April 22, 2014

Shocking Behavioral Therapy - The Safety and Effectiveness of Using Electric Shock Devices for Behavior Management


  I am including the Comments form The National Disability Rights Network on the safety and effectiveness of electroshock devices as a supposed "treatment" for autism and other developmental disabilities.  Please submit a comment if you have experience with this awful practice.


April 14, 2014  

Avena Russell
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 1535
Silver Spring MD 20993-0002 

Re: Written Testimony for Neurological Devices Panel of the FDA Medical Devices Advisory Committee, Docket No. FDA-2014-N-0238, Schedule for public meeting on April 24, 2014 
Dear Ms. Russell, 

The National Disability Rights Network (NDRN) appreciates having the opportunity to comment in advance of the Neurological Devices Panel of the Medical Devices Advisory Committee meeting later this month to examine the safety and effectiveness of aversive conditioning devices that use a noxious electrical stimulus.  

NDRN is the national membership association for the Protection & Advocacy (P&A) agencies / Client Assistance Programs (CAP) that provide legally-based advocacy services to persons with disabilities in every state, the District of Columbia, and U.S. territories. NDRN promotes a society where people with disabilities have equality of opportunity and are able to participate fully in community life by exercising informed choice and self-determination. For over 30 years, the P&A / CAP Network has been mandated by Congress, to protect the civil rights of individuals with disabilities of any age and in any setting including schools and other types of programs providing education services and supports.  

In January 2009, NDRN documented the horrific abuses of students in our report "School is Not Supposed to Hurt: Investigative Report on Abusive Restraint and Seclusion in Schools”  (http://ndrn.org/sr/SR-Report.pdf). In two subsequent reports, and through the Protection and Advocacy agencies, NDRN continues to hear of stories across the country where children have been injured and in some cases killed as a result of restraint, seclusion and aversive interventions. 

NDRN believes the FDA should ban the use of aversive conditioning devices that are intended to administer noxious electrical stimuli to the body to modify behavior.  

Based on the available research, and the work of the P&A / CAP Network with individuals with all types of disabilities, NDRN believes that the devices are both unsafe and ineffective in meeting their intended purpose. NDRN’s position is supported by the federal government, and other non-governmental organizations, as well as the professional academic literature. From a national perspective, it is important to note the substantial evidence, that is available that shows that evidence-based positive alternatives to behavior modification, such as the use of positive behavioral interventions and supports are safe, and effective for use with students with the most significant behavioral needs.

 Furthermore, NDRN fully supports the testimony submitted by the designated Protection and Advocacy agency in the state of Massachusetts, Disability Law Center, Inc. (DLC). DLC has directly worked with individuals who have been exposed to aversive behavioral interventions, such as the aversive conditioning device used by the Judge Rotenberg Center (JRC) in Massachusetts. DLC’s testimony submitted in response to the same federal register notice clearly articulates the safety issues based on the pain inflicted by the device, the misfirings of the device, and the long-term traumatic effects.  

The only school known to use an aversive conditioning device that delivers a noxious electrical stimulus, is the device called the Graduated Electronic Decelerator (GED) used with students at the Judge Rotenberg Center (JRC) in Massachusetts. While NDRN recognizes that the focus of the FDA is on all devices, it is important to note that JRC is the only known entity known to use such a device. As stated in DLC’s testimony, the device was both developed by and is manufactured by JRC.[1] As discussed in the written testimony of DLC, at any given time, residents may be wearing up to five GEDs simultaneously, so JRC residents are unaware of when, where, why and how many times they will be shocked. Furthermore, the GED has undergone many changes, and the current device used at JRC is unapproved despite JRC representing the GED was approved and warnings from the FDA to seek either clearance or approval of the devices. 

As a national organization whose members provide legally-based advocacy services to persons with disabilities across the United States, NDRN believes it is critical that the Panel both review the expertise of medical and industry professionals on safety and effectiveness but also take into account the lived experience of students who have been subjected to the use of aversive conditioning devices, such as the GED, and the experience of former teachers who have administered the electric stimuli. DLC’s testimony chronicles the physical harm to one student:

 

…the burns and scars from being repeatedly shocked on her stomach. Electrodes had actually burned into her skin, and she experienced long-term loss of sensation, and numbness in the lower left leg after being shocked there. She describes feeling “searing pain all the way down to the bottom of her foot” and how she was “left with no feeling in her skin from the knee down for a year.” When electrodes were accidentally placed on students’ spines, she witnessed others being violently bent backwards.”

 
Also, the Panel should take into serious account the video shown in the courtroom of Andre McCollins, a JRC resident from New York who was shocked 31 times, using the weaker GED, for failure to take off his coat. The video is available at http://www.myfoxboston.com/story/17409093/graphic-video-of-teen-being-restrained-shocked-played-in-court. As the video clearly demonstrates, the use of restraints and the aversive


[1] BRI News, Winter 1991, Behavioral Research Institute, RI. (Note: The Behavioral Research Institute (BRI) changed its name to the Judge Rotenberg Center (“JRC”) in 1994.  JRC is designated by the FDA as the manufacturer of the GED.  See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=147131&lpcd=HCB.  JRC/BRI refers to itself as the manufacturer of the GED. See “A Comparison of Long Term Decelerative Effects”, JRC Pub. No. 93-2, available at http://www.effectivetreatment.org/comp.html, noting (at p. 3) that it manufactured 100 GED units from 12/90 and 3/93.  DLC maintains that JRC engages in interstate commerce through the manufacturing process, and through the movement of students across interstate lines to attend JRC, and the use of the GED across state lines, when students are off-site.  See Barnes v. U.S., 142 F. 2d 648, 651 (9th Cir. 1944) (“Commerce so used in the statute is not confined in meaning to the actual transportation of articles across state lines, but includes the whole transaction of which such transporting is a part.”) (citations omitted).  JRC previously maintained that it was exempt from FDA jurisdiction as engaging in the “practice of medicine,” it is no longer asserting this argument or contesting FDA jurisdiction.

