June 2009

AMDA Board Member Visits Capitol Hill

On June 23, 2009, AMDA Board member Jonathan Evans, MD, CMD, visited Capitol Hill as a part of the Eldercare Workforce Alliance (EWA) Hill Day. Dr. Evans urged Congressional staff to pass measures increasing the federal match for all home and community-based services funded under Medicaid, expanding funding for Title VII, extending the federal minimum wage and overtime protection, providing loan forgiveness for geriatric training, supporting care coordination services under Medicare and Medicaid, and providing training and support for direct care workers and family caregivers.  

Dr. Evans and other representatives of the EWA pushed for three pieces of legislation to be included in health care reform: The Retooling the Health Care Workforce for an Aging America Act, The Caring for an Aging America Act, and The Geriatrics Loan Forgiveness Act. Dr. Evans visited with Sarah Dash, the health legislative assistant of Representative Rosa DeLauro (D-CA), sponsor of The Geriatrics Loan Forgiveness Act. “Representative De Lauro’s office is very sympathetic to workforce issues and voiced a broad understanding,” said Dr. Evans.

In addition, Dr. Evans met with Senator Patty Murray (D-WA)’s Labor Legislative Assistant Stephanie Arnold and Senator Robert Casey’s (D-PA) Legislative Aide Gillian Mueller. Senator Murray is chair of the Committee on Health, Education, Labor & Pensions’ Employment and Workplace Safety Subcommittee. Senator Casey is a member of the Senate Special Committee on Aging as well as the Health, Education, Labor and Pensions Committee.

Dr. Evans added, “The big take home message from the day was that we all need to get out there and help raise awareness to workforce issues. Contact your elected officials and let them know eldercare is important to you and your residents.”

The day also included a EWA-sponsored Congressional call-in as well as running an advertisement urging Congress to support workforce issues in the Congressional newspaper Roll Call. Click here to view the ad: http://www.amda.com/advocacy/legal/EWARollCallAdFINAL.pdf

To: AMDA Members Attending the AMA House of Delegate Meetings (Annual and/or Interim)

Given AMDA’s success at the June 2009 American Medical Association’s (AMA) House of Delegates (HoD) meeting with the "Nurse as Agent" resolution presented at Reference Committee B by Eric Tangalos (AMDA delegate) , we are compiling a list of regular attendees. We would like to use the list to share information relevant to long-term care and as well provide a 'heads-up" regarding our own policy issues.

If you are a delegate, alternate delegate or member of a state society or specialty organization and attend the AMA HoD meetings and would like to be included in communications, please send your name, which delegation you represent and your email address to Kathleen Wilson, PhD, at kwilson@amda.com.

Medicare Transitions Bill Introduced

Earlier this month, Oregon Representative Earl Blumenauer (D-OR) and Louisiana Representative Charles Boustany, Jr., MD (R-LA) introduced The Medicare Transitional Care Act of 2009 (H.R. 2773). Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) have introduced a companion bill in the Senate (S. 1295). The bill seeks to address continuity of care problems by providing more support to patients through comprehensive assessments prior to a hospital discharge, including an assessment of the individual’s physical and mental condition, cognitive and functional capacities, medication regimen and adherence, social and environmental needs, and primary caregiver needs and resources. It is hoped that the assessments would reduce the number of unnecessary re-hospitalizations.

The bill also would create a new benefit under Medicare designed to support and coordinate care for beneficiaries as they move from a hospital setting to their homes, skilled nursing facilities, or rehabilitation centers. Other transitional services include a visit to the care setting within 24 hours after the hospital discharge along with a home visit to help implement the plan of care.

"Unnecessary re-hospitalization is costly for our government and troublesome for our seniors. But it's also avoidable, and this legislation will help make sure the transition from hospital to home care is managed appropriately, which would improve the quality of care for our seniors and reduce our nation's health care costs," said Senator Jeanne Shaheen in a press release.

The legislation is modeled after the Transitional Care Model developed by the University of Pennsylvania, which has shown to produce significant health outcome improvements for patients, as well as reduce health care costs for chronically older ill adults. The bill has 5 co-sponsors and is supported by the AARP.

Scam Alert: CMS has become aware of a scam targeting physician offices

The Centers for Medicare & Medicaid Services (CMS) has become aware of a scam where perpetrators are sending faxes to physician offices posing as the Medicare carrier or Medicare Administrative Contractor (MAC). The fax instructs physician staff to respond to a questionnaire to provide an account information update within 48 hours in order to prevent a gap in Medicare payments. The fax may have the CMS logo and/or the contractor logo to enhance the appearance of authenticity.

