Janice Simmons is a senior editor and Washington, DC, correspondent for HealthLeaders Media Online. She can be reached at jsimmons@healthleadersmedia.com.
To provide more consistent labeling that is easier to understand on dispensed prescription packages, the U.S. Pharmacopeial Convention (USP) has issued a new set of recommendations to standardize prescription labels through format, appearance, content, and language of prescription labels.
The labeling was created following a request from the Institute of Medicine (IOM) to address limited health literacy, which impacts more than 90 million adults nationwide. One of the components of health literacy is the ability to properly understand medication instructions and important supplemental information, such as drug interactions.
Poor health literacy can lead to non adherence and medication errors, according to IOM, which may pose significant health risks to patients. Medication misuse results in over 1 million adverse drug events annually.
USP, a nonprofit organization that sets standards addressing the identity, strength, quality, and purity of medicines across the country, formed a Health Literacy and Prescription Container Labeling Advisory Panel in 2007 to find ways to improve prescription drug container labeling.
"Patients have the right to understand health information that is necessary to safely care for themselves and their families," said Joanne Schwartzberg, MD, co chair of the advisory panel. "Confusing medication labels is one area that can be improved considerably."
The advisory panel call for provisions to:
Organize the prescription label in a patient centered manner. Information should be organized in a way to best reflect how most patients seek out and understand medication instructions. The prescription container label should feature only the most critical patient information needed for safe and effective understanding and use.
Simplify language. The language on the label should be clear, simple, concise, and standardized. Only common terms and sentences should be used. Use of unfamiliar words—including Latin terms and unclear medical jargon—should be avoided. Ambiguous terms such as "take as directed" should be avoided—unless clear and unambiguous supplemental instructions and counseling are provided.
Use explicit text to describe dosage and interval instructions. Dosage, usage, and administration instructions must clearly separate dose from interval. They must provide the explicit frequency of drug administration, such as "Take 4 tablets each day" or "take 2 tablets in the morning and 2 tablets in the evening." Use numeric rather than alphabetic characters for numbers.
Include purpose for use. While confidentiality could be a problem for including this information, USP said current evidence supports inclusion of purpose for use language in clear, simple terms such as indicating specific use for high blood pressure, rashes, or stomach cramps.
Improve readability. Critical information for patients must appear on the prescription label in an "uncondensed, simple, familiar" language in minimum 12 point, sans serif font (e.g., Arial).
Provide labeling in patient's preferred language. Whenever possible, prescription container labeling should be provided in the patient's preferred language. Translations of labels should be produced using a high quality translation process.
Include supplemental information. Auxiliary information on the prescription container should be minimized and should be limited to evidence based critical information.
Standardize directions to patients. As e-prescribing becomes more widespread, standards should be developed for prescribing directions to patients. This can lead to consistency of language and use across many healthcare professions and systems. An important element is the elimination of Latin abbreviations, which are often misunderstood and susceptible to variation in translation.
Young adults up through age 26 who continue to stay on their parents' health insurance plans under the new healthcare reform provisions cannot be required by health insurers to pay more for their coverage than those family members currently covered, according to a new interim final rule released Monday by the Department of Health and Human Services. Also, under the rule, plans cannot vary benefits based on the age of the child.
The provision does not officially go into effect until Sept. 23, but more than 65 insurers, including WellPoint, Aetna, and Kaiser Permanente have agreed to implement it as early as this month to let graduating college seniors receive coverage through their parents' plans.
Annual premium costs for adding a young adult—using a mid range estimate—would be $3,380 in 2011, $3,500 in 2012, and $3,690 in 2013, according to HHS. This would raise premium costs for employers by 0.7% in 2011, 1% in 2012, and 1% in 2013. For non-group or individual policies, the annual premium costs are anticipated to be $2,360 in 2011, $2,400 in 2012, and $2,480 in 2013.
Approximately 2.4 million young adults are expected to be eligible for coverage under their parents' plans. In 2011, roughly 1.24 million (using mid-range estimates) are anticipated to enroll for dependent coverage; this number is expected to rise to 1.6 million in 2012 and 1.65 million in 2013.
Under the initial healthcare reform legislation, insurers or employer plans could provide coverage only to a child "who is not married." However, this language was changed under the healthcare reconciliation measure passed by Congress, and coverage now can be provided for a married child. However, an insurer or plan is not required under the interim final rule to cover that child's spouse or children.
