What the Wall Street Journal Tells Us About Complications After Surgery: Not Much

The Wall Street Journal published an article on Christmas day that told the story of an 83 year old woman who suffered a heart attack after a joint replacement at a rural hospital.  The story serves as an introduction to a piece about the higher cost and poorer care delivered at rural hospitals.  There are certainly some very interesting points I was not aware of with regards to financial incentives provided by the government to do procedures at rural ‘critical access’ hospitals, as well as higher 30 day mortality after joint replacement surgery at these rural hospitals.

The Wall Street Journal article does provide this nugget from a Harvard public health researcher: “Patients are getting bad outcomes, probably because they are getting procedures at hospitals without the experience to do it well.”  

This certainly may be true, but no data exists in the article to back-up this assertion.  Are there more infectious complications of the surgery?  Are there more re-operations? Are the surgeons that operate at these centers less experienced?

The aim of the initial CMS initiative to expand access to care for rural patients seems to have worked. More patients are getting surgery closer to home as a result.  It is troubling that mortality rates are higher at these hospitals.  Perhaps the answer is to take away the incentives and move surgeries back to the larger hospitals.  I don’t know, and the article isn’t particularly helpful in answering those important questions. I would hope the folks in our profession who help shape public policy, like the Harvard physician quoted in the study, would be a little more careful in implying causation when all that has been discovered is a hypothesis generating correlation.  My hope is that he isn’t advocating for changes to public health policy based on simple correlations.

I do take issue with the story used to make this point.  Unfortunately, a heart attack is a complication of any surgery.  It is not clear from the story what parts of care provided at this rural hospital were substandard.  Patients at teaching hospitals do have heart attacks post-operatively as well. Differences in outcome may relate to delays in access to subspecialists you need in this situation.  Unfortunately, this article doesn’t shed light on any of this.  It instead joins a laundry list of articles that leaves the distinct impression that something bad happened to a loved one at a hospital that was preventable. There are plenty of things I wish for.  

I would love to have a light saber, I would love even more to travel at light speeds in the Millenium Falcon, and most of all I would love to live in a medical world free of any harm.  Elon Musk would lead me to believe we are a lot closer to flying in a Millenium Falcon than we are to working in a zero harm environment.  Surgery, especially, is not close to a zero risk endeavor.  While I have found estimates reported in the literature to be overstated at times, as many as 10 million patients (out of 200 million undergoing non-cardiac surgery) worldwide are estimated to suffer a major cardiac complication. There is a possibility that your 80 year old grandmother will have a complication of surgery even if it takes place at an ivory tower institution, and even if every single medical and surgical practice standard is met.

As we usher in 2016, I do have a solution that will definitely sate everyone’s desire for zero risk.  In order to get to zero risk, I advocate we stop operating.  I feel safe in guaranteeing that there will be no complications of surgeries this coming year if there are no surgeries.

The author is a cardiologist based in Philadelphia.

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21st Century Cures Act: Away From the “Valley of Death”

By STEVEN ZECOLA

Most people would agree that the number of cures for debilitating and costly illnesses such as Alzheimer’s disease, Parkinson’s disease and cancer have been too few and far between.

To address this issue, the U.S. House of Representatives recently passed the 21st Century Cures Act, which now resides in the U.S. Senate for action.  The main thrusts of the Act are to increase government funding for research and to improve several regulatory processes.

Unfortunately, the Act does not address the root cause of the dearth of cures; namely, the inhospitable investment climate for research and development (“R&D”) culminating in the “Valley of Death” for most health-related discoveries.


II. Overview of the 21st Century Cures Act

The 21st Century Cures Act mandates a 3% real increase in the NIH budget per year for three years after enactment. It also provides an additional $1.86 billion a year in the form of an “innovation” fund that would primarily support young scientists and precision medicine.

