Regulatory Issues

New Short-Term Health Plans Have Large Coverage Gaps

New Short-Term Health Plans Have Large Coverage Gaps

There are large coverage gaps in short-term health plans that were approved Wednesday by the Trump administration.

The Halford Case Controversy: Are Institutional Review Board Regulations Too Strict?

The Halford Case Controversy: Are Institutional Review Board Regulations Too Strict?

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William Halford, PhD, reportedly administered a live attenuated herpes simplex virus vaccine to 17 participants at an off-campus hotel without approval from an institutional review board.

Medical Cannabis Legalization Associated With Reduced Schedule III Opioid Prescriptions

Medical Cannabis Legalization Associated With Reduced Schedule III Opioid Prescriptions

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In the United States, legalization of medical cannabis on a statewide basis was associated with a nearly 30% decrease in schedule III (but not schedule II) opioid prescription numbers and dosages for Medicaid patients.

Groups Urge CMS to Reconsider Suspending Risk Adjustment

Groups Urge CMS to Reconsider Suspending Risk Adjustment

Twenty-eight medical organizations, including AMA, sent letter to Administrator Verma of CMS

FDA Issues Complete Response Letter Rejecting Remoxy Approval

FDA Issues Complete Response Letter Rejecting Remoxy Approval

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In June 2018, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee met and voted against (14-3) the approval of Remoxy upon data review.

The FDA Has the Authority to Explain Drug Application Rejections or Approvals. They Should Use It

The FDA Has the Authority to Explain Drug Application Rejections or Approvals. They Should Use It

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The FDA has the ability within its governing laws to reveal to the public the reasons for its decisions to reject or approve drugs.

Better Care Quality Needed for Universal Health Coverage

Better Care Quality Needed for Universal Health Coverage

In order to achieve universal health coverage, stakeholders must focus on the quality of health services, including provision of effective, safe, timely, equitable, integrated, and efficient health services, according to a report published by the World Health Organization.

AMA Aims to Boost Affordability of ACA Marketplace Plans

AMA Aims to Boost Affordability of ACA Marketplace Plans

The American Medical Association House of Delegates has adopted policy to increase the number of people who obtain coverage through the Affordable Care Act by making marketplace plans more affordable.

Developing a New Set of Standards for Clinical Research Site Accreditation

Developing a New Set of Standards for Clinical Research Site Accreditation

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Can groups with varying viewpoints come together to agree on a set of standards for the accreditation process?

Alternative Payment Models Should Include Precision Medicine

Alternative Payment Models Should Include Precision Medicine

The American Medical Association has committed to working to integrate precision medicine into alternative payment models.

Myriad Issues at Play in Expanding Access to Investigational Drugs for Unmet Medical Needs

Myriad Issues at Play in Expanding Access to Investigational Drugs for Unmet Medical Needs

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Researchers evaluated the medical literature using terms including early access, compassionate use, pre-approval access, and named-patient programs.

As Immigration Policies Tighten, Physician Shortage Concerns Grow

As Immigration Policies Tighten, Physician Shortage Concerns Grow

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The travel ban on citizens from several Middle Eastern countries has affected several faculty members and students, some of whom were in the process of completing courses or exams that would allow them to apply for residencies.

Trump White House Freezes Billions Earmarked for Insurers Through ACA

Trump White House Freezes Billions Earmarked for Insurers Through ACA

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The White House announced earlier this month a plan to freeze billions of dollars of risk-adjustment payments scheduled to go to insurers through the Affordable Care Act.

Trials Supporting FDA Approval of Breakthrough Drugs Examined

Trials Supporting FDA Approval of Breakthrough Drugs Examined

Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups.

The Harmful Application of HIPAA: How to Protect Privacy and Patient Care

The Harmful Application of HIPAA: How to Protect Privacy and Patient Care

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Despite good intentions, HIPAA is shrouded in myth and misapplication that does more harm than good for both patients and physicians.

