In a new analysis of nursing homes, it’s been alleged that the quality of nursing home care and staffing has actually increased between 2009 and 2011, with most of their star ratings from CMS improving. Some homes saw a lower rating.  The number of one-star ratings has decreased and the number of four and five-star ratings increased. Star ratings are based on iinformation provided by the facility on health inspections, staffing, and quality measures.  Quality scores fluctuated the most within the 3 year study, and staffing scores maintained the most consistency. Check out the complete report with nursing statistics and more information here. This study is only as reliable as the information provided by the facilities.  They have figured out ways to manipulate the numbers and cover up incidents so their ratings increase.

See article at McKnight’s.

CMS Issues Sunshine Rule
By Joyce Frieden, News Editor, MedPage Today
Published: February 01, 2013

The Centers for Medicare and Medicaid Services issued a long-awaited rule Friday finalizing the details for a database that will list payments made to physicians by pharmaceutical and device manufacturers.

You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” Peter Budetti, MD, the agency’s deputy administrator for program integrity, said in a statement. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, “finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS,” the statement explained. “CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.”

Data collection will start on Aug. 1, CMS said, noting that “Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014 and CMS will release the data on a public website by Sept. 30, 2014. CMS is developing an electronic system to facilitate the reporting process.”

The rule “is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers,” the statement continued.

1.The event meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education, the American Dental Association’s Continuing Education Recognition Program, the American Academy of Family Physicians, the American Medical Association, or the American Osteopathic Association

2.The drug or device company doesn’t directly pay the speaker

3.The drug or device company doesn’t select speakers for the event or “provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program”

“We believe this reporting strategy appropriately separates accredited and certified continuing education from unaccredited and noncertified continuing education, so that consumers can better understand the nature of the payment received by a covered recipient,” the agency noted in the rule. “We also believe that educational speaking engagements should be separated from all other speaking engagements, promotional or otherwise.”

The American Medical Association responded cautiously to the release of the final rule. “The AMA will carefully review the new Physician Payment Sunshine Act rule,” AMA President Jeremy Lazarus, MD, said in a statement. “Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients … As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process.”

Others were more effusive. “This rule allows a long-delayed transparency measure to take effect,” Allan Coukell, director of medical programs at The Pew Charitable Trusts, said in a statement. “Public reporting of the financial relationships between doctors and drug or medical device companies will protect patients and help restore trust in our healthcare system. We applaud the Centers for Medicare and Medicaid Services for issuing the Sunshine regulation, which will now allow manufacturers to comply with their reporting obligations under the law.”

The CMS action comes after complaints by physicians and others that the agency was taking too long to issue the rule.

“We applauded its passage but, nearly 3 years later, we are disappointed that the [Sunshine Act] has yet to be implemented — especially in light of reports that the final rules are being held up at the White House Office of Management and Budget,” a group of prominent physicians, including former New England Journal of Medicine editors Marcia Angell, MD, and Jerome Kassirer, MD, wrote in a January letter to outgoing White House Chief of Staff Jack Lew.

“Financial relationships between physicians and drug and medical device companies can create conflicts of interest that threaten the quality of patient care and drive up healthcare costs,” the letter continued. “As our nation struggles with these problems, it is imperative that the administration implement the [Sunshine Act] without any further delay.”

The rule is scheduled for publication in the Federal Register on Feb. 8.

 

We wanted to share American Association for Justice’s comments to Center for Medicare Services (CMS), on the potential review of 42 CFR 483 Subpart B.   If the Agency is going to change  regulations affecting the quality of health care in nursing homes, they should be focusing on patient safety and increased accountability through such things as eliminating arbitration clauses and eliminating over medication problems better know as chemical restraints.

 

CMS has come out with a new paper stating that extensive research finds that the type of nursing home ownership and sponsorship affects the quality of care that facilities provide to their residents.  "Extensive research finds that the type of nursing home ownership and sponsorship affects the quality of care that facilities provide to their residents."   PDF is attached.

Excerpts from the report are below:

Both "impressionistic evidence" and empirical research documented differences in
quality related to ownership. For-profit and chain-operated nursing facilities tended to devote fewer resources to direct patient care, resulting in poorer quality of care for residents. 