February 20, 2014

Community Supported Employment - H476


For Most of the twentieth century it was assumed that people with significant developmental disabilities could not be employed in regular jobs at reasonable wages. In recent decades, we have demonstrated that people with developmental disabilities can be productive and valuable employees if they have specialized training and workplace supports. Community Supported Employment (CSE) services are intense, often one to one, on the job training and workplace assistance that can create real employment opportunities. CSE is the only Medicaid funded service that promotes employment for people with disabilities. It is available to people who qualify for the Developmental Disabilities Home and Community Based Services waiver.

In Idaho, Medicaid services for adults with developmental disabilities are allocated according to individual services budgets. The amount of a person’s budget is determined by a formula. The formula uses assessment scores, medical diagnoses and other factors to predict the cost of the services a person needs.  The participant decides the types and amounts of each Medicaid service they want within the formula based budget. However, the formula does not always work. Individual circumstances and issues sometimes require that the budget be modified to meet the person’s basic needs.

In 2011 the legislature passed H260 to implement $113,000,000 in Medicaid cuts ($34,000,000 General Fund).   One of the changes limited a person’s ability to modify the budget to changes necessary to protect the person’s health or safety. Employment is not a health or safety issue. This had the unintended consequence of seriously reducing access to community supported employment (CSE). From 2011 to 2013, the number of people getting or maintaining jobs through CSE dropped from 275 to 182. I believe that the trend is continuing and there are fewer people receiving these services today.

H476 would allow people to request modification of their individual service budget if the modification is needed to obtain or maintain employment. It does not restore the statute to the language before 2011. Employment is merely added to health and safety as a basis for requesting a budget Modification. Any modification requested would still have to be reviewed and granted or denied by Medicaid case managers.

If we could instantly develop a hundred jobs for people with developmental disabilities and return the program to 2010 levels, the impact to the state general fund would be about $235,000 (see Fiscal Note). It will probably take several years to return to that level of participation.

Passing H476 will open the door to real world work opportunities for hundreds people who have no other way to experience the benefits of employment. It is also an opportunity to demonstrate to employers the benefits of hiring people with disabilities and to show them how to support and accommodate these employees.

November 15, 2013

Idaho Medicaid Redesign

Idaho Medicaid Redesign:
  Promoting Independence for People with Disabilities
Medicaid Redesign is a proposal for major changes in Idaho’s health care financing system for people who cannot afford the cost of health care, including mental health care.
 
There are five components to Idaho Medicaid redesign:
  1. Accept the federal Medicaid Coverage Option
  2. Add Medicaid requirements to increase consumer responsibility
  3.  Eliminate the County Indigent Health Care Programs
  4.  Eliminate the State Catastrophic Care Fund
  5.  Shift state funded Community Mental Health Care to Medicaid.
Others have documented how these changes will save about $480 Million in Idaho costs over the next 10 years, how it will ensure access to health care for low income working families in Idaho, and how it can change our publicly funded health care from costly emergency room and hospital care to less costly preventive and supportive community care (http://gov.idaho.gov/priorities/Workgroups.html).
 
 This paper addresses the benefits of Idaho Medicaid Redesign for Idahoans with disabilities who have no health care coverage. Contrary to popular belief, not all people with disabilities and low incomes are eligible for Medicaid. Thousands of Idahoans with disabilities and chronic illnesses have income below 138% of the Federal Poverty Level but do not currently qualify for Medicaid coverage.
 
Idaho’s mental health care system is broken. Idaho Medicaid Redesign is the best option for vastly improving our system without significant state general fund expenditures.
 
75,000 Idahoans experienced a serious mental illness in the last year. Of those people, approximately 41,000 have a persistent and recurring serious mental illness which significantly impairs their ability to function in society. About 19,000 of these Idahoans receive treatment through the Department of Health and Welfare for these illnesses each year. Only about half of them are currently covered by Medicaid. Medicaid covered patients receive preventive and supportive services from private providers in the community as well as crisis assistance when needed. The remaining 9,000 to 10,000 Idahoans receive services from Department of Health and Welfare centers funded entirely by Idaho general fund appropriations. These services are currently limited to people in serious crisis who pose a risk to themselves or others, and people receiving services through the state mental health courts. This system does not have the resources to provide rehabilitative services, or community supports to prevent relapses and crises. People with severe and persistent mental illness need these services to move toward recovery rehabilitation and independence. Medicaid Redesign would use federal funds to provide the full range of Medicaid mental health services for this population. The federal funds would cover 100% of the treatment costs for three years tapering to 90% by the year 2020. This would save Idaho about $9.7 million per year while providing for a desperately needed shift from crisis management to prevention, rehabilitation and community supports. In short, Medicaid redesign would allow Idaho to radically improve our inadequate mental health system using federal funds.
 
