 billion merger between Cigna and Express Scripts will be the first of its kind.

AHA/ACC Release Updated Guidelines for Cholesterol Management

AHA/ACC Release Updated Guidelines for Cholesterol Management

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Updated cholesterol guidelines offer more personalized cardiovascular disease risk assessment.

Large Numbers of Negative Trial Results Impede Progress in Critical Care Medicine

Large Numbers of Negative Trial Results Impede Progress in Critical Care Medicine

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Excessive numbers of negative clinical trials — many of which may be false-negative trials — are a major impediment to the advancement of critical care medicine.

Persistent Expenses Associated With High-Cost Medicare, Medicaid Beneficiaries

Persistent Expenses Associated With High-Cost Medicare, Medicaid Beneficiaries

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Beneficiaries identified as "high cost" were likely to stay high cost over a 3 year period.

Without Medicaid Expansion, Poor Patients Forgo Medical Care

Without Medicaid Expansion, Poor Patients Forgo Medical Care

Doing without medical care is much more common among low-income residents of states that have not expanded Medicaid than among low-income people in other states.

FDA-Approved Test Provides Pharmacogenetic Reports Directly to Consumers

FDA-Approved Test Provides Pharmacogenetic Reports Directly to Consumers

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The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.

Reducing Race-Based Inequalities Across Health Care

Reducing Race-Based Inequalities Across Health Care

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Data show that there is a significant difference in how black patients are treated compared with patients of other races.

Simplifying Medicare Plan Finder Improves Plan Selection

Simplifying Medicare Plan Finder Improves Plan Selection

Simplifying an internet-based decision support tool provided by the Centers for Medicare & Medicaid Services to help older adults make good plan choices in the Medicare prescription drug (Part D) program could result in selection of lower-cost plans.

Hospitals Charge 479% of Cost of Drugs on Average

Hospitals Charge 479% of Cost of Drugs on Average

On average, hospitals mark up drugs by 479 percent of their cost.

Medicaid Expansion Linked to Gains in Insurance Coverage

Medicaid Expansion Linked to Gains in Insurance Coverage

Medicaid expansion was associated with gains in insurance among low-income adults with substance use disorders, but corresponding treatment gains were not seen.

Drug Prices Increase More Than Expected After Shortages

Drug Prices Increase More Than Expected After Shortages

Prices for drugs under shortage increase more than twice as quickly as expected in the absence of a shortage.

Maryland Legislature: Will Federal Courts Permit State Regulation of Drug Prices?

Maryland Legislature: Will Federal Courts Permit State Regulation of Drug Prices?

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In response to the growing burden of pharmaceutical products on state budgets, Maryland introduced House Bill 631 to prohibit manufacturer price gouging.

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

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The US Food and Drug Association has issued a draft guidance for helping prescription medications gain approval for nonprescription status.

Aetna-CVS Merger Approved

Aetna-CVS Merger Approved

A $69 billion merger between health insurer Aetna and pharmacy manager CVS Health has been approved.

Manufacturers Increase Drug Prices Twice as Fast During Drug Shortages

Manufacturers Increase Drug Prices Twice as Fast During Drug Shortages

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Prices of prescription drugs in short supply between 2015 and 2016 were found to increase more than twice as quickly as they would have in the absence of a shortage.

Generic Medications Offer Savings vs Brand-Name Combination Treatments

Generic Medications Offer Savings vs Brand-Name Combination Treatments

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The difference in spending by Medicare on brand-name combination medications and the cost of the equivalent generic constituents was an estimated $925 million for 2016.

Trump to Sign Bills Lifting Drug Price 'Gag Orders' on Pharmacists

Trump to Sign Bills Lifting Drug Price 'Gag Orders' on Pharmacists

Two bills that allow U.S. pharmacists to disclose drug prices to customers to help them save money are expected to be signed today by President Donald Trump.

Strategies and Considerations for Improving Global Healthcare

Strategies and Considerations for Improving Global Healthcare

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Although recent times have brought about significant technological and social advancements, the quality of healthcare worldwide continues to be inadequate.

FDA: Medtronic Update Addresses Cybersecurity Issue With CIED Programmers

FDA: Medtronic Update Addresses Cybersecurity Issue With CIED Programmers

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The vulnerability is associated with using an internet connection to update software between the Medtronic CareLink and CareLink Encore Programmers (models 2090 and 29901) and the Medtronic Software Distribution Network (SDN).

The Open Access Debate: Should Patients Freely Access Research?

The Open Access Debate: Should Patients Freely Access Research?

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Patients and their families are advocating for their right to access the latest medical research papers to help find potential treatments and understand health conditions.

Clinicians Raise Concerns About "Precision" Public Health in the Era of Genomics

Clinicians Raise Concerns About "Precision" Public Health in the Era of Genomics

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Although the trend of "precision public health" promises to change the landscape of the public health field, concerns surrounding the scientific, practical, and ethical implications have cast a shadow over the innovation.

AMA Opposition to the CVS-Aetna Vertical Merger Grows With Statement to DOJ

AMA Opposition to the CVS-Aetna Vertical Merger Grows With Statement to DOJ

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The American Medical Association has released a statement urging the US Department of Justice to block the CVS-Aetna merger.

Addressing Ethical Challenges Associated With Precision Medicine

Addressing Ethical Challenges Associated With Precision Medicine

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There is a continual debate regarding which approaches should be used to base stratification of patients to precision therapy.

Bioethics Concerns Should Be a Key Element in mHealth Technology Development

Bioethics Concerns Should Be a Key Element in mHealth Technology Development

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With the ubiquitous availability of digital technology such as smartphones, smart watches, health-related apps, and patient monitoring devices, the era of mHealth is upon us.

Addressing the Uncertainties of the Public Service Loan Forgiveness Program for Medical School Graduates

Addressing the Uncertainties of the Public Service Loan Forgiveness Program for Medical School Graduates

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The Public Service Loan Forgiveness (PSLF) program promises to forgive any remaining federal loan debt for employees at governmental or nonprofit institutions following 10 years of loan repayments.

Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets

Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets

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Until universal access to healthcare is ensured as a human right, researchers must keep important ethical concerns in mind when designing future clinical trials.

Medical Schools Phase Out Lectures as Education Shifts Outside the Classroom

Medical Schools Phase Out Lectures as Education Shifts Outside the Classroom

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Medical students are choosing to forego lectures to use the time studying for the Step 1 exam instead.

Challenges Associated With Proposed Changes to CMS Fee Structure

Challenges Associated With Proposed Changes to CMS Fee Structure

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A proposed restructuring of Centers for Medicare and Medicaid Services (CMS) Medicare Physician Fees may lead to an increase in required documentation and associated workload.

AHA, ADA, and Others Express Concern Around Proposed Legislation to Protect Those With Preexisting Conditions

AHA, ADA, and Others Express Concern Around Proposed Legislation to Protect Those With Preexisting Conditions

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The American Heart Association has published a statement in opposition of the latest Senate healthcare bill aimed at dismantling the Affordable Care Act.

Cochrane Data Release and the Case for Open Science

Cochrane Data Release and the Case for Open Science

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Cochrane's current policies allow only specific individuals with full library access to view and reuse data reports in their entirety.

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