Quality of care is now frequently evaluated across three domains. The three domains, first identified by A. Donabedian, are: structure (resources used to provide care; e.g., staffing); process (actions used to provide care; e.g., restraints); and outcomes (end results for patients; may be bad
outcomes, e.g., pressure ulcers, or good outcomes). Consistently, research in the quality of
nursing home care since the IoM report has reported that not-for-profit nursing facilities have higher nurse staffing levels and fewer health care deficiencies than their for-profit counterparts. For-profit facilities, particularly those owned by multistate chains, are more likely to reduce spending on care for residents and to divert spending to profits and corporate overhead
.

In 2011, the first-ever analysis of the ten largest for-profit nursing home chains reported that
between 2003 and 2008, compared to all other ownership groups, facilities owned by the top ten
for-profit chains had:
The lowest staffing levels;
The highest number of deficiencies identified by public regulatory agencies; and
The highest number of deficiencies causing harm or jeopardy to residents.

The Government Accountability Office (GAO) reported in 2011 that nursing facilities acquired
between 2004 and 2007 by the top ten private equity firms:
Had more total deficiencies than not-for-profit facilities;
Reported lower total nurse staffing ratios; and
Showed capital-related cost increases and higher profit margins, compared to other
facilities.

In 2010, the GAO reported that compared to other nursing facilities, Special Focus Facilities
(i.e., those identified by CMS as among the poorest performing facilities nationwide):
Are more likely to be part of a chain and for-profit, compared to other facilities;
Have fewer registered nurses per resident day; and
Are ranked lower on CMS’s Five-Star System.

The GAO reported in 2009 that compared to other nursing facilities, Special Focus Facilities,
which have more deficiencies and more serious deficiencies than other facilities, are:
More likely to be for-profit;
More likely to be part of chain; and
Have almost 24% fewer RNs/resident/day and fewer nursing staff at all levels/resident/day.

In September 2007, an investigative report in The New York Times found that:
Nursing facilities owned by private equity firms were 41% more profitable than other nursing
homes;
One facility it focused on, in the year after its takeover by a private equity firm, cut the
number of registered nurses in half and cut spending on nursing supplies, activities for
residents, and other supplies, leading to poorer resident care.

A recent study by LeadingAge New York, the association that represents not-for-profit nursing
facilities in New York State, found that not-for-profit facilities:
Performed better on most measures than for-profit facilities in the state;
Had fewer residents using antipsychotic drugs or with physical restraints;
Had lower hospitalization rates, and more discharges to home;
Had more nursing staff and fewer survey deficiencies and spent more money per day on
nursing costs and food.

A review and meta-analysis of 82 studies comparing quality of care in for-profit and not-for-profit
nursing facilities reported that nearly all the studies found higher quality, higher staffing, and fewer
pressure sores in not-for-profit facilities. Not-for-profit facilities had better outcomes on four
key measures of quality:
"More or higher quality staffing;"
Lower prevalence of pressure ulcers;
Lower prevalence of restraints; and
Fewer government-cited deficiencies.

The authors estimated that if all nursing homes in the United States were operated on a not-forprofit basis:
7,000 residents with pressure sores would not have them;
Residents would receive 500,000 more hours of nursing care each day.

McKnight’s had an article about thenew GAO Report showing that The Centers for Medicare & Medicaid Services need to make serious improvements in the tools it uses to evaluate the quality of nursing home care.  The Government Accountability Office conducted an investigation to determine whether CMS was doing an adequate job in monitoring implementation of the Quality Indicator Survey process. The GAO found that CMS has not established quality measures or performance goals to evaluate if QIS objectives are being met.

Both the GAO and the Department of Health and Human Services recommended that CMS “routinely monitor the extent to which progress is being made in meeting the objectives of the QIS and systematic methods for monitoring and facilitating states’ efforts to implement the QIS.”

 

Helping You Care is a great website with some great resources.  Recently they discussed the changes to CMS’ Nursing Home Compare website. 

"The current nursing home quality measures of the Compare tool will be replaced with new quality measures based upon a new version of nursing home resident assessments, starting in 2012.  The new measure will include input from the residents.  As part of the transition to new quality measures, the 5 Star Quality Rating that the tool has provided will not include the new measurement until April 2012. Starting in April 2012, findings of the new assessment measures will be part of the 5 Star Quality Ratings."

