Florida Clinical Labs Must Now Give Patients Direct Access to Their Laboratory Test Results

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lab testingBy: David Hirshfeld 

In an effort to help individuals access their health information so that they can become more actively involved in managing their own health care, several agencies within the Department of Health and Human Services promulgated a rule that modifies the Clinical Laboratory Improvement Amendments (“CLIA”) and the Health Insurance Portability and Accountability Act (“HIPAA”) in a way that supersedes Florida State laws governing the disclosure of laboratory test results directly to patients.

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Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

gavelThe Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records.  The underlined portions below are the new standards required for medical records as it relates to compounded medications.  These standards are effective September 9, 2013.Continue reading

The Preventionists Are Coming!

paul-revereThe popular conception in healthcare is that (1) a new law was passed, (2) it changed everything, and (3) in a bad way.  Over time, however, it should get clearer that, while there was a law passed, the law alone is not driving changes to our healthcare system: it’s our own demographics and behavior.  Most of the tax dollars currently fueling our healthcare system (and arguably our economy) are tied to an aging Boomer population that are soon to drop off the income producing cliff into the Medicare population.  Bye bye income earners; hello ridiculous public healthcare expenditures.  Though it is true that the timing for expanding public spending on healthcare (with the federal mandates aimed at employers and Medicaid eligibility expansion) could not be more poorly timed, the situation is more of a “Perfect Storm” than a surgical strike.

The financial stress of our changing population and of a historic utilization based healthcare system is causing our healthcare system to morph in every way.  “Health insurance,” with increasing cost, copays and deductibles and reduced benefits, is quickly ceasing to look like your father’s 80/20 major medical plan and starting to look more like catastrophic coverage.  Fee for service compensation is fast becoming “spoken” out of existence.  There are more “pay for performance,” “case rate” and other outcome and risk based compensation models than you can shake a stick at.  The simple truths are: payers have to deliver more with less; and patients have to bear more and more of their healthcare expenses.Continue reading

ACO Challenges Are Formidable

Final-ACO-RulesHanging this nation’s cost cutting/quality enhancing hopes on Accountable Care Organizations (ACOs) is bound to be frustrating and disappointing.  The ACO model seriously lacks sufficient real world grounding and is no magic pill.  Things like resources, operational capability and alignment (of financial incentives and direction) seem to have been overlooked or undervalued.

The ACO model is based on one fundamental assumption:  an expanded role of primary care physicians can slow cost increases and ensure better coordination of care.  That assumption is flawed for two reasons:  first, there is a large and growing primary care shortage; and second, the financial incentives in healthcare have driven a system based on acute, episodic interactions, leading to enormously fragmented clinical training and care.

We not only have inadequate resources to drive change away from acute, fee for services based care, but rather we lack resources that drive wellness. As one physician with a large hospital system recently said:  “We physicians are not trained to provide healthcare.  We’re trained to intervene when things go bad.”  Asking healthcare professionals and facilities to drive a model based on outcomes and resource consumption is theoretically possible, but a remarkable leap of faith (and training) is required, given they have made their livings off of sick people for so long.  That’s not to say that changing financial incentives from acuity to wellness and outcomes won’t work.  It’s just going to require training and proof that the players can make money with the new mandates.

As far as operations go, those with the greatest access to management, capital, IT and such are also the most expensive—hospitals.  It makes sense that the core objective of healthcare reform is to “squeeze the toothpaste tube” backwards from hospital to specialist to primary care physicians, but it’s a great leap of faith to expect that hospitals will or even can control costs.  In a healthcare system where providers admittedly are rewarded for doing more with more expensive things, the sharp turn required by the new law will require more than just a new law.  With all the current hospital-driven physician acquisitions, the increasing role of hospitals on the ACO issue looks at times more like turf guarding than any real cost-saving, quality enhancing move.

