Regulatory Issues

AMA Adopts Policy to Advance Gender Equity in Medicine

AMA Adopts Policy to Advance Gender Equity in Medicine

The American Medical Association (AMA) House of Delegates has adopted a new policy to study, act for, and advocate to advance gender equity in medicine.

Steps Taken to Increase Use of Electronic Tools in Medicine

Steps Taken to Increase Use of Electronic Tools in Medicine

Additional codes have been approved by the Current Procedural Terminology Editorial Panel for chronic care remote physiologic monitoring and internet consultations.

Republican Opposition to Obamacare: What's Done, What's to Come

Republican Opposition to Obamacare: What's Done, What's to Come

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Republicans who have fought against the Affordable Care Act (ACA) for years are at a crossroads after their opposition largely failed.

FDA Approval of Medication With a Digital Monitoring System: Major Breakthrough or "Brave New World"?

FDA Approval of Medication With a Digital Monitoring System: Major Breakthrough or "Brave New World"?

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Abilify MyCite adds a digital sensor to the medication aripiprazole. The sensor, an ingestible event marker, is activated by contact with stomach acids and transmits a signal to a skin patch the patient wears, which then transmits to an app.

AMA Proposes Policy Opposing Medicaid 'Lockout' Provisions

AMA Proposes Policy Opposing Medicaid 'Lockout' Provisions

A new policy opposing lockout provisions that block Medicaid patients from the program for lengthy periods and instead supporting allowing patients to reapply immediately for redetermination was adopted by the American Medical Association House of Delegates during the AMA's annual meeting in Chicago, according to an article published in the association's AMA Wire.

Marijuana's Uncertain Status: Closing the Gap Between State and Federal Policies

Marijuana's Uncertain Status: Closing the Gap Between State and Federal Policies

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Senator Elizabeth Warren introduced a bipartisan bill in June 2018 (S.3032) that would exempt most marijuana-related activities from the Controlled Substances Act when they are allowed under state or tribal law.

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

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The FDA continues to battle the nation's opioid problem even as it looks to detect and prevent the next threat.

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.

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