People with recent disabilities receiving Social Security Disability benefits often have no medical coverage.
When people first experience disability from an accident or an illness which prevents them from working, they can obtain Social Security Disability Benefits. Depending on the length of employment and the amount he or she has paid into the system these benefits often exceed the income level currently set for Idaho Medicaid. They will not be eligible for Medicare for two full years. Since they have lost their job due to disability they usually have no source of medical insurance coverage. Getting adequate medical care during the first two years after onset of disability can be crucial to future health, rehabilitation and recovery. Medicaid Redesign would provide federally funded medical coverage for this two year gap. Access to appropriate medical care during this interval is an essential part of rehabilitation and a return to independence and self sufficiency for many people.
 
People with disabilities due to chronic health problems need Medicaid coverage to avoid deterioration and possible institutionalization.
 
People with chronic health problems and disabilities are more likely to have lower incomes because of the limitations of their condition. Many people in households below 138% of the federal poverty level are in great need of preventive and ongoing medical care. These people in particular will benefit from Medicaid redesign by getting early and ongoing care, instead of waiting until their condition requires acute or emergency care. The state and counties benefit from the lower costs of care as well. Unlike most private insurance, Medicaid covers the cost of long term care. Long term care includes both institutional care in facilities like nursing homes and personal assistance services. Personal Assistance services are supports which help a person with a disability to perform daily tasks such as bathing, dressing, eating, and cooking when their disabilities make it impossible for them to do so without help. Medicaid community based services can delay or prevent the need for placement in long term care or nursing homes. This helps people to maintain their independence, and significantly lowers the cost of their care.
 
Health coverage for parents strengthens the health of families whose children have disabilities or special health care needs.
 
Parents’ health affects children’s health and well-being. The Institute of Medicine has reported that a parent’s poor physical or mental health contributes to a family environment that may impair the health or well-being of a child. Uninsured parents who don’t get care may be unable to work. Coverage for parents has a big impact on children.
 
DisAbility Rights Idaho (DRI) strongly supports the Idaho Medicaid Redesign because by filling in the gaps in coverage and making medical and mental health care available, we can greatly increase the opportunities for people with disabilities to achieve and maintain their independence, maximize opportunities for rehabilitation and recovery, and greatly improve Idaho’s mental health system using the federal funding available to Idaho.

February 14, 2013

On October 3, 2012, Idaho Department of Health and Welfare (IDHW) gave notice that it had proposed a new medical necessity definition for use in children’s cases.

If accepted by the legislature, the new definition reads as follows:

Medically necessary services for eligible Medicaid participants under the age of twenty-one (21) are health care, diagnostic services, treatment, and other measures described in Section 1905(a) of the Social Security Act (SSA) necessary to correct or ameliorate defects, physical and mental illness, and conditions discovered by the screening services as defined in Section 1905(r) of the SSA, whether or not such services are covered under the State Plan.   Services must be considered safe, effective, and meet acceptable standards of medical practice.

On July 20, 2012, Centers for Medicare and Medicaid Services (CMS), the federal agency that monitors a state’s compliance with the Medicaid program sent the IDHW two letters detailing its review of Idaho Medicaid’s Early, Periodic, Screening, Diagnostic, and Treatment (EPSDT) benefit for children under the age of 21.

As a result of this monitoring event, Idaho Medicaid was found out of compliance in four areas and specifically regarding the use of the state definition for medical necessity as applied to service requests for Medicaid eligible children under the age of 21.

Specifically, CMS wrote on page 8 of a report dated and sent to the IDHW on July 20, 2012:

Findings:  Idaho’s definition of medical necessity found in the aforementioned documents requires that “services are medically necessary if they can be reasonably calculated to prevent, diagnose, or treat conditions in the participant that endanger life, cause pain, or cause functionally significant deformity or malfunction; and there is no other equally effective course of treatment available or suitable for the participant requesting the service which is more conservative or substantially less costly.  Medically necessary services must also be of a quality that meets professionally-recognized standards of health care and must be substantiated by records including evidence of such medical necessity and quality.”  This definition of medical necessity is not consistent with federal rules and is too narrow in scope to be applied to Medicaid-eligible children.  EPSDT services include Section 1905(r)(5) of the Act requiring that “necessary heath care, diagnostic services, treatment and other measures described in Section 1905(a) to correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services, whether or not such services are covered under the State plan.”  This requirement to cover all medically necessary Section 1905(a) coverable services to individuals under the age of 21 ensures that these individuals receive any services determined to be appropriate for their specific illness or condition, regardless of any limitations a state may include in the Medicaid or CHIP state plan.  Idaho must revise its definition of medical necessity in all of its publications, State rules, the Medicaid State plan (including the benchmarks), and the State’s beneficiary and provider handbooks.

Corrective Action Required:  Idaho is required to submit a CAP (Corrective Action Plan) to CMS within 90 days of this report detailing the changes that will be made, and the processes by which the State will notify providers, update the definition, and any applicable rules, and/or policies/procedures.  In addition, CMS expects the State to provide a timeline of when they will submit SPAs correcting all areas where the State’s medical necessity definition and/or limits on Medicaid services is not in compliance with federal statute and regulations.