At the end of the day, all players have to answer the question “Did they reduce cost and enhance quality?”  It seems convincing that moving away from the fee for service model will change behavior.  We just need to make sure (1) there are sufficient resources to implement the change, and (2) financial and clinical issues are well balanced.  Time will tell, but meanwhile the current irony is that the most expensive link in the chain is best situated to actually operationalize the ACO concept.

Alignment is critical.  Financial alignment will require the players to believe they can all thrive in the new ACO model, yet physicians are historically leery of any hospital driven system.  In fact, given that hospitals are driving the ACO bus at the moment, the biggest fear among physicians is that they will be left out.  Even among physician-driven ACOs, the tension between primary care physicians and specialists is intense.  How much of any savings will go to primaries vs. specialists is no less divisive than the issue of the hospital/physician split of the shared savings.

Even more critical is the apparent lack of consideration given to the need for patient participation.  Where is the financial incentive for healthy patient choices and the disincentive for unhealthy patient choices?  Moreover, in a culture where more is more, why would anyone want to receive care from an organization that gets more by giving less?  Given further the ability of patients to wander in and out of ACOs and yet charge their ACO with the costs of non-ACO providers (who arguably have no stake at all in reducing expenses), the forecast for patient alignment is gloomy, but their buy in is critical.  It is difficult to see where patients have any stake in this change and would even be inclined to choose to be served by an ACO.  Many noted theorists have drilled on the glaring lack of patient alignment.  Rama Juturu and recent Wall Street Journal editorialists/economist Clayton Christensen have been outspoken about the need to enlist patients in the drive from intervention to prevention.  Patients that flock to ACOs (or whatever) will only do so if they see what’s in it for them.  The only thing an ACO can sell is results, outcomes.  And that’s gonna take time to measure and to sell.

At the end of the day, the threat of ACOs (and any vehicle to control healthcare costs more effectively) isn’t that they won’t work.  It’s that cost concerns will outstrip clinical ones.  While it can be argued that the employment of physicians by traditionally adverse players (like hospitals) will likely reduce the tension between them, it is precisely that tension that has always held the threat of “money over quality” at bay.  What will happen as hospitals and other healthcare players employ more and more physicians?  One can only hope that it is not silence and that, as found in some well established systems in the Midwest and West, respect for the different and necessary roles of ensuring both quality and economic survival will balance out, regardless of the healthcare delivery model that emerges.

What You Need to Know About the Physician Feedback/Value-Based Payment Modifier Program

Via CMS.gov

What?
The Physician Feedback/Value-Based Payment Modifier Program provides comparative performance information to physicians and medical practice groups, as part of Medicare’s efforts to improve the quality and efficiency of medical care.  By providing meaningful and actionable information to physicians so they can improve the care they deliver, CMS is moving toward physician reimbursement that rewards value rather than volume.

The Program (which is specific to Fee-For-Service Medicare—not Medicare Advantage) contains two primary components:

  • The Physician Quality and Resource Use Reports (QRURs, or sometimes referred to as “the Reports”) Select “QRUR Templates…” option from the menu on the left side of the page
  • Development and implementation of a Value-based Payment Modifier (value modifier)

Select “Value-based Payment Modifier” from the options on the left side of the page.

Why? 
This program supports the transformation of Medicare from a passive payer to an active purchaser of higher quality, more efficient health care through the value-based purchasing (VBP) initiative.  Physician feedback reporting was initiated under Section 131 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), and was expanded by section 3003 of the Affordable Care Act of 2010. The Affordable Care Act directed CMS to provide information to physicians and medical practice groups about the resources used and quality of care provided to their Medicare Fee-For-Service patients, including quantification and comparisons of patterns of resource use/cost among physicians and medical practice groups. Most resource use and quality information in the QRURs is displayed as relative comparisons of performance among similar physicians or groups.  Section 3007 of the Affordable Care Act mandated that, by 2015, CMS begin applying a value modifier under the Medicare Physician Fee Schedule (MPFS).  Both cost and quality data are to be included in calculating payments for physicians. By 2017, the Value-based Payment Modifier is to be applied to all physicians who bill Medicare for services provided under the physician fee schedule.

