Outpatient drug rehab can help you get back on the right track. Here are the answers to four commonly-asked questions about this form of addiction treatment.
Being diagnosed with substance use disorder is an important step towards recovery, and finding the best addiction treatment becomes the next. Outpatient drug rehab comes in a number of forms to suit different patient needs. But what, exactly, is outpatient drug rehab, and how does this type of drug treatment work? More importantly, is outpatient addiction treatment as effective as inpatient drug treatment? Read on for the answers to these vital questions and more.
In outpatient drug rehab programs, you access addiction therapies and treatment at specific times, while maintaining your normal place of residence.
These programs do not require overnight hospital visits. You’ll get to stay in your own home and simply visit the center during your allotted time slots. This type of drug rehab allows you a more flexible schedule, in comparison to inpatient treatment. It gives you time to attend to your other duties and responsibilities, especially if you can’t afford to miss work.
American Addiction Centers notes that those with less severe cases of substance use disorder may begin their treatment in an outpatient setting. Patients enrolled in intensive inpatient rehab programs may also transition to outpatient forms of treatment as their treatment progresses.
"There are differing levels of care including IOP (intensive outpatient programs), MAT programs (Medication Assisted Treatment programs), and outpatient counseling, to name a few," Melissa Smallwood, LPC, tells WebMD Connect to Care.
American Addiction Centers notes that there are different levels of intensity within outpatient rehab programs, including:
Partial hospitalization programs (PHPs). These programs are also known as “day treatment”. Within them, patients are cared for by an interdisciplinary medical team that provides treatment for complex or unstable medical or psychiatric conditions. These types of programs are also well-suited to patients who need a high level of medical or mental health support, but do not require 24-hour supervision. In a PHP, you’ll typically receive at least 20 hours of intensive treatment per week.
Intensive outpatient programs (IOPs). Like PHPs, these programs employ the expertise of an interdisciplinary medical team. However, they will generally have fewer medical and clinical support services. You’ll typically receive 9-20 hours of treatment per week.
Standard outpatient programs (OPs). These programs focus on helping patients make the necessary behavioral changes to recover from substance use disorder. Medical services are absent or minimal within these programs, although patients can receive referrals for intensive services as needed. You’ll typically receive 9 or fewer hours of treatment per week.
The specific characteristics of your program will depend on the treatment or therapy approaches of your chosen rehab facility.
Generally though, treatment will begin with you working with a staff member to develop a treatment plan based on the severity of your condition. This might include setting recovery goals and learning your program’s dos and don’ts. The program may also ask you to do regular drug tests or complete assignments and tasks outside of your regular sessions.
According to the National Institute on Drug Abuse (NIDA), intensive day programs and group counseling therapies can be as effective as residential programs. Your specific program’s success, of course, will depend on a number of factors—such as your specific medical history and co-occurring conditions, as well as your program’s structure and ethos.
NIDA also notes that addiction is a disorder that can be treated successfully, and getting the right treatment (whether it’s outpatient or inpatient) helps you take back control of your life.
The goal of drug rehab, including outpatient programs, is for you to recover from substance use disorder and go back into being a productive member of your school, family, or workplace. To achieve this, you’ll need to fully invest in your program.
"It truly depends on the client and their motivation for change, external support system, drug of choice, and a myriad of other factors whether or not they will achieve long term sobriety," Smallwood says.
If you or a loved one are struggling with addiction, WebMD Connect to Care Advisors are standing by to help.
If you’re thinking of enrolling in an inpatient drug rehab program, it can be helpful to get some key questions answered while you zero in on your best options.
The aim of both inpatient and outpatient rehab facilities is to treat substance use disorder and help you lead a full, independent life. Both types of treatment can be beneficial, but those with severe addictions should consider inpatient drug rehab, which offers intensive treatment. Read on to get the answers to 5 key questions about this important form of addiction treatment.
According to the National Institute on Drug Abuse, inpatient drug rehab best suits individuals with severe drug addiction problems, and those with coexisting physical or mental disorders.
Inpatient rehabilitation facilities require you to stay 24/7 in the clinic. There, you'll receive not only medical treatment, but also psychological support and services. These programs typically include medically-supported detoxification and withdrawal treatment as well as cognitive behavior therapy and counseling. They also include relapse prevention, skill-building activities, and follow-up care after you complete your program.
It should be noted that a residential program isn't the same as a 24/7 intensive inpatient drug treatment program. While residential programs typically offer many of the same services as intensive inpatient ones, residential programs do not come with intense 24/7 medical monitoring, according to American Addiction Centers.