CMS Physician Payment and Policy Changes Proposed for 2019

CMS Physician Payment and Policy Changes Proposed for 2019

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CMS issued a proposal to update payment policies, quality provisions, and payment rates for services under the Medicare Physician Fee Schedule on or after January 1, 2019.

Government and Industry Lead the Way in Funding USPSTF Systematic Reviews

Government and Industry Lead the Way in Funding USPSTF Systematic Reviews

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Researchers sought to assess the frequency of specific government agencies and organizations in their funding for the review studies.

New Rules May Constrain Docs' Ability to Treat Chronic Pain

New Rules May Constrain Docs' Ability to Treat Chronic Pain

New laws and regulations designed to limit the use of prescription narcotics may further constrain doctors' ability to treat patients.

International Group Develops Best Practices for Drug Packaging

International Group Develops Best Practices for Drug Packaging

Medical safety organizations and advocates from over 20 countries address the use of technologies to reduce errors and establish an international barcode standard for drug labeling and packaging.

FDA Outlines Plan for Increasing Nonprescription Drug Availability

FDA Outlines Plan for Increasing Nonprescription Drug Availability

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The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the New Drug Application (NDA) process and "is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription," said Gottlieb in a press statement.

New Laws Are Needed to Protect Health Data Shared Online

New Laws Are Needed to Protect Health Data Shared Online

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People often reveal detailed, sensitive data about their health via new technologies.

The Fight for Patient Privacy Under Big Data Analytics

The Fight for Patient Privacy Under Big Data Analytics

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Introduced by the Trump administration in March 2018, the MyHealthEData initiative seeks to broaden patient access to electronic health records and insurance claims information.

Growth in Healthcare Employment Has Led to Rise in Healthcare Costs

Growth in Healthcare Employment Has Led to Rise in Healthcare Costs

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In an era in which technology constantly evolves and becomes smarter by the day, it's not surprising that healthcare costs continue to climb.

Medicaid Expansion Ups Access to Rehab in Young Adults With Injury

Medicaid Expansion Ups Access to Rehab in Young Adults With Injury

Utilizing the Healthcare Cost and Utilization Project State Inpatient Databases, changes in insurance coverage and risk adjusted outcomes among adults aged 19 to 44 years who were hospitalized for injuries before and after Medicaid expansion are explored.

Health System Expansions Place Patients at Risk for Safety Concerns

Health System Expansions Place Patients at Risk for Safety Concerns

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System expansions in the current healthcare environment are making clear impacts on clinical care and patient safety.

FDA: Draft Guidance for the Inclusion of Pregnant Women in Clinical Trials

FDA: Draft Guidance for the Inclusion of Pregnant Women in Clinical Trials

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The US Food and Drug Administration (FDA) has issued draft guidance for industry regarding the science and ethics of including pregnant women in drug development clinical trials.

ACP: Delay, Denial of H-1B Visas Disruptive to Training, Patient Care

ACP: Delay, Denial of H-1B Visas Disruptive to Training, Patient Care

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The denial or delay of visas for international students is disruptive to both the training program and to patient care.

FDA Working to Mitigate Burden of Drug Shortages for Patients

FDA Working to Mitigate Burden of Drug Shortages for Patients

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The US Food and Drug Administration has committed to reducing unexpected disruptions in the supply chain of drugs and medical supplies resulting in shortages.

ACP Outlines Steps to Improve Women's Healthcare Equity

ACP Outlines Steps to Improve Women's Healthcare Equity

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The American College of Physicians has released 7 position statements supporting equality in healthcare for women.

Global Variation in Personal Health Care Access and Quality

Global Variation in Personal Health Care Access and Quality

Researchers used the Global Burden of Diseases, Injuries, and Risk Factors Study 2016 to examine personal health care access and quality with the Healthcare Access and Quality Index for 195 countries and territories, as well as subnational locations.

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