Employer sponsored health plans that are considered "grandfathered" under the healthcare reform plan and therefore exempt from various requirements still will be required to offer insurance for dependents up until age 26.
However, grandfathered plans can exclude an adult child under 26 if that child is eligible to enroll in another employer sponsored health plan such as a plan through their job unless it is the plan of the other parent's employer. But, beginning in 2014, that exclusion will not be available to them.
In April, healthcare employment showed a steady growth pattern with an increase of 20,000 jobs since March—including a gain of about 6,100 jobs among hospitals, according to the monthly figures released Friday by the federal Bureau of Labor Statistics (BLS). Overall, in the past year the healthcare area has grown by more than 244,000 jobs, to 13.7 million.
Among hospitals, the largest healthcare employer, more than 43,000 jobs have been created since April 2009, according to the BLS seasonally adjusted figures. Current employment in the hospital area is now more than 4.7 million.
The only healthcare area reviewed by BLS seeing a decline in April was employment in physicians' offices—down by 300 jobs since March. However, physicians' offices have added more than 45,000 jobs since last year, for a total of 2.3 million jobs.
Overall, ambulatory care services saw an increase of 9,400 jobs from March. This includes home healthcare services, which showed a healthy increase of 6,400 jobs from the previous month, while outpatient care centers rose by 1,700 jobs.
Jobs in nursing and residential care facilities grew by 4,600 from the previous month, for a total of 3.1 million jobs nationwide. Of that amount, 2,300 more jobs were added from March for nursing care facilities.
The Department of Veterans Affairs (VA) has become the first hospital system nationwide to develop and implement a new method of monitoring and classifying where complex and difficult inpatient surgeries should be performed—based on specific criteria among its 112 surgery programs—to promote quality care and safer surgeries.
The VA, the country's largest hospital system, began in 2007 to look for ways to "close and prevent gaps in surgical care," said Robert Petzel, MD, the VA's undersecretary of health.
Following an expert work group's review of surgical standards, the VA conducted onsite studies of its hospitals between June 2009 and March 2010. Using this information, the VA assigned each of its medical centers an inpatient "surgical complexity" level: complex, intermediate, or standard.
Using criteria developed by 16 surgical advisory boards, including 80 experts, VA has authorized 66 hospitals to conduct "complex" inpatient surgeries, 33 hospitals to conduct "intermediate" inpatient surgeries, and 13 to conduct "standard" inpatient surgeries.
Those hospitals with a "complex" rating were designated as requiring special infrastructure—such as facilities, equipment and staff—to allow intricate operations, such as cardiac surgery, craniotomies, and total pancreatectomies.
Those facilities with an "intermediate" rating may perform surgeries such as colon resections, repairs of abdominal aortic aneurysms, and complete joint replacement. And, those with a "standard" complexity rating may perform inpatient surgeries requiring limited infrastructure—such as hernia repair, cholecystecomy, urologic procedures, and ear, nose, and throat surgeries.
"If a patient requires a surgical procedure that exceeds the facility's complexity rating, VA will ensure that the patient receives the required care from another provider," Petzel said.
The initiative is expected, though, to affect only a small number of surgical procedures. The VA provided over 357,000 inpatient surgeries for veterans during 2009. Based on 2009 figures, the VA anticipates that 0.1% of "intermediate" or "complex" surgeries (approximately 364 patients) would now be referred to another provider. The VA healthcare system currently provides services to 6 million veterans annually.
Five facilities that have previously conducted some "intermediate" surgeries will now perform "standard" surgeries in house and ensure that patients obtain other procedures nearby from the best qualified providers. These are the surgery programs at VA hospitals in Alexandria, LA; Beckley, WV; Fayetteville, NC; Illiana at Danville, IL; and Spokane, WA.
The VA's surgical review program is expected to be expanded to include standards for outpatient surgery. Each of the VA's 21 hospital networks has developed a surgical strategic plan to ensure that veterans receive needed care during the implementation process.
During the next month, a new patient's healthcare bill of rights will be put into place at the federal level to provide "simple and clear information about their choices and their rights," President Obama announced on Saturday during his weekly radio address.
This new bill of rights will set up an appeals process "that will enforce those rights" and will prohibit insurance companies from limiting access to a patient's preferred primary care provider, obstetrician-gynecologist, or emergency room care, Obama said during his talk that focused on recent healthcare reform changes implemented during the past several weeks.