The length of each patient stay varies. But in general, it can range between 90 to 180 days. This will, of course, depend on your personalized treatment plan.
"The detox stage typically lasts a week but can be up to 10 days long. The residential treatment stage is usually between 30 to 90 days in length," Susan Julius, a family and addiction medicine specialist at Avenues Recovery Center, tells WebMD Connect to Care.
Your expenses will depend on several factors, including:
“Generally, private inpatient rehab ranges from $10,000 to $25,000. However, some programs can go up to $100,000, depending on amenities and privacy. The good news is that insurance can cover some or all of the cost of treatment.” Elliott Michael Smith, CEO of The Ohana Addiction Treatment Center, tells WebMD Connect to Care.
Inpatient drug rehab facilities typically don’t allow their patients to leave. After all, you're there to focus on getting better. But this also depends on your personal situation.
“There are, however, times when some centers will allow for court appearances, for example. All centers are different,” says Julius.
Some inpatient drug facilities also allow supervised outings.
“Sometimes, [patients] can leave with supervision. Many programs do go out into the community under supervision on adventure therapy outings or to the gym and stores. The purpose of this is to support their recovery and ensure safety,” Smith continues.
Coverage for inpatient rehab treatments is available through Medicare Part A. But how much coverage you’ll get will depend on your specific insurance plan and your chosen drug rehab facility.
“Medicare can cover short-term inpatient drug and alcohol rehab. But the rules around coverage can be complicated. Most facilities that do accept Medicare are generally ‘in-network’ facilities. Some patients pay out of pocket and request reimbursement directly from Medicare to cover their treatment. It’s best to speak directly to Medicare about coverage,” Smith suggests.
If you or a loved one are struggling with addiction, WebMD Connect to Care Advisors are standing by to help.
We use a two part-study design, combining a randomized controlled trial (RCT) and a longitudinal follow-up design.
The main study is a randomized control superiority trial, comparing the intervention group (IG) with a waiting-list control group (CG). For legal reasons, any insurant of the statutory German Pension Insurance (GPI) whose application for medical rehabilitation was approved by the GPI will receive a rehabilitative intervention. Therefore, it is not possible to use an entirely untreated CG, but a waiting-list CG can be realized. After inpatient rehabilitation in the Bad Reichenhall Clinic has been approved by the GPI, patients receive a letter informing about the study and screening for their eligibility. If no response is received within 14 days, a reminder will be sent to the patients. If patients meet the inclusion criteria, they are asked to participate. After consent has been obtained, participants will be randomized to the IG or CG. In the IG, participants will start inpatient rehabilitation within 4 weeks after randomization. Data will be assessed at randomization (T0), at the beginning (T1), the end (T2), and three months after inpatient rehabilitation (T3). The CG will start inpatient rehabilitation five months (i.e. 20 weeks) after randomization. CG data will be assessed at randomization (T0), at four weeks (T1), at seven weeks (T2) and at 20 weeks (T3, beginning of inpatient rehabilitation) after randomization. The crucial reference intervals for the primary research questions are T0 to T2 and T0 to T3 for both IG and the CG. Since CG starts PR 19 to 20 weeks after T0, which is 3 months after the discharge time-point of IG, it will be possible to compare the results of IG with those of the (still) untreated CG during these initial 19 to 20 weeks. However, it may be possible that for the CG, arrival at the rehabilitation clinic (at T3) already has an effect on several outcome parameters. To estimate this "arrival effect", an additional measurement time point (T3a) for the CG at 10 (+/-3) days before T3 has been included.
The second part of the study is a longitudinal cohort study. In addition to the data collected in the first part of the study (RCT), data at 6, 9 and 12 months after inpatient rehabilitation in the IG and data at the end of and at 3, 6, 9 and 12 months after inpatient rehabilitation in the CG will be collected. Longitudinal data from both groups will be combined to one sample. Fig. 1 illustrates the study design. Note that measurement time points of the IG and CG have a parallel timing only from T0 to T3. Participants not returning the postal questionnaires on time will be reminded by phone. If necessary, questionnaires will be sent again by mail to the patient.
