As FDA Considers Pulling Phenylephrine, Doctors Consider Patient Alternatives

After a U.S. Food and Drug Administration (FDA) panel this week advised against phenylephrine as an effective decongestant when taken orally, doctors are reconsidering what to prescribe patients for a stuffy nose.

After a U.S. Food and Drug Administration (FDA) panel this week advised against phenylephrine as an effective decongestant when taken orally, doctors are reconsidering what to prescribe patients for a stuffy nose.

The FDA advisory panel said oral forms of phenylephrine – a nasal decongestant commonly found in over-the-counter drugs like Nyquil, Benadryl, Sudafed and Mucinex – don’t work. 

The panel said the ingredient does not absorb into the body as previously thought and is no more effective than a placebo when taken in pill form.

Dr. James Clark, an allergy and immunology specialist with Charleston Area Medical Center, said while they take longer to work, over the counter steroid nasal sprays are a safe and effective alternative. However, they require patience on the part of the patient.

“One of the best ways to alleviate nasal congestion is the regular use of a steroid nasal spray, and those are all over the counter now,” Clark said. “The problem is those medicines don’t work right away, you have to use them regularly for a few days minimum before you start to see improvement.”

Examples of steroid nasal sprays include Flonase, Rhinocort, Nasonex and Nasacort. They work by helping to minimize allergy symptoms like sinus congestion, sneezing, itchy or runny nose and itchy/watery eyes.

Clark said most medicines for allergies use a combination of antihistamines and decongestants to make them more effective. He said while topical non-steroid decongestants work rapidly, they need consideration because of their rebound effect and propensity for addiction. 

Rebound congestion is caused by using nasal decongestant sprays for more than three days in a row. The blood vessels in nasal passageways can become sensitized to the active ingredients and react by swelling as the medication wears off.

Non-steroid decongestants include Naphazoline, which works by temporarily narrowing the blood vessels, and Oxymetazoline, which is sold under the brand name Afrin, works the same way. It is used for nasal congestion, allergic reactions of the eye, and facial erythema associated with rosacea. 

Clark said oral decongestants like Sudafed that contain pseudoephedrine work well, but have purchase restrictions. In 2006, over-the-counter medications containing pseudoephedrine were moved behind the pharmacy counter because of concerns they could be used to make illicit methamphetamines. Sudafed PE which contains phenylephrine is readily available over the counter. 

Clark said he is not a big fan of decongestants in general because of the way they work.

“Number one, they shrink down the caliber of a blood vessel,” Clark said. “What causes congestion is blood vessels being swollen. And when you shrink down the caliber of a blood vessel you increase the pressure in there so decongestants like Sudafed have the potential to increase blood pressure, which isn’t good in older people, and also in males it can cause problems with the prostate.”

Last year sales of products containing phenylephrine totaled nearly $1.8 billion.

If the FDA takes the panel’s advice and pulls phenylephrine from the market, manufacturers would be required to remove all products containing the ingredient from store shelves.

Manufacturers like Procter & Gamble and Johnson & Johnson, as well as pharmacy chains, which sell over-the-counter cold and allergy pills would be affected.

The same panel of researchers that advised the FDA about phenylephrine, questioned the drug’s effectiveness in 2007. 

The FDA allowed the products to remain on the market pending additional research.

COVID Costs Rise For W.Va. Healthcare System

The costs of treating COVID-19 patients are mounting, and they present a significant burden on the healthcare system in West Virginia, a state already hit by lost revenue from reduced visits to the emergency department and the canceling of non-emergency surgeries.

Many COVID-19 patients require long periods in the Intensive Care Unit and longer stays overall. Jeff Sandene, the executive vice president and chief financial officer at the Charleston Area Medical Center, pointed to one patient who was in the hospital for 34 days earlier this year. The total charges were $470,00. 

“When I looked at the ICU stays, they were anywhere from one day to 49 days of stay,” Sandene said in July. “A lot of times they’ll start off in the medical/surgical bed and then have to be intubated in an ICU. We had quite a few that required 30 to 40-plus days of ICU care.”

David Sanders is one such patient. He spent two months in the hospital and 32 days on a ventilator. He lost an entire month of his life with no memories of what happened. 

“When I first got off the vent, I still had the trach in so I couldn’t talk,” Sanders said. “That was very, very frustrating when I was trying to communicate with friends, family members and with the medical staff. I basically had to pass notes back and forth.”

Now that he is back home, Sanders’ medical bills continue to mount. After being physically inactive for nearly two months he requires physical therapy four days a week.

