Published on the April 26, 2012, ObGyn.net website
By Whitney L.J. Howell
A year after the Food and Drug Administration (FDA) quickly and controversially green-lighted the pre-term birth prevention drug Makena® to compete directly with long-used 17P, some arguments have cooled, but the battle for marketplace dominance continues.
Makena® and its developer KV Pharmaceuticals met harsh backlash last year from providers, payers, and professional societies, when the drug received FDA approval, won an instant monopoly, and immediately set the cost per weekly injection at $1,500. Until then, the unapproved, compound drug 17P, priced at $10 per dose, was the only therapy proven to stave off premature births.
Makena® supporters pointed to FDA regulations and consistency standards as proof it was a superior product. However, there’s still no evidence indicating it is more effective than 17P, said Bob Silver, M.D., maternal and fetal medicine division chief at University of Utah Health Sciences.
“There’s no proven clinical benefit to using one over the other. They both have the same biologically active compound,” he said. “The only difference is one is FDA approved. That may mean the drug is more consistent and less likely to have contaminants, but most reputable compounding pharmacies do a very good and safe job.”
Clinically, both 17P and Makena® reduce the likelihood of early deliveries by one-third among women who have experienced a previous premature birth. As of 2008, according to the National Vital Statistics Report, pre-term birth accounts for nearly 13 percent of births nationwide.
What’s changed, however, is KV Pharmaceuticals’ approach. According to company February reports, the price tag for patient co-pay per injection has plummeted to approximately $10 – comparable to 17P charges. That reduction softened much of the industry’s initial negative reaction.
Based on the same report, doctors and patients have received 6,500 vials of the drug, and approximately 3,700 patients have either started treatment or are in the process of either doing so or awaiting insurance approval. In addition, more than 250 payers, both commercial and Medicaid, now reimburse for Makena® injections.
But the cheaper price and growing positive sentiment still isn’t enough for some providers to choose Makena® over 17P. Prescribing 17P is a long-term practice for many, often preceding the 2003 New England Journal of Medicine study heralding the compound’s efficacy, and they aren’t likely to change it without substantial evidence showing another drug is better, Silver said.
Makena® prescription rates will likely vary by region, he said, based on marketing efforts, physician preferences, and agreement from third-party payers to cover the injection. But in Utah, 17P remains largely the drug of choice.
“A lot of doctors in my community are using 17P because of the cost, and they’re accustomed to working with a compounding pharmacy,” he said. “There are also plenty of third-party payers in Utah who work with the compounding pharmacies.”
For some providers, Makena® symbolizes the bloated U.S. healthcare system – an overpriced network built to support the pharmaceutical industry’s bottom line. For these physicians, prescribing Makena® will never be an option.
“The big problem is KV Pharmaceuticals decided to price the drug, which had already gained widespread acceptance through a well published study, at approximately $1,500 a week. The cost of healthcare is destroying this country, and this is an area in which we cannot afford to give in,” said Nicholas Fogelson, M.D., an obstetrician with Palmetto Health Richland Hospital in Columbia, S.C., “As an Ob/Gyn physician, I will not write a single dose of this drug, and I encourage my colleagues to do the same.”
Some third-party payers, such as UnitedHealthcare, have policies covering Makena® injections, but women still face roadblocks to access, said Sarah Verbiest, DrPH, MSW, MPH, University of North Carolina Center for Maternal and Infant Health executive director. That’s why, she said, the state launched an initiative in April 2011 to increase 17P availability.
“There’s no silver bullet or single answer that will allow us to address all pre-term births,” she said. “When we think of 17P, it’s one clinical tool we have in our toolbox. So, we provide support for use in practice, including how bill for it, how to find a compounding pharmacy, and how to get it quickly to ensure women get all the shots.”
And, it’s increased access to this preventive therapy that’s most important, Utah’s Silver said, regardless of concerns over previous pricing or the safety of compound versus manufactured drugs.
“Pre-term birth is such a bad problem,” he said. “All of the preparations are relatively safe and can reduce risk. The one patients can get from a reputable pharmacy and they can afford is the one they should use.”