Study design and measurement occasions; PR: pulmonary rehabilitation; M: months; W: weeks; not shadowed: data for randomized control trial; grey shadowed: data used only in the longitudinal study
Patients are eligible for the study if they are approved for PR, have a physician diagnosis of asthma (ICD-10: J45) at T0 and have uncontrolled asthma based on an Asthma Control Test (ACT) <20.[1,29,30] Patients will be excluded if they have cognitive impairment, inadequate German language ability, or severe concomitant diseases that might mask the results of asthma rehabilitation (for example cancer and severe cardiac/orthopedic or psychiatric comorbidities). The initial diagnosis of asthma will be confirmed by a pulmonologist at admission to inpatient rehabilitation. If the initial diagnosis cannot be confirmed, the patient will be excluded from the study.
Participants will be recruited consecutively. All patients meeting the inclusion criteria and providing informed consent are randomly assigned to the IG or CG by a study nurse at the time of their PR approval. Randomization will be stratified according to age. The randomization list (with computer-generated random numbers) is created by the Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences at the University of Würzburg (concealed allocation).
Patients themselves cannot be blinded due to the time-point of the start of their inpatient rehabilitation. However, those who deliver the rehabilitation treatment are unaware whether the patient is a study participant, a participant of the IG or the CG, or a regular inpatient outside the study.
Calculation of trial size is based on our primary outcome, the ACT, assessed three months after the inpatient rehabilitation. A previous longitudinal study of asthma patients in the Bad Reichenhall Clinic (without a CG) showed changes between start of inpatient rehabilitation and three months after inpatient rehabilitation of (Cohen's) d > 0.5. However, this value might overestimate the effect of inpatient rehabilitation compared to a control group. Therefore, trial size was calculated to detect a difference of d = 0.3 at T3 between the IG and CG. Using alpha = 0.05 and power = 0.8, 352 participants are required, but assuming a drop-out rate of 30%, a total of n = 504 patients will be recruited.
Latent curve models will be used to analyze the course of the primary outcome in the longitudinal follow-up study. As a rule of thumb, N > 100 cases should be included in the computation of these models. Even with a conservatively estimated drop-out rate of 50% until T6 for IG and T8 for CG, N = 152 patients would remain in the study, which is sufficient.
As shown in Fig. 1, both groups receive a 3-week PR that meets the structural requirements of German healthcare insurance providers.[31,32] The PR is carried out by a multi-professional team (physicians, psychologists, physiotherapists, sports scientists, social workers, nutritional consultants) and will be tailored individually to each patient's needs. The rehabilitation program will be reviewed at least once a week as part of the doctor's weekly rehabilitation ward round.
The rehabilitation program includes the following non-drug therapy components (O = obligatory for all participants, except those with individual contraindications, F = facultative if needed):
Physical training (O) consisting of three obligatory components: a) endurance training scheduled for 5 units per week for 45–60 min each, during which outdoor sports and training in water (e.g. Aqua Fitness, Nordic Walking) are performed. Exercise intensity is controlled by BORG Scale and heart rate; b) strength training scheduled for 3 sessions per week of 45–60 min each and c) whole-body vibration-training scheduled 7 times per week. In addition, inspiratory muscle training (F) is provided for patients with inspiratory muscle weakness and is scheduled for 7 sessions per week, each for 21 min, of which 2 per week are supervised.
Comprehensive patient education (O) consisting of two obligatory components: a.) patient education regarding asthma for one week with 7 units of 45 min; b.) one session of practical medical inhalation training and/or peak flow meter use for 60 min. In addition, patients also receive allergy awareness and trigger avoidance training (F) if required (one 60-min session).
Respiratory physiotherapy (O) consisting of 3 units of group respiratory physiotherapy per week with learning of pursed lips breathing (O) for 45 min each. If necessary, patients may also receive the following optional components (F) including: a) individual breathing training by physiotherapists; b) training of Buteyko breathing techniques for patients with dysfunctional breathing; c) physiotherapy seminar on coughing techniques for patients with cough problems; d) mucolytic inhalation therapies (e.g. saline inhalation, for patients with mucostasis (4).
Psychosocial support (F) such as social counseling, individual psychological counseling and/or group therapy will be offered if necessary (Patient Health Questionnaire (PHQ-9) > 9 points, Generalized Anxiety Questionnaire (GAD-7) > 9 points or if indicated by their physicians).
Comprehensive smoking cessation program (F) will be offered to all smokers.
Comprehensive nutritional counseling (F) will be offered to patients with food intolerance or allergies or over- and underweight.
