Health Affairs:FDA and Primary Care

Health Affairs briefing at the National Press Club in Washington, DC,

The clinical and economic virtues of provider consolidation have long been recognized by policy experts, but in recent years, research has shown that large provider organizations may use market power to obtain relatively high prices from payers without necessarily delivering superior quality. On May 19, Health Affairs will release a package of "Web First" papers examining questions regarding provider consolidation.

Follow live Tweets from the briefing at @HA_Events, and join in the conversation with #HA_ProviderConsolidation.  We invite you to a Health Affairs briefing at the National Press Club in Washington, DC, where the authors will present their findings and engage in a discussion with a panel of expert responders and the audience. The papers and the briefing are supported by a generous grant from The Commonwealth Fund.

WHEN:	Monday, May 19, 2014 9:00 a.m. - 10:30 a.m.
WHERE:	National Press Club 529 14th Street NW Washington, DC 13th Floor (Metro Center)

FDA  Fast-track for new drug development

Physicians and Pharma have long complained about the length of time for new drug approval by the FDA for clinical use.  Pharma is required to perform Clinical Trials, I, II, and III to test for toxicity, effectiveness, and possible side-effects. Various amounts are quoted for the process of approval.  These add significantly to the costs of biochemical and pharmacological production. Health Affairs and the Robert Wood Johnson Foundation describes a new expedited drug development pathway designed to speed up the Food and Drug Administration's (FDA's) premarketing approval process for drugs and devices that treat serious or life-threatening conditions. Created under a 2012 law, the Food and Drug Administration Safety and Innovation Act (FDASIA), a drug may be designated a "breakthrough therapy" if it shows far more promise over comparable treatments already on the market. At that point, the FDA will initiate a special rapid approval process. The pharmaceutical industry has responded positively to this law, and as of last month the FDA has received 178 requests for this designation. The law, whose full impact will not be known for several years, carries significant implications for approaches to clinical development, patient access to new drugs, and the drug regulations process itself.

Social Media Response to Release of Medicare Payments to specific Physicians

Josh Seidman discusses the implications of the social media response to the release of information on Medicare payment to specific physicians. This is the first time physician reimbursement amounts have been released to the public.

Primary care physicians are suffering "agenda overload"

ABOUT HEALTH AFFAIRS:

Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears each month in print, with additional Web First papers published weekly at www.healthaffairs.org.

Laudable but excessive prevention and public health initiatives have been added to the work load of primary physicians who are already hard-pressed to comply with a multitude of bureaucratic requirements. These additonal requirements may have a negative effect on primary care duties.

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Developmental challenges for HIT

Health Care Development Challenges have developed into a ‘crowdsourcing tool for health foundations. The rewards are substantial, and come at a time when developers are searching for funding.  Make your choice. More Challenges, More Prizes! We launched three more challenges this week. Apply Now! Pilot Health Tech NYC Deadline May 23, 2014 Total Prizes: $1,000,000 California Health Care Foundation Design Challenge Deadline: June 27, 2014 Total Prizes: $10,000   NYS Health Innovation Challenge Deadline: July 24, 2014 Total Prizes: $43,000   PCORI Matchmaking App Deadline: August 15, 2014 Total Prizes: $150,000 Palo Alto Medical Foundation Challenge Official Launch: June 11, 2014 RWJF Plan Choice Challenge Official Launch: Coming Soon

Meaningful Use--------for Whom ?

Meaningful Use for Whom ?

Some time ago when EHR was fairly new and systems were immature and not user friendly a new term came into existence,  “Meaningful Use”.

At the time I was never impressed with the early user interface, it was clunky and more important not intuitive.  Intuitive systems are designed with a GUI that leads the user to the next step. It also affords a quick learning curve.  I focused on the ‘ethnology’ or the study of the human-machine interface.  The center of that is the human, not the technology, ie. Provider Centered.

Ethnology is hindered when the user is forced to guess where to go next, or find the screen that  he/she needs to perform the next step.  Based upon current average levels of intelligence and reading comprehension (as studied and defined by competent educators), that is at the eigth grade level, with large print, and pictures.

Be that as it may when I heard the term ‘meaningful use’.  I was excited to interpret that term as what I recommended in many blogs and in conversation with HIT and Health Consultants.

My optimism was bashed when MU was defined. Like many I read into the term as something I wanted to occur.  Nothing could have been further from the truth. I am disappointed as well as most providers.  It cost a fortune.  The coming conversion to ICD-10 will accomplish the same end point.

M.U. has turned out to be nothing more than bureaucratic bloat of the worst type, mandated and defined by an agency that was not interested in EHR as useful for users.  Those who desigined it  were focused passively on receiving the data for analytics.  They placed the cart before the horse.  The resulting system is sabotaged by the disinterest, as well as outright hostility by providers and even health consultants. The system was designed by health bureaucrats and pseudo population health experts.   In my day it was called ‘epidemiology”, a term that evaporated in the last two decades. Epidemiology is defined in Wikipedia and the Dictionary. It was subverted and re-defined by HHS and CMS.

