1_hope march 2008.pub

Long Term Care and the 2008 General Assembly eral Assembly this year on SB 315; view of Medicaid home and communi-however, the House voted to adopt the SB 42 continues the Select Joint Com-
this session. Although many issues adds additional responsibilities for structuring, other important issues The Commission has been very in- of the bills impacting long term care caid issues such as nursing home case and senior housing and services that mix rates. SB 302 covers a wide range of health
SB 315 establishes a cap on Medicaid
beds in the state, but does not restrict the addition of Medicare or private Health Facility Administrators pay beds. Under the cap, Medicaid (nursing home administrators) Board beds can be bought, sold, or moved; from 14 to 13 members by eliminating however, there cannot be an increase the hospital administrator position. in the total number of Medicaid beds The Board has had difficulty obtaining reaches 95%. The current nursing The introduced version of the bill home bed moratorium expires on called for reducing the board to 11 March 30, 2008. SB 315 is effective members. HB 1172 also addresses a number of
rules to implement: (1) a screening tions. The bill requires, beginning July 1, 2008, and until June 30, 2009, that a als seeking long term care services; (2) NewsBriefs a process of prior approval for certain services agency obtain an employee's individuals seeking admission to a limited criminal history not more than H.O.P.E.
March 2008 ~ Vol. 7, No. 3
5224 S. East Street
Inserts in this Issue
Indianapolis, IN 46227
Phone: 317-472-0677
Fax: 317-472-0695
three business days after the date that an employee be- quirements established in the regulations or the re- gins to provide services. The bill also includes a provi- quest for bids will receive a letter informing them of sion that establishes criteria when a nursing home is not required to provide CPR on a patient who is found After the program begins, bidders that did not be- dead and does not have a do not resuscitate order. come contract suppliers generally cannot receive Medicare payment for competitively bid items. How- Medicare Announces Single Payment Amounts
ever, they may choose to continue in the Medicare on Durable Medical
program as grandfathered suppliers for existing cus- tomers if they supply certain rented items or oxygen The Centers for Medicare & Medicaid Services (CMS) or oxygen equipment to Medicare beneficiaries. Bid- has completed the bid evaluation process and an- ders that do not become contract suppliers for the first nounced the single payment amounts for the first round of bidding may bid in future rounds of compe- round of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) com- petitive bidding program. The competitive bidding The current Medicare fee schedule payment amounts program will offer beneficiaries in the designated will continue for beneficiaries who do not reside in competitive bidding areas (CBAs) access to quality the first round CBAs and for items that are not sub- DMEPOS products and services with lower out-of- ject to the Medicare DMEPOS Competitive Bidding pocket costs. The only Indiana area affected is the Program. The list of contract suppliers will be availa- Cincinnati metro area in Indiana. The second round of ble on the web page listed below when all contracts bids will be starting soon and affect the Indianapolis metro area and the Indiana portion of the Chicago met- www.cms.hhs.gov/CompetitiveAcqforDMEPOS/ Under the program, the single payment amount will ISDH Executive Board Rejects Aging-in-Place
become the Medicare allowed payment amount for the competitive bidding items for beneficiaries who reside The Indiana State Department of Health Executive in the CBAs. Consistent with current CMS practice, Board rejected a proposed rule that would have al- Medicare will pay contract suppliers 80 percent of the lowed residents of licensed residential care facilities single payment amount for each competitively bid that are a part of a comprehensive care facility to re- item. The beneficiaries will be responsible for the re- main in their unit when their needs exceeded those maining 20 percent of the single payment amount. As a result of the competitive bidding process, the amounts that Medicare will pay for the 10 product cat- Quarterly Compliance Update: "Everyday
egories included in Round 1 of the DMEPOS Compet- Compliance, Prevention & Response"