Other findings of non-compliance in the July 20, 2012 report are as follows:

·         Informing – Idaho’s provider manuals, and Idaho’s booklet entitled “Idaho Health Plan Coverage – A Benefits Guide to Medicaid, Children’s Health Insurance Program (CHIP) and Premium Assistance” (Idaho’s primary informing material for participants) are inconsistent when explaining covered services in excess of limits, and appears to limit EPSDT services to conditions discovered only during a well-child screen;

·         Access to Services – The State’s requirement that parents facilitate the completion of the multi-page form entitled “Request for Additional Services (RAS) (EPSDT),” in order to receive prior authorization for 12 select services above the limits specified in the Medicaid State plan, burdens parents with obtaining complicated medical documentation, and has the potential to present barriers to beneficiaries under 21 years old accessing medically necessary services;

As a result of its investigation, CMS made several other statements in the July 20, 2012 report regarding children’s Medicaid services in Idaho and recommended that Idaho Medicaid:

·         Perform additional education to enrolled Medicaid providers related to both the availability of, and processes and procedures regarding how to request services  beyond limits for the under 21 population (page 3);

·         Ensure that all informational materials contain consistent language and messaging regarding service availability, limits, and prior authorization processes (page 4); and

·         Ensure that Health Connections (HC) representatives emphasize to Primary Care Physicians (PCP) that receipt of services beyond limits is not contingent upon a Medicaid/CHIP client being up-to-date on well-child checks (page 4).

On page 14 of the July 20, 2012 report, CMS found the following:

·         Findings:  The State’s Requirement that parents facilitate the completion of the multi-page form entitled “RAS (EPSDT),” in order to receive prior authorization for 12 select services provided by DDA above the limits specified in the Medicaid State plan, burdens parents with obtaining complicated medical documentation and has the potential to present barriers to children accessing medically necessary services.  States can specify the amount, duration, and scope for services in the State plan.  However, limitations cannot be based on the location of a provider (i.e., school district, outpatient community setting, etc.).  Furthermore, the State cannot set limits on a subset of providers that are qualified to provide a specific service (i.e., all physical therapists that meet the required qualifications and have signed a provider agreement as a Medicaid provider in Idaho are subject to the same rules for State plan services).

Corrective Action Required:  The State must immediately revise its RAS form so that parents are not burdened with obtaining complicated medical documentation.  Additionally, the State must submit a SPA (State Plan Amendment) or SPAs to correct the inconsistencies in the current Basic and Enhanced benefit packages where limitations are different for services based on the location of the provider.  The State must provide evidence to CMS within 90 days of this report documenting the required changes to the RAS form have been made.

Regarding limits on services and services coordination, on page 17, CMS in its July 20, 2012 report required that:

·         The State must remove and/or revise all language in published materials (IDAPA rules, provide handbooks/manuals, beneficiary information, etc.), to clarify that medically necessary services over and above Medicaid State plan limits are available for individuals under the age of 21.  Additionally, within 90 days from the date of this report, the State will provide a timeline for amending all publications.  In addition, the State must amend the provider manual to remove the service coordination limit to accurately reflect the State plan. 

·         For service coordination and mental health, there were zero requests for services beyond limits, and a high ratio of therapy requests were denied for not being submitted in advance of rendering services.  While this may indicate that service limits in Idaho are set so that very few eligible beneficiaries need additional services, CMS is concerned that it may indicate a lack of familiarity with the prior authorization limits and process.  The State should distribute information regularly in the Medicaid Provider Newsletter to ensure providers have current information regarding the prior authorization process, and that services beyond regular limits should be requested for patients under the age of 21 when the provider believes them to be necessary.

In another letter sent to the IDHW by CMS dated July 20, 2012, CMS explains in Attachment B necessary specific language revisions that must be made to IDHW Information Materials.  Specifically, the Children’s System Re-Design Frequently Asked Questions must contain:

·         Language must specify that all individuals under age 21 are eligibility (sic) for EPSDT services, even if enrolled in the adult HCBS waivers.  More clarity is needed to specify which services are Medicaid 1905(a) services, and which are HCBS services.

Attachment E of the July 20, 2012 letter addresses the Fair Hearing Process.  CMS made the following comments:

·         Services cannot have a lifetime limit of 36 months.  There is no information on how the family can appeal the decision or request a fair hearing.

If anyone is interested in receiving a copy of the final evaluation by CMS, please contact the DRI Pocatello Office.