Fear and loathing in meaningful use

When it comes to the topic of meaningful use, Colin Banas, MD, is driven by fear. And he's far from being the only one.

Although several stages have been adopted by providers with some arm twisting and extortion using reward and penalty to incentivize installation of EHRs with MU embedded.  This required expensive alterations to existing EHR systems. Although late in the  game, several medical organizations caution:

AMA Wants Major Changes in Meaningful Use

Meaningful use has been around for two years. A large number of users have attested to stage I, fewer to stage II and the deadline for stage III is pending. Meaningful use has been a great source for consternation among providers, and a boon to HIT consultants.  It is an expensive journey for provider and hospitals. HHS produced incentives for providers to adopt electronic health records. and penalties for those who would not adopt EHR a penalty. The incentives were inadequate since few providers realized there were 3 stages for meaningful use.  Deadlines are approaching for the implementation of MU and penalties in the form of penalties (reduced reimbursement) are near. ICD-10 deadlines have been extended due to pushback from providers.  This is due to a lack of resources, and the preceeding upgrades of EHR and meaningful use.

AMA has a wish list of MU improvements

In a detailed letter sent to both CMS Administrator Marilyn B. Tavenner and National Coordinator Karen B. DeSalvo, MD, the American Medical Association has put forth a long list of ideas to make meaningful use work better for physicians.

This effort must be joined also by specialty societies, other provider advocate organizations, such as Doctors4PatientCare, the Association of American Physician, The support of these parallel organizations is critical since the AMA represents only 25% of the physicians in the U.S.

Thrill is gone as meaningful use strains

It seems just about everybody has a gripe or two concerning the meaningful use program: software vendors that make electronic health records systems, hospital CIOs, the very people charting the related committees and, of course, physicians.

There still remains a lack of a guiding organization with standards of ethnology.  It may exist for other industry IT and record systems, however for health care it is a ‘black hole’.  There are indications that the Food and Drug  Administration is considering EHR as a patient related function and should be included in the FDA’s regulatory arm.  The FDA is well  along with proposals to regulate mobile health apps.

Source:  Meaningful Use Table and Charts for Staging.  (CMS)

Openness and Transparency

Medicare recently released figures for physician billing It included all physicians who bill CMS for services.  CMS requires a ‘current procedural code’ (CPT) for each visit, outpatient, inpatient, laboratory, imaging and/or medication and durable medical equpment. There are numerous modifiers, such as those for bilateral proceduress and the like. The data was released without explanation or definition.  The codes are uniform and identical across all specialties.  This is the first time such complete information was released to the general public.

CMS uses the data to track and analyze billing practices. It is used to analyze for fraud and abuse. CMS studies the numbers for outliers...who bill the most….using a specific code. Some CPT codes are used to determine the amount of complexity or time involved in a patient visit.  CMS has specific items which are required to code for the level of complexity of the visit.  The CPT codes are complicated and providers will often consult with or have a ‘reimbursement expert’ to code. Except for general internal medicine most specialists use a relatively narrow range of CPT codes according to the procedures they do. (gastroenterology, ophthalmology,urology, radiology etc.

(NPR) National Public Radio broadcast information given by CMS and also commentary by a  physician who  heads the kidney transplant program at the University of Colorado.  The program is the only facility in Colorado providing these services and referrals come from a wide area, even beyond Colorado.

The data revealed the following. Some physicians  coded every visit at the maximum level of reimbursement (rare), some appeared to up-code or bill more than the standard level for some or all visits. Some even down-coded to avoid being selected for an audit.  They chose to decrease income to avoid such an audit which is time consuming and expensive. The outcome of many of the audits is a demand for repayment of the amount CMS determined was billed in excess of the supporting documentation.  Providers must document in the medical record exactly what systems (kidney, lung, heart, skeletal) were examined, and the amount of time for the visit.  The CPT code must be justified by the medical record.  CMS provides guidelines for each level of care. In surgical cases the code also includes all post-operative care for a defined period of time depending on the complexity of problems.

Physicians are the ultimate responsible person who attests to the level of billing and it’ accuracy.

In some cases the data reflects billings for multiple providers who  work for another provider. The data has nothing to do with quality of care. Frequently new procedures develop and it may take months for CMS to announce a code for the new procedure.  The rapid advances in medicine and surgery often result in procedures and/or tests for which there is no code.

Missing from the information is the necessary linkage between a diagnosis and a procedure, without which the claim is denied. If the ICD code and CPT do not fit CMS’s definition the claim will be denied.  CMS has a vast data base on what CPT codes match which ICD code.