Some of the other measures of nursing home quality that have been included in the Nursing Home Compare tool include staffing data and data from health inspections.   As explained in a recent article, “Navigating the Health Care System,” by Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality (AHRQ), also part of HHS:

“Staffing and health inspection data add important information and will continue to be a factor in each nursing home’s overall rating. The staffing measure tells you the average staffing levels—such as the number of registered nurses, licensed practical nurses, and certified nursing assistants—for each resident each day. This is a good benchmark, but it has limits. It does not show the number of nursing staff present at any given time or describe the amount of care give to any one resident. The health inspection measure looks at many major aspects of care in a nursing home. This includes how medicines are managed, whether food is prepared safely, and whether residents are protected from inadequate care. Inspections take place about once a year, but they may be done more often if the nursing home has several problems to correct. ”
 

Diane Derby at WSPA did a 7 On Your Side Investigation called State of Care that reported the problems that families like the Sextons have with Magnolia Manor-Inman.   Dorothy Sexton was a resident at Magnolia Manor-Inman, a nursing home owned and operated by Sparks, Maryland based Fundamental Long Term Care Holdings, L.L.C.

Sexton’s family who visited often complained about the neglect but the administrator, Dale Lyles, ignored their pleas for help.  "All Dale will ever tell you is he’s looking into it," said Sexton. Some of the issues include giving the resident the wrong medication, not responding to call bells, and allowing her to sit in a dirty diaper for hours without help.

Pam Dukes is DHEC’s Deputy Commissioner of Health Regulation and admitted that due to numerous complaints DHEC has inspected Magnolia Manor in Inman three times this year.  Dukes claimed DHEC would be making at least four mandatory unannounced visits each year, instead of once every two years to more than 480 facilities statewide.  DHEC will limit the focus of inspections to issues involving quality of care.  Dukes told WSAP there still is a way to check out many facilities online. (Click here to check out a facility)   The ratings are based on health inspections for topics like proper management of medications or protecting residents from abuse, staffing, and quality measures like how well the nursing home prevents and treats skin ulcers.

Magnolia Manor in Inman received 1 out of 5 stars on it’s overall rating from Medicare. The Medicare website says the total number of health deficiencies for this facility is 15. In South Carolina the average is six.

Click here to make a FOIA request.   To file a complaint against a nursing home or assisted living facility contact your local Long Term Care Ombudsman’s office. Click here to locate one in your area. You can also file a complaint with SC DHEC by clicking here.

 

Nursing homes are required to properly assess residents.  A big part of that ongoing assessment is documentation.  The latest version of the Minimum Data Set is very detailed.   The form has to be filled out upon admission and periodically during the resident’s stay, and again upon the resident’s discharge. This has added to the workload of overstressed and underpaid staff at the typical nursing home but it is essential for quality care. 

The questionnaire requires several hours to fill out, in part because it requires nurses to interview residents at length. Medicare use the questionnaire to set reimbursements to nursing home operators, and state regulators use it to check on the facility’s quality of care.

One of the authors of the form was surprised to discover how little experience even the best staff members had in probing the patients’ needs one-to-one.

"It was very revealing to me that they weren’t doing the interviews because of the time pressures that are currently in nursing homes to get the meds passed and the vital signs checked, that the kind of fundamental assessment that needs to be done was getting short shrift."

The Centers for Medicare and Medicaid Services offered training materials including videos demonstrating patient-interviewing techniques for sections in the questionnaire such as mood, cognition, pain, preferences.  Turnover among residents is much greater now than it was when the first questionnaire was developed more than a decade ago.

See L.A. Times article here.

Measures for Public Reporting and Quality Improvement to be Used in Nursing Home Compare

To improve the quality of care in nursing homes for the 1.4 million Americans who currently reside in facilities across the country, the National Quality Forum (NQF) has endorsed 21 measures to be used to care for both long-term residents and short-stay patients. The NQF-endorsed measures will be used in the Centers for Medicare & Medicaid Services’ Nursing Home Compare, an online database for consumers to compare the care provided in more than 17,000 nursing homes across the country.

In 2004, NQF endorsed an initial set of measures for publicly reporting care in nursing homes. With the completion of the current project, the 17 measures that were previously endorsed will be retired and, in some instances, replaced by the newly endorsed measures. These measures were recently retired in the transition to CMS’ updated data collection instrument, the Minimum Data Set 3.0 (MDS 3.0).