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Closely Monitoring the 26.5% Medicare Physician Payment Threat

Via HCMA, SGR Advocacy Alert from the AMA – – – –  The negotiations between Speaker Boehner and President Obama on the Lame Duck tax and deficit reduction package are at an impasse. There is a very real threat of the 26.5 percent Medicare physician payment cut taking effect on January 1, 2013, at least temporarily.

If Congress does adjourn without addressing the payment cut being induced by the sustainable growth rate (SGR) formula, the Administration announced today that the Centers for Medicare and Medicaid Services will follow normal claims processing procedures.

That is, claims will not be held and Medicare carriers will process payments for physician services provided after December 31 under the normal 14-day cycle required by law.  Payment for these claims would be based on the new, lower fee schedule conversion factor of $25.0008, as opposed to the current rate of $34.0376.

At this time, it is impossible to predict whether the 112th Congress will find a way to pass a stop-gap measure before adjourning, how long such a measure would last, or how long payment cuts will be in effect before legislation can be passed after the 113th Congress convenes in January.  It is highly unusual for a new Congress to enact significant legislation in the first month of its session, but the circumstances facing our nation today are far from typical.

It is inexcusable that Congress is once again putting the 47 million Medicare patients and the practices of physicians who provide them needed health care at significant risk.  The Medicare program has become unreliable and its instability undermines efforts by physicians to implement new health care delivery models that stand to improve value for seniors and other beneficiaries through better care coordination, chronic disease management, and keeping patients healthy.

The AMA believes that the financial disruption this situation will cause for physicians and their practices is unacceptable, and we will continue to fervently convey this message in the strongest possible terms to Congress and the Administration, as we have for the past several weeks.  Our patient and physician grassroots networks have been activated, and we are seeking your voices to tell Congress just how deeply its inaction will affect you.

Despite these efforts, at this time we feel compelled to advise physicians to start making plans for steps they can take to mitigate this disruption and meet their own financial obligations in January, in case the 26.5 percent cut actually takes effect.  Given the potential impact on practice revenue in early January, physicians should be certain adequate arrangements are in place to sustain their practices.  For those physicians who are forced into the untenable position of limiting their involvement with the Medicare program because it threatens the viability of their practices, we urge that patients be notified promptly so that they, too, can explore other options to seek health care and medical treatment.

Florida Board of Medicine Set to Tackle Telemedicine Issue

laptop doctor

Florida laws that pertain to telemedicine are precious few.  In fact, there is really only one regulation dead on target, and that requires face to face physician contact with a patient in order to write a prescription.  The impact of the hormone replacement therapy (HRT) providers was pretty immediate, but the legal issues related to telemedicine are just not currently addressed in Florida law.  Does providing a telemedicine consult create a physician patient relationship?  What are the requirements related to the medical records arising out of the consult, and who owns the records?  These issues and many more are simply not handled.  And yet, if it is true that telemedicine will be an important tool in the effort to both broaden the availability of care while reducing associated costs, we can be sure that Florida law will evolve on these issues.Continue reading

Perceived Risk Outweighs Actual Harm in Assessing $1.5M HIPAA Fine

The Office of Civil Rights’ recent assessment of a $1.5 million fine for HIPAA violations should be a shrill wakeup call to all health care organizations that use (or allow their physicians to use) portable devices containing patient identifiable information.  The sanction stems from a physician’s lost laptop computer containing protected health information (ePHI).