The bill also provides for changes to the current approval processes including provisions for making data from NIH-funded clinical trials more easily available to researchers, facilitating collaborative research, speeding up the review of new vaccines by the Advisory Committee on Immunization Practices, requiring a strategic plan every five years to identify research opportunities and strategic focus areas, reducing administrative burdens on researchers, and limiting the term of office of directors of centers and institutes to five years (with reappointment by the NIH director possible). The bill also requires the directors of each institute to “establish programs to conduct or support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk, but have the potential to lead to breakthroughs” and “set aside a specific percentage of funding, to be determined by the Director of NIH for each national research institute, for such projects.”

III. Critique of the Act

While the provisions of the 21st Century Cures Act are admirable, the Act does not address the underlying reason for the dearth of cures.  That is, the regulatory process adds excessive and unpredictable risk, cost, and delays to research and development that result in a “Valley of Death” where most scientific discoveries remain unfunded.

An approach to overcome this obstacle is summarized here and explained in more detail in a position paper posted at http://ift.tt/1NUZbRQ .  In a nutshell, Congress needs to create an environment that provides for increased incentive for private capital formation to fund R&D without compromising consumer safety.

IV. Summary of Proposed Amendment to Address the Valley of Death in Research and Development

The following five provisions summarize the approach to improve private capital formation for research and development in health-related initiatives.

To ease any concerns between the balance of benefits and public safety with this program, the following recommendations could be rolled out in one or two areas such as Alzheimer’s disease, Parkinson’s disease and/or metastatic cancer where patients have more suffering and less hope for a cure.

The proposed approach is as follows:

1) Congress would limit the FDA’s role in preclinical research to surveillance.

2) Each pre-approved, qualified professional research organization filing a Phase 1 drug application would receive a provisional license from the FDA within 60 days from the time it provided the details of its trial and put a corresponding deposit into an escrow account.

Likewise, applications for Phase 2 and Phase 3 trials would also be subject to a 60 day review cycle and would require additional funds to be deposited into an escrow account, the amount of which would be subject to the size of the trials. A sample deposit schedule follows:

Phase 1 – $250,000 per trial participant
Phase 2-  $100,000 per trial participant
Phase 3 –   $50,000 per trial participant

The above schedule would produce escrowed deposits as follows:

Number of Participants       Incremental Deposit   Cumulative Deposit
Phase 1 20 – 40                       $5M – $10M                 $5M – $10M
Phase 2 100 – 200                   $10M – $20M                $15M -$30M
Phase 3 1000 – 3000                $50M – $150M             $65M – $180M

The FDA would have the authority to reduce the above deposits for special considerations.

3) An industry organization would be required to provide regular reports to the FDA for purposes of oversight (along with the reports provided by individual research organizations with the results of each phase of its trial). This industry organization would have the authority and responsibility to audit individual trial results and to maintain a secure whistle blower system.  A reward would be paid to whistle blowers whose efforts led to the successful prosecution of fraud by a licensee.

4) The FDA would have authority to seek injunctions from the U.S. Court of Appeals to stop any new drug, procedure or device that it believed was unfit for human application.  If a company were found to be in violation of the FDA’s safety guidelines, the company would lose its license and forfeit its escrowed funds.

5) Research organizations would be required to maintain and submit relevant health statistics on patients for one year from commercial launch.  Sixty days after such filings, the FDA would issue a commercial license and the escrowed funds would be returned to the licensee if a Court had not granted an injunction.

Likewise, if the research organization voluntarily abandoned its program during development, the deposit would also be refunded.

Such an approach would place the risk, pace and costs of both pre-clinical research and clinical trials principally under the control of qualified research organizations.  The effect would be greater funding opportunities for the private sector to pursue promising research opportunities.

In addition, the Amendment would strengthen the FDA’s surveillance and enforcement powers for purposes of protecting consumer safety, and put the proper incentives and penalties in place to forestall the introduction of unsafe products to the public.

V. Conclusion

While the 21st Century Cures Act recognizes and addresses a significant issue in the health and welfare of our country, it does not solve the underlying problem causing the lack of significant health-related cures.