“Choosing where to go for long- or short-term care in a nursing home is an incredibly important decision,” said Janet Corrigan, NQF president and CEO. “Patients and their families need reliable information on the quality of care being provided in skilled nursing facilities so they can make informed decisions about the place they will receive care on a daily basis. The quality data derived from these measures will provide important information about infection rates, patient care experiences, and the general health of residents in nursing homes across the country.”

The 21 NQF-endorsed nursing home measures assess patient outcomes and the patient’s own experience of care for both long-term residents and short-stay patients. The measures address falls, infections, pressure ulcers, and the general health of residents and patients. Examples of endorsed measures include:

• percentage of patients who received influenza and pneumococcal vaccinations;
• percentage of residents with urinary tract infections;
• percentage of residents who need increased help with activities of daily living; and
• patient experience of care surveys for both long-term residents and short-stay patients.

NQF’s Steering Committee on Nursing Homes was co-chaired by David Gifford, MD, MPH, Director, Rhode Island Department of Health, and Christine Mueller, PhD, RN, FAAN, Associate Professor and Chair, University of Minnesota School of Nursing.

“These measures will help consumers better understand and compare quality of care when selecting nursing homes and will help them to monitor care once they or a family member is in a nursing home,” said Dr. Gifford. “Nursing homes can also use these measures to benchmark how they are doing compared to others in addressing important nursing home quality of care issues.”

NQF is a voluntary consensus standards-setting organization. Any party may request reconsideration of the 21 endorsed recommendations, in whole or in part, by notifying NQF in writing no later than April 1, 2011. (To access the appeals form, go to the Nursing Homes project page, then go to the section on appeals and click on the link to the standards directory.) For an appeal to be considered, the notification must include information clearly demonstrating the appellant has interests that are directly and materially affected by the NQF-endorsed recommendations and that the NQF decision has had (or will have) an adverse effect on those interests.

Endorsed Measures

• Physical therapy or nursing rehabilitation/restorative care for long-stay patients with new balance problem (RAND)
• Percent of residents experiencing one or more falls with major injury (long stay) (CMS)
• The percentage of residents on a scheduled pain medication regimen on admission who report a decrease in pain intensity or frequency (short stay) (CMS)
• Percent of residents who self-report moderate to severe pain (short stay) (CMS)
• Percent of residents who self-report moderate to severe pain (long stay) (CMS)
• Percent of residents with pressure ulcers that are new or worsened (short stay) (CMS)
• Percent of high-risk residents with pressure ulcers (long stay) (CMS)
• Percent of residents assessed and appropriately given the seasonal influenza vaccine during the flu season (short stay) (CMS)
• Percent of residents assessed and appropriately given the seasonal influenza vaccine (long stay) (CMS)
• Percent of residents assessed and appropriately given the pneumococcal vaccine (short stay) (CMS)
• Percent of residents assessed and appropriately given the pneumococcal vaccine (long stay) (CMS)
• Percent of residents with a urinary tract infection (long stay) (CMS)
• Percent of low-risk residents who lose control of their bowels or bladder (long stay) (CMS)
• Percent of residents who have/had a catheter inserted and left in their bladder (long stay) (CMS)
• Percent of residents who were physically restrained (long stay) (CMS)
• Percent of residents whose need for help with activities of daily living has increased (long stay) (CMS)
• Percent of residents who lose too much weight (long stay) (CMS)
• Percent of residents who have depressive symptoms (long stay) (CMS)
• Consumer Assessment of Health Providers and Systems (CAHPS®) Nursing Home Survey: Discharged Resident Instrument (ARHQ)
• Consumer Assessment of Health Providers and Systems (CAHPS®) Nursing Home Survey: Long-Stay Resident Instrument (ARHQ)
• Consumer Assessment of Health Providers and Systems (CAHPS®) Nursing Home Survey: Family Member Instrument (ARHQ)

The National Quality Forum (NQF) operates under a three-part mission to improve the quality of American healthcare by:
• building consensus on national priorities and goals for performance improvement and working in partnership to achieve them;
• endorsing national consensus standards for measuring and publicly reporting on performance; and
• promoting the attainment of national goals through education and outreach programs.

Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison.