Asthma

Atrial Fibrillation

Autoimmune Diseases

Biologics

Biosimilars

Blood Cancer

Breast Cancer

COVID-19

Cardiovascular Diseases

Depression

Dermatology

Diabetes

Digital Health

Drug Coverage

Eyecare

Friedreich Ataxia

Gene Therapy

Graft Versus Host Disease

Heart Failure

Hemophilia

Hypertrophic Cardiomyopathy (HCM)

Leukemia and Lymphoma

Liver Disease

Lung Cancer

Mental Health

Multiple Sclerosis

NSCLC

Neonatal Care

Obstetrics-Gynecology & Women's Health

Oncology

Opioids

Pain

Pediatrics

Plaque Psoriasis

Population Health

Post-Acute Care

Prescription Digital Therapeutics

Pulmonary Arterial Hypertension

Reproductive Health

Respiratory Conditions

Safety & Recalls

Sleep Disorders

Solid Tumors

Spinal Muscular Atrophy

Substance Use Disorder

The Improving Patient Access Podcast

Type I Diabetes

Type II Inflammation

Ulcerative Colitis

Urology

Urothelial Carcinoma

Vaccines

Vaccines: 2023 Year in Review

Women's Health

News

Media

Between the Lines

Expert Interviews

K-Cast

Medical World News

Podcasts

Population Health Perspectives

Conferences

Partners

Publications

All Publications

MHE Publication

Formulary Watch Supplements

Formulary Watch Spotlights

Supplements And Featured Publications

Events

2024 PBMI Annual National Conference

PBMI MAP

Virtual Events

CME/CE

Resources

Emerging Leaders

Interactive Tools

PBM Leaders

Subscribe

Articles

Here’s what you missed this week on Managed Healthcare Executive.

MHE Week in Review – Trump Victory, Improving Your 2026 MA Star Ratings and More

Laila Gharzai, M.D., LLM, from the Department of Radiation Oncology at Northwestern University explains the concept of financial toxicity and how it affects breast cancer treatment outcomes. 

Why Financial Toxicity is About More Than Just Affording Treatment 

Canadian study reveals that women who undergo early menopause are less at risk for asthma than women who experience menopause late. 

Late Menopause Associated with Greater Asthma Risk

Member experience, outcomes and medication adherence are the key areas of performance that Medicare Advantage plans should focus on to improve Star Ratings.

Improving Your 2026 MA Star Ratings: Insights and Recommendations

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do Not Sell My Personal Information

Managed Healthcare Executive

Facebook

LinkedIn

Resource Centers

Eye Care

Spotlight

ID Week 2024

AMCP Nexus 2024

AHIP

AIDS Conference

ATS 

Business

Business Strategy

Chronic Disease

Consumers

Drug Costs

Drug Pipeline

Formulary

Health Management

Health/Disease Strategy

Hospitals & Providers

Industry Analysis

Pharmacy

Politics and Policy

Practice Management

Reimbursement

Technology

1rem

Authors

Thinking of “Carving Out” Specialty Benefits? Your Questions Answered

The FDA has proposed that nonprescription drugs that contain phenylephrine be removed from pharmacy shelves. Phenylephrine is a nasal decongestant used in nonprescription cold products, such as Mucinex and Sudafed and other products, that the regulatory agency says is not effective.

“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a 

The agency conducted a review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective.

The use of phenylephrine in nonprescription cold medications has increased since 2006, when sales of any products containing pseudoephedrine were placed behind the pharmacy counter. Pseudoephedrine can be used to make methamphetamine. Congress, as an amendment to the Patriot Act, the 

, began requiring photo identification and a log of sales of pseudoephedrine-containing products.

In response, many manufacturers of cold products reformulated their products with phenylephrine instead of phenylpropanolamine, ephedrine, and pseudoephedrine.

But research over many years has questioned the effectiveness of phenylephrine as a nasal decongestant. In fact, 

 on research done in the 1970s suggested that phenylpropanolamine and pseudoephedrine were effective decongestants but that oral phenylephrine was not. (

 is no longer available because it was found to be associated with strokes.)

, researchers found that oral phenylephrine was not significantly more effective than a placebo in alleviating nasal congestion in adults. Researchers conducted a systematic review involving searches on PubMed, Cochrane, and Scopus databases and identified four articles that compared oral phenylephrine with placebo or standard care and their effect on congestion and nasal airway resistance.