To read the story in its original location: http://hcp.obgyn.net/pregnancy-and-birth/content/article/1760982/2065642?pageNumber=2
Published on the April 27, 2012, DiagnosticImaging.com website
By Whitney L.J. Howell
Recent recommendations for lung cancer CT screening from the American Lung Association (ALA) are expected to improve early detection of the disease. They’ll also likely increase your work flow and could change the way insurance providers pay for screenings.
Released on Monday, the ALA guidelines call for CT screening for all current and former smokers from ages 55 to 74 who have smoked a pack of cigarettes a day for at least 30 years. This formal push could lead to additional organizations joining the chorus, calling for improved diagnostic services.
“Hopefully, this recommendation will lead to more encouragement for us to get lung cancer screening approved through third-party payers,” said Reginald Munden, MD, radiology professor with M.D. Anderson Cancer Center. “The ALA has a high profile, so it is one of the organizations that will increase the odds of that happening.”
Although a final cost effectiveness analysis is still forthcoming, Munden posited this pressure could prompt insurance providers to approve funding for lung cancer screenings.
The ALA’s clinical suggestion is rooted in the findings from the National Cancer Institute National Lung Cancer Screening Trial (NLST). The study demonstrated CT screening can detect pre-symptomatic lung cancer in high-risk populations and reduce associated deaths by 20 percent compared to chest X-ray.
ALA chief medical officer Norman H. Edelman, MD, acknowledged the bar for patients to be screened is high, but said current research only supports applying the recommendation to this group.
“There’s always a risk with everything that we do. There’s a risk of unneeded lung biopsies or excessive radiation. All we can do at this time is look at the best data to make a screening recommendation for the 55-to-74-year-old long-term smoking populations,” he said. “We’re not saying yea or nay about other populations – just that there’s not enough scientific evidence to make any recommendations at this time.”
In addition to supporting the use of CT screening in this population, the ALA also recommended providers only conduct screenings in a low-dose CT machine. It’s also important, Edelman said, to run the studies in multidisciplinary centers that offer a variety of care modalities to patients. When a screening identifies a nodule, many types of providers join the care team, and having them in one location is a convenience to the patient.
To read the remainder of the article: http://www.diagnosticimaging.com/ct/content/article/113619/2065828
Published in the Spring 2012 Johns Hopkins Nursing magazine
Lactation Specialists Offer Help
By Whitney L.J. Howell
Whether it’s her first child or third, breastfeeding can be difficult for any mother. When something just isn’t working right, Deborah Dixon, BSN, RN, IBCLC, or one of her five board-certified colleagues steps in.
As The Johns Hopkins Hospital’s (JHH) lactation consultant coordinator, Dixon helps mothers and babies master breastfeeding or use supplementation strategies. Since arriving in 2007, she’s enhanced the lactation support program to assist mothers with low milk supply.
“We always prefer human milk to formula, so I introduced evidence-based information
about supplementing at the breast to obstetricians, midwives, and neonatologists,” she says. “Now, we’re the state’s only hospital with a specified supplemental feeding policy.”
JHH lactation specialists complete 20 hours of basic breastfeeding training through courses offered twice annually. In addition, Dixon mentors one nurse toward international board certification in lactation every semester and accepts lactation consultant interns from other education programs.
Under Dixon, the number of breast-feeding mothers has skyrocketed. Previously, only 26 to 42 percent of mothers at JHH initiated breastfeeding. Today, thanks to seven-day-a-week lactation coverage, between 60 and 92 percent do so.
Dixon also collaborates with JHH’s pediatric nurse practitioners to establish specific feeding plans. Recently, she and pediatric nurse practitioner Suzanne Rubin, DNP ’11, MPH, MS ’97, CRNP-P, devised breastfeeding plans for late preterm infants and infants with hyperbilirubinemia.
Lactation guidance isn’t limited to post-delivery days. Mothers can attend bi-monthly prenatal breastfeeding classes. After birth, lactation specialists also call mothers at one-week, one-month, and three-month intervals to assess progress. Weekly new-mother meetings also let women discuss concerns.