Medicare FFS providers, including physicians, non-physician practitioners, should be wary of this type of request. If you receive a request for information in the manner described above, please check with your contractor before submitting any information. Medicare providers should only send information to a Medicare contractor using the address found in the download section of the CMS.gov website found at http://www.cms.hhs.gov/MLNGenInfo/ or http://www.cms.hhs.gov/MedicareProviderSupEnroll.

Long Term Care Legislation

A new bill, the Geriatric Loan Forgiveness Act, was introduced this session by Representative Rosa DeLauro (D-CT). The bill allows certain geriatric health training to be included as a year of obligated service to the National Health Service Corps Loan Repayment Program. Obligated service requires participating physicians, nurse practitioners, physician assistants, and other qualifying mental health providers to serve two years at an approved site in a Health Professional Shortage area. The repayment program currently forgives up to $50,000 in exchange for the two years. Once the participating individual completes the first year of obligated service through geriatric training they must provide geriatric health services during their second year of service.

The bill aims to address the national shortage of geriatric specialists by allowing geriatric training to count toward the obligated service years. In a press release on the bill, Representative DeLauro said, “There are currently fewer than 9,000 geriatric physicians practicing in the United States, far below the 36,000 or more needed to effectively care for the nation's booming population of seniors by 2030. The numbers are similar across health care disciplines, including nursing, social work, psychology, pharmacy and psychiatry.”

The bill is supported by AMDA and the Eldercare Workforce Alliance. AMDA is a member of the 28-member Alliance, which was established to advance the recommendations of the Institute of Medicine’s report, “Retooling for an Aging America: Building the Healthcare Workforce”. Other members include AARP, American Geriatrics Society, and American Society of Consultant Pharmacists.

Also introduced was the Patient Safety and Abuse Prevention Act sponsored by Senators Herb Kohl (D-WI) and Susan Collins (R-MA). This bill, which has been introduced in previous sessions, establishes a program to identify efficient, effective, and economical procedures for long-term care facilities or providers to conduct background checks on prospective direct patient access employees on a nationwide database. AMDA supports criminal background checks for nonlicensed health care workers. In cases where a licensing board does not already inquire regarding an individual’s criminal background, those individuals also should be subject to checks.

Some bills that have sparked debated in the past also were reintroduced including the Fairness in Nursing Home Arbitration Act. The bill, introduced by Senator Mel Martinez (R-FL) and Representative Linda Sanchez (D-CA) establishes that a pre-dispute arbitration agreement between a long-term care facility and a resident (or anyone acting on the resident's behalf) shall not be valid or specifically enforceable. Consumer organizations support the legislation.

Moreover, a bill aimed at having greater transparency in nursing homes was reintroduced. The Nursing Home Transparency and Improvement Act of 2009, which was introduced by Senators Herb Kohl (D-WI and Charles Grassley (R-IA), would require nursing homes to divulge information on direct and indirect owners, as well as anyone who takes part in management, administration, facility leasing or governance, and lender of $50,000 or more. “Improving the quality of care in nursing homes is a constant challenge. More transparency, better enforcement and improved staff training are needed, and this legislation works to make changes in those areas and improve the quality of life of nursing home residents and to empower the family members and loved ones of those residents,” Grassley said in a statement.

AMDA continues to monitor legislation affecting long term care. To see these and other bills AMDA is monitoring visit: http://www.amda.com/advocacy/legal/factsheet_111.cfm.

AMDA Delegate Eric Tangalos Reports In from the AMA House of Delegates

The American Medical Association’s meeting was dominated by the address of President Barack Obama on June 15, 2009.  This was an all-day event and the first time a president has addressed the House of Delegates (HOD) since President Ronald Reagan in 1983.  By the time you read this report, both the Senate and the House of Representatives will have presented their health care reform proposals.  Stay tuned to the government option to compete with private insurance.

On June 16, AMDA had one resolution before the HOD and the “Nurse as Agent” went through with flying colors.  I was able to reassure the reference committee that AMDA’s resolution had nothing to do with any extension of scope of practice (a very sensitive topic) and made the analogy that we wanted nurses in long term care facilities to be able to do the same thing with verbal orders for narcotics as we do in the hospital.  I further explained that the difficulty many of our members have recently experienced reconfirming narcotic orders already given.  I described the additional steps with pharmacists, faxes, and phone calls that have long been required by the US Drug Enforcement Agency, but only recently enforced.