“The physician told me in the hospital that for every day that I was inactive, it takes three days to get my muscle back,” he said. 

He expects it will be about 90 days until he is fully recovered since he did get some physical therapy in the hospital before he was discharged. A nurse also visits him once a week at home as well. 

Sanders is a state employee and has PEIA insurance. He said his out of pocket expenses are approximately $1,500 and insurance paid the rest. He wasn’t able to provide a grand total of the charges the hospital billed for his care. 

The West Virginia Hospital Association tracks patients in hospitals throughout the state. The latest numbers they have are for the month of April, but those figures show that charges for the average COVID patient are $21,000 higher than other in-patients and COVID patients stay in the hospital more than four days longer. 

Data from the hospital association for April covers the average charges by primary insurance providers. 

  • Medicare: 48 patients with average charges of $59,000
  • Commercial Insurance: 25 patients with average charges of $64,000
  • Medicaid: 10 patients with average charges of $53,000
  • Government: 6 patients with average charges of $71,000
  • PEIA: 3 patients with average charges of $98,000
  • Self-Pay: 2 patients with average charges of $180,000

That list, while likely not reflecting additional, out-of-hospital care, accounts for more than $6 million in healthcare costs and only covers April before the pandemic really took off in West Virginia.
Highmark Health replied in an email that the company had spent more than $40 million on COVID-19 treatment and care throughout West Virginia, Pennsylvania and Delaware as of June 30. 

News reports indicate that men are more likely to have severe outcomes from COVID-19. In April, 48 women in West Virginia were hospitalized compared to 46 men, but the average charges for men were $73,700 versus $54,800 for women, for a difference of just under $19,000 per patient. 

Even the relatively small numbers of deaths and hospitalizations in West Virginia add up to millions of dollars in expenses that will affect the healthcare and insurance industries. According to the hospital association statistics, of the 17 patients who died from COVID-19 in West Virginia hospitals in April, the average charges for each was $129,000. 

Sandene said that many COVID patients in southern and central West Virginia have government-backed insurance. And that is a problem for the hospitals. 

“Medicare and Medicaid, PEIA have always paid less than the cost of the care that we provide. COVID just compounded that because our length of stays are higher and we’re using much more resources,” he said. 

In the earlier example that Sandene provided of the $470,000 patient, the insurance provider paid $440,000, leaving a $30,000 bill.

Colton Mearkle is a charge nurse at Ruby Memorial Hospital in Morgantown, West Virginia. His floor in the hospital is dedicated to caring for COVID patients that aren’t in ICU and on ventilators. But even those patients require additional care and precautions. And that’s where the drain on resources comes in. 

Before being converted to a COVID-19 floor, he and his team provided care for thoracic patients. They had one nurse for every three patients. They have lowered that ratio to 1:2 meaning they have added another 4 nurses per shift. 

There has been much talk about the additional costs of personal protective equipment for health care providers. Mearkle detailed what he and his fellow nurses wear for each patient contact. 

“We wear a capper, which consists of a helmet, that circulates the air on top of that, a shield hooks to it,” he said. “It filters the air inside this helmet. On top of that we have to wear the yellow gown. We double glove. And then we have shoe covers that we wear as well.” 

For Sandene, the challenges are varied, but they all come down to forecasting the future.

“The thing that keeps me up at night is trying to understand and project what does the new normal look like,” he said. “I think everything I’ve read, that’s exactly what healthcare across the US is doing. How do you right-size the organization to take care of the new normal new volume that you have?”

Appalachia Health News is a project of West Virginia Public Broadcasting, with support from Marshall Health and Charleston Area Medical Center.

Some Hospitals In W.Va. Will Remain Under A ‘No Visitor’ Policy As State Continues To Reopen

Updated on June 19, 2020 at 5:30 p.m.

As West Virginia continues to ease coronavirus-related restrictions this week under Gov. Jim Justice’s safer-at-home order, including nursing home visitations, some hospitals in the state are choosing to keep their doors shut to most visitors.

This week, WVU Medicine announced it would begin easing visitation restrictions at their hospitals statewide ⁠— except WVU Medicine East in the Eastern Panhandle. 

 

A zero visitation policy remains in effect at Berkeley Medical Center and Jefferson Medical Center, with exceptions for end-of-life care, pediatrics, the neonatal intensive care unit, and obstetrics patients. To enter the hospital, everyone is required to wear a mask at all times. 

 

The two medical centers are the only hospitals to serve Berkeley and Jefferson Counties, with the exception of the Martinsburg VA Medical Center.