October 4, 2012

Measuring a Person’s “Need” for Developmental Disability Services

There is a trend in some states, including Idaho, to use some combination of assessment tools to arrive at a number (usually a dollar amount) which is supposed to reflect a measurement of the person’s “need” for services.  If we assume that such needs can be adequately expressed by a number, it  would make the difficult task of allocating an individual budget for services much simpler. In fact the dream of having an objective, quantifiable measurement of a person’s need would make everything so easy, straightforward, fair, and justifiable that it is irresistible. However, like so many beautiful dreams, the only thing standing in the way of having such a measurement is reality. 
It is not hard to figure out what a person with a developmental disability needs. Any team of reasonable people who know a person well, with someone who has some professional expertise in that person’s particular disability, can usually reach a firm consensus on what the person needs. This method of person centered individual planning has been the standard for over thirty years.  Indeed, no one really questions that this is the proper way to develop a plan for developmental disability related services. However, now Idaho and other states have decided that there is better way to limit services by creating a  “budget”  for the person based on assessment scores and a weighted  formula. Then the state refuses to pay for services which exceed the budget even if the services are clearly considered “needed” by everyone who actually knows and works with the person.  Why would the formula method be better? We are told it is based on a scientific measurement of the person’s “need”, and it eliminates distortions caused by conflicts of interest and perverse incentives in the system.
To examine this idea we must have a working definition of what we mean by “need”.  Is it just enough support to keep the person out of an institution, jail, or a hospital? Is it whatever they used last year? Is it what other people with similar diagnosis and scores used last year on average?  I suggest that none of these is even close to what most of us mean by “need” for developmental disability services.  People with developmental disabilities, by clinical and legal definitions are people whose disability has caused them to fall behind their non-disabled peers in several major areas of life activities. The goal of all treatments and therapies is to improve the functional ability of the person, as much as possible, to the level experienced by their typical peers. Much of this improvement can be accomplished by adaptation and accommodation. If walking is not a reasonable goal, then independent mobility using a wheelchair may be the goal. If driving a car is not possible, then maybe learning how to use public transportation (when it is available) is a worthwhile goal. In any case the goal of developmental disability services is to develop independence in activities of daily living, and enable the person to be integrated into their community and included in the range of activities that everyone else enjoys. This usually requires some combination of skill development, adaptations and accommodations or supports. So I propose that the standard for what developmental services a person “needs” are those services which will have a meaningful positive impact on the person’s ability to achieve the highest level of independence , the highest level of integration into their communities, and the greatest opportunity to engage in typical activities. This includes services and supports which safeguard health and safety, preserve freedom from institutionalization, maximize independence and participation in typical community activities.
Is this asking too much? Consider whether a heart patient “needs” a procedure which will restore her to full physical vigor or if she only “needs” enough treatment to stay alive with severe limitations on her activities. We all consider that people “need” the treatment and therapy that brings them as close to a typical level of functioning as possible. Developmental disabilities should be treated no differently.
The term “developmental disability” is not a clinical term. It was created by an Act of Congress in 1975 (and broadened later) to cover a range of disabling conditions which share certain characteristics. They are manifested before the age of 22, and they cause significant functional impairments in different areas of life activities and interfere with development of the skills and abilities needed for independence and self sufficiency. The term includes conditions which cause intellectual disability such as Down syndrome, physical disability such as cerebral palsy, and social/behavioral disorders such as autism. It covers a vast range of conditions occurring alone, in combinations or with other chronic health problems and disabilities. So measuring the needs of people with DD is not as simple as measuring the need of people with a single diagnosis like diabetes. Since the services and supports needed by people with DD are related to their activities of daily living, independence, and integration into community life, their needs change with their individual circumstances.  A person living in Boise may need a period of one to one skill building to learn to use public transportation. A person living in Hazelton with the same level of disability may just need a ride. These individual differences may not be enough to change the mean distribution budgets of people in urban versus rural areas, but they are real nevertheless. Individual “person centered” assessment and planning teams can and always have been able to recognize these needs and suggest a reasonable plan to address them. Why are states abandoning this simple and straightforward way of determining a person’s needs in favor of formulas and budgets for people with disabilities? I will suggest a few possibilities.
Strong pressures from governors and legislators to reduce the amount and growth of Medicaid expenditures coupled with federal restraints on reducing services create a motivation to change the way “needs” are defined.  Federal statutes and regulations require states to provide the amount of services needed to accomplish the purpose of the service.  Cutting services requires a rationale which allows state agencies to reduce services while still claiming to meet the person’s “need”.
It is painful and difficult to review individual plans and find things to cut out. No one wants to be the “bad guy” and decide what services to deny. If the person has a budget and it is decided by a formula, no one is to blame. The formula cut your budget and you decide what services you want to give up in order to stay under the budget. There is no one to persuade that the budget is inadequate. Arguments are limited to proving that the budget setting process was not followed.
Formulae seem objective and scientific. “You and your family and your team thought you needed that amount of services, but we just measured your need with our formula and apparently, you don’t. You can’t argue with science.”
Pre-set budgets present a safe way to introduce self determination principles to DD services. When restrictions on the types of services and the providers of services are lifted to give people with DD choices, Medicaid agencies need some way to limit expenditures. Pre-plan, formula based budgets are one way to accomplish this.
Sometimes teams feel pressured to recommend more services than a person wants or needs because of parental concerns, conflicts of interest, or perverse incentives built in to the system.
Do formulae actually predict the needs of people with DD? 
They probably do predict a reasonable budget for some people. How many people get budgets for more than they “need”, or less than they “need”?  To answer this question we need to agree on some working definition of “need” and find a way to measure it for each individual person.  Idaho, like some other states, uses a method which calls for the data from each budget year to be compared to the previous year and to measure the degree to which certain pre-selected variables predict a variation in the individual’s budget. Medicaid uses a regression analysis method to adjust the weight given to certain variables.  The assumption of this method is that general variations in budgets are exactly equivalent to variations in individual needs. But the budgets are set by the system and variations are restricted by the budget setting method. In 2010, Idaho Medicaid dramatically increased the number of people who are assigned their formula based budgets instead of their prior year budgets. This artificially increases the apparent predictive power of the formula. At the same time, Idaho Medicaid has restricted the ways that people are allowed to appeal the decision and prove that the budget does not actually meet their needs.  If we were to test the real ability of the formula to “measure” a person’s “need” for DD services we would compare the formula budget to the actual cost of a plan of services prepared by a competent interdisciplinary team using Person Centered Planning methods. Unfortunately, our system does not allow person centered planning to take place independent of the restrictions of the formula predicted budget. A 2009 analysis of the model refers to the client’s need only in quotation marks and repeatedly describes guesses about whether prior year budgets or prior year expenditures are closer to the person’s “need”. The analysis uses statistical regression methods which exclude “outliers” to “clean” the data. These methods are sound statistical procedures for analyzing trends or central tendencies of large data sets. They do not help us to know what each individual actually needs. In fact, individuals with unusual needs (i.e. “outliers”) are treated as statistical “noise”. 
In the real world, lots of factors interfere with a person’s ability to get access to all of the authorized services. Hospitalizations, family vacations, illness, staff shortages and turnover can all reduce a person’s actual use of DD services without reflecting a reduced need for the service. When we look at these effects over the whole population, these factors (and others) will always reduce utilization of the budget for some percentage of the people participating. But it will not be the same people from year to year.  A person who has a budget which is only half of her actual “need” will still use less if her direct support staff quits and she can’t get another for two weeks. Someone looking at her expenditures will conclude that she didn’t even need the amount in her budget or she would have used it.  In part the analysis used by Medicaid in 2009 to change the model, uses this false assumption.  The effect of repeatedly applying this reasoning will work to constantly and artificially shrink the estimate of people’s needs as measured by the formula without any actual change in the needs of the participants.
The only other current check on whether budgets are meeting people’s needs is to look at “Critical Incident” reports, institutionalizations and emergency room visits. These events are important parts of evaluating the adequacy of the services but they only reveal the most spectacular failures, not chronic insufficiencies of services. People who receive less service than they need will merely continue to function at much lower levels of independence and integration than they would with a more appropriate level of services.
Conclusion:
We need to have some consensus about what a person’s “need” for DD services is. I propose that a person’s need for DD services is:
The amount of services which has the best reasonable chance of minimizing the functional limitations caused by the person’s disabilities relative to their typically functioning peers, and the adaptations and accommodations the person needs to participate in typical integrated activities in their community.
The best way to determine that amount is an individual assessment of the person in their circumstances by a team of people which includes, the person, people who are familiar with the person and their circumstances, and at least one professional who is competent to recommend and design a person centered plan of services to meet those needs.
If we want to monitor the success of the formula, we need to measure how well the formula predicts the level of services recommended by the team in a person centered plan of services. Prior year expenditures, prior year budgets and weighted factors for diagnoses are, at their best, only correlated with a person’s needs. The best measurement of anything is direct observation.  In science, we only rely on indirect measurements (i.e. measurements of other things which are correlated with the thing we are trying to measure) when direct observation is impossible.
We need to ask each person centered planning team to develop a plan based on the above definition of “need”, determine the cost of the plan and document it. We need to carefully consider whether the plan is influenced by family overprotection, conflict of interest or perverse incentives built into the system. If this seems likely, objective justification should be required. The formula based budgets can be compared to this cost to see how well the formula does in matching the plan costs in each case as well as how they do on average.
 On the other hand, if we actually know what the person needs, why do we need a formula at all?
In future blogs I will look in more depth at the Idaho Children’s Benefits Redesign and the budget formulae in use for that part of the DD services program.