Two pharmacists, Randy C. Hatton, Pharm.D., and Leslie Hendeles, Pharm.D., both from the College of Pharmacy at the University of Florida, began their research of phenylephrine in 2005 and eventually filed two petitions with the FDA for a review of the evidence and additional studies. Their efforts led the FDA to convene two advisory committee meetings, the most recent being in October 2023. All 16 members of the 

 on the question of whether the data support that orally administered phenylephrine is effective as a nasal decongestant.

, Hatton pointed out that phenylephrine was first approved before 1962 and later available for over-the-counter use in 1976. The modern FDA was created by the 1962 Kefauver-Harris Amendments, which created the structure for well-controlled clinical trials in people with a focus on safety and efficacy. Prior to this, manufacturers did not have to prove a new drug was effective, and chemistry studies were enough to show safety.

“But what about the drugs that were approved before 1962? This window has become a loophole that some OTC drugs fall through,” Hatton wrote in the 

 article. “For nonprescription drugs, 10 years after the 1962 amendment to the Food, Drug and Cosmetic Act, the 

FDA established the OTC monograph process

, which required products that hadn't been proved effective to be reconsidered.”

For now, the FDA says products that contain phenylephrine are still available. But the agency is seeking comment on the proposed order through May 7, 2025, and will then issue a final order on phenylephrine.


An FDA advisory committee last year agreed that the data do not support phenylephrine as an effective nasal decongestant.


Formulary Watch

Clinical

FDA Suggests Removing Nonprescription Decongestant from Market 

Immigration, the economy and character of the candidates dominated the presidential election that former president Donald Trump won handily yesterday. Healthcare issues stayed largely in the background, with the exception of abortion and, over the final weekend, some statements made by Robert F. Kennedy Jr. about fluoridation.

“With no big health reform debate to command the attention of the nation and no big health proposal from either candidate, this is not a ‘health care election,’” Drew Altman, president and CEO of KFF, wrote in mid-October.

But now that Trump has won and the Republicans have gained control of the Senate (the House is still in doubt), attention is turning to how the new administration might reshape federal healthcare policies and programs and revisit long-held predicates of public health priorities and policies.

The futures of the Affordable Care Act (ACA), the signature achievement of the Obama administration, and the Inflation Reduction Act (IRA) the signature healthcare achievement of the Biden administration, are now  cloudier than they would have been in a Harris administration, although that may less true for the  IRA than the ACA.One near-term issue is the enhanced ACA premium subsidies that greatly reduced the premium cost of individual coverage purchased on the ACA exchanges. Congress must decide next year whether to continue them or not. Wtihoout 

In the final week of the campaign, Republican House Speaker Mike Johnson made a remark in an exchange at one campaign event that seemed to suggest he was in favor of replacing the ACA. Several days later in an interview he said that was a misinterpretation. “We are laser-focused on improving healthcare, as we are every area. We need higher quality care in many parts of the country, we need greater access, we need lower costs,” Johnson said. 

Johnson, a Louisiana Republican, referenced the 

 as a source of healthcare ideas. In the current Congress, the caucus consists of 16 Republicans physicians, pharmacists and dentists and is chaired by Rep. Andrew Harris, Maryland’s only Republican congressman and an obstetric anesthesiologist.

 on the what the Trump presidency will mean for healthcare next Thursday, Nov. 14, at 12 noon ET. 

In the Senate, Sen. Bill Cassidy, a gastroenterologist, is expected to play a prominent role in the development of any healthcare legislation. He is expected to chair of Committee on Health, Education, Labor and Pensions (HELP), a position currently held by Sen. Bernie Sanders, the progressive independent from Vermont.

Lindsay Bealor Greenleaf, J.D., MBA, vice president and a state and federal health policy expert for ADVI Health, said in an interview today that the Republicans have moved on from outright repeal of the ACA. "It is way too entrenched," she said. She foresees, though,  curtailment of federal spending on the program, which might include a trimming of premium subsidies, and more flexible benefit design. 

Any influence that Cassidy and Harris may have on Trump administration changes to the ACA may pale in comparison to the disruptive, attention-grabbing role of Kennedy if Trump follows through on statements he made on the campaign trail. “I am going to let him go wild on health. I am going to let him go wild on the food. I am going to let him go wild on medicine,” Trump said about Kennedy at his campaign Madison Square Garden rally on Oct. 27.