"Already, we are seeing a healthcare system that holds insurance companies more accountable and gives consumers more control," he said.
Today, the administration will announce new rules that will permit unmarried young adults who are not eligible for coverage elsewhere to continue to stay on their parents' insurance through age 26 starting this month—instead of the original date (Sept. 23) specified in the healthcare reform bill. This earlier date will permit young graduates and others to retain coverage following graduation, the President said.
In April, Health and Human Services (HHS) Kathleen Sebelius wrote to insurers across the country requesting the move-up date for this population group. Several large insurers initially agreed—with nearly 70 insurers following suit. The President requested that employer-sponsored healthcare plans follow the course of the commercial insurers to match the move-up date
The President also brought up recent efforts—what he called "real tangible elements"—to accelerate the timeline to implement provisions of the healthcare reform law that stop the practice of rescission or dropping insured individuals from plans.
The President also used the opportunity to again challenge Anthem Blue Cross, and its parent company, WellPoint, over a proposed 39% premium increase on California announced last month; the company backed down last week from the increase after discovering "numerous and substantial errors" in a filing that had supported the increase.
Pay for performance—finding ways to reward healthcare providers for achieving high-quality care for their patients—has become a popular topic across the country. But can this idea apply across-the-board to hospital CEOs as well?
In legislative action north of the border this week, this question is close to becoming a reality in which compensation for top executives at Ontario's 154 hospitals could see their compensation go up or down depending on their organizations' performances.
On Monday, Ontario Premier Dalton McGuinty proposed legislation to assist the province in getting a better return on investment in areas such as healthcare and postsecondary education. One of the first targets, he said, would be compensation for hospital CEOs—14 of whom made more than $500,000 last year.
While the "Excellent Care for All Bill" is not expressly designed to lower salaries and bonuses for top executives-compensation still could fluctuate depending on how those CEOs perform, according to Health Minister Deb Matthews, in comments that appeared in Toronto's The Globe and Mail.
But, she said that the new rules would now make executives accountable not just for the financial health of their hospitals—but for how effectively they put patients' needs first. This would mean looking at how the hospitals were reducing rates of infection among their patients or how many patients were being readmitted shortly after being discharged from the hospital.
And under the new legislation, medical errors would be reported directly to patients and hospital executives—a practice that is already in taking place in large teaching hospitals, according to Matthews. Every hospital also would be required to measure quality using different metrics, such as standardized patient surveys, and would be required to post annual quality improvement plans on their Web site.
According to reports, the hospitals do not appear concerned that the Ontario government will try to further assume a greater hands-on role in the process. Instead, the task of overseeing the development of a quality improvement plan would remain with each hospital's board of directors. In the long run, an unspecified portion of a CEO's compensation would be tied to achieving the hospital's objectives, Matthews said.
"This is a vote of confidence in the local governance of hospitals," Matthews was quoted at a news conference at Toronto General Hospital, where she was surrounded by clapping and smiling hospital CEOs.
So if the legislation is approved, will it work in Ontario—without a great deal of panic among hospital executives? Well, maybe. Take the Niagara Health System, for instance. When asked about the legislation, Niagara's board chairman told The Welland Tribune that the system had put "building blocks in place" that link quality measures to the health system CEO's pay.
"It's always been included. This is nothing new to us. It's just formalizing the process—across the province," she said in reference to the legislation.
So is this a bellwether of what could occur in the U.S.? While no state or federal law like the Ontario measure is likely to be passed, the pressure is rising on CEOs to make sure quality issues—everything from stopping hospital acquired infections to improving disposal of medical waste—-are responded to promptly. Many boards—like the one in Niagara—do hold their CEOs accountable to addressing quality goals.
But should CEO compensation specifically be tied to the progress—or lack thereof—of making hospitals safer or more efficient? And who should decide what standards best determine improved quality?
These are questions that are likely to ignite heated debate. But as quality becomes a louder battle cry on the healthcare landscape, it's hard to think why those in charge should not be held to the same standards as the "troops"—the frontline providers delivering care to patients.
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The Department of Health and Human Services (HHS) announced Tuesday it is moving up by three weeks the start of the Early Retiree Reinsurance Program—to June 1, 2010—from the date initially required by the new healthcare reform law.
The temporary program is designed to make it easier for employers to provide coverage for early retirees age 55 and older who are not currently eligible for Medicare. This program will end in 2014, when early retirees will be able to choose from additional coverage options through the health insurance exchanges.
In announcing the change, the White House and HHS said that the percentage of large firms providing workers with retiree coverage has declined from 66% in 1988 to 31% in 2008. The new reform legislation will provide $5 billion in financial assistance to employers to help them maintain coverage for early retirees. Employers can use the savings to either reduce their own healthcare costs, provide premium relief to their workers and families, or a combination of both.
"Rising costs have made it hard for employers to provide quality, affordable health insurance for workers and retirees, said HHS Secretary Kathleen Sebelius in a statement. "As a result, many Americans who retire before they are eligible for Medicare are worried about losing health insurance coverage through their former employers, putting them at risk of losing their life savings due to medical costs."
Sebelius predicted that an estimated 4,500 employers—3,000 private businesses and 1,500 state and local governments—would be seeking federal aid under the reinsurance program.
Employers who are accepted into the program will receive reinsurance reimbursement for medical claims for younger retirees not eligible for Medicare, along with their spouses, surviving spouses, and dependents. Health benefits that qualify for relief include medical, surgical, hospital, prescription drug, and other benefits that may be specified by the HHS, as well as coverage for mental health services.
The amount of the reimbursement to the employer plan is up to 80% of claims costs for health benefits between $15,000 and $90,000. Those claims incurred between the start of the plan year—usually Jan. 1—and June 1 are credited towards toward the $15,000 threshold for reimbursement. However, only medical expenses incurred after June 1, 2010, will be eligible for reimbursement under the program.
Eligible employers can apply for the program through HHS. Both self funded and insured plans can apply—including those plans sponsored by private entities, state and local governments, nonprofits, religious entities, unions, and other employers. Applications will be available by the end of June.
The Business Roundtable expressed its support for the program. "The Early Retiree Reinsurance Program reduces costs and allows many of our member companies to continue providing this critical coverage," said Roundtable President John J. Castellani.
A joint research initiative to test new technologies for predicting incidents of central line associated bloodstream infections (CLABSIs) will be conducted by the Centers for Disease Control and Prevention and the Premier healthcare alliance. The reporting of these adverse events will be automatically sent to the CDC's National Healthcare Safety Network (NHSN), the groups announced Monday.
This initiative is based on the success of a pilot project of CDC's Prevention Epicenter Program, which identifies and evaluates effective healthcare associated infection (HAI) prevention strategies with research through a network of academic centers.
The initiative will analyze specific traits of positive blood cultures across a subset of Premier's more than 2,300 member hospitals. This will be used to develop an automated electronic surveillance tool for accurately predicting the presence of CLABSIs. Researchers from the Chicago Prevention Epicenter at Stroger (Cook County) Hospital, in Chicago, will evaluate the tool to determine effectiveness.
If the tool works, it would be used as part of a decision support process to flag potential CLASBIs events and to avoid additional infections. The tool also will be used to automate a more standardized method of HAI detection and to assist reporting to NHSN using data already used within existing health information systems.
"By decreasing the time involved in identifying HAIs, more energy can be placed on prevention activities," said Denise Cardo, MD, director of CDC's Division of Healthcare Quality Promotion.
Central line associated bloodstream infections currently affect approximately 250,000 patients in the U.S. each year, according to the CDC. Associated costs can range from $5,734 to $22,939 per patient.
Research and testing of the CLASBIs electronic surveillance tool is expected to take about two years. At the end of the initiative, the tool will be included in Premier's SafetySurveillor, a Web based application used for automated infection control, surveillance and medication management. The tool will be made publicly available for use with other infection prevention offerings.
Healthcare providers need additional time and greater flexibility to meet criteria of the Centers for Medicare and Medicaid Services' proposed electronic health record rule published earlier this year, a coalition of 51 groups told Health and Human Services Secretary Kathleen Sebelius in a May 3 letter.
They wrote that while they "fully support" the purpose of the American Recovery and Reinvestment Act of 2009 to "encourage the adoption and use of EHRs," they are asking that it be done "in a manner that will remove barriers to and promote the widespread adoption of health information technology.”