itive Bidding Program overall average 26% less than Rebecca Bartle, R.N., Regulatory Affairs Director of- Medicare's previous payment amounts. Savings for HOPE, will lead this ½ Day Session on April 10th. beneficiary out-of-pocket cost and Medicare range This update will focus on Everyday Compliance, Preven- from 14% on negative pressure wound therapy devices tion & Response. The session will address specific inter- and accessories up to as much as 43% on mail order ventions for maintaining ongoing compliance, tactics for prevention of common citations, and manners of provid- diabetic supplies. Beneficiaries in these CBAs will er response when unfortunate events occur. The foun- begin seeing savings on July 1, 2008. The single pay- dation will be the Immediate Jeopardy citations since ment amounts can be found on the CBIC website at: September of 2007 as well as the most commonly cited deficiencies and a look at the new ISDH CPR Guide- CMS is notifying all bidders of their bid results. Win- Attendees will leave this session with an acute aware- ning bidders will be mailed contracts requiring their ness of vulnerable areas of compliance but will also be signatures. Qualifying bidders whose bids were not in provided suggested manners of how to decrease the the winning range may still receive a contract offer facility's vulnerability through everyday practices and from CMS if one of the winning bidders decides not to become a contract supplier. Bidders whose bids were The brochure with full details of the session is included disqualified because their bids did not meet the re- allowed in the current residential care rules. The able (A/R) will be set up to recover the overpayment. facility, the resident or their legal representative, Following review of the RA, providers who disagree and the resident’s physician would have had to with any adjustment amounts may request an adminis- agree and the facility would have had to ensure that trative review by writing to the following address: The Board expressed grave concerns with resident safety, how these situations would be surveyed, and the burdens and pressures on physicians under such a system. Terry Whitson, Assistant Health In the request explain why you disagree with the ad- Commissioner, presented the Board with a sum- justment amount and include copies of all pertinent mary of comments received and issues raised at the documentation. Detailed information about the admin- public hearing, as well as comments provided to istrative review process is available in the Indiana him privately by individuals who did not want to Health Coverage Programs (IHCP) Provider Manual. oppose the rule publicly “because of perceived or actual pressure to support the rule” from their or- AARP Appoints New State Director
AARP Indiana has announced the appointment of June Mass Adjustment of Medicare Part A
Lyle as state director. Lyle joined AARP in 2002 as Crossover Claims
associate state director for public policy, and has EDS will process a mass adjustment of Medicare served as interim state director since September 2007. Part A crossover claims with dates of service from Prior to joining AARP, she was an attorney in private October 1, 2001 through March 26, 2002. During practice specializing in consumer, utility, and environ- this time an emergency rule was in effect that capped Medicaid reimbursement of crossover As state policy director, Lyle led AARP Indiana’s leg- claims at the Medicaid allowable rate. The State islative advocacy efforts, working with staff and vol- was sued and prevented from implementing this unteers to pass key legislation to improve the lives of emergency rule as well as three others. On appeal, Hoosiers 50+. Significant victories included laws on the court found in favor of the State and sent the prescription drug assistance, predatory mortgage lend- case back to the trial court for a determination of ing, home and community based health care services, the amount the State was owed in restitution from and security freeze/identity theft. Lyle directs a state providers (See IFSSA v. Amhealth et al, 790 office staff of six people, who serve the interests of more than 880,000 Hoosier members of AARP. The lawsuit involved the nursing facility industry’s challenge of four emergency rules that, in aggre- gate, reduced Medicaid reimbursement. As a result State Senator David Ford Dies
of a settlement with the plaintiffs, only Medicare Four-term lawmaker David C. Ford (R-Hartford City) Part A crossover claims will be adjusted and re- has died. Ford died on March 5th at his home from complications related to pancreatic cancer. Senator The adjustments will begin appearing on the March Ford was 59. He had been receiving hospice care and 18, 2008 remittance advice (RA). These claims chemotherapy following hospitalization for what ap- will have an ICN number starting with 56, which peared to be flu-like symptoms in mid January, but reflects a mass-adjusted claim. An accounts receiv- had kept closely atop Statehouse events this legislative session via telephone and computer, Senate President Pro Tem David C. Long (R-Fort Wayne) said. Billing Roundtable—April 22
Senator Ford was tapped in 2007 by Long to serve as The next meeting of the HOPE/IAHSA Billing
Assistant Majority Floor Leader and chair of the Sen- Roundtable has been set for April 22 from 10:00
a.m to noon at the IAHSA Office. All are welcome.