The ICD-9 codes have been in existence since       . To further complicate matters a new expanded series of codes, ICD-10 will go into effect in the next 12 months.  The original date for compliance (October 2014) was extended because of providers and hospitals informing CMS and HHS they would not be able to comply with that mandate.  The number of ICD codes expands from 14,000 to over 60,000.  The data in the released information is based upon ICD-9.   The expansion of the ICD codes will require expensive EHR software upgrades and in some cases a new EHR.  Some  providers already replaced their systems several years ago due to early mandates for interoperability and other features.  This amounts to billions of dollars for providers.  The cost may well be more than the ‘fraud and abuse’ claimed by CMS.   CMS  has no provision for the expense of providers to continually be required to upgrade in order to bill.  This is a recurring problem.  CMS quarterly modifies its list of CPT codes and instruction for modifiers as well.  These are hidden costs to medical care, and their is little to no information available to the public regarding these CMS requirements.  The expense from these requirements is never ending and repetitive.

Private Insurers also becoming more open and transparent

Aetna, Humana, UnitedHealthcare to supply healthcare cost data for new transparency tool

Three major insurers are partnering with a not-for-profit group to provide consumers with greater access to healthcare cost information, the group announced Wednesday morning. (MODERN HEALTHCARE)

FULL STORY »

Openness and transparency not only apply to financial information, but more important to the physician-hospital-patient interaction.  Unfortunately patient centered medicine is still far from reality.  The transition from a physician led system has been a subtle erosion of ‘captain of the ship’ to a member of the team mind-set.

Affordable Care Act------Silk Scarf or Pig's Ear ?

Silk Scarf or Pig’s Ear ?

President Obama and the Democrats insist that the Affordable Care Act is working and has increased the number of insured, yet most Americans do not like the law.

The question now is what kind of bang did we get?  

Figures from the Heritage Foundation in their Consumer Power  Report “Obamacare Squandered $1.2 Billion on Failed Exchanges

It all began when HBX was enrolling carriers for each state. At best it was a difficult sell with much arm-twisting   In Maryland, Mississippi, New Mexico, and South Dakota, officials had to beg and plead just to get one carrier into the state’s private market.

Continuing problems are ongoing in many state exchanges. There’s only one insurance carrier – Blue Cross Blue Shield – in West Virginia’s exchange.

Hawaii is another consensus pick, and some experts say the state might never be able to support its Obamacare exchange. Hawaii was near the bottom for total enrollment, signing up just 15 percent of its eligible population, and had the second-worst mix of young adults. The state’s exchange also suffers from the fact that Hawaii had a low uninsurance rate to begin with – meaning there’s a smaller pool of potential customers there, which makes the state less attractive to insurers. Hawaii’s “Health Connector” has signed up the smallest number of people of any state in the country and has no plans to finance their operations moving forward. Their current plan appears to be to all-but-close-up-shop and outsource all of the exchange functions to the state Department of Human Services. The state’s leading insurance company says it is time to pull the plug. Expect this one to be official any day now.

Health care analysts are also keeping an eye on premiums in Maryland, Mississippi, New Mexico, and South Dakota, where officials had to beg and plead just to get one carrier into the state’s private market.

The expected rise in premiums will vary greatly from state to state, smaller states with fewer enrollees and a bias toward older and sicker people will see sharp rises in premiums.  It’s impossible, though, to say with any certainty whether a particular state will see an above-average price increase next year.   Maryland, Mississippi, New Mexico, and South Dakota,  are among those HBXs to watch.   Minnesota’s exchange has been a disaster, and they recently brought in [Deloitte] on a nine-month $4.95 million contract to fix it. It is unclear whether they will be successful.

Vermont, the tiny state with giant ambitions to use Obamacare as a stepping stone to single-payer, government-run health care is still facing enormous problems dealing with its tiny population. They are using CGI, the same vendor that failed on the federal healthcare.gov, and have given them a deadline of July 2 to get the site working. It is unclear what Vermont will do if they fail to deliver by that date.

The total is $ 1.2 billion…..and it is not over, yet

HTE DIGEST Vol 1 No. 3

Telehealth puts powerful tools in the hands of providers

Honeywell HomeMed President John Bojanewski takes a look at the evolution of telehealth and its impact on the provider-patient relationship

Reimbursement issues have delayed adoption of telehealth, however

insurers and CMS are gradually accomodating it’s use.

mHealth still untapped resource for docs

For the most part, providers are still wary over the mHealth movement. And this caution just might be preventing them from big care improvement opportunities, say the findings of a new study.

Docs get mHealth help to handle tough conversations

In a sign that some companies are swinging back from consumer-directed healthcare and looking to help the providers, one firm is developing a web-based and mobile platform to assist doctors in talking to patients about changing difficult behavior patterns.