Lactation specialists offer free consultations to all JHH staff members too. “If a new mom is having a problem, she can make an appointment to see us,” Dixon explains. An employee pump room within the Hospital is also available.
“We’ve made a huge impact,” Dixon says. “We’re teaching moms to let babies lead the dance. It makes breastfeeding so much easier.”
To read article in its original location: http://magazine.nursing.jhu.edu/2012/04/mentoring-moms/
Published in the Spring 2012 Johns Hopkins Nursing magazine
By Whitney L.J. Howell
If you ask Kelly Hendrix, RN, her work as a general contractor isn’t too different from her work as a nurse in The Johns Hopkins Hospital’s Emergency Department. Both use a healing touch.
“You must also be a people person.” Hendrix adds. “As a nurse, you listen to what your patient needs and use your skills to help them. As a contractor, you aren’t trying to make people feel physically better, but you’re trying to make them feel better emotionally by giving them a lovely home.”
Hendrix and her husband created their home improvement company, Building Solutions, five years ago. They focus on renovating older homes, reclaiming each structure’s former beauty. “I love taking something that has been completely wrecked and turning it into something amazing,” she says. As long as a house has a solid foundation, they can make any other repairs, including framing, plumbing, and electrical work. Much of her role includes talking with the customer to determine preferences and pricing out each job.
It’s also been fun for her to watch the Hospital’s new clinical building come together. In fact, one of the building’s most interesting features parallels one of her favorite parts of contracting—the tile. Made partially from recycled glass, the tiles in the new building sparkle. “When you come across a lot of tile, the shimmer is just a nice touch to see,” she observes.
While Hendrix enjoys working as a contractor, she hopes other women will be inspired by her success. “I want women to stop saying, ‘I can’t do it.’ Watch HGTV. You can do it. It’s easy,” she says. “You don’t have to worry
about calling someone to take care of things. You can look it up online and figure it out.”
To view the article at its original location: http://magazine.nursing.jhu.edu/2012/04/building-better-lives/
Published in the Spring 2012 Johns Hopkins Nursing magazine
Second Unit at JHH Honored
By Whitney L.J. Howell
The Johns Hopkins Hospital’s Weinberg Intensive Care Unit (WICU) is shining with excellence. The WICU, in the Department of Surgery, received the Beacon Award for Excellence from the American Association of Critical-Care Nurses (AACN) in November, becoming the only unit in Maryland to receive the award in 2011.
The honor, coupled with the Beacon Award won by the Department of Medicine’s Medical Intensive Care Unit in 2010, recognizes individual units that distinguish themselves by improving every aspect of patient care. It also demonstrates the clinical nurses’ dedication to their work says Sam Young, MS, RN, ACNPC, CCNS, CCRN, the WICU’s clinical nurse specialist.
The AACN’s report recognized the strengths of the unit as its proven interdisciplinary practice, culture of excellence, and leadership. The WICU’s cultivation of shared governance and patient- and-family-centered care is unique. “The unit’s open culture sets us apart,” Young says. “Nurses have opportunities to grow, to be autonomous, and to collaborate with others.”
To facilitate that freedom, WICU nurse manager Donna Prow, BSN, RN, started group meetings. Up to 14 nurses meet for team-building, practice updates, and idea-sharing. “The entire staff has a voice,” says nurse clinician III Carol Maddrey, BSN, RN. “That breeds pride within our unit and gives everyone the confidence that we can make a difference.”
The most significant change has been embracing patient-centered care. The WICU expanded visiting hours to 20 hours a day, making it easier for family and friends to visit. A new “family involvement menu” lets visitors choose ways to help, such as assisting the patient with grooming. Having loved ones nearby also improves patient-nurse-family communication. “Visitors can report subtle personality or behavior changes nurses might not notice,” Young explains.
Young says the WICU receives many thank-you letters, and “performance star” boards posted in the unit allow patients and visitors to recognize staff. “It shows our customers we like what we’re doing,” she says. “The WICU is a good experience for them.”