In a video call with his supporters early last week, Kennedy said Trump had promised him “control of the public health agencies, which are HHS and its subagencies, CDC, FDA, NIH and few others and then also USDA.” Trump campaign officials pushed back against a promise and cabinet position for Kennedy. 

In an interview conducted in a townhall format on NewsNation townhall,, a cable television network, Kennedy said Trump had asked him “to reorganize” the federal agencies that deal with human health, including the CDC, NIH, the FDA, and as well as some agencies in the USDA.” 

Regardless of his exact role, Kennedy seems positioned to be a high-profile figure in the Trump administration. In the NewsNation townhall, Kennedy said Trump had asked him to clear up the corruption and end the conflicts of interest and “return these agencies to their rich tradition of gold-standard, empirically based, evidence-based science” and to “measurably reduce chronic disease in our children in two years.”

"I think it is the hot topic to watch," Greenleaf said of Kennedy's role in the administration. The Trump-Kennedy relationship is new and one that healthcare interest group and policy experts are still trying to figure out. A position requiring Senate confirmation may be out of the question, she noted, but even having a role in the White House Kennedy could be significant. Kennedy might be put in charge of a commission or committee investigating the causes of chronic disease, particularly among children, she said.

Kennedy, who endorsed Trump in August after suspending his own independent bid to become president, is championing a “Make America Healthy Again,” or MAHA, campaign that plays off of Trump’s Make America Great Again slogan and movement. On his MAHA website, Kennedy says the goal is to rid public health agencies of the pharmaceutical industry influence, ban food additives and change polices to reduce ultraprocessed food. The website has merchandise for sale, including a $35 embroidered baseball cap that says "Make America Healthy Again." 

On Nov. 2, Kennedy caused a stir with a social media post that revived fluoridation of public water supplies as a controversy.  On the first day of a Trump administration the White House would advise U.S​. water systems to remove fluoride from the public water supply, Kennedy wrote. “Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease,” his post said. 

Public health and dental organizations have defended fluoridation as important to oral health.

Patrick Cooney, of The Federal Group who has decades of Washigton, D.C. experience as lobbyist and as a congressional staff earlier in his career, noted that the power has swung back and forth between Democrats and Republicans for several elections. The 2024 result  highlights that the "public continues to want significant change in the economy to impact their daily lives," Cooney said.
"Over the next several months the new Trump Administration and the 119th Congress will get on with the business of governing," Cooney said, "As that happens, we will have a clearer picture of where health care regulation, cost, and access to care issues will head."

The future of the Affordable Care Act looks cloudier but the hot topic is the role that Robert F. Kennedy Jr. may play in the new administration. 

A Hot Take: What the Trump Win Will Mean for U.S. Healthcare

Two of Los Angeles’ largest health insurers will invest $90 million over the next five years to improve health care and access to social services and housing for Los Angeles County’s homeless population.

The partnership between L.A. Care Health Plan, the largest publicly operated health plan in the U.S., and Health Net, a subsidiary of Centene Corp., a for-profit insurer with Medicare and Medicaid plans, launched two new street medicine programs in July 2024 aimed at coordinating care for their unhoused members.

Funding for the programs will come from California’s Housing and Homeless Incentive Program (HHIP), a voluntary program that was part of a five-year effort designed to improve health outcomes and the quality of life of people enrolled in Med-Cal, the state’s Medicaid program. HHIP has funds for Medi-Cal managed care plans that have projects that assistpeople who are unhoused. L.A. Care is earmarking 70% of its HHIP money for the programs, and Health Net, 30%.

“As a public entity, our mission is much broader than you would assume,” says Sameer Amin, M.D., chief medical officer at L.A. Care Health Plan. “It is a responsibility to help these people in ways that are far outside … a normal insurance plan.”

Martha Santana-Chin, Medi-Cal president for Health Net of California, says that finding permanent housing for “the most vulnerable of the vulnerable” will allow members to focus on their health and cut down on emergency department visits
and hospitalizations.

California, with an estimated 180,000 people without housing, has the largest population of homeless people of any state in the U.S. Los Angeles County’s 85,000 homeless citizens are second only to those of New York City. Approximately 40,000 to 50,000 of the county’s homeless people are L.A. Care members, and between 20,000 and 25,000 are covered by Health Net.

Both insurers have worked with the doctors, nurses and social workers who provide street medicine to people living on the streets or in encampments. But care was hit or miss. The companies decided to collaborate and coordinate care and created the Field Medicine Program and the Skid Row Collaborative.