May 15, 2012

Idaho Medicaid Managed Care Proposal

DisAbility Rights Idaho’s Comments on Idaho Proposal to Contract with a Managed Care Organization (MCO) for Medicaid Services for People Who are Eligible for Both Medicaid and Medicare.

Introduction:

The Idaho Department of Health and Welfare (IDHW) has requested public comment on their proposal to contract with a Managed Care Organization (MCO) to provide Medicaid services to people who are eligible for both Medicaid and Medicare (Dual Eligible). This contract is intended to cover not only the types of medical services typically handled by health insurance companies, but also mental health services including psychiatric rehabilitation services, home and community based, long term care services and developmental disability related community supports. There are important differences between traditional medical treatment services and these community based support services which require careful and cautious planning and implementation. Although there are examples of MCO contracts covering some of these services in other states, we have not found any examples of states with a significant history of using a single MCO contract to provide all of these services statewide. This proposal appears to be without precedent.

The degree of uncertainty and the potential for large scale unpredictable changes in Idaho Medicaid in the next three years is enormous.
  1. Idaho is currently preparing a Request for Proposals (RFP) for an MCO contract for Medicaid mental health services.
  2. That contract is expected to be expanded to include substance abuse services after about a year of implementation.
  3. Sometime this summer, the U.S. Supreme Court is expected to rule on the constitutionality of the Affordable Care Act.
  4. In 2014, if the Act is upheld or partially upheld, a large number of people with severe and persistent mental illness (SPMI) will become eligible for Medicaid. Most of them will also be eligible for Medicare.
  5. Implementation of the Children’s Developmental Disability Redesign and changes in the Adult Developmental Disability including changing authority to §1915(i) are in process.
If the Mental Health MCO is different from the Dual Eligible MCO, there will be overlap or conflict between the populations served. Since the Mental Health MCO will already be in place by the time the Dual Eligible MCO is initiated we should expect to see large shifts of participants and costs into and between these two contracts as each of the events described above occurs. These shifts will cause confusion, and disruptions which are generally not beneficial to the participants or anyone else involved in the process. Even if the same MCO wins both contracts, the differences in terms and “per member per month” (PMPM) rates between the two contracts will cause problems. It may be unreasonable to expect any system to absorb all of these separate but interconnected changes in such a short period of time. Coordination of all of these change processes may simply overwhelm a newly created system which has no history or precedent.