ate Committee on Economic Development and Tech- To RSVP, contact Becky Carter at 317-733-2380 or
nology. In addition, Senator Ford was an active mem- [email protected]
ber of the Judiciary, Tax and Fiscal Policy, and Educa- HOPE BOARD OF DIRECTORS
Senate District 19, which Ford represented since 1994, Blake Jackson, Chairman
includes all or parts of Adams, Allen, Blackford, Grant and Wells counties. Senator Ford was a legisla- Robert S. Decker, President
tor very interested in the needs and concerns of Indi- Charles Bowman, Secretary
Association Alerts Older Adults About
Telemarketing Calls
James Burkhart, Treasurer
Less-than-honest telemarketers are calling older adults John W. Bartle
and persons with disabilities to sell their Medicare Ad- vantage plans. With less than a week to go before the March 31 enrollment deadline, "there will be multiple Daniel Houston
opportunities for-less-than-honest individuals to offer products and services that may not be Medicare ap- proved, or individuals who will say they are Medicare representatives,” according to Melissa Durr, Chief Ex- Stuart B. Reed
ecutive Officer of the Indiana Association of Area And the recipients of those calls are feeling the pres-sure. “This is not uncommon as we experienced simi-lar events last year,” Durr said. “In the past week, we have been alerted to two cases of possible fraud in  Shred or tear into small pieces all mail solicita- East Central Indiana.” Durr says that Medicare does tions, bank records or any other discarded docu- not make home visits or unsolicited phone calls. She ments that contain identifying personal infor- offered a variety of ways to protect, detect and report  Be aware of scams; if you’re told you just won a “If someone contacts you and pressures you to buy,  If it sounds too good to be true, it probably is. hang up your phone or close your door,” Durr said. Questions about the viability of products or services Durr recommends that if you suspect someone is try- being offered for sale can be explored on your own. ing to coerce or steal information, you should contact Making sure you understand what you are buying, your local Area Agency on Aging at 1-800-986-3505. what is covered, what the cost of a product or service is, and how to cancel if you change your mind are all important questions the salesperson should be able to 2008 Wage Survey
answer. If they can’t, then you should probably de- Durr offered additional tips that will help older adults sisted living members. The survey is in an electronic and persons with disabilities detect and prevent them- format and members who choose to participate may enter their own data, confidentially, at their conven- ience. Each eligible member will receive a mailed noti-  Never sign anything you don’t understand; have an fication of the process, log-in and password, and due date. Because of federal law interpretation, a strict participation deadline will be enforced. All participants Stay socially active; isolation increases your risk will receive a complimentary copy of the survey re- sults. Our intent is to begin the participation process  Don’t give out your credit card or bank account by early April. Watch for more information via mail and numbers over the telephone or Internet unless you MedPAC Considers Recommendations to
stration program using recovery audit contractors (RACs) in California, Florida and New York in 2007. Change SNF Payment System
The Medicare Payment Advisory Commission The RAC demonstration program, created by the (MedPAC) issued its official March 2008 Medicare pay- Medicare Prescription Drug, Improvement, and ment policy report to Congress. MedPAC is an inde- Modernization Act of 2003 (MMA), is designed to pendent federal body that advises the U.S. Congress find and correct improper Medicare payments paid on issues affecting the Medicare program. MedPac is to health care providers participating in fee-for- recommending a revised system that would include service Medicare. One of the areas that they have improved payment components for "non therapy ancil- been overturning is the 3-day qualifying stays for laries" (mostly drugs), therapies, and an outlier pay- Medicare payment in LTC, although 85% of the collections have come from inpatient hospitals. According to MedPAC, aggregate Medicare margins for Approximately 96 percent of the improper payments freestanding SNFs were above 10% for the last six identified by the RACs in 2007 were overpayments years. In 2006, the aggregate margin was 13.1%. Med- collected from health care providers; the remaining icare margins are estimated to reach 11.4% in 2008. 4 percent were underpayments repaid to health The report suggests that SNF payments are more than care providers. The demonstration program began adequate to accommodate anticipated cost growth so in California, Florida and New York in 2005 and MedPAC is recommending that the Congress eliminate expanded into Massachusetts, South Carolina, and the update to payment rates for SNF services for fiscal Arizona in 2007. The first three states are those states with the largest number of Medicare claims.
MedPAC recommends that the Congress establish a
Expansion into Indiana is slated for March of
quality incentive payment policy for SNFs in Medicare 2008.
to tie payments to patient outcomes. MedPAC identi- fied the rates of community discharge and potentially avoidable re-hospitalization as two important goals for http://www.cms.hhs.gov/apps/media/press_releases SNF patients in developing a quality incentive payment policy. Using re-hospitalization rates as one perfor- mance measure “represents a step toward having mul- Home Health Spending Growth