Congress could jumpstart private funding for research and development of promising discoveries by adopting the above recommendations in an Amendment to the 21st Century Cures Act.

To minimize concerns for public safety, the approach recommended here could be achieved with an Amendment that would apply only to specific research areas such as Alzheimer’s disease, Parkinson’s disease and/or metastatic cancer where suffering is the greatest and hope is fleeting.

Out of an even further abundance of caution, Congress could implement this Amendment on an optional basis, thereby letting research organizations choose between this approach and the more traditional approach outlined by the Act and the FDA.

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How Should Errors In the Patient Medical Record Be Addressed?

This summer an article in USA Today talked about Regina Holliday’s efforts to make the medical record more easily and promptly available to patients so it becomes as a tool patients use as they engage in co-managing their own care. Her cause is just and her story is compelling, so I was dismayed at the pushback saying: Not so fast. There are lots of errors and ambiguities in the record, so it is in everyone’s best interest to make the record hard for patients to obtain.

What a concept.

The commonest examples listed  by opponents of patient access to patient information reflected a combination of poor communication with patients and concern about the extra work that transparency might require for institutions and clinicians. For example:

“…the majority of patients don’t understand differential or provisional diagnoses and want those removed, because they say they are an error. The majority of patients don’t understand trade versus generic drug names, and want those removed because they are an error. The majority of patient’s don’t understand autopopulation of fields (when you click normal) and say the doctor didn’t ask me those things, and want them removed because they are an error; the majority of patients don’t understand spontaneous abortion, and definitely want that removed it, because they never had an abortion; the majority of patients don’t want “dependence on” anything included in their records, and want it removed because it’s an error…. they are very unhappy with all the errors in their medical record. And then, there are the legitimate errors due to poor documentation on admission, hospitalists who see the patient once and don’t review the record adequately, and nursing staff who just want to get their charting done and go home.”

Wow! Everyone who works with medical records knows that the record is full of both errors and ambiguity.  The question is what to do about it. There are two general categories of response.

(1) Make it hard for the person with the most to gain or lose (that would be the patient) to see the record, because that reduces the awareness of the problem and the pressure to fix it.

(2) Make it easy for the person with the most to gain or lose (that would be the patient) to see the record, because that increases awareness of the problem and creates both incentive and opportunity to fix it.

I understand the implications of cumbersome, user-hostile, and error prone documentation. Like all clinicians, I get 100+ page documents after my patient’s 5 day stay in the tertiary care center, where key data is intermixed in (obscured by) a flood of trivia, and which no one has gone through or vetted. Like all clinicians, I have to deal with the letter from the orthopedist about my patient’s  which incorrectly states she is HIV positive.

I spend all day with patients, trying to help them understand their health (or illness) and use the health care system. I am painfully and exhaustingly aware of how complex medicine is, and how imperfect our information and documentation systems are.  I just don’t think that hiding the flaws from the patient  makes any sense.

Look at it this way. What if my bank said they didn’t want to give me an itemized statement of my transactions, explaining that it includes technical financial terms, is hard to understand, and is likely to have errors? They don’t want me to be confused, upset, or angry, so if I submit a written request and pay a reasonable copying charge, they will send me my balance and a summary limited to total deposits, withdrawals and interest within 30 days?  I’d lose confidence in my bank and find another. And I would tell all my friends to do business elsewhere.

When an institutions or a clinician tells a patient that the record cannot be made promptly available because it is too ambiguous, has errors, and might be upsetting, that is a terrible and frightening message. It undermines trust. A reasonable patient will ask, if I can’t trust the institution to share with me in real time an accurate accounting of what they do and why, is there any reason I should trust them to put me to sleep, cut me open, and take out parts? Or irradiate me? Or infuse toxic chemicals?