 

WVU Medicine said in a news release the decision to keep the no visitor policy in place in the Eastern Panhandle was because the region continues to see an increase in coronavirus cases. 

 

Berkeley County has seen the highest number of new positive cases in the state for weeks. 

 

Charleston Area Medical Center Health System has had a no visitor policy in place since March, but that changed on Jun. 15, 2020 when the health system began implementing a phased reopening for visitations. The health system will enter phase II of its reopening on Monday.

 

Mon Health System, however, began easing its visitation restrictions on June 9, requiring all visitors to wear masks and to be screened at the entrance. To date, visitors under 18 are still prohibited, and visitors will be asked to use hand sanitizer before and after visiting a patient’s room or the facility.

Appalachia Health News is a project of West Virginia Public Broadcasting, with support from Marshall Health and Charleston Area Medical Center.

Staying Home Doesn’t Mean You Can’t Stay Healthy – Experts Promote Telehealth During Coronavirus

Medical experts have spent years promoting telehealth as an option for rural areas with little access to in-person care.

Now, after West Virginia Gov. Jim Justice issued a “stay home” order that took effect on Tuesday, March 24, some medical providers are offering telehealth as a way to keep more people healthy at home during the coronavirus. 

Dr. Jennifer Mallow at WVU Medicine describes telehealth as “the use of communication and information technology to share information.”

“We can provide clinical care,” Mallow said. “We can provide education, we can provide public health, we can provide administrative services at a distance.”

Telehealth spans several methods and types of technology, most prominently phone and video conferencing.

Mallow and Dr. Steve Davis, a WVU associate professor, are working on a pilot to provide telehealth options to patients with traumatic brain injuries, disabilities and the elderly.  

Davis said he foresees elements of the project helping those who are particularly vulnerable to the coronavirus.

“The patient can [stay] at home, because we don’t want them to come in and be exposed, or expose other people, to COVID-19,” Davis said.

Virtual Urgent Care Visits, Free Of Charge

WVU Medicine is offering video urgent care appointments at no cost, for anyone more than five years old who is experiencing symptoms potentially related to the coronavirus. The WVU-owned Ruby Memorial Hospital in Morgantown also has been operating a 24-hour phone line, at 304-598-6000, option 4, since mid-March.

On Thursday, March 26, WVU reported going from six to 538 video visits in the course of three weeks. Their phone appointments experienced a similar spike, from 20 to 671 in the same length of time. 

In Kanawha County, the Charleston Area Medical Center is opening up its 24/7 Care app for urgent video appointments to the public.

“As a nation, as a world actually, you’re trying to flatten the curve and get ahead of this virus,” said Rebecca Harless with CAMC’s ambulatory services. 

Normally, Harless said an urgent care visit at CAMC would cost $49 out of pocket. Right now, anyone who may be displaying coronavirus symptoms can use a “COVID” coupon to get a free appointment.

“They’re able to speak to a provider, one of our employee providers, and understand where they fall, where their symptoms fall in that algorithm of, you know, ‘Am I okay to stay home?’” Harless said. “A lot of people are really scared out there right now.

Rather than everyone flood the hospitals and clinics at once, West Virginia Commissioner for Public Health Dr. Cathy Slemp recommends people stay at home if they are experiencing symptoms at a non-life-threatening level. 

“If you are waiting for test results, or you are thinking you might have this, or you know you have it, you want to treat it as if you do,” Slemp said at the governor’s March 24 press briefing. “So what you do is, first, you want to stay home. If you need to go to the grocery story, someone else goes for you. At the pharmacy, you don’t want to be around other folks.”

Efforts To Loosen Federal Restrictions On Reimbursement

Slemp told the press on Wednesday she and the West Virginia Department of Health and Human Resources are working on educating providers throughout the state about telehealth, and what options providers have for implementation.

Traditionally, getting paid for telehealth has been a challenge. Regulations from the federal Department of Health and Human Services, which regulates Medicare for people 65 years old and up, only reimburse telehealth services when there’s an available video option.

This makes it difficult for most providers to offer phone-only services, which could aid elderly patients living in rural areas without reliable broadband access.

The West Virginia Bureau for Medical Services, which oversees Medicaid for low-income people and families, normally enforces the same requirement for telehealth.

According to Commissioner Cindy Beane, the state already allows Medicaid to reimburse phone and audio-only appointments, to keep more people at home.

“Truly, we’re in an emergency. We’re waiving all your normal things that you have to worry about, as providers,” Beane said. “Especially when we know that the person’s sick, we don’t want them going to the ER. We want you to call, and route them the appropriate way.”