The reference committee eliminated one word in our proposal (“facility” was redundant) and the resolution went to the consent calendar and was passed.  The American Academy of Family Physicians and the Great Lakes Caucus spoke up to support the resolution.  It is now AMA policy “That our American Medical Association urge the US Drug Enforcement Agency to amend its regulations to recognize nursing staff as agents of the prescriber/physician in long term care facilities.”  As it now stands if a patient were to need a controlled substance for acute or escalating pain, the current regulations require one of two actions before a controlled substance is dispensed from the pharmacy; (1) the nurse phones the verbal order to the pharmacist, who transcribes the order into a formal prescription, which is then faxed to the physician, who signs it and then faxes it back to the pharmacist, (2) the physician gives the verbal order to guide the nursing care and then creates a new prescription and faxes it to the pharmacist.

The issue of the three-day stay eligibility requirement also came up yet again.  I testified in support of eliminating this means test for nursing home skilled admission and reminded the reference committee that it was AMDA that first brought up this issue in the early 1990s.  This rule has become more impractical and less meaningful with each passing year.  I also asked that it would be nice to see the policy eliminated before I personally have to confront the necessity of a three-day stay for my own nursing home admission!

AMDA has one seat at the AMA House of Delegates.  For AMDA/AMA members, it is important to designate AMDA as representing your interests each time you renew your AMA membership.  In these difficult times, it is important to continue to have AMDA presence known and our policy interests supported by the “House of Medicine”.

Respectfully submitted,

Eric Tangalos, MD, CMD, AGSF, FACP
AMDA Delegate to AMA House of Delegates

PPAC Addresses Value-Based Purchasing and Recovery Audit Contractors

The Practicing Physician Advisory Council (PPAC), an advisory council to the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services (CMS), made a series of recommendations concerning CMS’s Value-Based Purchasing Program at the council’s June 1, 2009 meeting attended by AMDA. Director of the program, Thomas Valuck, MD, JD, Medical Officer and Senior Advisor, Center for Medicare Management, provided an overview of a sample Medicare Resource Use Report that will be sent to physicians across the country. The report, developed as part of Medicare’s new Physician Resource Use Measurement and Reporting Program, provides physicians with confidential information on how the resources used in the care of their Medicare patients compares with that of their peers. The programs’ goal is to ultimately compare the cost of care to the quality of care provided. The hope is that physicians who show high resource use as compared to their peers will either alter their practices to lower costs or have reasons, such as the population they serve, for their high costs.

While PPAC expressed support for the general idea of comparing physician resource use, PPAC members expressed concern about the validity, reliability, and applicability of the report’s data. Specifically, PPAC recommended that CMS present information on the statistical accuracy of the data supplied in the report and provide a description of how this data should be used. In addition, PPAC stated that resources use varies depending on the type of patients a provider sees. Another factor that accounts for the difference in resource use is the expenses of training residents and medical students, rather than poor resource use. PPAC recommended that CMS include risk adjusting physicians’ resource use data for attending physicians in academic medical centers to recognize the risks, benefits, and expenses of training residents and medical students.

Likewise, PPAC urged CMS to compare physicians in the same peer group to provide more useful and valid data. For example, the report currently provides data for all general internists, so a physician who sees patients in the nursing home setting would be compared to other general internists who may see patients in different settings. PPAC recommended that CMS plan to correct the attribution methods to more accurately reflect the physician’s peer group comparison and the physician’s actual contribution to the cost of care attributed to him or her.

Lastly, while CMS reiterated that it has no plans to make these reports public, PPAC recommended that CMS notify physicians at least two years prior to any public release of such data. CMS currently is sending these reports to physicians asking them to volunteer to provide feedback and comment on the report.

Recovery Audit Contractors

CMS has continued to provide outreach about the upcoming Recovery Audit Contractors (RAC) program. The program, made permanent by the 2006 Tax Relief and Health Care Act (§302), will initially review claims data from October 2007 through February 2009. Initial reviews, that will likely begin this month, will be automated reviews (no medical record required) with more complex (medical record required) scheduled for 2010. RACs will review claims on a post-payment basis and will use the same Medicare policies as the local Medicare carriers. CMS will use N432 code on all remittance advice to indicate that the adjustment had been made based on a recovery audit.