If I were a malpractice attorney, I think I would want a drawer full of letters from hospitals explaining that they are not making the record transparent to the patient because of ambiguity and errors. I can hear it now: “Ladies and gentlemen of the jury. The hospital has admitted in writing that their documentation is ambiguous and often incorrect. Why should we believe their claim that the information in the record supports their statements that….?”

The excuse “we need to make it hard to access the record because it is poor quality” just doesn’t work for me. The reverse is true. We need to make it easy for the patient to access the record so we can do a better job of making it accurate and usable. The best way to make the record accurate and understandable is to make the default be that the patient knows what is going into the record when it is going into the record and while it is being used, not days, weeks, or months later when it has been retroactively revised or redacted in the interest of the institution or clinician.

We should all document care with the assumption that we are recording what we are thinking, and why we are doing what we are doing, with the information we have at hand. That is, we are telling the truth. This way, we and the patient are on the same page, both literally and figuratively.  If the record accurately reflects what we are doing and the information we are using, even though it may at times be confusing, ambiguous or contain errors, we have nothing to hide.

Yes, it may require more time and effort on the part of the clinician and the system. So be it.  Inconvenience for the clinician, the institution, or the clinical and support staff,  pales beside the imperative of putting the best interest of the patient as the first priority that trumps all others.

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The 2016 Regulatory Landscape: A Review For Health Care Watchers

The healthcare industry in the U.S. is highly-regulated at the state and federal levels, and the balance between the two depends on what part of the industry you’re in. To illustrate—

  • Health insurers are overseen by state insurance regulators, but the Affordable Care Act added a new layer of federal oversight. The current tussle between HHS and the National Association of Insurance Commissioners over what constitutes an accessible network of providers is a case in point.
  • The 56,000 retail pharmacies are overseen by states, but drug manufacturers and distributors are overseen by the FDA and FTC, and the 3000 compounding pharmacies find themselves regulated by both.
  • Physicians are primarily self-regulated by their state licensing and disciplinary boards, but federal rules that require transparency (Physician Sunshine Act) about their performance and prescribe limitations in their business dealings (Stark rules) take precedent.

  • The regulatory framework for post-acute providers is equally complex: each sub-sector has its own combination of state and federal (i.e. assisted living, hospice, et. al.) and all follow Medicare guidance for quality and safety, in addition to provisions added by state authorities in their Medicaid programs.
  • Hospitals largely operate under state oversight through Certificate of Need laws (“Health Planning Resources Development Act” of 1974 is in place in 36 states) and others but Medicare (CMS) is the single biggest force in day to day regulatory compliance and the Affordable Care Act added a significant set of new federal mandates.
  • And in emerging sectors like digital and retail health, distance medicine, self-diagnostics and smart devices, over-the-counter therapeutics and probiotics, et. al., the regulatory framework is equally complex and dynamic. For example, recently the FDA added regulations for smart devices that capture and transmit vitals to caregivers and consumers themselves and advertising claims by “healthy foods” are getting increased attention from the FTC.

Not surprisingly, healthcare issues show up routinely on state ballots: assisted suicide, restrictions on abortion and contraceptive services, and others are prominent. In Colorado, for instance, they’ll vote on becoming a single payer system in 2016.  So healthcare oversight at the state level is significant.

But the federal role in policing healthcare is increasing and is arguably center stage in health reform. It’s understandable: the federal government spends more than $1.1 trillion on healthcare annually, or 28% of the total federal spending.1 Opponents of the Affordable Care Act used “government run healthcare” to characterize the role of the federal government in its reforms while its proponents called attention to its provisions giving state’s wide latitude in its implementation. Nonetheless, it’s clear the federal government plays a huge role, and it’s growing.

2015 was a case in point: King v. Burwell, the permanent fix to the Sustainable Growth Rate (SGR) pay formula for physicians, clarification of CMS value-based payment program, the first mandatory bundled payment program (CJR), Medicaid waivers and the budget deal reached two weeks ago that delayed the Cadillac, Medicare Device, and Insurance Premium taxes are just a few of the year’s headliners.