In addition, patients will receive a routine check-up and if necessary, current asthma medications will be optimized according to the current guidelines. This is an obligatory part of the rehabilitation in Germany. Any changes to medications will be documented. Adverse events and complications during rehabilitation are recorded by the physicians on a standardized basis in the medical survey sheet at the end of rehabilitation.
The primary outcome is the mean change in AC, assessed by ACT. Secondary outcomes include mean changes in HRQoL, 6-min walk distance (6-MWD) and Sit-to-stand-test, lung function parameters, Eosinophils, dyspnea, depression, anxiety, smoking habits, illness representations, self-management skills, work ability, subjective prognosis of return to work, sick leave, medication beliefs and medication adherence. Measurement instruments for all outcomes and measurement occasions can be found in Table 1. Lung function parameters, 6-MWD, FeNO, and Eosinophils are assessed at the start and the end of the inpatient rehabilitation by staff of the PR. All other outcomes are assessed via questionnaires.
Asthma Control. Asthma Control will be assessed by using the Asthma Control Test (ACT).[30,33] The ACT consists of five items that assess (1) activity limitation, (2) daytime shortness of breath, (3) awaking due to asthma symptoms, (4) needed puffs of reliever medication and (5) a global judgment of asthma control. All items refer to the last 4 weeks. They are scaled from 1 to 5. The sum of scores indicates asthma control. An ACT score of 20 – 25 indicates controlled asthma and of <20 indicates uncontrolled asthma. A minimal important difference about 3 was identified.
Health Related Quality of Life. Asthma specific HRQoL will be assessed by both, the Saint George's Respiratory Questionnaire (SGRQ) and the standardized version of the Asthma Quality of Life Questionnaire (AQLQ). The SGRQ uses 50 items to capture the three domains Symptoms, Activity and Impacts as well as a Total scale. All scales are computed by weighted sums of the respective items. The scores range from 0 (no impairment) to 100 (maximum impairment). A minimal important difference (MID) of 4 is established for COPD, a MID for asthma has not been reported up to now. The standardized version Asthma Quality of Life Questionnaire (AQLQ) contains 32 questions to capture the four domains Symptoms, Activity limitation, Emotional function and Environmental stimuli to measure the functional problems that are most troublesome to adults with asthma. The survey period covers the past 2 weeks. Each question is answered on a 7-point scale (1 = severely impaired - 7 = not impaired at all). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items from those domains.
Generic HRQoL of patients is measured using the Euroqol questionnaire (EQ-5D-5L) and the EQ visual analogue scale (VAS). The EQ-5D-5L is a standardized instrument applicable to a wide range of health conditions for use as a measure of health outcome. It is especially suited to cost effectiveness analyses as it can be used to generate quality-adjusted life years. The descriptive system of the EQ-5D-5L comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A German utility index is currently being developed.
Subjective Health. Global rating of change (GRC) in subjective health is assessed using a single item that compares current subjective health with subjective health at the beginning of the inpatient rehabilitation. The response scale ranges from -7 (much worse) over 0 (no change) to 7 (much better).
Symptoms. Severity of dyspnea, cough, sputum and pain will be assessed with response to seven 11-point numeric rating scales. Scale values range from 0 (no symptoms) to 10 (worst imaginable symptom severity).
Fatigue. The Brief Fatigue Inventory (BFI) will be used to measure fatigue. This short questionnaire assesses severity of and impairment from fatigue with ten questions. The subscales and the total score range from 0 to 10, with higher values indicating higher severity/impairment. A German version exists and has been proven reliable and valid.
Depression and Anxiety. The PHQ-9 and the GAD-7 will be used to assess depression and anxiety.[43,44] All items are scored on a 4-point Likert scale (0 = not at all, 1 = several days; 2 = more than half of the days; 3 = nearly all days). Besides using the sum of scores (which range from 0 to 27 in PHQ and 0 to 21 in GAD-7), we will also classify individuals with values of >10 as indicating a clinically relevant depressive disorder (PHQ-9) or a clinically relevant anxiety disorder (GAD-7).
Illness Representation. The 9-item Brief-Illness Perception Questionnaire (B-IPQ) will be used to capture 8 aspects of illness representations (i.e how illness perceived by the patient: Consequences, Timeline, Personal control, Treatment control, Identity, Concern, Understanding and Emotional response. Each aspect is assessed by one item, except for Emotional response, which is assessed by two items. All items use a 0 to 10 response scale. Furthermore, perceived causes of asthma attacks are assessed via an open-ended response item, which asks for the three most important causal factors of their illness.