PPAC had expressed concern about the RAC program at its previous meetings stating that CMS should consider paying for any physician expenses for providing medical records to the RACs. PPAC recommended that CMS assess the time required of the physician and other providers, the resources involved, and hence, the cost per physician or provider for RAC medical records requests. As a follow up, PPAC recommended that CMS reconsider its decision not to pay physicians for the costs of copying medical records in response to RAC requests.

CMS will continue to provide outreach to communities across United States and provide further updates at subsequent PPAC meetings.

For more information about the RAC program please visit http://www.cms.hhs.gov/RAC/01_Overview.asp#TopOfPage.

The next meeting is scheduled for August 31, 2009 in Washington, DC. For more information on the PPAC please visit http://www.cms.hhs.gov/FACA/03_ppac.asp.

AMDA Meets with FDA on Defining Emergency Situation for Verbal Orders for Class II Medications

On May 22nd, AMDA and other long term care (LTC) stakeholders met with Food and Drug Administration (FDA) agents.  LTC and hospice was represented by AMDA, Gerontological Advanced Practice Nurses Association, American Society of Consultant Pharmacists, National Hospice and Palliative Care Organization, American Health Care Association, and American Association of Homes and Services for the Aging, pharmacy service providers, as well as individual LTC physician representation. Staff and counsel from the FDA divisions of the Center for Drug Evaluation and Research, Division of Anesthesia, Analgesia and Rheumatology Products, and Controlled Substance were in attendance.   

Currently, the only time that a pharmacist can dispense a Class II (CII) drug to a nursing home or hospice patient based upon a verbal order from a prescriber is when there is an "emergency situation." Under the law, the FDA defines an emergency situation - not the DEA.  In other words, the DEA sets the regulation but the FDA defines this terminology. In this case, the DEA has decided to make their interpretation of what that (emergency situation) exactly means. The DEA has deferred this to the FDA. The FDA expressed interest in discussing this issue, so a meeting was set up through Dr. Doug Throckmorton of the FDA. 

Under the DEA regulations, the term emergency situation is defined as:  (1) immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;  (2) no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II, and (3) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing.  In order to qualify for the definition “emergency situation”, all three requirements must be met.

The DEA is interpreting number (1) from above as the time it takes for a resident to receive the drug. Since LTC facilities do not have on-site pharmacies, there is a delay from the time a drug is ordered to the time the drug is delivered. Due to this delay, the DEA is interpreting that drugs can never be “immediately” administered in LTC settings. Therefore, from the DEA’s perspective, an emergency situation is a rare event. The DEA is stating that they feel the emergency situation exception – being able to take a verbal order for the controlled substance – is being abused; pharmacists are being cited for violations because they are responding to verbal orders from the prescriber.  

While, the DEA’s focus is in enforcing the law, the FDA is focused on patient needs and safety. However, the FDA is not as familiar with the patient population in LTC and hospice as is the Centers for Medicare & Medicaid Services (CMS).  They also were unfamiliar with treatment guidelines and standards of practice in LTC and they were not involved in the development or approval of the new CMS survey guidelines (F-Tag 309) and therefore were not aware of how the DEA’s interpretation of “emergency exception” affected the CMS surveyor guidance.  Stakeholders feel that the regulation should be consistent with CMS’ interpretation of what constitutes quality of care with respect to pain management in the LTC setting

The purpose of this meeting was to enlist the FDA as allies in AMDA’s advocacy to dialogue with the DEA and request that the FDA provide the DEA with an interpretation of the ER situation that is firmly driven by patient’s needs, not law enforcement. The following points were stressed in the meeting:

1. Within nursing home and hospice settings, it is fair to say that emergency situations are quite frequent and that they are dictated by patient need.  Patients being served in LTC and hospice have variable and fluctuating care needs.  Standards of practice dictate that these needs must be addressed whenever they occur without delay.
2. Although CMS has developed extensive regulations to address quality of care and timeliness of treatment, there is not an identifiable precedent for defining “emergency situation” based upon the time it takes to deliver drugs to the patient or administer treatment. Rather, all definitions focus on the status of the patient. Further, in developing the survey protocol on medication administration in nursing facilities, CMS considered, but rejected, defining timely administration of medications based upon a specific timetable or number of hours. Notably, CMS recognizes that a delay in acquisition may impede timely administration and adversely affect a resident’s condition but it in no way diminishes the resident’s need for the medication. This would be tantamount to saying that a person experiencing a heart attack did not require emergency services because the ambulance was unavoidably delayed by heavy traffic as it attempted to respond to the 911 call.
3. In the LTC and hospice practice settings, nurses are providing care to patients/residents based upon the orders of the practitioner.  The nurse acts as the agent of the practitioner, communicating care needs and taking orders.  Practitioners, generally, are not on site and many are not practicing in an office where there is ready access to fax machine, when they are verbally ordering a CII medication. In addition, 40% of AMDA physician members do not have an office practice.  Even those with offices are “on the run” most days, going from setting to setting. This means that in most instances, when a new patient is admitted who requires pain medication, or when there is a change in the resident’s condition necessitating an adjustment to pain medications, the practitioner will not be near or have access to a fax machine.
4. The FDA’s interpretation of “emergency situation” should be consistent with CMS’ interpretation of what constitutes quality of care with respect to pain management in the LTC setting.  CMS guidelines on quality of care and standards of practice (treatment guidelines) are designed to ensure the appropriate use of pain medications.  Whether an order is verbal or sent via fax has no impact on whether the drug is being appropriately prescribed.  As defined in F-Tag 309, residents must be given rapid relief of “excruciating pain”. In addition, CMS states, “it is important that the facility recognize and address pain promptly.”
5.  Regardless of length of stay or reason for admission, the majority of nursing home residents and hospice patients experience medical instability, multiple complications, fluctuating conditions, and diverse co-morbidities (coexisting diseases and risk factors). It is important that any requirements related to the prescribing, dispensing and use of medications in nursing homes and hospice relate to these clinical realities (pain management in the nursing home population is fluid, not static). In other words, it is  impossible to anticipate a resident’s fluctuating needs for pain medication or know when their condition will change that requires immediate pain relief. The inability of the practitioner to use a verbal order to authorize the pharmacist to dispense pain can result in significant delays in delivery and administration of pain relief, leaving the patient at risk of experiencing pain or having diminished control over pain and exposing the facility to liability for failure to meet quality of care standards.
6. The LTC and hospice representatives requested of the FDA to ask the DEA the following question. “If the purpose of the DEA ruling is prevent diversion, how does faxing a prescription into a pharmacy versus verbally confirming (and sending in a signed prescription within 7 days of the verbal order) increase the chance of diversion”?
7. A summary of the meeting was sent to the FDA on Friday May 29th.

AMDA along with stakeholders will follow-up with the FDA in the near future to ascertain the results of this meeting.

The Pioneer Network Will Host a Webinar on the New Quality of Life Revisions to LTC

A Webinar Series for Providers

The Centers for Medicare & Medicaid Services (CMS) has recently issued a new survey and certification letter that revises guidance to surveyors for several requirements related to quality of life and environment. As a result, surveys after June 17, 2009 will be conducted with a sharpened focus on elements of quality of life. These revisions were developed from last year's symposium on person-centered living environments, co-sponsored by CMS and Pioneer Network.

The webinar series includes two ninety-minute sessions. The complete series is open to all, and will be offered twice on your choice of dates:

Wednesday, June 10
Session One:Making Choices and Adapting the Physical Environment and
Wednesday, June 17
Session Two: Feeling At Home

Hosted by Evvie Munley Senior Health Policy Analyst for AAHSA

OR

Thursday, June 11
Session One: Making Choices and Adapting the Physical Environment and
Thursday, June 18 
Session Two: Feeling At Home 

Hosted by Lyn Bentley, Director of Regulatory Services for AHCA

AMDA staff is reviewing the revised Tags and will be listening in on the Webinar series. For more information and to register for this Webinar please visit  http://www.pioneernetwork.net/Events/Webinars/LTCGuidance/.

Secretary Sebelius Announces Appointment of Cindy Mann as Director of the Center for Medicaid and State Operations

U. S. Health and Human Services Secretary Kathleen Sebelius today announced the appointment of Cindy Mann to serve as Director of the Center for Medicaid and State Operations (CMSO), part of the Centers for Medicare & Medicaid Services (CMS). Mann most recently served as a research professor and executive director of the Center for Children and Families at Georgetown University's Health Policy Institute.

"Cindy Mann has decades of experience in health care financing at the federal and state level, and vast knowledge of health care policy," said Secretary Sebelius. "She has devoted her career to working on behalf of children and families, the elderly and people with disabilities. She will be an outstanding leader at CMSO, particularly as the nation moves forward with health care reform."

The Survey and Certification Group and Nursing Home Branch are in the CMSO. They oversee the survey and certification of nursing facilities, training of state surveyors, and publication of surveyor guidance.

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