Singularity Health Law Blog

Digital Medicine - A LIFESAVER?

Robin Cook and Eric Topol had an interesting article in the Wall Street Journal today entitled “How Digital Medicine Will Soon Save Your Life.” They predict that digital medicine will arrive soon with “force of a hurricane. The promise of individualized “tailored” medicine’s advance with the prospect of cheap gene decoding, nanotechnology and smart phone’s playing the role of physician avatars, silently monitoring our body chemistry and organ functioning is certainly appealing and probably within the realm of near realization. They note the recent FDA approval of VISI, a device that monitors heart electricity, respiratory rate, blood oxygen, and blood pressure without a cuff and transmits the data to a medical office. They predict that the advent of digital medicine will democratize medicine permitting patients to own or control their medical data which they can transmit over the web. They see this as a shift away from the “medical - industrial complex.”

 

The authors see problems and unanticipated problems related to privacy, misuse of information and patients being overwhelmed by the information available to them. They suggest that the FDA will have to play a major role to ameliorate those issues. This is somewhat funny. The reality is that if the FDA plays a major role in this futuristic model it is far more likely to be the problem than the solution. It still clings to the 19th Century approach to approval of medicines that work for the majority, but not all of the public and to obstruct the access to drugs that work for a minority of patients, with appropriate molecular structures, but not for the majority.  To reach the great advances and lower costs that the author’s envision there will need to be a hurricane running through the FDA.

Peter W. Huber. The Cure in the Code.

Book Review: Peter W. Huber. The Cure in the Code: How 20th Century Law is undermining 21st Century Medicine.Basic Books (Nov. 2013).

Mr. Huber provides an intense guide to the exploding scientific developments in molecular medicine and the legal and regulatory impediments that threaten to cripple its promise of cheaper and more effective medicine through individualized treatment applications. Modern molecular and genomic advances in medicine, coupled with the exponential increases in computing power and attendant increase in algorithmic data analysis capability opens up the potential for great leaps in medical knowledge and treatment effectiveness.

Standing in the way, however, is the federal Food and Drug Administration with an antiquated system of approvals for new developments in medicine. Mr. Huber argues that the gold standard for FDA approval, the double blind based studies of broad effectiveness against a placebo, are too expensive, too time consuming, too unethical and too narrow. They are too narrow in the sense that they are too broad, requiring a demonstration of effectiveness in a large population, dealing with a specific medical issue, without focusing on the drugs applicability to specific molecular potential in individual cases.

The author refers to this as the “old magic bullet” model, with a single simple cause directly linked to a single effect. He asserts,

 

[A] high level of complex and statistically elusive biochemical diversity likewise makes it impossible to judge a drug’s efficacy or most of its potential side effects using a conventional, one dimensional statistical analysis of data in biochemically indiscriminate Trials.

 

Mr. Huber notes that the FDA relaxed the reins somewhat in dealing with the multi-virus issues inherent in HIV treatment, speeding drugs to market like AZT and the creation of “drug cocktails” for attacking the virus, when one drug alone was insufficient.  Since then, the FDA has retreated to a more regressive pattern of focus on testing large scale applications of individual drugs to broad populations rather than providing support for wider experimentation by doctors and patients based upon biomarkers and molecular diversity to generate the type of success and failure information that can provide meaningful advances in medical knowledge. The answer he suggests requires a radical reorientation of the FDA, with the focus of Baysean statistical analysis on a broad range of evidence.

 

CAN THE FDA REGULATE YOUR STEM CELLS?

In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.

 

ON LINE PRODUCTS HELP OFFENDERS PASS DRUG AND ALCOHOL TESTS.

Late last month in St. Charles, Missouri, a 34 year old man named Sydney Levin, on probation for illegal substance possession and felony stealing, was discovered using a prosthetic product known as the Whizzinator to pass synthetic medical grade urine in lieu of his own. He was charged with possessing a “forging instrument” and released on a $25,000. bond. The Whizzinator contains an artificial penis connected to a 4 oz. bag to contain the synthetic urine.  There are heating elements in the apparatus that elevate the temperature to human body levels.  The device comes in three colors, white, black and brown. The product is advertised at $149.95 plus shipping and handling. Rapid Clean Clean Pee is advertised at $15.95 a pack.

WHEN WILL COMPUTERS THINK?

The Obama Administration recently announced the formation of the “Brain Activity Map Project” to be funded by the National Institutes of Health and other public and private foundations and organizations to undertake a ten year study of the human brain. The effort, which is similar to the organized effort to map the human genome is expected to cost at least 300 million dollars a year over the ten years. It is anticipated by scientists that it will be much for complex and difficult to undertake than the genome project. The hope is to develop a complete model of brain activity and the process of neuron firings that lead to cognition.

 

DENTAL PATIENT SEEKS EXTRACTION FROM “SILENCER” CONTRACT.

There are a number of “silencer” contracts that have been marketed to dental and medical professionals as a means of keeping bad reviews from patients off of the internet.  Typically these agreements provide that in exchange for maintaining the confidentiality of the patient’s medical records the patient agrees not to make any critical reviews of the professional services received on the internet. These agreements also sometimes provide that the patient assigns his or her future intellectual property rights in reviews of the professional to the professional so that the professional can require web sites to “take down” adverse reviews.

 

CALIFORNIA STREAMING: TELEHEALTH ADVANCEMENT ACT

The often contentious California legislature passed the Telehealth Advancement Act of 2011 without opposition achieving broad advances in the expansion of medical services in rural areas of the state. It expands the Telehealth Development Act of 1996 to all licensed health care providers and proscribes insurance plan requirements for an in person relationship to obtain consent. Consent can be verbal and must be recorded. Failure to obtain consent is deemed "unprofessional conduct."

 

The new Act provides for advancing hospital credential approval of distant consultants and specifies that insurance companies may not place limits on settings where telehealth services may be provided. The Act does state that it is not to be used to mandate telehealth service in settings that insurance companies deem inappropriate.

 

The Legislature in enacting the law sought to dispel any doubt about the future of telemedicine in California.

 

It is the intent of the Legislature to recognize the practice of telehealth as a legitimate means by which an individual may receive health care services from a health care provider without in-person contact with the healthcare provider. 

 

CONCIERGE MEDICINE | MEDICARE OVERLAP TRAP

According to a GAO report in 2005 approximately seventy five percent of those physicians providing concierge medicine services do not opt out of Medicare, but provide some services either as a participating or non-participating physician. Those physicians must be very careful to assure that they do not charge concierge customers for any service that might be otherwise covered by Medicare which can create a potential claim for over-billing for medicare services in violation of the False Claims Act.

MEDICARE PROVIDERS | THE “OPT OUT” OPTION.

There is a fair amount of confusion afoot concerning the obligation or not of physicians to accept Medicare patients.  There is no requirement that any physician accept Medicare patients or refrain from limiting the number of Medicare patients accepted into the physician’s practice. There are circumstances when it may be in the best interest of a physician to “opt out” of Medicare.  The growth of concierge medicine  in some respects makes it safer for physicians to “opt out” of Medicare in order to avoid stepping afoul of the Medicare fee limitations by charging for services that might be construed by CMS or the OIG as being extra contractual charges which might implicate the federal false claim statute. According to 2005, General Accounting Office Survey of providers of concierge medicine, only about 25% of them had opted out and were practicing on the cash only high wire without the Medicare safety net.

 

OBAMA BLUE BUTTON INITIATIVE PUSHES PHR DOWNLOAD PROGRAMS

 Recognizing the critical health care need for accurate historic  patient health records, the Obama administration has developed what it calls a “Blue Button” download initiative at the Department of Veteran Affairs, CMS and HHS. These are all programs that permit patients to go on-line and download their own medical records that they can share with their providers, caregivers and trusted others.  Some of these programs are now operational.  In the lead is the VA ( www.myhealth.va.gov ) where approximately 60,000 veterans have already accessed their records.  Medicare recipients can also access their records now at www.mymedicare.gov . Only about 5,600 have done so. There are about 47 million medicare recipients and 1 million veterans.