Subjective Self-management. Subjective self-management will be assessed using the Skill and technique acquisition scale from the Health Education Impact Questionnaire (heiQ™,[46,47]). The items are scored on a 4-point response scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). The overall score is computed as the unweighted mean of all items, with higher values indicating a higher subjective judgement of self-management.
Medication Adherence and Medication Beliefs. Patients will complete the Medication Adherence Report Scale (MARS-D). This is a 5-item questionnaire with a 5-point response scale (1 = always to 5 = never). The sum of the individual answers can range from 5 to 25 points, with higher values indicating better medication adherence. The 10-item Brief Medication Questionnaire (BMQ) will be used to assess patient's medications beliefs on two scales. The scale Necessity assesses patients' beliefs about the necessity of prescribed instruments and the scale Concern assesses patients' concerns about prescribed medications. Both scales range from 5 to 25 points with higher values indicating higher belief of necessity/higher concerns.
Lung Function Measurement. Forced expiration in one second (FEV1), vital capacity (VC), residual volume (RV) and total specific resistance (SRtot) are determined using spirometry and body plethysmography (MasterLab, CareFusion, Hoechberg, Germany) before and after bronchodilation with a short-acting bronchodilator in accordance with recommendations of the national guidelines.[50,51]
Resource use. Resource use will be determined based on answers to the FIMA-Lu questionnaire, a modified Version of the FIMA questionnaire, a German instrument to assess health-related resource use. For direct costs, the number of visits to a general practitioner, specialist care, ambulatory clinics in hospital, physiotherapy, days spent in hospitals and intensive care units and medication administered will be documented. For indirect costs, work absenteeism days will be documented.
Exercise Capacity. The 6-MWD will be measured using a track length of 30 m according to the European Respiratory Society/American Thoracic Society technical standards. At T0 and T1 respectively, each patient performs the test twice with an interval of one hour. The best test will be included for analysis.
Work Ability. Subjective work ability will be assessed by the first item of the Work Ability Index (WAI), the Work Ability Score (WAS). It compares current subjective work ability to the lifetime's best. The 11-point scale ranges from 0 (complete incapacity to work) to 10 (lifetime's best work ability). The WAS shows high correlations with the overall WAI score. Furthermore, the 4th Item of the WAI is used to assess health-related limitation of current work ability, with values ranging from 1 (total incapacity to work) to 6 (no limitation). In addition, subjective prognosis of employment status will be assessed using the 3- items of the Subjective Prognostic Employment Scale (SPE Scale). The three items assess patient's belief (a) to remain at work until retirement and (b) whether their health will be permanently jeopardized and (c) whether they are considering applying for a disability pension.
Sport Activity, Smoking Habits and Medication use. Two items will be used to assess sport activity. In Item 1, the patient indicates whether he or she exercises regularly (at least 2 times per week) and in item two the kind of exercise performed (e.g. gym, sports club, lung sport group). Current smoking status (current smoking yes or no) and number of cigarettes per day will be documented. Furthermore, patients' use of antibiotics or cortisone in the last three months (yes/no; number of uses) will be documented.
Socio-demographic Data and Employment. Information regarding socio-demographic data and employment status will be collected.
Data Management: Data of all measurement time-points will be collected in the Bad Reichenhall Clinic. Questionnaire data will be entered into Microsoft Excel by two study nurses (independent double data entry by two individuals). A unique ID number will be assigned to each patient and personal data (name, address) will be stored in a completely separate file. The list with assigned ID numbers and personal data will be stored in the Bad Reichenhall Clinic and will not leave the center. Other anonymized data will be sent to the University of Wuerzburg and the Helmholtz Zentrum Munich for further data management and data analyses.
Primary and secondary outcomes will be analyzed according to the intention to treat approach. All randomized patients will be included in the analysis. Missing data fulfilling the assumption of missing (completely) at random will be imputed using multiple imputation procedures. In addition, because it may be possible that some patients will not start with the inpatient rehabilitation or decide to drop-out of the study, we will also analyze results based on a "per protocol" approach[58,59] including only patients remaining in the study until T3.
The analysis of the primary and secondary outcomes at T2/T3 will use analysis of covariance (ANCOVA) with treatment group as a fixed effect and baseline value of the respective outcome as a covariable. Adjusted mean differences and confidence intervals will be reported. In addition, moderating effects of the following baseline variables on the primary outcome will be analyzed: ACT, gender, age, quality of life (assessed via SGRQ Total Score), anxiety (assessed using GAD-7) and depression (assessed using PHQ-7). For all models, statistical model assumptions (linearity, homoscedasticity, normality of residuals) will be tested. If model assumptions are violated, appropriate analysis methods (e.g. robust regression, log-transformation) will be used.