tiple providers and settings mutually accountable for The Centers for Medicare & Medicaid Services lowering the number of potentially avoidable re- (CMS) reports that home health care continues to be the fastest-growing component of all personal health care spending. Spending increased 9.9 per- The 30-page SNF section can be accessed at: cent in 2006. There are currently about 8,500 home www.medpac.gov/chapters/Mar08_Ch02d.pdf. health agencies in the United States and 7.6 million people receive home health care each year. CMS Clarifies Inpatient Part A Billing for No-
Payment Claims
A new article from the Centers for Medicare and Medi- Seniors & Federal Rebate Checks
caid Services (CMS) explains the circumstances under Social Security beneficiaries who have not filed a which a skilled nursing facility must submit a no-pay federal tax return may be eligible for a federal tax bill. Facilities must submit a bill for a beneficiary who rebate check if they file a 2007 tax form. The pay- has started a spell of illness under the Part A benefit for ments of at least $300 for individuals or at least every month of the related stay even though no bene- $600 for married couples filing a joint tax return are fits may be payable. In addition, facilities must submit part of the economic stimulus package recently no-payment bills for beneficiaries who have previously passed by the Congress and signed into law by received Medicare-covered skilled care and subse- quently dropped to a non-covered level of service but continue to reside in a Medicare-certified area of the To qualify for a payment, a recipient’s 2007 Social facility. The CMS article reflects no changes in existing Security benefits combined with certain benefits policy, but simply clarifies Chapter 6 of the Medicare paid by the Department of Veterans Affairs and/or Claims Processing Manual, SNF Inpatient Part A Bill- other earned wages in that year must total at least $3,000. Supplemental Security Income (SSI) does http://www.cms.hhs.gov/MLNMattersArticles/download not count as qualifying income for the stimulus pay- ment. To receive the stimulus payment, recipients must file a 2007 IRS Form 1040 (long form) or Form CMS Program Identifies $371.5 Million in Im-
1040A (short form) by the filing deadline of April 15, proper Medicare Payments in Three States
2008. All the recipient has to do is to file a 2007 tax return and the IRS will do the rest; they do not need The Centers for Medicare & Medicaid Services (CMS) to contact the IRS or fill out any other special forms. has announced that $371.5 million in improper Medi- The IRS will automatically calculate and send the care payments has been collected from or repaid to payment. This payment will not affect recipients’ health care providers and suppliers as part of a demon- Social Security benefits and they will not have to pay taxes on it next year. The IRS will begin mailing checks in For assistance with appeals or with an application, check early May. (WAHSA E-News, 3-6-08) http://www.in.gov/idoi/shiip/ for information about health insur- ance counseling in Indiana operated by the Department of Insur- Study Suggests Medicaid-Sponsored Home Care
Reduces Nursing Home Use
A recently released study of Medicaid-financed nursing home use Private Medicare Plans’ Cost Questioned
over 18 months in 2001 and 2002 finds that in states such as Ore- A New York Times article discusses a recent Congressional gon that have extensive community based long-term care ser- study which showed that private Medicare plans often cost ben- vices, Medicaid-covered nursing home stays were shorter than eficiaries more than the traditional government-run Medicare the national average. The numbers suggest that where seniors program. Although many private plans advertise extra benefits have alternatives, their nursing home stays are more likely to be and low costs the study showed that many people in private for acute care following a hospitalization or for a shorter period at plans face higher costs for home health care, nursing homes and some hospital stays. About one-fifth of the 44 million Medi- care beneficiaries – 9 million people – are in private plans, The study reports that over half of enrollees beginning Medicaid- financed nursing home spells were already residing in nursing homes when Medicaid began financing part of their stay, with 29 The Government Accountability Office found that “48 percent of percent obtaining coverage within six months, 5 percent between Medicare Advantage beneficiaries were in plans that had an out- six and 12 months, 7 percent between one and two years, and 9 of-pocket maximum.” T he limits typically ranged from $2,750 to $4,600 a year and averaged about $3,500. But, the report said, certain costs are not counted toward the out-of-pocket limits The report confirms the continuing trend that most nursing home established by some insurers. Thus, it said, among Medicare residents are among the older old. The average of nursing home plans with out-of-pocket limits, 29 percent exclude the cost of resident who entered in 2002 was 76 years of age, with 32 per- some cancer drugs, 23 percent exclude the cost of somemental cent each being between the ages 75 and 84 and 85 and older. health services and 21 percent exclude home health care ex- Twenty percent were under age 65 and 16 percent between ages http://aspe.hhs.gov/daltcp/reports/2008/mfNHserves.htm. The accountability office found that private Medicare plans “allocate about 87 percent of total revenue ($683 of $783 per member per month) to medical expenses; approximately 9 per- Some Medicare Beneficiaries Will Lose Part D Low
cent ($71) to nonmedical expenses, including administration, Income Subsidy on April 1
marketing and sales; and approximately 4 percent ($30) to the The Social Security Administration (SSA) has begun mailing "SSA plans’ margin, sometimes called the plans’ profit.” (New York Medicare Prescription Drug Assistance Notice of Termination" letters to some beneficiaries who are currently receiving the low- income subsidy (LIS) or "Extra Help." The letters are being sent Study: Many Assisted-living Residents Under-Treated