The groups signing the letter included the American Hospital Association, the American Medical Association, the American Academy of Family Physicians, the American College of Physicians, the American Psychiatric Association, the Association of American Medical Colleges, and the Medical Group Management Association.
The proposed rule currently "takes an 'all-or-nothing' approach where failure to meet any one of the requirements means the provider will not receive an incentive payment," they say. This approach fails to acknowledge that providers have made "enormous progress in creating and maintaining EHRs to improve patient care and safety."
These requirements are asking for too much, too soon, they added. Specifically, the healthcare organizations say the requirements include advanced functions such as computerized provider order entry, clinical decision support, and electronic medication reconciliation, which generally occur at the end of a multi year transition to EHRs.
The proposed phase in period for this "aggressive set of requirements is unrealistic," and it fails to acknowledge that "providers adopt EHR functions incrementally and are in different places in their adoption process," according to the letter.
If the current rule is finalized, it would likely result in providers with advanced HIT systems not meeting requirements in fiscal 2011. For those physicians in small practices and rural providers, the letter notes, "the unrealistic timeframes are even more problematic because they have further to go in their implementation of EHRs compared to larger providers."
The coalition's letter parallels many concerns expressed by both House and Senate members in letters sent in March to the acting CMS administrator. Like Congress, the groups are asking to extend the transition to meaningful use to 2017—consistent with the stimulus legislation.
The groups also are asking for a less-restrictive definition of hospitals. Of concern is CMS's proposal to use Medicare provider numbers to distinguish hospitals for EHR incentive payment purposes. "There is no standard approach to exactly which facilities a Medicare provider number encompasses and, in many hospitals, a single provider number can include multiple sites of a hospital system," say the healthcare organizations.
The groups are therefore calling CMS to define a hospital "as a discrete facility of service, so that individual sites of hospitals are eligible to separately qualify for the incentives." Since CMS does not currently collect data by individual hospital sites, it would have avenues by which it could do so—such as through cost reports.
The organizations also are calling for less burdensome reporting requirements on providers. To do this, they are asking for CMS to require reporting of only "HIT functionality measures that can be generated directly from EHRs"—with no need for manual chart reviews. Also, they say CMS should postpone requirements on quality metric submissions until the "means to capture the data from EHRs and submit the data to CMS is validated."
Two recent purchases of sizable, not-for-profit health systems by for-profit entities may be signaling a shift toward increased consolidation within the healthcare industry, according to a new analysis by Moody's Investors Service.
If this becomes a trend it could place additional pressure on the remaining not-for-profit healthcare organizations in the same markets to not only operate more efficiently, but also offer a potential new source of capital for not-for-profits considering a merger or sale, Moody's said in its analysis on for-profit investment in not-for profit hospitals.
In March, Detroit Medical Center, which owns 10 hospitals or specialty centers and a laboratory in Michigan, signed a letter of intent to be purchased by Nashville based Vanguard Health Systems, a for profit company that owns 15 hospitals in Arizona, Illinois, Massachusetts, and Texas. The price tag includes $417 million to retire DMC's bonds. Vanguard also will invest $850 million over five years in major capital projects.
And several days later, New York private equity firm Cerberus Capital Management, announced plans to acquire Caritas Christi Health Care in Massachusetts. Caritas runs six Catholic hospitals in the Boston area. Under the terms of the agreement, Cerberus will assume CCH's debt and invest $400 million in future projects.
From the perspective of not for profit hospitals, these types of alignments could create "conflicting possibilities," according to Moody's. Those not-for-profit organizations initially capable of attracting for profit partners will benefit. But this could mean that the remaining independent not for profits--including small independent hospitals and lower-rated health systems--may face "operating challenges and increased competition" from their newly capitalized competitors.
The overall effect could be an increased rate of mergers of not for profits with both other not for profits and for profit firms, the Moody's analysis said.
The Massachusetts and Michigan healthcare markets have historically been dominated by not for profit operators. While the two transactions are subject to many approvals and further negotiation, they will "materially alter the competitive landscape of these markets," Moody's said.
As one example, disclosure practices of hospitals under the ownership of large for profit entities could become less detailed--providing their not for profit competitors with a disadvantage with respect to access to information.
Several other factors that may make consolidation more likely are:
Increases in reimbursement pressures across all payers
Greater needs for cost controls and access to economies of scale
Increases in competition for physicians, suppliers, and patients