“The difference now is that we are also assigning individuals to primary care providers to take care of their longitudinal journeys and care coordination needs beyond the episode of addressing their immediate needs in the street,”
says Santana-Chin.

The $60 million allotted to the Field Medicine Program includes money for 10 new street teams, building a technological infrastructure and incentive pay for providers. The money is also intended for all the resources needed for primary, preventive, longitudinal, and urgent health care, chronic disease management, pharmacy and social services. “Part of the program is to get [patients] early [on] so they don’t have to run into the emergency department or be hospitalized for weeks on end,” Amin says. One-third of the $60 million was used to build the Los Angeles County Department of Health Services Crocker Street campus, which is expected to open nin early 2025.

The remaining $30 million underwrites the Skid Row Collaborative. Skid Row is home to the highest density of unhoused people in the county. To meet the long-term goal of permanent housing for their members, the companies are working with local agencies and organizations and have pledged an additional $114 million over the next several years to set aside 1,900 rental units. “We can’t have our services be a road to nowhere,” Amin says.

“We still have a lot to do,“ comments Santana-Chin. “By no means have we fixed all the problems. But I believe that we are paying attention to this like we have never [done] before. I’m very excited about that.”

L.A. Care Health Plan and Health Net are teaming up to provide care for 85,000 people in Los Angeles County who don’t have housing

Homeless Does Not Have To Mean Health Plan-Less

Better access to eye care may be making a dent in the rates of diabetic retinopathy among Native Americans.

About 13.6% of American Indians and Alaska Natives have 

, which is double the proportion  of White Americans with the disease. According to 

 from the SEARCH for Diabetes in Youth Study (SEARCH), between 2002 and 2015, the rate of diabetes diagnoses rose steadily among 10 to 18 year olds in the US: 4.8% overall, 3.7% among American Indians and Alaska Natives.

 suggests that diabetic retinopathy incidence and progression in that population are “substantially lower than they were 30 or more years ago and are now comparable with estimates from non-American Indian and Alaska Native populations examined in the last 20 years.”

Using data from the IHS teleophthalmology program, 

, Ph.D., of Estanda Solutions Inc., of Wayne, Pennsylvania, and others examined the incidence of diabetic retinopathy among American Indians and Alaska Natives adults. Their retrospective cohort study, conducted between 2015 and 2019, included adults with diabetes and no evidence of diabetic retinopathy (DR) or mild nonproliferative DR (NPDR) in 2015 who were reexamined at least once during 2016-2019.

Of 7,097 patients who had no DR in 2015, 18% had mild NPDR or worse in 2016-2019. The incidence rate from no DR to any DR was 69.6 cases per 1,000 person years at risk. Roughly 6% of participants had a 2-plus step increase from no DR to moderate NPDR or worse; 27% of those with mild NPDR progressed to moderate or worse; 2.3% progressed to severe NPDR or worse.

Noting that the estimates of DR incidence and progression were lower than those previously reported for American Indians and Alaska Natives, these researchers suggest extending the time between DR re-evaluations for certain patients in this population, “if follow-up compliance and visual acuity outcomes are not jeopardized.”

The researchers give credit to IHS programs, such as the Special Diabetes Program for Indians and the American Telemedicine Association Category 3 teleophthalmology program. Both have increased access to diabetes treatment services; the teleophthalmology program alone conducted 264,437 examinations of 120,075 patients between 2000 and 2021. 

“Coinciding with this expansion of diabetes programs and medications,” the researchers say, “the prevalence of diabetic eye disease in American Indian and Alaska Native individuals served by the IHS teleophthalmology program appears to have declined.”

Findings reported in JAMA Opthalmology show substantial decrease from 30 years ago.

Diabetic Retinopathy on the Decline Among Native Americans

Studies show that prolonged mechanical ventilation (PMV) is associated with many financial and clinical risks, including, higher rates of ICU-acquired weakness (ICUAW) and readmission.[i]

Researchers attempting to address this dilemma have found that transferring PMV patients to settings that specialize in ventilator weaning could be beneficial for those whose conditions are otherwise stable.

Clinical and Financial Outcomes at Kindred Hospitals

Kindred Hospitals provide specialized acute care and rehabilitation for medically complex patients, and have a particular expertise in treating ventilator patients

CVS Caremark

Articles

Latest Updated Articles