to beneficiaries who did not provide SSA with information it re- The majority of elderly people in assisted-living or residential quested to determine their continuing eligibility for the LIS. care facilities are not receiving all of the medications they need for four common conditions, according to new study findings, a Beneficiaries who do not act immediately upon receiving the letter Reuters report stated. To investigate whether the elderly were to request an appeal will no longer receive the LIS to pay for Part facing problems due to a lack of needed medications, Dr. Philip D premiums and cost-sharing effective April 1. D. Sloane of the University of North Carolina in Chapel Hill re- Beneficiaries who believe they are, or even might still be, eligible viewed the medical records of 2,014 people 65 years of age or for the LIS should contact SSA within 10 days of receiving their older, Reuters reported. All study participants were residents of letter to request an appeal. If they do so, they can continue receiv- assisted-living or residential care facilities. ing LIS until their appeal has been decided, regardless of whether Sloane and his colleagues found that among people with a his- it is decided in their favor. Call SSA at 1-800-SSA-1213 (1-800- tory of heart attack, more than 60 percent were not taking aspi- rin, and three-quarters were not receiving beta-blockers, com- In addition to taking action to file an appeal, beneficiaries should monly used to prevent repeat attacks. And, among people with the bone-thinning disease osteoporosis more than 60 percent They can reapply for LIS, even if they are not currently eligi- were not taking calcium supplements, and more than half were ble, if their circumstances change, making them eligible once given no treatment at all, the Reuters report noted. again. Beneficiaries who do not appeal must wait until April 1 More than 60 percent of subjects with congestive heart failure to reapply. Otherwise, the applications will be considered were not receiving an angiotensin-converting enzyme inhibitor -- duplicates and will not be processed by SSA. Applications a common drug for this condition -- and more than one-third of can be made by calling SSA at the above number or by filing stroke patients were not given drugs to prevent future blood on-line at http://www.ssa.gov/prescriptionhelp/. clots. "The absence of potentially beneficial treatments in such Their current drug plan will contact them to let them know high percentages of residents of these facilities raises the spec- how much their premium will be, starting April 1, without the ter of an important quality problem in the care of older patients," Dr. Jerry H. Gurwitz told Reuters. (Advance for Health Infor- They will have a 3-month special enrollment period, starting April 1, to enroll in a different drug plan, if they choose not to remain in the one in which they are currently enrolled. Diabetes Presents Growing Problem for
In an accompanying editorial, Mitchell J. Schwa- Nursing Homes
ber, MD, MSc, and Yehuda Carmeli, MD, MPH, of the Tel Aviv Medical Center, Israel, write: "The owned and operated Diabetes is "enormously prevalent" in nursing homes. solution is not to categorically deny antibiotics to providers of health care, One out of every four residents over the age of 65 is the severely demented elderly, or even to impose housing, and assistance diagnosed with the disease, according to a new report limits on their use or their spectrum as a matter of from the Institute for the Future of Aging Services. policy. We must, however, begin to consider every Researchers analyzed the 2004 National Nursing decision to use antibiotics in this population as we Home Survey, which includes data representing 1.32 would decisions regarding other treatment modali- million nursing home residents over age 65. Among ties, including resuscitation and major surgery. That the findings: Non-white residents were twice as likely is, we must ask whether the interests of the patient to have diabetes as white residents; diabetic residents are being served by using antibiotics. We must fur- were younger than their non-diabetic counterparts; ther ask whether the use of antibiotics in each spe- and the prevalence of diabetes in U.S. nursing homes cific patient justifies the risk placed on others by was higher in 2004 compared to previous years. IFAS their use. (Nursing Homes eNewsletter) is the applied research arm of the American Associa- tion of Homes and Services for the Aging. Medical Organizations Issue New Guide-
Those afflicted with the disease are at a greater risk line on Drugs to Treat Dementia
for developing other conditions that can affect their Further research urgently needed to address gaps in quality of life and care needs, according to research- knowledge about the clinical effectiveness of phar- ers. Among the examples shown in the report, diabet- macologic management of dementia. A committee ics are more likely to take more medication and arrive representing the American College of Physicians at a nursing home with pre-existing circulatory prob- (ACP) and the American Academy of Family Phy- lems. Diabetics are also 56% more likely to have a sicians (AAFP) found no convincing evidence demonstrating that one therapeutic treatment for The research was published in the February 2008 is- dementia is more effective than another. sue of Diabetes Care. To view the report, please go to The committee reviewed dementia literature for outcomes such as cognition, global function, behav- ior/mood, and quality of life/activities of daily liv- Study Raises Concern over Antibiotic Use in
ing. The committee found that high-quality scien- Nursing Home Dementia Residents
tific evidence was limited and so developed cau- Antibiotics appear to be frequently prescribed to indi- tious recommendations on current pharmacologic viduals with advanced dementia in nursing homes, treatment of dementia: especially in the two weeks before death, according to Clinicians should base the decision to try thera- a report in the February 25 issue of Archives of Inter- py with the FDA approved drugs for dementia nal Medicine. "This extensive use of antimicrobials on an individualized assessment of the patient. and pattern of antimicrobial management in advanced Clinicians should base the choice of drugs on dementia raises concerns not only with respect to in- tolerability, adverse effect profile, ease of use, dividual treatment burden near the end of life but also with respect to the development and spread of antimi- Further research is urgently needed to address crobial resistance in the nursing home setting," the gaps in knowledge about the clinical effective- ness of pharmacologic management of demen- "The proportion of residents taking antimicrobials was seven times greater in the last two weeks of life Currently five drugs are approved by the FDA for compared with six to eight weeks before death," the dementia: four acetylcholinesterase inhibitors authors write. Thirty of the 72 courses (41.7%) in the [donepezil (Aricept), galantamine (Razadyne, last two weeks of life were administered intravenous- Reminyl, Nivalin), rivastigmine (Exelon), and ta- ly rather than by mouth, a method that may be un- crine], and one neuropeptide-modifying agent comfortable for residents with advanced dementia. [memantine (Namenda)]. These drugs do not cure The results support "the development of programs dementia (there is no cure at this time) or repair and guidelines designed to reduce the use of antimi- brain damage. They may improve symptoms or crobial agents in advanced dementia." “Doctors, patients, and family caregivers desperately want • 46% for pain management
information on how to treat this disease,” said Amir Qaseem, • 30% for pressure ulcers
MD, PhD, MHA, senior medical associate in the Clinical Pro- • 40% for physical restraints
grams and Quality of Care Department at ACP. “It is disheart- In addition to improving quality measures, nursing home ening to find out that all we have to work with is these five leadership collected data and evaluated their certified nursing drugs, and the evidence on these is scant. Consider that in 50 assistant (CNA) turnover with tools and education provided years, one in 45 Americans will suffer from Alzheimer’s dis- by the QIO. The leadership reviewed human resource poli- ease. This is a huge problem.” (Nursing Homes/LTCM cies, hiring practices, orientation practices, and mentoring opportunities. Through this evaluation and organizational changes, the CNA turnover made a 13% relative improve- Medwatch - Fentanyl Transdermal Patches: Recall
ment from baseline in 2006 to re-measurement in 2007. Due To Gel Leak That May Lead To Respiratory
Depression and Overdose
Few Studies Explore MRSA Prevention Strategies
Actavis Inc. announced a nationwide recall of certain lots of for Nursing Homes

Fentanyl transdermal system CII Patches sold in the United Methicillin-resistant Staphylococcus aureus (MRSA) is mak- States and labeled with an Abrika or Actavis label. The prod- ing news as a dangerous, sometimes fatal disease, for hospi- uct may have a fold-over defect which can cause the patch to tal patients, and in recent cases, students. MRSA is also a leak and expose patients or caregivers directly to the fentanyl major source of illness acquired in nursing homes, yet few gel. Exposure to fentanyl gel may lead to serious adverse studies have looked at how to prevent its spread among elder- events, including respiratory depression and possible over- ly residents, according to a new review. Close living proxim- dose, which may be fatal. The lots covered by this recall in- ity, multiple medications, pressure sores, and catheters all clude doses of 25, 50, 75, and 100 mcg/hr and are listed in the make nursing homes ideal for breeding and spreading firm's press release. See the complete MedWatch 2008 safety MRSA; however, nursing homes appear to have been summary, including a link to the firm's press release, at: shortchanged in the medical literature on prevention, despite www.fda.gov/medwatch/safety/2008/safety08.htm#Fentanyl studies repeatedly reporting that residents are at higher risk. Significant Improvement Shown in Quality
"Much of the research effort around MRSA to date has fo- Improvement Goals
cused primarily on hospitals," said Carmel Hughes, lead re- view author. Hughes, a professor of primary care pharmacy In an effort to improve the quality of care for Indiana nursing at Queen's University Belfast in Northern Ireland, and col- home residents, Health Care Excel (HCE), the Indiana Medi- leagues searched for randomized and controlled clinical trials care Quality Improvement Organization (QIO), provided edu- that focused on infection control interventions in nursing cation and technical assistance to 84 nursing homes as part of the national Nursing Home Quality Initiative (NHQI). Hughes said introducing effective interventions in hospitals Data were collected during an 18-month period, from January might be easier because hospitals have isolation facilities and 2006 through June 2007. By directly involving nursing home greater access to infection control expertise. Infection control staff in the redesign of care delivery through a person-centered training is not routinely available in nursing homes, she add- approach, and provision of data to monitor progress over time, ed. "It is likely that an intervention for MRSA in nursing the 84 participating nursing homes were able to make signifi- homes will consist of screening recently admitted residents to the nursing homes, hand washing, and high standards of cleaning and decontamination," Hughes said. "It will be im- Goal 1: Decrease the percent of residents who experience portant for some staff members to make infection control a priority and that this is communicated to all other staff." Rig- Goal 2: Decrease the percent of residents who have pressure orous testing in the nursing home environment and detailed notes about such interventions will help ensure that they are Goal 3: Decrease the percent of residents who were physically The review appears in the 2008 Issue 1 of The Cochrane Li- As a result of working closely with nursing home providers brary, a publication of The Cochrane Collaboration, an inter- through on-site visits, conducting regional workshops and tel- national organization that evaluates medical research( Nurs- econferences, and bringing nationally known, long term care experts to statewide meetings, nursing homes collectively pro-duced the following Relative Improvement Rates. CDC Website is a One-Stop Site for Flu Information:
http://www.cdc.gov/flu/ Everything you need to know is in one place! Immediate Jeopardy Citations Released
meet the needs of its residents, in that protimes During a March 14th meeting with the long term care as- and International Normalized Ratios (PT/INR) sociations, the Indiana State Department of Health re- (measurements of clotting times) for residents leased narrative summaries for six Immediate Jeopardy on Coumadin (blood thinner) were not obtained citations which occurred at five facilities during the month according to physician’s orders for 3 of 3 resi- dents on Coumadin in the total sample of 13, and 2 of 3 residents on Coumadin in the supple- mental sample of 15. This resulted in clotting The facility failed to ensure the heating ventilation times being too long with potential for serious equipment was in proper working order, in that injury, and 1 resident actively bleeding and be- when a resident complained of the lack of heat in ing hospitalized and transfused with fresh fro- his room, the facility staff provided the use of an electric space heater rather than repair the heat- ing unit. The use of the electric space heater pre- sented the potential to cause resident burn/injury The facility failed to initiate cardiopulmonary resuscitation (CPR) for a resident with a signed advance directive that indicated the resident chose to have efforts made to prolong his life. The facility failed to provide care and services for This affected 1 of 1 resident reviewed who had 2 of 7 sampled residents who had significant de- expired at the facility in the sample of 11. The cline in their condition when the resident displayed facility also failed to ensure 5 of 67 residents vomiting, followed by increased respiratory rate currently residing in the facility had physician’s and decreased responsiveness, care and treat- orders which matched their chosen advance ment were not provided in a timely manner, result- ing in the resident’s delayed transfer to the hospi- tal and death. And, when another resident dis- Bed Rail Entrapment (From the ISDH
played increased unrelieved pain in the leg after a Newsletter)
fall and the facility received an X-ray report show- There recently was a tragic death of a resident in an ing a fracture, the resident was not assessed and Indiana nursing home involving bed rail entrapment. Facilities need to be checking the bed rails being used for residents. Please be especially observant of the rails on any of the beds in the facility that have more The facility failed to follow their established poli- than 4 3/4 inches between the bars. Please review the cies and procedures for Wander Guard placement guidance provided from CMS on F323 and from the which resulted in an elopement from the secured FDA website for information about entrapment in hos- dementia unit by a cognitively impaired resident with a known history of elopement risks. This elopement occurred as a result of the nursing staff’s failure to replace a Wander Guard bracelet. The resident was returned to the facility by the police. The facility failed to provide adequate monitoring for residents on Coumadin (blood thinner), in that they failed to monitor protimes and international normalized ratios (PT/INR) (measurement of clot- ting times), for 3 of 3 sampled residents on Coumadin, in the sample of 13, and 2 of 3 supple- Regardless of the purpose for use, bed rails (also re- mental sample residents on Coumadin in the sup- ferred to as "side rails," "bed side rails," and "safety plemental sample of 15, as ordered by the physi- rails") and other bed accessories (e.g., transfer bar, cian, and ensure abnormal PT/INRs were reported bed enclosures), while assisting with transfer and posi- to the physician and acted upon, This resulted in tioning, can increase resident safety risk. Bed rails clotting times being too long with potential for seri- include rails of various sizes (e.g., full length rails, half ous injury, and 1 of the sampled residents on rails, quarter rails) that may be positioned in various Coumadin actively bleeding and being hospital- locations on the bed. In 1995, the FDA issued a Safety ized and transfused with fresh frozen plasma to Alert entitled "Entrapment Hazards with Hospital Bed Residents most at risk for entrapment are those who The facility failed to obtain laboratory services to are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain, uncontrolled body move- 120 mm (4 3/4 inches), representing head breadth. ment, hypoxia, fecal impaction, acute urinary retention, etc. that ISDH Addresses QMA Inservice Verification
may cause them to move about the bed or try to exit from the bed. All qualified medication aides (QMAs) must submit the "Qualified The timeliness of toileting, appropriateness of positioning, and Medication Aide Record of Annual Inservice Training" form as other care-related activities can contribute to the risk of entrap- part of their certification renewal process. Each form is reviewed for both the required inservice education topics and mandatory six hours. During the review process additional information may Entrapment may occur when a resident is caught between the be needed to clarify the inservice information. mattress and bed rail or in the bed rail itself. Technical issues, The ISDH has discovered a few cases where the information such as the proper sizing of mattresses, fit and integrity of bed submitted on the inservice form was falsified. This includes situ- rails or other design elements (e.g., wide spaces between bars in ations such as the QMA did not attend the inservice or the in- the bed rails) can also affect the risk of resident entrapment. structor's signature was not the instructor's actual signature. US Dept. of Health and Human Services, Food and Drug Admin- istration (August 23 1995). FDA Safety Alert: Entrapment Haz- If there is some question about the information on the form, the ISDH will initiate an investigation. The ISDH takes falsification of records very seriously and will take enforcement action if records US Dept. of Health and Human Services, Food and Drug Admin- are falsified. If falsification of found, the QMA's certification will istration, Hospital Bed Safety Workgroup. (April 2003), Clinical be revoked. If the QMA is also a CNA that certification will also Guidance for the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings. Retrieved November 11, 2005 from http://www.fda.gov/cdrh/beds/. State Releases New Guidance on CPR
For some time the Indiana Department of Health has been Dimensional Limits for Identified Entrapment Zones 1-4 pressed to review the practice of citing facilities, often with Imme- [The following is an excerpt from the Hospital Bed System Dimen- diate Jeopardy, for failing to perform CPR on an individual who sional and Assessment Guidance to Reduce Entrapment - Guid- has expired and for whom CPR would be futile and inappropri- ance for Industry and FDA Staff (Issued March 10, 2006)] ate. There may be times when a resident expires unexpectedly during his or her sleep and is not discovered until a period of FDA is recommending dimensional limits for zones 1 through 4 at time after death. Cardio-Pulmonary Resuscitation is an aggres- this time because we believe the majority of the entrapments re- sive medical procedure that should not be employed when there ported to FDA have occurred in these zones. We based these is no possibility of recovering a life. Under this guidance, the fa- recommended limits upon the body parts entrapped in these indi- cility must develop a policy, which is approved by the medical vidual zones identified through adverse event reports and entrap- director, to guide staff on when an exception to CPR would be ment scenarios described in the reports. A summary table (Table 3) of the hospital bed dimensional limit recommendations appears If the facility does not have a policy and the resident does not have a DNR order, then the surveyor will expect CPR to be per- The Hospital Bed Safety Workgroup developed and validated test formed until CPR is deemed not necessary by the physician. methods to measure and assess gaps or openings in zones 1-4 of hospital bed systems, reprinted in Appendix F. As a member of Subsequently, ISDH was asked to clarify whether this policy ap- the Hospital Bed Safety Workgroup, the Federal Drug Administra- plies to licensed residential care facilities. tion (FDA) participated in the development and validation of these test methods. FDA recommends these test methods as an ac- The CPR policy is based on an appropriate facility policy for im- ceptable approach for assessing hospital bed gap sizes in accord- plementing CPR. The basis of a facility policy would be an appro- ance with the dimensional limitations described below. The test priate assessment of the resident. A physician or nursing assess- methods and tool used to conduct these tests are available ment would be expected as part of the facility policy criteria in through the Hospital Bed Safety Workgroup (see Appendix B). If an alternate approach is used to assess gap sizes, FDA recom- mends that the dimensional limits used in any alternative ap- The concern of ISDH was whether the residential care facility proach be at least as stringent as the ones described below. would have the necessary physician or nursing staff present at the facility needed to perform the assessment. Residential care Zone 1 is any open space within the perimeter of the rail. Open- facilities are not necessarily required to have nursing staff on site ings in the rail should be small enough to prevent the head from at all times [410 IAC 16.2-5-1.4(b)]. If the residential care facility entering. A loosened bar or rail can change the size of the space. does not have nursing staff on site, there will not be a qualified The Hospital Bed Safety Workgroup and International Electrotech- individual to assess the resident pursuant to the policy. In that nical Commission (IEC) recommend that the space be less than case the facility is likely obligated to initiate CPR unless there is a do not resuscitate order. If there is a nurse on site who can make the necessary assessment and the facility has a CPR poli- Becky Bartle’s next Quarterly Compliance Update is on cy, the ISDH CPR policy would be applicable to residential care Look for the brochure included with this newsletter. Sommer Barnard Attorneys
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CLOZARIL: Starting a Patient 1. Call the CLOZARIL National Registry (CNR) to obtain a rechallenge number and to confirm that you and your pharmacy are registered. 2 . Obtain a baseline WBC with ANC from patient. If within normal limits, WBC ≥ 3500/ mm3, ANC ≥ 2000/ mm3, prescribe CLOZARIL tablets. 3. Submit WBC and ANC information to the registered pharmacy. 4. Please be pre

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