So what’s ahead for 2016? An even busier agenda for federal regulation of healthcare – here’s a preview:

1-Mega-Merger Decisions: The Department of Justice and FTC should announce the outcome of the proposed insurance mergers (Anthem-Cigna, Aetna-Humana) along with the Walgreens-Rite Aid and Pfizer-Allergan deals in the middle or second half of 2016.2,3  And the FTC will continue its scrutiny of hospital mergers, having challenged three high profile deals in recent months:  Penn State Hershey Medical Center and Pinnacle Health System, Cabell Huntington (W.Va.) Hospital and St. Mary’s Medical Center, and Advocate Health Care and Northshore University Health System.4

2-Medicaid Expansion and Waivers: 31 states and DC have expanded Medicaid to date. CMS has shown flexibility in approving alternative expansion waivers, including most recently Michigan’s that included a 7% beneficiary income contribution feature. Arizona is awaiting CMS’ response on its waiver petition and in five states (Alabama, Louisiana, South Dakota, Virginia, and Wyoming), legislative support is building.5 Beyond Medicaid, other waivers are on the federal review docket:

  • Section 1115 and 1915 Waivers – California and CMS are finalizing terms on an extension of the state’s Bridge to Reform waiver that expires in 2016, and Texas awaits approval on its pending 1115 waiver – both include Delivery System Reform Incentive Payment (DSRIP) programs, $15.3 billion in Texas and $6.7 billion in California. And Iowa’s request to transition to Medicaid Managed Care has been pushed back by CMS with a potential March 1 start.6
  • Section 1332 State Innovation Waivers – Seven states (Arkansas, California, Hawaii, Massachusetts, Minnesota, New Mexico and Rhode Island) have expressed an interest in 1332 Waivers, but the December guidance HHS released is viewed as restrictive. So few states are likely to apply and only those like Hawaii that would like to make small changes around the edges are likely to apply.7

3-Drug Pricing: 1% of drug prescriptions consume 31% of total drug expenditures in the U.S. and overall spending on drugs is expected to increase more than 10% annually again this year.8 Escalating drug costs will be a hotspot for federal attention. Consider:

  • CMS: CMS hosted a public forum in November to find solutions on improving patient access to affordable prescription drugs and one month later published Medicare Part B and D data (total spend, spend per beneficiary, average beneficiary cost share) on 80 prescription drugs representing 33% of Part D and 71% of Part D spend.9
  • Congress: The Senate Finance Committee released its 18-month investigation into the pricing strategies of Gilead’s Sovaldi and Harvoni and the Senate Special Committee on Aging held a hearing on drug pricing by four pharmaceutical companies: Valeant Pharmaceuticals, Turing Pharmaceuticals, Retrophin Inc, and Rodelis Therapeutics. 10
  • Candidates: Secretary Clinton is proposing a $250/month cap on out-of-pocket drug spending, importation, prohibition of industry pay for delay tactics to keep generics off the market. Senator Sanders1 supports importation and prohibition of pay for delay. And GOP candidate platforms favor reforms of the FDA2 to bring drugs to market faster. 11

4-Court Challenges: The courts will continue to be a focus for challenges to the Affordable Care Act and issue opinions in other pertinent healthcare matters:

The Supreme Court is slated to hear six cases with healthcare implications, notably the religious non-profits objection to contraceptive coverage opt-out accommodation in Zubik v Burwell and the constitutionality of Texas restrictions on abortion providers in Whole Woman’s Health v Cole. 12

In Federal Courts, there are several False Claims Act cases and Teladoc’s suit against the Texas Medical Board for requiring an in-person first visit to a clinician prior to a virtual visit authorization.13

Attention to the False Claims Act is certain to be a key focus in 2016 Court proceedings. And House Republicans are suing the Administration for expending funds for cost-sharing for eligible Exchange Plans, alleging the funds were not appropriated by Congress.  The case is moving forward in Federal Court.14

