Regulatory Issues News Archive
The $67 billion merger between Cigna and Express Scripts will be the first of its kind.
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.
Beneficiaries identified as "high cost" were likely to stay high cost over a 3 year period.
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.
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.
Data show that there is a significant difference in how black patients are treated compared with patients of other races.
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.
On average, hospitals mark up drugs by 479 percent of their cost.
Medicaid expansion was associated with gains in insurance among low-income adults with substance use disorders, but corresponding treatment gains were not seen.
Prices for drugs under shortage increase more than twice as quickly as expected in the absence of a shortage.
The US Food and Drug Association has issued a draft guidance for helping prescription medications gain approval for nonprescription status.
In response to the growing burden of pharmaceutical products on state budgets, Maryland introduced House Bill 631 to prohibit manufacturer price gouging.
A $69 billion merger between health insurer Aetna and pharmacy manager CVS Health has been approved.
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.
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.
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.
Although recent times have brought about significant technological and social advancements, the quality of healthcare worldwide continues to be inadequate.
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).
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.
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.
The American Medical Association has released a statement urging the US Department of Justice to block the CVS-Aetna merger.
There is a continual debate regarding which approaches should be used to base stratification of patients to precision therapy.
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
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
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 students are choosing to forego lectures to use the time studying for the Step 1 exam instead.
AHA, ADA, and Others Express Concern Around Proposed Legislation to Protect Those With Preexisting Conditions
The American Heart Association has published a statement in opposition of the latest Senate healthcare bill aimed at dismantling the Affordable Care Act.
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.
Cochrane's current policies allow only specific individuals with full library access to view and reuse data reports in their entirety.
More than half of the new approvals of Breakthrough Therapy drugs were based on a single pivotal trial.
Compassion and communication for both patients and families are among the most important factors involved in providing end-of-life care.
The American Medical Association House of Delegates has adopted a policy that sets health equity as a goal for the U.S. health care system.
Appropriate and standardized regulation of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment
After ACA was implemented, self-employed individuals and wage earners without employer-sponsored health coverage offers had coverage gains equal to or greater than those of people not employed.
Both generic and brand manufacturers are protected from legal liability from failure-to-warn claims in most jurisdictions.
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.
Republicans who have fought against the Affordable Care Act (ACA) for years are at a crossroads after their opposition largely failed.
Additional codes have been approved by the Current Procedural Terminology Editorial Panel for chronic care remote physiologic monitoring and internet consultations.
FDA Approval of Medication With a Digital Monitoring System: Major Breakthrough or "Brave New World"?
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.
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.
The FDA continues to battle the nation's opioid problem even as it looks to detect and prevent the next threat.
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.
There are large coverage gaps in short-term health plans that were approved Wednesday by the Trump administration.
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.
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.
Twenty-eight medical organizations, including AMA, sent letter to Administrator Verma of CMS
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 ability within its governing laws to reveal to the public the reasons for its decisions to reject or approve drugs.
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.
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.
Can groups with varying viewpoints come together to agree on a set of standards for the accreditation process?
The American Medical Association has committed to working to integrate precision medicine into alternative payment models.
Researchers evaluated the medical literature using terms including early access, compassionate use, pre-approval access, and named-patient programs.
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.
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.
Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups.
Despite good intentions, HIPAA is shrouded in myth and misapplication that does more harm than good for both patients and physicians.
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.
Researchers sought to assess the frequency of specific government agencies and organizations in their funding for the review studies.
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.
New laws and regulations designed to limit the use of prescription narcotics may further constrain doctors' ability to treat patients.
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.
People often reveal detailed, sensitive data about their health via new technologies.
Introduced by the Trump administration in March 2018, the MyHealthEData initiative seeks to broaden patient access to electronic health records and insurance claims information.
California Attorney General Xavier Becerra pledged to lead the fight to protect the Affordable Care Act.
In an era in which technology constantly evolves and becomes smarter by the day, it's not surprising that healthcare costs continue to climb.
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.
System expansions in the current healthcare environment are making clear impacts on clinical care and patient safety.
The denial or delay of visas for international students is disruptive to both the training program and to patient care.
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.
The US Food and Drug Administration has committed to reducing unexpected disruptions in the supply chain of drugs and medical supplies resulting in shortages.
The American College of Physicians has released 7 position statements supporting equality in healthcare for women.
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.
Patients served by the beleaguered Veterans Affairs health system may have wider access to private care, thanks to a bill approved Wednesday by the Senate.
Overall, 9.1 percent of individuals in the United States were uninsured in 2017, which was not significantly different from the level in 2016.
Researchers discuss generic drug market failure, whereby a generic drug manufacturer increases the drug price, which can compromise care.
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."
Patients who use medical marijuana may be more likely to use prescription drugs for both medical and nonmedical purposes.
Making Alternative Payment Plans Mandatory: Inherent Risks and Pitfalls in Reducing Healthcare Costs
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.
Regulatory requirements are likely to be an important aspect of physician dissatisfaction with electronic health records that is driving burnout.
Only 19 percent of organizations use computer software to monitor compliance with Final Rule.
The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4-17 years of age.
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.
Survey finds that 98 percent of respondents report experiencing drug shortages on a consistent basis.
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.
Researchers examined the scale and growth trajectory of the online marketplace for marijuana by analyzing aggregate internet searches and the links searchers typically found.
The Department of Justice, under the guidance of Attorney General Jeff Sessions, has withdrawn a number of protections afforded to people with disabilities under the Americans with Disabilities Act.
The position paper focuses on the 4 accepted principles of healthcare: beneficence, nonmaleficence, justice, and respect for autonomy.
A recent paper examines the circumstances in which public good outweighs the requirement that researchers receive individual consent to use a person's data.
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.
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.
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
Experts advise that should the CDC be banned from using certain words, it could give rise to at least 7 harmful consequences.
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.
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.
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.
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.
The Centers for Medicare & Medicaid Services has launched an initiative to examine which provider regulations should be discarded or revamped amid concerns that the regulations are reducing the amount of time that physicians spend with patients.
The Food and Drug Administration's Commissioner Scott Gottlieb, MD, has issued a statement regarding the deadly risks associated with the botanical substance, kratom.
Enhancing health equity and addressing societal healthcare disparities is dependent on American medical schools committing to a social mission.
Clinical Pain Advisor Articles
- Reviewing the Use of Buprenorphine in Perioperative Pain Management
- IASP Updates Classification of Chronic Pain
- Galcanezumab Provides Persistent Preventive Effects in Episodic, Chronic Migraine
- IASP Updates Diagnosis Criteria for Chronic Primary Pain for ICD-11
- Early Physical Therapy for Musculoskeletal Pain May Reduce Opioid Use
- Reviewing the Use of Buprenorphine in Perioperative Pain Management
- External Trigeminal Nerve Stimulation May Alleviate Migraine Pain
- Galcanezumab Provides Persistent Preventive Effects in Episodic, Chronic Migraine
- Pulsed Ultrasound May Be Effective for the Treatment of Rib Fractures
- CDC: Top 10 Drugs Involved in Drug Overdose Deaths
- Chronic Secondary Headache or Orofacial Pain IASP Classification
- Ultrasound-Guided C2 Coblation May Be Effective for Cervicogenic Headache
- Case Study: Fever and Headache in an Adolescent Boy
- Racial Disparities May Have Widened After Hospital Readmissions Reduction Program Implementation
- Cervical Dysfunction Needs Clarification to Identify Link With Headache