Latent change models will be used for exploratory analyses of the course of the primary and the secondary outcomes in the follow-up longitudinal study.[61,62]
Data regarding resource utilization and work absenteeism will be documented retrospectively by the patient. A self-administrated questionnaire based on the FIMA questionnaire has been developed specifically for patients with pulmonary problems. The monetary valuation of resource use will be based on the valuation rates calculated by Bock et al.. Analysis of cost data will be performed with a model with a gamma distribution and a log-link to account for the skewed distribution of the data. A 95% confidence interval for the cost difference will be estimated based on 1,000 bootstrap replications using the percentile method.
In the longitudinal follow-up study, the annual costs before and after rehabilitation will be compared by paired t-test. Alternatively, bootstrap resampling with 1,000 resamples will be used to compute p-values because cost differences may have a skewed distribution.
All statistical Analysis will be performed using SPSS, R & SAS software.
Wednesday, August 3, 2022
The United States’ exact False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems. The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face FCA liability for suggesting providers use their devices in any way the FDA has not approved (and in this case, warned against).
Prometheus manufactures a pelvic muscle rehabilitation system and accompanying rectal pressure probe used to treat pelvic floor disorders. The FDA approved the probe for single-person use, but Prometheus allegedly trained providers to reuse the device on multiple patients by covering the probe with a glove or condom. Prometheus also allegedly instructed providers to re-use another company’s probe with a different pelvic rehabilitation system it manufactures, despite the FDA having approved the probe only for one-time use. The FDA even required warnings on the probes’ packaging, “restricted for single person use only,” and “[d]o not re-use.”
To prove an FCA violation, the government will have to show that Prometheus’ alleged off-label use instructions caused providers to submit false claims, that Prometheus knew this (or recklessly disregarded the falsity), and that the contraindicated use was material to Medicare’s decision to pay the providers’ claims. To establish the knowledge element, the government alleges that Prometheus knew the probes were single-user or single use, and also knew that its provider customers were submitting claims to Medicare for procedures using the devices because Prometheus instructed providers on how to bill the pelvic rehabilitation services. The government is attempting to prove materiality using Medicare’s coverage requirement that procedures must be “reasonable and necessary.” The Centers for Medicare and Medicaid codified the definition of “reasonable and necessary” just last year, including the requirement that procedures be “[f]urnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition …” The government alleges that re-using the rectal probes was not “reasonable and necessary,” even if the underlying procedures and treatment might have been. It seems that the government is also attempting to show falsity based on the failure to satisfy the “reasonable and necessary” requirement.
This is not the first time the government has wielded the FCA against medical device manufacturers for off-label uses of their products. In 2018, AngioDynamics settled for $12.5 million over allegations that it misleadingly promoted its drug-delivery product LC Bead as doing more than the FDA had approved. Some of the largest FCA settlements on record have been with pharmaceutical manufacturers promoting off-label use of their drugs: Pfizer settled for $2.3 billion—$1 billion of which was an FCA settlement—for off-label marketing of Bextra, and Warner-Lambert pled guilty in 2004 and paid a $430 million settlement in connection with promoting its drug Neurontin for off-label uses.
But all hope is not lost for medical device manufacturers. The 9th Circuit recently declined to penalize a medical device manufacturer for marketing its products for a use that FDA expressly contraindicated on the labels. In Dan Abrams Co. v. Medtronic Inc., Case No. 19-56377 (9th Cir. Apr. 2, 2021), the 9th Circuit affirmed partial dismissal of relator’s FCA claim and found that Medicare does not distinguish between on-label and off-label uses in determining whether to pay claims, and that even contraindicated uses are eligible for payment if they are medically necessary and reasonable. The court went on to note that merely showing that harm can occur from off-label or contraindicated use is not enough to satisfy materiality, because every surgery carries risk. The Southern District of Florida followed suit with its exact decision in United States ex rel. Watt v. VirtuOx, Inc., dismissing relator’s allegation that defendant’s use of a medical device was not medically necessary or reasonable simply because it was off-label.
Prometheus declined to file a motion to dismiss and instead proceeded to file its Answer on July 18, 2022. Thus, if not settled, the case will be decided on either a motion for summary judgment or at trial. But even where the government’s and relators’ complaints do not survive a motion to dismiss, it can be costly to battle the allegations. Device manufacturers should keep this in mind when marketing their devices for off-label use.
Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, Number 215
After contracting COVID-19, President Biden quickly appeared on video to show Americans that, while he’s fighting off the symptoms, he’s doing fine. But even if he’s back on the campaign trail in a day or two, that doesn’t necessarily mean the COVID conversation about Biden’s health is over.
Public health officials warn that millions of Americans who contract the virus go on to suffer from what is known as “long COVID.”
What is it?
It depends on who you ask.
A pounding heart when simply getting off the couch, difficulty concentrating, difficulty breathing, chest pain, and ongoing fatigue are just a handful of persistent symptoms of long COVID — scientifically known as Post-Acute Sequelae of SARS-CoV-2 infection (PASC), according to the Centers for Disease Control and Prevention (CDC).
“There is no agreement on how to define and diagnose long COVID,” writes Heidi Ledford at Nature. “The World Health Organization’s attempt at a consensus, published in 2021, has not proved popular with patient advocates or researchers, and studies continue to use a range of criteria to define the condition.”
Dr. Alba Azola, assistant professor of physical medicine and rehabilitation at Johns Hopkins Medicine, says the inability of health professionals to settle on a definition is hurting efforts to treat it.
“It becomes very challenging at times to be able to support these claims,” Azola said. “I think advocacy regarding understanding the syndrome, the knowledge that we have so far, and the limitations when it comes to certain medical testing is important.”
Long COVID is a problem that is not going away, health experts say.
According to the CDC, 60% of the U.S. population and 75% of children have been infected with COVID-19.
The American Academy of Physical Medicine Rehabilitation (AAPMR) recently released new guidelines for treating the impacts of long COVID. They also urged government and health care systems to prepare for the long-lasting consequences affecting people, according to Steven Flanagan, Rehabilitation Medicine Department chair at New York University Langone Health.
“These are folks that can’t go back to work in the same capacity that they were doing before they became sick with COVID-19 and developed long COVID,” Flanagan said. “We are trying to take the ‘dis’ out of ‘disability.’ We can work with employers and school systems to get folks back, but it’s not going to happen overnight.”
With the unclear definition comes less-than-solid numbers of long COVID’s reach. An estimated 8 million to 26 million Americans have experienced or are currently experiencing at least one symptom of long COVID, according to the American Academy of Physical Medicine and Rehabilitation Long COVID Dashboard. Estimates that between 5% and 50% of COVID cases will lead to long COVID are so vague they tend to undermine trust in the analysis and make it harder to get public officials to commit to taking action, public health advocates say.
Two significant debates continue to rage over long COVID: Is the syndrome connected to the severity of the original “acute” case, and do vaccinations help prevent its onset? President Biden’s case appears to be mild. Will that help?
Some studies have found no correlation between how badly COVID symptoms hit and the likelihood of suffering from long COVID later.
Others, like Dr. Jonathan Whiteson of New York University’s Langone Health Center, say there is some correlation, but it is hardly 100%.
“We are seeing many people who had mild symptoms and were never hospitalized in the acute phase develop cardiovascular disorders,” Whiteson said. “Up to 4% of individuals who had mild disease have had a stroke or myocardial infarction in the post-acute stage. This is very significant.”
Symptoms of long COVID aren’t just reserved for older individuals, but have also been found in school-age children and adolescents, Whiteson said.
“Because of the uniqueness of this virus, we are projecting that cardiovascular disease could affect a much younger population,” Whiteson said. “Just like diabetes is a risk factor for cardiovascular disease, COVID-19 could be one, too.”
As for the impact of vaccinations, Whiteson also sees a correlation.
“When we look into the long COVID period — three to six months out — we are seeing in those people who are unvaccinated more significant cardiovascular consequences and disability,” Whiteson said. “Again, it is an important call to action to get the message out there that vaccinations reduce the risk of severe disease, reduce the risk of hospitalization, and do have a long-term positive impact.”
But a exact study conducted by VA St. Louis Healthcare System, which examined 13 million cases, found the vaccine reduced the risk of long COVID only by 15%, substantially less than other estimates.
Currently, 41 post-COVID-19 clinics collaborate with the American Academy of Physical Medicine Rehabilitation as well as practitioners from multiple other healthcare disciplines.
In Ann Arbor, Dr. James Neuenschwander treats children and adults with complex, chronic health problems who have not responded to conventional therapies. While a handful of his patients suffer from long COVID, Neuenschwander also treats patients with vaccine injury. He said the symptoms for both are very similar. One symptom is myocarditis — an inflammation of the heart muscle reported as a symptom of long COVID and a possible complication of the vaccine by the CDC.
“We know that both COVID-19 and the vaccine can activate or reactivate an autoimmune disease,” Neuenschwander said.
In addition to releasing a guide on cardiovascular complications, the American Academy of Physical Medicine Rehabilitation has released guides on fatigue, breathing discomfort, and cognitive symptoms.
According to the AAPMR, there is not a one size fits all approach to treating patients. Each treatment plan should be individually tailored.
“I think we’re in a state right now where there’s recognition that long COVID is real,” Flanagan said. “It’s not just patients being anxious. It’s a real condition.”
Elaine Mallon, a former fellow with the National Journalism Center, writes about politics and public policy for InsideSources.com.
The MarketWatch News Department was not involved in the creation of this content.
Jul 28, 2022 (Market Insight Reports) -- According to the research report titled 'Global Occupational And Physical Therapy Services Market Size study, by Setting (Hospitals, Outpatient Clinics, Others), by Application (Orthopaedic Physical Therapy, Geriatric Physical Therapy, Neurological Physical Therapy, Cardiopulmonary and Pulmonary Physical therapy, Other), by Payor (Public Health Insurance, Private Health Insurance/Out-of-pocket) and Regional Forecasts 2022-2028', available with MarketStudyReport, global occupational and physical therapy services market is projected to witness substantial growth through 2022-2028, observing more than 15.8% CAGR during the analysis timeframe.
The rising prevalence of chronic diseases and the increasing number of relevant therapists are some of the major factors driving the growth of global occupational and physical therapy services market.
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For the uninitiated, physical therapy (PT) and occupational therapy (OT) are types of rehabilitative treatments. Mobility, strength, and range of motion are all objectives of physical therapy while rehabilitation after an injury, helping elders experience physical and cognitive changes, and aiding children with impairments to participate fully in school and social situations are all examples of occupational therapy approaches.
However, the market is expected to experience slower growth due to a shortage of physical therapy facilities in emerging economies over the forecast timeline.
In terms of setting, the market is divided into outpatient clinics, hospitals, and others. Based on the application spectrum, the global occupational and physical therapy services industry is categorized into cardiopulmonary and pulmonary physical therapy, neurological physical therapy, geriatric physical therapy, orthopedic physical therapy, and others.
By payor type, the market is segmented into private health insurance or out-of-pocket and public health insurance.
The geographical bifurcation of this business space extends to Asia-Pacific, North America, Europe, as well as Latin America with key emphasis on the U.S., Canada, U.K., Germany, France, Italy, Spain, India, China, Japan, South Korea, Australia, Brazil, and Mexico, and the rest of the world.
North America occupational and physical therapy services industry is expected to generate commendable returns through the forecast timeline, owing to availability of an advanced medical infrastructure, technological developments and the growing incidence of mental disorders.
Asia Pacific market, on the other hand, is anticipated to be the fastest-growing region in the forthcoming years, ascribed to the rising government expenses in the healthcare sector.
The major companies operating in global occupational and physical therapy services industry landscape are Select Medical, PT Solutions, ATI Physical Therapy, Encompass Health Corporation, U.S. Physical Therapy, Upstream Rehabilitation Inc., Athletico Physical Therapy, and Kindred Healthcare LLC
Question & Answer: Global Occupational and Physical Therapy Services Market
Question 1: Why is global occupational and physical therapy services market observing constant growth through 2028?
Answer: The rising prevalence of chronic diseases and the increasing number of relevant therapists are some of the major factors driving the growth of global occupational and physical therapy services market.
Question 2: Why is North America occupational and physical therapy services industry witnessing constant growth through the forecast period?
Answer: North America occupational and physical therapy services industry is expected to generate commendable returns through the forecast timeline, owing to availability of an advanced medical infrastructure, technological developments and the growing incidence of mental disorders.
Question 3: Which companies constitute the competitive terrain of the global occupational and physical therapy services market?
Answer: The major companies operating in global occupational and physical therapy services industry landscape are Select Medical, PT Solutions, ATI Physical Therapy, Encompass Health Corporation, U.S. Physical Therapy, Upstream Rehabilitation Inc., Athletico Physical Therapy, and Kindred Healthcare LLC
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