Incentives to Provide Effective Preventive and Supportive Mental Health Services
It is imperative that the financial incentives built into the system reward high quality care and effective preventative practices. It has been demonstrated that it is possible to save money by employing effective preventive and support services for several chronic conditions such as asthma and diabetes. There is evidence that bundling traditional physical health with mental health treatment can reduce the cost of traditional medical care and reduce psychiatric hospitalization. However, these demonstrations placed the burden for the cost of psychiatric hospitalization on the MCO.
1.    If the cost of hospitalization is borne by the state, the MCO has an incentive to place people in state hospitals and to delay their return to the community as long as possible. Unless the full cost of hospitalization in state hospitals is somehow charged to the MCO, there is no incentive to prevent hospitalization or to have robust mental health supports to prevent recidivism.
2.    The system should also provide incentives for preventing people with SMI from entering the criminal justice system or jails, or committing suicide. All of these events can actually lead to cost shifting or cost savings for the MCO unless the payment system provides disincentives for these events.

DD Services and Supports
The PMPM method does not by itself provide incentives for effective DD supports services or treatment. The goal of these supports is to increase the capacity of the person for self determination, independence and community integration. The success of such services is not measured by their physical health status or need for more expensive medical treatment. Short of institutional placement, there is no consequence to the MCO for providing inadequate or ineffective services and supports. Placement in a state facility like SWITC would even be a net savings to the MCO and for certain individuals ICF/ID placement could be a savings over a robust and effective community supports plan. To be effective, there must be a strong incentive to provide effective developmental services and supports. This can only be accomplished with a robust and accurate quality assurance system and well designed incentives to meet the expectations of that system. We are not aware of any examples of such a system. Traditional health insurance plans do not have expertise or experience with these services.
1.    The MCO should be required to contract with a highly qualified, independent entity to evaluate the quality and effectiveness of DD supports and services.
2.    IDHW should consider carving out DD supports and services from the plan or preserving them as a fee for service system. With a robust system of quality assurance and care management practices.

Enrollment:
1.    Require that consumers have at least 90 days to make a choice among plan providers.
2.    Require plans to contract with community-based organizations such as Independent Living Centers, and others.
3.    Include programs for people with mental illness, to educate potential enrollees about their options and to assist them in selecting delivery systems that best serve their individual needs.
4.      Allow enrollees to change plans at any time, without imposing a lock-in period.

Provider Networks:
Many dual eligibles have longstanding, beneficial relationships with providers that might not be in the existing network of a health plan or delivery system that participates in the program. To maintain continuity of care and respect these relationships, participating plans should:
1.    Maintain an open network provider system in order to contract with providers that are not currently in the network.
2.    Offer single case agreements that allow participants to continue seeing their current provider without arbitrary limits on the duration of the relationship.
3.      Require that all providers are trained on independent living and mental health recovery approaches.

Long Term Services and Supports (LTSS):

The goal of LTSS for dual eligibles should be to promote their independence, choice,
dignity, autonomy and privacy. LTSS must emphasize community and home-based services over institutional care in compliance with the Olmstead v. L.C. and E. W.  decision.
1.    LTSS services and should be based on conflict of interest free comprehensive evaluations which include an evaluation of functional status, social and vocational needs, socioeconomic factors, personal preferences, and the ability to obtain accessible services.
2.    Require plans to maintain current levels of LTSS until a comprehensive assessment is conducted.
3.    Contract with LTSS providers who have the capacity and expertise to meet member needs.
4.    Have the beneficiary play the central role in the LTSS assessment and in the development of an LTSS plan.
5.    Support family care giving through designation of family members as paid aides when consumers request this, as well as through respite services.
6.    Provide personal care assistant services, including an option for self-directed services.
7.    Ensure that people with developmental disabilities (DD) have the opportunity to participate in the My Voice, My Choice HCBS Waiver option.
8.    Ensure that people with both a developmental disability and a mental illness have coordinated LTSS from providers with expertise in supporting both conditions.

Care Coordination:

Most health insurance companies have no experience with community based services for people with SMI or DD.  Typical health plan care coordination generally consists of having a nurse call the member occasionally on the phone. Case Management and Service Coordination services for people with SMI or DD must be much more “hands on”. It must include regular face to face meetings and intervention or advocacy on behalf of the member with other providers and community contacts such as landlords or the courts. Traditional health plan care coordination must not replace these vital support services. Plans must be required to contract with qualified and experienced DD service coordinators and SMI case managers, and whenever possible to continue with the member’s current services.

The care coordination team must include a LTSS provider or coordinator (could be the case manager or the TSC) who is responsible for maintaining the LTSS. Few PCPs are able or willing to perform this function.

LTSS care coordinators will often be needed for people receiving home care LTSS as well.

Crisis Services:

People who require LTSS for physical disability, DD, or SMI are at risk for crises in their lives and in their care needs. Plans will need to be able to quickly approve and provide additional services to deal with a crisis caused by a change in the person’s physical or mental health status, the imminent loss of living arrangements, unpaid supports, or other catastrophic events.  The ability of the system to respond to unexpected crises in the community without resorting to institutional placement should be a key requirement of the plan.  The plan should also be well coordinated with non-Medicaid crisis services and be able to access them when needed.

Compliance with Olmstead v. L.C. and E.W. and Best Practices for community based services.