Importantly, the OCR’s investigation could not establish whether ePHI was used or even accessed, partly because the device was lost in a foreign country.  However, it was not necessary to definitively conclude if any data had been compromised; the OCR was more concerned that the offending provider had not implemented appropriate measures mandated by the HIPAA Security Rule which could have reduced, mitigated or eliminated the risk altogether.  For the OCR, the heart of the matter was the fact that the covered entity failed to fully assess and evaluate the risk to the confidentiality and security of ePHI on portable devices used by its physicians in their personal activities, and failed to have a process to address when such devices are lost.  In this case, it was the incident itself that caused the organization to formalize and take responsive measures.  The barn door was closed after the horse got out.  To the OCR, the covered entity’s reactive, rather than proactive approach, was totally at odds with HIPAA Security Rule concerns and the mandated obligations of covered entities.

The facts are fairly simple.  A research physician from a Massachusetts specialty hospital facility was traveling to South Korea to give a lecture when he misplaced his backpack in a public area.  A personal laptop, containing health information of several thousand patients, was in the backpack.  The computer was eventually “detected” a few weeks later when it was connected to the internet, and its hard drive was later remotely “wiped”, however, the device was not recovered.  The incident was then reported to the OCR in accordance with the breach notification requirements of the HIPAA Security Rule.

This is an instructive case for a number of reasons.  For one, it is important to recognize that the OCR’s investigation was prompted by the obligatory “breach notification” it received from the provider.  The OCR’s inevitable investigation in turn revealed that there was significant noncompliance with multiple aspects of the Security Rule.  Notably, the OCR determined that the covered entity had lax control over, and little knowledge concerning its own physicians’ use of laptops issued to them by the organization.  Physicians were permitted unfettered access to the entity’s information, took their devices off-site where they were used for personal activities, and could remotely download information and install applications freely to these personal devices.  Further, while the laptop in question was password protected and had “LoJak” tracking and wiping software, encryption was not employed.  Further, many weeks passed before a hard drive wipe was effectuated and only after it was determined that the device had been connected to the internet.  In short, the OCR concluded that the entity had neither conducted an adequate security assessment nor established necessary policies or procedures addressing laptop use, and had not promulgated an appropriate response procedure.  Instead, it reacted to the lost laptop in a scramble of ad hoc activity and only instituted organization-wide changes as a result of this episode.

The most significant issue for the OCR in assessing a $1.5 million fine was not whether the incident caused actual harm to any patient, but the degree of risk of potential harm and whether reasonable steps and safeguards should have been in place to mitigate any data breach.  In short, the entity should have anticipated laptops would be lost and it should have addressed the attendant risks through a deliberate process and in a manner that is “situationally” appropriate for the organization.  Here, the organization abrogated such a duty, thus prompting a fine that may be disproportional to the perceived harm.  This outcome should prompt providers to seriously regard the HIPAA Security Rule, and the OCR’s enforcement efforts, and to abandon any “no harm, no foul” notions they might apply when security breaches occur and must be reported

From Intervention to Prevention

“Healthcare Reform,” “PPACA” and “ACOs” all have one certain thing in common:  cost-saving change.  Though debate swirls about politics, timing and the particulars of change, it seems clear that the changing demographics of our country (aging baby boomers) in our economic climate is not sustainable as is.  And it’s no surprise that a compensation system based on how much is done and how much it costs leads to greater expense.  An economic reward system that drives costs up as more and more people are set to join the ranks of the insured (through mandated health insurance and expanded Medicaid) simply underscores the timing of the change.  What does that mean for physicians?

Physicians are asking three key questions:

  1. Is there a future for small or solo practices?
  2. Is fee for service really gonna change?
  3. What can I do right now to adapt?

The Future of the Small Practice

The only solid answer is “less.”  It really depends on complex things like the demographics of where the doctor practices and the number of competitors close by.  That said, as change happens, the hardest hit will likely be the smaller practices, since they lack the personnel and financial resources to weather the change and to invest in adaptation.  Many small practices will likely experience change in such a way that the best they can hope for is to survive, rather than thrive.  Even worse, solo practitioners already know what it’s like to handle all the duties as a physician, keep track of business operations and keep the patients flowing into the practice.  Exhausting.  Without substantial support and resources, it’s just not realistic for most solos to expect to keep up.

