Patient Quality-of-Life, Providers with Incentive Payments, Real-World Evidence, and Reducing Healthcare Costs through New Innovations ()
1. Introduction
Year-2017 United States Congress enacted a new program that was named Value-Based Care. S.5249—Preserving Patient Access to Value-Based Care Act 117th Congress (2021-2022) [1] . The program was created to provide an improved care for patients through a wide diversity of evidence based care which may improve the outcomes for patients and is believed to give a better Quality-of-Life for patients especially in Serious or Life-threatening conditions or diseases [2] . See also under 21st Century Cures Act [3] and Medicare for All Act [4] . The New Medical Innovation evidence-based care looks at Real-World Evidence [5] and Real-World Data [6] as proof the patient outcomes have improved from these therapies. This health care community is using these data points to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
Book title: Refining Health Care Creating Value-Based Competition on Results by Michael E. PORTER and Elizabeth O. TEISBERG [7] , published in May 25, 2006 following ten years of research into why the health care industry did not conform to the principles of competition seen in all other sectors of the economy. The program was created to provide an improved care for patients through a wide diversity of evidence based care which may improve the outcomes for patients and is believed to give better Quality-of-Life for patients especially in Serious or Life-threatening conditions or diseases. The evidence-based care looks at Real-World Evidence, Real-World Data, and will be at the forefront for more Life Sciences Companies and physicians.
The physicians should research Life Sciences Companies to find compatible therapies that will provide benefits to their patients in Serious or Life-threatening illnesses. As the prominent therapy using pharmaceutical prescription drugs which are prescribed today, these Life Sciences Companies shall have to prove that their treatment effects are beneficial to the patient, the patient will also be asked by the Insurance Companies if the treatment has benefited them, the Insurance Company will take all the evidence under consideration when coming to a conclusion through a variety of levels for decision making if the treatment is giving an evidence-based improvement to the patient. If the patient does not believe the treatment is working for their condition and there is no sufficient evidence to prove that the treatment is providing an improvement to the patient health, then the Insurance Company may request or demand a refund from the Life Sciences Companies with fees other charges and actions and may prohibit further treatment to the patient of that service.
The goal is to get patients to actively manage their well-being instead of a delayed response until they get into a Serious or Life-threatening illness. The patient can be an Ambassador [8] for their own health [9] and if the physician finds a measurable treatment to improve the patients’ outcome [10] then Insurance Company will make payments to the physician easier and more stable than the hit and miss payouts by Insurance Companies.
2. Methodology
Value-Based Care was created to benefit patients through an evidence based approach to treatment. Evidence based means that a physician or Life Sciences Company have to provide evidence that a treatment can improve a patient health through a measurable method. A measurable method may include blood reports, testing like Computerized Tomography (CT) and Position Emission Tomography (PET) scans, clinical observation, patient input and any other testing forms that can prove the patient health has improved without harmful side-effects countering the improvement. Value is also just as important as evidence. A value has to be achieved from the treatment that saves on costs of traditional treatments. This is very important for Medicare and Insurance Companies to reduce costs for patient treatment and is a “must” for the program to be successful.
3. Results and Discussion: Real-World Evidence and Real-World Data
On November 13, 2020 Medicare and Insurance Companies agreed to provide value payment for Real-World Evidence to Golden Sunrise for its Innovation treatment under procedure codes—Cellular Therapy M0075. If the patient shows a measured improvement to the service then the Insurance Company will allow continued service from the Life Sciences Company. This service may continue indefinitely as long as at the end of the contracted term there can be provided measured improvement in the patients’ targeted or overall health. It is also a desired result from the Value-Based Care program that patients can be at home during the care process. This will help to save money for Medicare and Insurance Companies to reduce lengthy hospital stays and give patients care in the privacy and comfort of their home.
On March 25, 2019 the Investigator’s Brochure from Golden Sunrise was given to an Investigator for the U.S. Food and Drug Administration (FDA), which he in turn archived in the FDA Scientific and Technical Library to provide knowledge to the FDA of conditions that could benefit cancer patients with Golden Sunrise Innovation the Establishment Identification No.: 3012327979 (Table 1 and Table 2).
Golden Sunrise supplies treatments to the Life Sciences industry that provides Value-Based care for patients that are in search of Quality-of-Care and can be provided a treatment that not only improves patients’ overall health but saves
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Table 1. Comparison of the cancer treatment side-effects, quality-of-life, and costs.
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Table 2. Comparison of the cancer treatment results of benefit patient experience and life expectancy.
the Insurance Company money. Golden Sunrise Innovation has provided improved outcomes to patients in Serious or Life-threatening conditions or diseases. This lifesaving New Medical Innovation shows measured improvements to patients from Real-World Evidence and reduces or eliminates hospital stays. Patients taking Golden Sunrise Innovation have shown in surgical record results that blood loss has been greatly reduced during and after surgery and recovery times are greatly reduced making hospital stays and outpatient care improved.
Golden Sunrise Innovation patients’ medical report background and results [11] to support Value-Based Care program.
3.1. Patient with COVID-19 (Coronavirus)
R.H. is a 51-year-old Hispanic male was COVID-19 positive on 04/02/2020 per his Nephrologist (physician). The physician referred patient to Golden Sunrise for the Innovation treatment on 04/08/2020 after patient failed a five days course of Hydroxychloroquine and Azithromycin. Patient symptoms started a few days before, about 03/30/2020, and they had not improved any on that combination of medicine per the patient. Patient symptoms are the same: Fever every day (the highest one hundred and three point five (103.5˚F) degrees Fahrenheit), chills, extreme fatigue, severe generalized muscle achiness and pain, severe headaches, tightness in his chest with breathing and frequent dry coughing, throat irritation, insomnia, poor appetite with several pond weight loss, and ongoing diarrhea, no nasal congestion. Patient sense of smell and taste has not been affected. Patient has had Diabetes Mellitus type II for some fifteen years and is on insulin. Patient has diabetic peripheral neuropathy and chronic tinnitus and balance problems from the diabetes. Patient suffers from Asthma, using Symbicort inhaler twice a day as usual, no use of rescue inhalers, i.e. Albuterol, etc. Patient has no history of hypertension or kidney or cardiac problems. Results: The day after patient started the Innovation on 04/08/2020. Patient fever started the Innovation. Patient remained afebrile by day #6 of treatment on 04/13/2020. Essentially asymptomatic after the Innovation taken on day #8 on 04/15/2020 except for some persisting chest tightness and cough. Asymptomatic for five days and COVID-19 positive on 04/17/2020. Day #11 for feeling warm (although temperature was only ninety-eight point nine (98.9˚F) degrees Fahrenheit) and minor cough. That same day patient jogged for two miles. Because it was unclear if some cough and chest tightness was asthma or COVID-19 related, patient continued with the Innovation. That was taken on 04/22/2020 day #15 of treatment. Patient never had any more worsening of cough or chest tightness other than what was consistent with baseline asthma symptoms per patient. COVID-19 test, (not detected) negative on 04/24/2020 but repeat was positive on 04/28/2020. COVID-19 test, positive on 05/04/2020, day #28 of follow-up (perhaps eighteen days asymptomatic) (Table 3).
3.2. Patient with Stroke
D.H. is a 69-year-old white male that has sporadically taken the Innovation since Year-2015. Patient has a history of blood pressure issues, Sarcoma, and COVID-19. Patient had stroke on February 22, 2023 suffering from a blood clot in the brain. Patient was flown to LAC + USC Medical Center that evening. Patient was flown there because they planned to do surgery to remove the blood clot. When patient arrived, he looked good and had strength in his arms and legs. His evaluation on February 24, 2023 was that the clot had dissolved enough that he no longer required surgery and on February 25, 2023 he was discharged from the hospital without weakness or slurred speech. Results: Because the patient had been taking the Innovation and had been following a healthy diet with exercise the patient had a reduced severe response to the stroke. If the patient had not taken the Innovation the risk of severity could have been greatly increased and the patient may have had to receive surgery for the blood clot. The physician at the LAC + USC Medical Center after reviewing the blood report and medical scans had recommended to the patient that he continue taking the Innovation to reduce further potential risk.
3.3. Patient with Surgery: Abnormal Uterine Bleeding and Chronic Pelvic Pain
L.C. is a very pleasant 55-year-old premenopausal female, who presented with history of abnormal uterine bleeding and chronic pelvic pain. Outside imaging
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Table 3. COVID-19 (Coronavirus) laboratory results.
revealed an enlarged uterine with multiple uterine fibroids. Management options were discussed with the patient and after verbalizing understanding, the patient desired to proceed with hysterectomy. Ovarian preservation versus oophorectomy was reviewed with the patient including risks, benefits and alternatives. After verbalizing understanding, the patient desired oophorectomy. Results: As a result of taking the Innovation, the surgeon and the medical professionals were very impressed at the controlled bleeding during radical hysterectomy. On October 31, 2022 complete radical hysterectomy included debridement of excessive scar tissue patient had that took approximately thirty minutes longer than normal, but due to how well it was going, overall it only took one and half (1.5) hours instead of the projected time of three (3) hours it normally takes. Family patient they were in disbelief at how well patient was doing without any narcotic pain medication. Patient was very mobile and walking cautiously but without pain two (2) miles within the first ten (10) days (Table 4).
3.4. Patient with Menopause and Bone Loss
S.T. is a 59-year-old white female who was diagnosis osteoporosis, asthma, migraines, headaches, neck pain, arthritis, sleep issues, and hip pain. Results: On July 18, 2017 began the Innovation has overall dramatic results for pain that does not seem to have any real cause. It also has an effect on patient nails and skin. These changes were fairly quick. Taking more time is the slight to moderate improvement in thumb arthritis, GERD symptoms, neck migraines, and foot pain. Hip pain is reduced but most significant pain remaining. Patient has a relatively steady energy supply and do not feel hunger as much. Sleep has been difficult, the first three weeks patient didn’t sleep enough, but felt fairly good. The last week patient has been sleeping more, but don’t feel rested. The Innovation have affected bone metabolism by demonstrating improved bone density in patient with osteoporotic bone. Number based on densitometry has shown a reversal in L1 - L4 from −3.6% to 3.4% in two years (Table 5).
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Table 4. Operation of surgery results.
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Table 5. Bone mass measurement densitometry trend: L1 - L4 T-score results.
3.5. Patient with Type 1 Diabetes (T1D)
N.O. is a 20-year-old white male who was diagnosis Type 1 Diabetes (T1D) and wears an insulin pump to help regulate his diabetes. Results: On June 13, 2019 he started the Innovation during the process his blood sugar dropped from over 440-mg/dl to 59-mg/dL in the matter of two hours. Patient was shocked when he checked his blood sugar. Patient felt great, did not feel shaky, he had energy, and he was very alert (Table 6).
3.6. Patient with Intermittent Explosive Disorder and Attention Deficit Hyperactivity Disorder
J.W. is a 10-year-old white male who began treatment with physician psychiatrist in Visalia California when he was 6 years old. He has been diagnosed the fragile-X syndrome. He was diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) (F90.1), and Intermittent Explosive Disorder (IED) (F63.81). He has been treated over the years with Tegretol, Vyvanse, Zoloft, and Risperdal; he had a trial at another medical center of R Baclofen. Psychiatrists have also treated him with Gabitril, and Nudexta. He was taking Zoloft 150 mg in the morning, Risperdal 1 mg at bedtime, and Vyvanse 40 mg in the morning. Results: On July 07, 2016 he started the Innovation twenty drops twice a day. On July 25, 2016, his mother reported as of this date that he was more focused and calmer. His level of perseveration has decreased dramatically. His mother stated that the other day he was organizing the DVD player in their home and “that’s not like him.”
3.7. Patient with Attention Deficit Hyperactivity Disorder
S.W. is a 64-year-old white male who began treatment with psychiatrist when he was 57 years old. He was initially diagnosed with anxiety disorder Not Otherwise Specified (F41.9) and ADHD without hyperactivity (F90.0). Stimulant medication was not effective in treating his focusing problems so Wellbutrin was used. Clorazepate was used to help with his anxiety. He did well with this combination of medicines until November 2014. He was diagnosed then as having diabetic neuropathy and was treated with Lyrica. He complained then that the medicine made him feel “fuzzy” and he could not be productive at work. In February 2015 he stopped the Clorazepate because he was afraid of having Alzheimer’s disease and decreased the Wellbutrin on his own to decrease the fuzziness. He restarted the Clorazepate, eventually. In April 2016 he was taking Cymbalta 60 mg in the morning and Ambien 10 mg at bedtime. His family doctor had ceased the Wellbutrin and Chlorazepate. He was being treated at that point in time with
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Table 6. A fasting blood sugar level results.
methadone and Lyrica. He complained again of feeling fuzzy, tired, and unable to do his work. Results: In July 2016 he was started with the Innovation twenty drops twice a day. He reported two and a half weeks later that he had more energy and motivation. He was more productive and able to do his work and his pain had been reduced by thirty percent.
3.8. Patient with Schizoaffective Disorder and Polysubstance Abuse
S.R. is a 39-year-old white male who was first seen when he was 28 years old. He was transferred from another physician and was taking Wellbutrin-SR 100 mg three times a day, Clozaril 600 mg at bedtime, Zoloft 200 mg in the morning, Topamax 100 mg at bedtime, and Aricept 20 mg at bedtime. He had a significant history of substance abuse, including marijuana, crack cocaine, mushrooms, and acid between the ages of 17 & 21 years old. He was diagnosed with schizoaffective disorder (F25.9) and Polysubstance abuse. He was treated with multiple medications over the years to try to help reduce his psychotic symptoms and increase his sociability. In June 2016 he was taking Vraylar 6 mg in the morning, Fanapt 6 mg twice a day, Nudexta 20 - 10 twice a day, Chlorazepate 30 mg at bedtime, Prozac 40 mg in the morning, Clozaril 300 mg at bedtime, Abilify 30 mg in the morning, and Gabitril 4 mg at bedtime. Results: On July 07, 2016, he was started with the Innovation twenty drops twice a day. He returned on July 21, 2016, reporting that he had decreased the Clorazepate to 15 mg at bedtime, his Prozac had been increased to 60 mg in the morning and he had been on the Innovation for two weeks as well as the other medications listed above. He reported, “My brain can keep up with my mind”. He stated, “My brain is aware of my body”. He reported increased energy, clearer thoughts, and non-racing thoughts. He also reported that he had a dry patch of skin on the back of his head that was now gone.
3.9. Patient with Alzheimer’s Disease
L.H. is an 86-year-old white female who was diagnosed as having Alzheimer’s disease and lives in a skilled nursing facility. She was on a liquid diet, sleeps most of the time, was confined to a wheelchair or a moving bed, and had intermittent episodes of agitation and flat facies. She has been treated with ImunStem ten drops twice a day for two and half weeks. Both staff and family report that she is less agitated, more alert, and smiling. Results: After thirty days on the Innovation the nurses’ report there are no longer any agitated episodes and she spends more time awake. On exam, the patient opened her eyes and focused on my face. There was no facial expression, but the patient appeared to try and move her lips as if she wanted to talk. (This was a new behavior). When I asked her to move her finger if she could understand me, she did.
3.10. Patient with Lymphocytic Leukemia
M.B. is a 69-year-old white male who has been treated for chronic Lymphocytic Leukemia for the last five years. He started taking the Innovation twenty drops twice a day in October of 2015. This was because of the concern about falling red blood cell counts and platelet counts. His white blood cell count, though elevated remained elevated, and fluctuant. Results: In October 2015, his red blood cell was four point zero five (4.05) and his platelet count was ninety (90). In April 2016 his red blood cell count was four point nineteen (4.19) and his platelet count was one hundred and five (105). It was felt that this was a significant increase in both his red blood cell count and platelet count (Table 7).
3.11. Patient with Substance Abuse
R.B. is a 62-year-old white male who was first evaluated on August 19, 2016. He is taking Actos, Metformin, Lorstan, and Travastin for diabetes mellitus, high blood pressure, and glaucoma. There is no history of past substance abuse. He was interested in trying the Innovation to see if it would make any difference to his medical problems. He also complains of mild symptoms of depression including anergia, lack of motivation and feeling depressed about his physical problems. He was diagnosed with depressive disorder Not Otherwise Specified and started on the Innovation twenty drops twice a day. Results: The patient reported after eight weeks of the Innovation treatment that his energy and motivation have increased. He also reported that he was feeling less depressed. He reported that he was able to tolerate higher loads of carbohydrates without changing his diabetes medications, which also affect directly his energy and motivation.
3.12. Patient with Colon Cancer
J.O. is a 45-year-old white male diagnosed with advanced stage four colon cancer. He was diagnosed in January of 2016 and was not thought by the attending physician that he could have a positive outcome as the cancer was in mastitis and had spread throughout his body. His symptoms included a damaged liver, renal obstruction, lung polyps, anxiety, depression, and severe lack of energy. The patient received the first cycle of chemotherapy in March 2016. Results: In April 2016 the patient received his first dose of the Innovation administered orally at forty drops three times daily. At this time the patient showed noticeable improvement in overall health in minutes. The patient showed an improvement in energy levels as the next day he was playing basketball, mental focus, depression, and anxiety improved noticeably and his outlook on life was a positive
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Table 7. A chart the innovation before and the innovation after results.
Comparison of red blood count and platelet count from October; 2015 through April; 2016.
hope. His tumors have shrunk and since the treatments of the Innovation and chemotherapy he has had no major side effects such as hair loss, debilitating constipation, depression, anxiety, weight loss, or nausea. He has not had to visit the emergency for complications except for a staph infection at his injection port. The patient is doing well and can function without interference with his normal lifestyle. The patient has been motivated to tell others of the benefits of taking the Innovation that it can help others with Serious or Life-threatening conditions or diseases (Table 8).
3.13. Patient with Autism/Seizure
J.A. is a 2.5-year-old male that was diagnosed with Autism/Seizure. His symptoms included: seizures, drooling, hyperactivity, disorientation, lack of pain stimuli, poor communication skills, and uncontrollable outbursts. He was diagnosed in October 2016 and was considered near the highest level of autism that provided government programs to assist with his mental state. He has an unknown regimen of prescription medications, and government assistance is provided for the re-education of motor skills. Results: In December 2016 he began oral administration of the Innovation at two drops per 12 fluid ounces of milk. In approximately four days his parents noticed he was aware of his surroundings and responded to the parents’ directions. He was also noticed to cease drooling and felt pain in normal situations (such as falling while playing). He also had a reduction in seizures. He improved where no known seizures are being observed and he is more responsive to direction, his drooling has not returned and he is acting like a normal 2.5 years old.
3.14. Patient with Advance-Stage Parkinson’s Disease
S.R. is a 62-year-old black male that was diagnosed with advanced-stage Parkinson’s disease. He was diagnosed 4 years ago and has had a steady progression of
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Table 8. A chart the innovation before and the innovation after results.
Comparison of white blood count and platelet count from April; 2017 through November; 2017.
Parkinson’s disease. The symptoms include, slurred speech, an unsteady (uneven) gait, memory loss, depression, tremors and occasional falling. He has taken the prescribed medication, which had only intermittent results. Results: In April of 2015 he began taking the Innovation oral administration at thirty drops twice a day. He states he feels more stable as he can walk on his own, has no more falling episodes, can focus better (clearer thought), has reduced tremors and has significantly reduced his depression. He has also returned to his previous employment.
3.15. Patient with Excessive Menstrual Bleeding and Painful Menstrual Periods
R.W. is a 16-year-old female that has had excessive menstrual bleeding and long painful menstrual periods since Year-2013. She took Vicodin every month on the first day of her period. She had a debilitating pain that interfered with her lifestyle and activities and kept her confined to her home. Results: In October of 2016 she began taking the Innovation oral administration at thirty drops per day. After three weeks, her menstrual bleeding reduced and her pain had been alleviated. Her period duration had dropped by half and she could function in public as normal.
3.16. Patient with an Enlarged Prostate
R.G. is a 60-year-old male diagnosed with an enlarged prostate. He had been to multiple medical professionals that have treated him for everything from bleeding eyes to a heart attack. Physicians have recommended various surgeries for his prostate but the patient did not want to have these surgeries because of the possible adverse outcomes. Results: In October 2017 he was administered ImunStem while in the hospital being treated, within three minutes he felt an improved feeling in his prostate which felt like less pressure and less pain. He continued to improve over four months and no longer requires invasive procedures to alleviate prostate swelling (Table 9).
3.17. Patient with Multiple Sclerosis (MS)
E.B. is a 46-year-old white male diagnosed with Multiple Sclerosis (MS) in November 2016. He was the first suspect as having Lyme disease but upon further testing it was found to be MS. He experienced a continual degradation of motor function until he was bedridden, and he had almost total immobility of his legs and arms. The caregiver would assist the patient with all movement including bathroom activities. Results: The patient began taking the Innovation in October 2017 and showed a positive response for the first dose. Throughout treatments, the patient has experienced improved motor function to where he can sit in a wheelchair and move and can sit on the toilet without the aid of the caregiver. The patient continues to show marked improvement as the treatment progresses (Table 10).
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Table 9. A chart the innovation before and the innovation after results.
Comparison of estimated Glomerular filtration rate, white blood count, and platelet count from October; 2017 through December; 2017.
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Table 10. A chart the innovation before and the innovation after results.
Comparison of white blood count and platelet count from September; 2017 through December; 2017.
3.18. Patient with Esophageal Cancer
R.H. is a 54-year-old white male who was diagnosed on December 26, 2016, with esophageal cancer in stage two after the patient collapsed for no apparent reason and began spewing blood. The patient was rushed to the local emergency room where testing immediately began and the diagnosis was made. The patient refused standard medical cancer treatment (chemotherapies). Results: The patient began taking the Innovation on February 20, 2017 and showed improvements in both reports blood reports and medical scans. The physician at the hospital after reviewing the blood report and medical scans recommended: “resume regular diet” and receive another checkup in four weeks (Table 11).
The patient can be an Ambassador [12] for their own health, the physicians should research Life Sciences Companies to find compatible therapies that will benefit their patients’ condition [13] . As the prominent Life Sciences Companies treatments that are prescribed today shall have to prove that their effects are beneficial to the patient, the patient will also be asked if the therapy has benefitted for them and the Insurance Company will take all the evidence under consideration when coming to a conclusion if the therapy is giving an evidence-based improvement to the patient. If the patient does not believe the therapy is working for their condition and there is no sufficient evidence to prove that the therapy is proving an improvement to the patients’ health, then the Insurance Company may request a refund from the Life Sciences Companies with fees and other charges and prohibit further treatment to the patient of that service. However, if the patient shows a measured improvement to the service then the Insurance Company will allow a continued service from the Life Sciences Companies. This service may continue indefinitely as long as at the end of a term or as payment is requested there can be provided to the Insurance Company a measured improvement in the patients’ target treatment or overall health. It is also a
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Table 11. A chart the innovation before and the innovation after results.
Comparison of white blood count, mean platelet volume and platelet from January; 2017 through March; 2017.
desired result from the Value-Based Care program that patients can be at home during the care process. This will help to save money for Medicare and Insurance Companies to reduce lengthy hospital stays and give patients care in the privacy and comfort of their homes as needed.
4. Conclusion
This paper provides patient medical report results for the measurement based on Real-World Data. The Value-Based Care program can save a substantial amount of money for Medicare and Insurance Companies, save substantial time for health care workers by reducing caseloads, and reduce work for physicians by giving in home services to patients as needed using Golden Sunrise New Medical Innovation. This will also reduce or eliminate hospital stays and substitute home care which may greatly reduce pay outs by Medicare and Insurance Companies.
Acknowledgements
The authors would like to thank Michael E. Porter and Elizabeth O. Teisberg for their contributions to the creation of Value-Based Care. The authors would also like to thank United States Congress for the passage of legislation that gives Value-Based Care and its benefits to the people of the United States of America. The authors further acknowledgement and thank the staff of Oakview Medical Clinic in Visalia California for their support and professionalism in regards to patient care. The authors further acknowledgement Sonja Fontana, D.N.P., FNP-C and Dr. Stephen R. Meis, M.D. for their Real-World Data that makes this article possible.