To read the article in its original location: http://magazine.nursing.jhu.edu/2012/04/wicu-wins-beacon-award/
Published in the April 2012 AAMC Reporter
By Whitney L.J. Howell
In late February, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released the proposed rules for Stage 2 of meaningful use and corresponding certification requirements. The rules introduce new measurements that doctors and hospitals will be required to meet to receive incentive payments for implementing electronic health records (EHRs).
The Stage 2 meaningful use rule is part of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was included in the 2009 American Recovery and Reinvestment Act. Under HITECH, hospitals and providers can receive Medicare and Medicaid incentive payments for adopting certified EHRs, using health IT in “meaningful” ways, and reporting clinical quality measures. CMS began making payments under the Stage 1 rule last year. With the law, Medicare hospitals and physicians who do not use health IT “meaningfully” will be penalized beginning in 2015. CMS has proposed criteria to determine which providers would be subject to this penalty. In most cases CMS plans to use a 2013 reporting period to identify proactively which providers are subject to a penalty, said Lori Mihalich-Levin, J.D., AAMC director of hospital and GME payment policies for health care affairs.
Industry leaders are still dissecting the details of the Stage 2 rule, but several key points already have emerged that will affect how providers approach meaningful use.
“CMS is obviously moving toward improved interoperability and information exchange,” Mihalich-Levin said. “However, there are some serious flaws with some of the proposed measures.”
The AAMC plans to submit its concerns to CMS and ONC by the May 7 deadline.
The biggest red flags in the new rule, Mihalich-Levin said, are proposals that require actions by third parties—in this case a patient—for the hospital or physician to meet the requirements. For example, hospitals and physicians must provide patients with online access to their health information. But in order to receive credit for meaningful use, at least 10 percent of patients must log on and actually view their records. An additional measure calls for at least 10 percent of patients to send their physician a secure, online message about their health care.
The problem, she said, is that there are no incentives for patients to comply, and providers cannot control whether patients feel comfortable with electronic communication, or have access to it.
“Hospitals can’t meet that requirement by implementing technology,” said Rod Piechowski, senior director of health information services at the Healthcare Information and Management Systems Society (HIMSS). “They must engage the patients on a different level, get them to take action, and recognize the value of the data. It’s a little bit out of their direct control.”
The proposed rule also increases the reporting requirements for many existing measures. For example, while Stage 1 called for 30 percent of medications to be ordered through computerized provider order entry, Stage 2 bumps the requirement to 60 percent of medications, and includes laboratory and radiology orders.
“This could be something that’s a minor change, but it will still require extra work to make sure we get the right groundwork in place,” said Tom Smith, chief information officer for Chicago’s NorthShore University HealthSystem. “It’s certainly a good idea to move away from writing down prescriptions on paper—ordering 100 percent of medications through e-prescribing would be great.”
Physicians and other clinicians who are eligible for the meaningful use incentives through Medicare also could benefit from the rule’s group reporting proposals. Rather than collecting quality measure data from each physician individually, beginning in 2014, CMS will allow doctors in group practices to report as a single unit.
“When you have a practice of hundreds or thousands of physicians, it’s logical to identify performance on clinical metrics as a group,” said Mary Patton Wheatley, AAMC manager of physician quality and payment policies. “Instead of a faculty practice trying to report measures for a variety of specialists and subspecialists (many of whom do not have relevant measures that can be reported through an EHR), the group reporting option allows the practice to focus on a single set of measures that makes sense for the practice as a whole and improves quality for the patient.”
Under the quality reporting requirement, beginning in 2014, hospitals would be able to choose which measures they report. While the element of choice is appealing, there are concerns about how this will ultimately impact the flow of measures used in other programs, including value-based purchasing.
It’s important to remember that any of these proposed measures could change in the final rule, which is expected this summer, Mihalich-Levin said. Until then, she recommended that institutions familiarize themselves with the various proposals. She added that after receiving feedback on the proposed Stage 1 requirements, CMS addressed many of the AAMC’s concerns in the final Stage 1 regulations. Over the next few months, the AAMC will review the proposed Stage 2 rules and encourage member institutions to provide feedback.