The MCO must be in full compliance with the community integration mandate of the Americans with Disabilities Act (ADA) and the Supreme Court decision in Olmstead v. L.C. and E.W. Although the ADA has lesser implications for private health insurers, the Medicaid program must comply with Title II of the Act and the community integration mandate. This will require the contractor to make community services available in cases where institutional placement would be less expensive. It also requires services to help prevent hospitalization for people with mental illness.
1.    There must be incentives and requirements in the plan to provide for recovery oriented, person centered plans of service.
2.    The plan must allow for self directed services in all areas of long term services and supports including mental health.
3.    DD services should emphasize self determination, community integration, employment opportunities and training for eligible individuals.

The proposal for a single MCO contract for all Medicaid services for all people with dual eligibility is unprecedented and moves Idaho into uncharted territory in LTSS models. IDHW should be extremely cautious and move slowly and deliberately toward this project. Planning to implement it in the current time frame with such an array of both known and unknown variables (e.g. the Mental Health MCO contract, the implementation of the ACA, the pending decision in the Supreme Court on the constitutionality of the ACA, the efforts to redesign DD services, several pending federal lawsuits) may be too ambitious and ill advised.

If Idaho does proceed at the proposed pace, there are serious issues to be addressed in the areas of DD services, mental health services and other LTSS.

Submitted by

James R. Baugh
Executive Director, DisAbility Rights Idaho.

August 24, 2011

Psychosocial Rehabilitation (PSR) is NOT the same as Developmental Therapy.

One of the misguided changes made to Idaho Medicaid benefits in order to cut the budget, is the refusal to allow a person who has both a psychiatric illness and a developmental disability (DD) from receiving both developmental skill building services and psychosocial rehabilitation.  People who have both diagnoses are expected to give up treatment for one or the other. This makes no more sense than asking a person with both diabetes and heart disease to pick which one they want to receive treatment for.
There are about 600 Idahoans on Medicaid who have a developmental disability (such as autism, or intellectual disability) and also have a severe and persistent mental illness, or emotional disturbance.   Dealing with both of these conditions at the same time can be very challenging.  Idaho Medicaid covers both developmental services (like developmental therapy and residential habilitation) and mental health services (like psychosocial rehabilitation, and partial care). However, under a new rule recently enshrined in Idaho Code by H 260, Idaho Medicaid will cover only one of these services even if the person qualifies for both.  The rationale for this approach is that since all of these services include teaching skills, any one of the services can accomplish the same goals.  Unfortunately, the fact that the services all include some type of skill building is the only thing that they have in common. The Department of Health and Welfare’s (H&W) web site offers this one sentence justification: “A participant may obtain all of his specific skill training service needs through one program even when he has dual diagnoses”. But just saying something does not make it so.
The Department’s own rules do not allow Developmental Disability Agencies (DDA) to provide PSR, unless they are also a licensed Mental Health PSR provider. Their rules also require specific credentials and certification of the people who provide PSR which is not required of people who provide DDA services. [i] Agencies which provide developmental therapy and Intensive Behavioral Intervention must be licensed and meet and meet a host of requirements, not required of PSR agencies.[ii] People who provide developmental therapy must be supervised by people with specific credentials and experience in developmental disabilities. [iii] PSR providers are not. Although these services both include skill building, they require radically different capabilities, training, credentials and supervision.  How is it that DDAs are qualified to provide PSR services to people with a dual diagnosis but not to other people with severe and persistent mental illness? Why should we believe that PSR workers are qualified to provide Intensive Behavioral Intervention to people with dual diagnosis but not to other people with developmental disabilities?
Most people with both diagnoses will choose to keep their DD services and abandon their PSR.  This will happen because many of these people need the DD services for day to day maintenance. For many adults their living situation is tied to their DD services, as in Certified Family Homes or in Supported Living apartments.  For these people, giving up DD services means being forced out of their homes.  The overall effect of this policy will be a wholesale loss of PSR services for people with both a developmental disability and a severe and persistent mental illness.  This will result, over time, in increased mental illness symptoms, emergency room admissions, involuntary hospitalizations, arrests and other costly consequences as well as unnecessary increased suffering.  Some of these people are already experiencing these problems.
PSR providers are trained in psychiatric rehabilitation and must be credentialed by the USPRA. The service includes helping clients to recognize emerging symptoms, or changes in symptoms, helping people work through difficulties caused by delusional thinking, general self care for mental illness, monitoring symptoms and medications, insuring that clients participate in ongoing mental health care, maintaining housing and when appropriate employment, and problem solving for other life stressors.  DDA staff simply is not generally qualified to do these things and are not expected to do them based on DDA rules.
PSR providers however are not trained in designing individual developmental plans, intensive behavioral intervention, behavior shaping, reinforcement schedules or many other components of developmental programs. Medicaid requires specific training and certification for DD service providers which are not required for PSR workers.
The idea that DDAs will provide the same mental health symptom management, mental health monitoring, and psychiatric rehabilitation that people with severe and persistent mental illness receive through a qualified and credentialed PSR provider; or that a PSR provider will provide the same intensive behavioral and developmental training that DDAs provide, is a convenient fiction to justify elimination of a service for purely budgetary reasons.  When we make policy decisions based on convenient fictions there are always undesirable consequences.
This policy has been in effect since January 2011. It will take more time for the damage done by this policy to become evident or widespread.  However, there are people who are already experiencing adverse effects such as suicide attempts, hospitalizations and arrests.


[i] IDAPA 16.03.10.130 (PSR agency requirements)
[ii] IDAPA 16.04.11 (Developmental Disability Agency requirements)
[iii] IDAPA 16.04.11.420 (DDA staff qualifications)