“The past and current model of direct to consumer marketing and sales leaves

the patient to making treatment decisions without collaboration with their provider”

Study: Docs need to promote mHealth apps

“As a corollary to consumers purchasing mHealth apps, doctors must provide leadership

collaboration with their patients.”  If patients are going to accept this a formula should be available for some insurance coverage or be certain the patient can and will be able to afford the application. A verbal recommendation should be reinforced with a written prescription, which has a stronger meaning.

Black Book names leading practice EHRs

“It's no easy feat to be the best, even in the healthcare IT space, but one EHR vendor has come out on top, earning the highest scores for client experience and customer satisfaction in the small practice category.” This news is germane because a large number of users are very dissatisfied with current EHRs.

More modern and contemporary EHRs are now in the market.  Replacement costs will be significant.

Why penalize the early EHR adopters?

The way John Berneike, MD, sees it, being an early adopter of electronic health records has put him in line for unintended punishment under Stage 2 meaningful use.  Many providers purchased new EHRs several years ago to meet requirements for interoperabilty and now are faced with additonal mandates, as well as another expensive change to diagnostic coding, expanding ICD-9 to ICD-10.

HTE DIGEST Vol 1 No 2

HTE Health Train Express is Celebrating 10 years of publishing on the internet. Throughout this month we will publish articles from the past ten years.

JAMA (Journal of the American Medical Association) study claims low value care cost Medicare $8.5 B

A substantial number of Medicare Beneficiaries receive low value medical care. Several criteria were used to measure low value care. Medicare spent $8.5 billion, or $310 per beneficiary, on services detected by the study's more sensitive measures of low-value care, while spending on low-value services with more specific definitions totaled $1.9 billion, or $71 per beneficiary.

That accounted for 0.6 percent to 2.7 percent of overall spending, depending on the measures' level of sensitivity. While representing "modest proportions" of total Medicare spending, the researchers note the findings suggest widespread overuse of unnecessary treatments. JAMA Study  KHN Study

SPOTLIGHT ON... First 2015 rate filings show premium hikes

Virginia is first state to release rate proposals for 2015. Premium rates will rise 3.3% (KFHP), 8.5% (Wellpoint Anthem). to accomodate poorer health of many new members likely to boost their health care utilization.

Aetna: Bumpy road ahead for ACOs

Webinar events  Mark Your Calendars:  A collection of free webinars of timely subjects

> Next-Generation Subrogation Solutions - Wednesday, June 4, 2014, 12pmET / 11amCT / 9amPT

> Healthcare's new entrants: Who will be healthcare's Amazon.com? - Wednesday, June 3rd, 11am ET / 8am PT

> New Rx Savings Strategies for Payers - SPONSORED BY: Elsevier

> The Growing Challenge of Medical Identity Theft - Thursday, June 5, 2014 | 1pm ET, 11am PT

> The Internet of Things: How connected devices put data in your hands - Thursday, June 12th, 1pm ET / 10am PT

> Developing for the Internet of Things: Challenges and Opportunities - Wednesday, June 18th, 2pm ET

> Boosting physician adoption of CPOE to maximize its benefits - Wednesday, June 25th, 2pm ET/ 11am PT

Better MLR compliance reduces consumer rebates

Insurers issued about $513 million in rebates for 2012 under the medical-loss ratio requirement, according to a Commonwealth Fund report released Tuesday. That's half of the amount paid in 2011, showing greater compliance by insurers with the Affordable Care Act's MLR rule.  Commonwealth Fund announcement and study (.pdf)

CMS decided to increase the Medicare Advantage payment rate by 0.4 percent after it proposed in February to lower rates for plans,  Despite the reversal, some insurers like Aetna and Humana have still predicted Medicare Advantage payments will drop by as much as 4 percent.

Health IT News:

> Within two decades, Google might dominate the medical technology industry as the company currently spends $8 billion a year on research. Article

Shortage of Health IT Professionals Imperils Health Care Reform…

During the past ten years  adoption of EHR, HDX, and Hospital EHRs created a tsunami of demand for experienced IT professionals.  Despite funding for training of HIT personel via the HITECH ACT ongoing demand has created a shortage, impacting EHR installations, and Health Care Reform.  Much of Health Care Reform requires integration of data silos and data analytics

Is Meaningful Use is On the Ropes?

Controversy and disagreement continues in regard to Federal mandates for inclusion of Meaningful use standards for electronic health records. Meaningful use was designed to guide transition to EHRs that would exchange data, increase patient involvement, and allow data collection for analysis.  Providers are mandated to either modify their present EHR or completely replace their software.  This comes at a time when there are many competing increases in bureaucracy, planned adoption of the ICD-10 diagnosis tables.  Providers have said that the definition of Meaningful Use by HHS is not the same as meaningful use by providers.  EHRs continue to be inconsistent, not user friendly, nor intuitive.