Smith agreed the proposed rule offers several benefits to teaching hospitals, but he cautioned that many of the meaningful use measures will require additional work from hospitals and physicians. Achieving certification or compliance, he said, will take time and resource investments to produce positive results.
According to Piechowski, hospitals that are just getting started on health IT will benefit from what others have learned.
“Hospitals should pay attention to what others have done, stay connected, get involved, and get ahead of the curve,” Piechowski said. “That is the best thing they can do. The people who are just getting in now are in an advantageous situation.”
Despite the challenges, health IT adoption is on the upswing. According to CMS, 35 percent of hospitals were using EHRs in 2011, compared with 16 percent in 2009. In addition, 85 percent of hospitals have said they plan to implement meaningful use and take advantage of the incentive payments by 2015. CMS will likely release proposed rules for Stage 3 of meaningful use in 2014 for implementation in 2016 and beyond.
To read article at original location: https://www.aamc.org/newsroom/reporter/april2012/279214/meaningful-use.html
Published in the April 12, 2o12, Billian’s HealthDATA/Porter Research Hub e-newsletter
By Whitney L.J. Howell
They’re in nearly every drug store, ready to provide a flu shot, answer questions about a skin rash, or conduct a blood pressure screening. And, every year, more retail health clinics (RHCs) appear to meet patient needs at an opportune time and place.
But with their increasing use of health information technology (HIT), RHCs are quickly moving from being clinics of convenience to being helpful partners in the overall healthcare system. This beefed-up use of technology makes it easier for patients to keep their doctors looped into their health history.
Although these clinics aren’t intended to be permanent or full-service medical homes, they do offer a wide variety of services that supplement the preventative care patients receive from their primary care providers. For example, patients can go to RHCs for routine cholesterol and blood pressure screenings; a variety of vaccinations; or treatment of respiratory infections, allergies, or some skin conditions.
The clinics are also a more affordable avenue for people who need care, but find themselves outside of the healthcare system. Data reported by the American Academy of Family Physicians has estimated a $40 service in an RHC could potentially cost more than double that in a doctor’s office, $120 in an urgent care facility, and $325 in an emergency room. Given that 16 to 27 percent of clinic patients have no health insurance, based on a 2011 RAND report, and only 39 percent have an existing relationship with a primary care provider, the lower cost could be beneficial not only to the patient’s pocketbook, but in the prevention of potentially future healthcare costs associated with developing chronic conditions.
“Retail health clinics are a huge convenience to patients,” said Mary Griskewicz, senior director of health information systems with the Healthcare Information and Management Systems Society (HIMSS). “They can be screened, get their flu shot, have a rash examined, and all of this is usually within 20 feet of the pharmacy where they can get medication.”
The Rise of the Retail Health Center
When RHCs first entered the market, some in the healthcare industry pushed back. Even though they are staffed by qualified nurse practitioners and physician’s assistants, many physicians contended they were inadequate clinical settings that should only be used in the most extreme circumstances.
Now, however, that opposition is disappearing, and RHCs are flourishing. In a healthcare environment where greater access is often the name of the game, a growing number of industry leaders now see these clinics as valued partners in providing preventative and primary care services.
“You are starting to see a newfound cooperation in the marketplace between retailers and their local hospital systems and physician groups,” said Thomas Charland, chief executive of Merchant Medicine, a research and consulting firm that tracks retail medical care service growth, related in a New York Times blog post earlier this year. “Physicians’ resistance is slowly melting away.”
The population of RHCs seems to have ballooned after two years of near-stagnant growth. Between 2010 and 2011, the number of these clinics rose by 11.2 percent to 1,355 nationwide. And, this trend shows no signs of slowing.
To date, retail drug stores, including Walgreen’s and CVS, have been the RHC leaders, with their Take Care Clinics and MinuteClinics, respectively. Currently, Walgreen’s has 350 Take Care Clinics nationwide, as well as 350 worksite locations. In addition, Walgreen’s announced last month that it will expand its relationship with the Tufts health plan in Massachusetts. CVS also has a considerable RHC presence – 650 MinuteClinics and a plan to add 500 more over the next five years.
Other retail giants, such as Walmart and the grocery store chains Kroger and Safeway, have launched RHC efforts within the last year.
Major hospitals and health systems are also adding clinics in retail areas in an effort to meet patients where they live and work. Recently, the Mayo Clinic opened its “Create Your Mayo Clinic Health Experience” in Minnesota’s Mall of America.” Mayo Clinic believes healthcare in the future won’t be limited to doctors’ offices and hospitals. Medicine needs to adapt to peoples’ changing needs, including seeing people where they are and when it is convenient for them,” said David Hayes, M.D., the clinic’s medical director, in an interview with FierceHealthcare. “Mall of America is the ideal gateway for many of Mall of America’s visitors to access Mayo Clinic in non-traditional ways.”
Connecting Patient Information
Despite being exempt from most Meaningful Use requirements and ineligible to receive incentive payments, HIMSS’ Griskewicz said implementing an electronic health record (EHR) is the most important HIT solution an RHC can employ. The nurse practitioner or physician’s assistant won’t complete the same level of patient history intake as a doctor’s office does, but an EHR allows them to document the encounter in some way. Patients can also potentially leave the clinic with access to an electronic copy of the record meant for his or her primary care physician.
According to Gabe Weissman, external relations manager with Walgreen’s, the company jumped head-first into HIT and developed its own EHR. The system allows any Walgreen’s nationwide to access a patient’s health records. For example, a provider in one of the Take Care Clinics can access the health records of a Pennsylvania resident who needs healthcare while on vacation in Florida.
“We’re working to ensure patients realize there are alternatives to the emergency room. We’ve formed relationships so nurse hotlines in hospitals are aware of Take Care Clinics and can route people there for services that aren’t appropriate for the ER,” he said. “We make sure we’re sharing records with primary care providers in the appropriate health system while filling a niche for slightly less emergent care.”
Walgreen’s also offers online appointment scheduling and recently launched an initiative through the social network Foursquare. Patients can use the smartphone application to electronically refill prescriptions, transfer prescriptions between Walgreen pharmacies, and schedule reminders to take medications.
The retailer’s Take Care health system was recently awarded Pointclear Solutions’ HIT Innovation Award for 2011 in recognition of its “innovation of online tools that allow patients, physicians and pharmacists to interact in near real-time, making patient health and wellness incredibly efficient for all participants, moving the healthcare industry dramatically forward,” according to a recent Pointclear press release.
One big challenge to fully utilizing an EHR still remains. There is often limited coordination between the RHC and a physician’s office or hospital. There simply are not enough resources available to safely and successfully link the RHC’s system with the wide variety of EHRs used by other clinical settings in each geographic area.
“The one problem with this situation is that there isn’t full EHR interoperability between pharmacies, hospitals and physicians,” she said. “Even if retail clinics are using an EHR, if it isn’t tethered to a physician’s office, the doctors aren’t getting the full picture.”
The one exception is e-prescribing – the only Meaningful Use requirement that does affect RHCs. Using e-prescribing services, such as Surescripts’ Clinical Interoperability, links provider, pharmacy and payer, and eliminates the need for pharmacies and physician offices to fax or mail prescription orders and patient information. Instead, with a few keystrokes, RHCs and providers can partner to compile more thorough patient histories that will lead to better, more efficient care in the future.
Griskewicz cautioned, however, that without proper staffing to fill the medication orders sent via an e-prescribing tool, the interoperability is ineffective.
More To Come
As quickly as RHCs are expanding, so are the HIT solutions to support them. Griskewicz predicted that most growth will occur with mobile technology, giving RHCs the ability to give patients their health information in easy-to-transport formats. The overall impact, she said, will be a positive effect on patient health and well-being.
“I encourage retail clinics. I encourage them to continue to use health information technology to work with outside organizations,” Griskewicz said. “They should continue down this path as technology evolves to make these health services more convenient for patients. It’s not just about bringing customers in and selling the candy on the shelves, but about improving the health of the patient.”
To read the article in its original location: http://www.porterresearch.com/Resource_Center/Blog_News/Industry_News/2012/April/Retail_Health_Clinics_on_the_Rise.html