The coronavirus response bill that passed the Senate on Thursday, March 26, gives federal officials the authority to waive the video-only requirement. 

The U.S. Center for Medicare and Medicaid Services already announced on March 17 it temporarily waiving certain HIPAA requirements, such as restrictions that forbidding patients and providers from using “everyday communications technologies” such as Skype and Facetime, and other restrictions barring certain patients from taking their calls in-home, versus an approved facility. 

The Struggle With Broadband

“Broadband, I mean, is an issue, pandemic or no pandemic for us,” said Williamson Health and Wellness chronic care director Amy Reed.

The Williamson Health and Wellness Center in Mingo County is a federally qualified health center that offers patients a range of services including behavioral, dental and pediatric. It recently began offering and promoting video and phone appointments to its patients who are technologically able, as Medicare and Medicaid allow.

Reed said she and others at Williamson Health have noticed the development making a difference for some.

“We know that our population, the patients that we serve, are more vulnerable, they’re more at risk,” she said. 

The U.S. Census estimated in 2018 almost 19 percent of the Mingo County population was over 65 years old. That same year, the U.S. Census estimated almost 20 percent of the entire state was over 65. 

The Centers for Disease Control and Prevention reports people older than 65, and those with pre-existing health conditions like HIV and asthma, are at a higher risk for catching the coronavirus than others. 

“So, it’s made a huge difference in being able to provide them what they need, and not send them to the hospital, not send them to the emergency rooms,” Reed said. “We’re actually able to look at them and have those conversations.” 

Reed says she wishes telemedicine was something she could offer to every patient year-round, due to the age, health needs and lack of transportation of the population they serve. But she’s worried the waivers won’t remain in place after the pandemic ends, and that these services won’t be allowed to continue. 

Reed also said the health center would have more requirements to meet, as a federally qualified health center offering several types of practice, than other primary care providers in the state. 

“There’s a huge risk just because, you know, you get your patients dependent on that, they see that it’s there. ‘Oh, you’re doing it now, why can’t you do it later?’” Reed said.

Davis at WVU said he hopes once the pandemic subsides, some of the changes in federal regulations will remain in place. 

“As we look at sustainability,” Davis said, “one of my hopes is that, one of the good things about the COVID-19 is that we’ll come out of it and will realize, ‘ah, we can use telehealth for all of these things, and we ought to be paying for it.’”

Marshall Health through Marshall University is partnering with the Mountain Health Network in Cabell County to develop telehealth options for residents there. 

Mon Health in and around Monongalia County is collaborating on services with CAMC. As of Friday, March 27, Mon Health announced that entails virtual video visits for primary care, psychiatry, behavioral health and urology with plans to expand into neurology, obstetrics and cardiology appointments. 

This service requires reliable internet access and is for patients with minor medical conditions. Mon Health said Friday they are waiving associated patient fees for this service. 

Emily Allen is a Report for America corps member. 

 

New Medical School Campus to Launch in Charleston

A new regional medical school campus is expected to launch next June in Charleston.

 

The initiative is a collaboration between the West Virginia School of Osteopathic Medicine and Charleston Area Medical Center who announced the two organizations had signed a letter of intent earlier this week.

 

Charleston Area Medical Center is providing space for the campus, including use of its existing training facilities, according to a press release.

 

Over the next year, the West Virginia School of Osteopathic Medicine will determine a curriculum for the campus, appoint accredited faculty and perform administrative functions at the site.

 

In a press release, CAMC chief executive officer David Ramsey said the collaboration is part of an effort to educate, recruit and keep highly trained health care providers in Southern West Virginia.

Appalachia Health News is a project of West Virginia Public Broadcasting, with support from Marshall Health and Charleston Area Medical Center.

CAMC Announces 40 of 300 Job Cuts

One of West Virginia’s largest employers is expected to eliminate 300 jobs by the end of this year. Recently, the hospital announced how 40 of those jobs will be cut.

WCHS-TV reports the Charleston Area Medical Center will get rid of the positions effective Nov. 4.

Company spokesman Dale Witte said most of the positions are nurse practitioners, but also include some physician’s assistants.

Witte said the job cuts are part of the hospital’s plan to eliminate 300 jobs by the end of the year. The hospital is expected to lose about $40 million this year.

Back in July, CAMC president and CEO Dave Ramsey said the cuts are necessary because of a the declining population in West Virginia and recent changes in Medicaid and Medicare reimbursements.

The hospital is facing nursing shortage but Witte said the job cuts do not eliminate bedside nurses. He said the company is working to find other jobs for the people whose jobs are being cut.

 

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