Even larger practices are not often run like a business.  The professionals that generate the revenue often manage as well.  Moreover, most medical practices do not market or do any serious “back office” magic (revenue cycle management).  As such, change hits small practices especially hard.  Implementing even new EHR requirements can be consuming for a small practice.  How will it be as changes are made to reduce cost and improve quality?  How will it be when practices begin to see there is opportunity in change, that they may actually make more money in a risk based compensation environment?  Rougher.  Like a herd of buffalo when attacked, circling together is a good strategy.

That said, the vision has to be clear.  Why circle together?  Most medical practices are combining and growing to guard market share, not to manage costs or measure and demonstrate quality.  This is probably the biggest reason why we see larger practices in single specialties, not multi-specialty or primary/specialty based practices.  Most physicians that are adapting by joining larger practices are doing so for the same reason why buffalos circle together—the threat of change.  Though size alone is no panacea, larger practices are definitely in a better position to adapt.

Let’s face it:  few are running after change in healthcare right now.  Few see the opportunity and are leading the charge.  Most are waiting or are just setting the stage.  And most large practices are, at best, a good platform where change can be implemented and costs can be shared and spread among a larger pool.

Will There be a Change to Fee for Service Payment?

Yep.  Simple as that.  It’s already happening.  Bundled payments are in place, even in Florida.  Capitation is old hat for many now.

When?  Over time…  Not right away.  Even ACOs aspirants are selecting just one sided risk, testing the water as they see how well they do to reduce costs, improve quality and “earn” their right to bonus money.  Physicians that think fee for service will thrive for decades are kidding themselves, at least in the insured market.  Is there a basis for it in a “second tier” or concierge sort of environment?  Probably.

What Can I Do Right Now?

First, accept that we are approaching a new paradigm of healthcare delivery.  The current model of disease/injury crisis management has prepared no one for the move from intervention to prevention.  And yet, systems that are solidly based in wellness and prevention stand to profit most from the change we all face.

Second, look to shore up you business model.  That means:

  1. Look to join a larger practice that is committed to thriving in the future risk-based compensation scenario.  If the practice is there just to thrive in a fee for service environment and has no commitment to thriving in a risk based compensation model, keep looking;
  2. Market.  Most practices do not market at all, and yet consumers are selecting medical care in the most unlikely environment—the internet;
  3. Look at anything concierge-like.  Most of the public conversation centers around the insured market, mostly the Medicare Shared Savings Program (which has spawned the ACO concept).  What about the rest of the consumers?  As the insured market gets squeezed (remember that consumers are feeling the pressure too with heightened copays, deductibles and benefit limits), you can expect growth of the “second tier,” those who want more and are willing to pay for it;
  4. Build in wellness and prevention.  Not all practices lend themselves to wellness related services that can reduce healthcare costs, but those that do must look at ways to offer cost-saving, wellness and prevention-oriented services;
  5. Enlist the patients.  The concept of “partnering” with patients is strange, but consider the amount of savings and the enhancement of outcomes if physicians could incentivize healthy patient behavior.  Though absent from the public policy conversation, health care businesses that build in patient accountability stand to win big in a payment system that rewards clinical outcomes and cost savings.

Change is frightening.  Even “good” change is frightening.  Just look at all the upset stomach meds sold at airport kiosk counters.  Physicians have a terrific burden at this time.  They not only hold our health in their hands.  They are expected to have skills and time to help create a new environment in which care will be delivered.  Denying change in the healthcare sector is a waste of time and energy.  Looking for ways to thrive in it and even drive it is wise.

The Florida Healthcare Law Firm Goes National

Followers & Friends – BIG Announcement coming out today! If you haven’t seen our new NATIONAL platform, check it out here at www.nationalhealthcarelawfirm.com and stay tuned for our #healthcare #legal news at 2pm EST !!!