5-Pending Guidance and Final Rules: HHS has 153 new regulations in development, including several noteworthy rules (proposed and final) to be released in 2016:

  • Medicaid Managed Care – In April, CMS will release a final a rule modernizing regulation of Medicaid managed care plans, the first update to the regs since 2002. 15
  • 340B Drug Discount Program: HHS is expected to issue guidance on three changes: 1- tightened eligibility; 2- a civil fine on drug manufacturers that charge above a ceiling price for 340B drugs; and 3- establishment of a dispute resolution process for entities that are overcharged for 340B drugs.16
  • Tobacco & E-Cigarettes – Four rules addressing tobacco related issues are pending including if electronic cigarettes should be regulated as a drugs or device, if sales to minors should be banned, and testing requirements. 17
  • Generic Drug Labeling3 – In July, FDA will release a final rule on whether generic drug manufacturers may unilaterally update safety labels to accommodate new safety risks.18
  • Discharge Planning – In November CMS will release a final rule requiring all hospitals (including long-term care hospitals and inpatient rehabilitation facilities, critical access hospitals, and home health agencies) develop a written discharge plan for all inpatient and many outpatients. 19
  • Common Rule (Scientific Research) – In March, HHS and 15 other agencies will release a final rule updating the “Common Rule,” governing the oversight of scientific research involving human subjects. 20
  • *Not HHS* – Employer Wellness Programs– The Equal Employment Opportunity Commission will finalize regulations clarifying what incentives may be offered for spousal participation in employer sponsored wellness plans and harmonization of the Americans with Disabilities Act with wellness participation incentives. 21
  • Merit-Based Incentive Payment System – In March, CMS will release notice of proposed rulemaking defining the elements and methodology for MIPS, which replaces several Medicare value-based payment programs in 2019, and for incentive payments for alternative payment model participation. 22
  • Meaningful Use – The final rule for Meaningful Use in 2015 and Beyond elicited feedback on how to integrate Stage 3 with the Merit-based Incentive Payment System (MIPS), suggesting the Stage 3 changes could be adjusted. 23
  • Pain Med Overuse: The CDC is reevaluating its draft opioid guidance (due to industry and internal HHS concerns) and it intends to release a final version in 2016. 24
  • Drug Manufacturer User Fees: The FDA will begin negotiations for reauthorizing the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) 25
  • Biosimilar naming: The FDA is expected to release its biosimilar naming guidance and continue its review of 7 pending applications. 26

6-Medicare Alternative Payment Program Updates: In 2016, CMS will continue its acceleration of the volume to value transition in its payment programs.  It will provide additional updated clinical and financial results for its alternative payment model programs and other guidance on…

  • Medicare Shared Savings Program (MSSP) – Hospitals, physicians and other providers are awaiting a final rule on 2017 cost and quality benchmarking methodologies. 27
  • Home Health VBP – January 2016 is the start of the Home health value based purchasing program, a mandatory program for providers in 9 states. 28
  • Next Generation ACO – The first performance year begins January 1 (pending participant announcement) and applications for the second cycle are due in June.29
  • Comprehensive Care for Joint Replacement Model – In early 2016 CMS will finalize the list of ICD-10 diagnosis codes to identify applicable cases and on April 1st the mandatory program will begin for providers in 67 regions. 30

7-New overarching laws that impact Healthcare Markets directly: In addition to final guidance on current laws and pending regulations, several new laws will get Congressional attention with significant impact across the healthcare industry. A few…

  • Trans-Pacific Partnership – The Administration is pushing passage but it faces challenges in Congress. Senator Hatch and others are concerned with its reduced exclusivity of biologics from 12 years to as few as 5 citing its potential to reduce drug manufacturer investments in new biologics. 31
  • 21st Century Cures – This law, passed by the House last July, provides funding for the NIH through 2018 and authorizes the FDA to focus efforts around “precision medicine.” The Senate released its version of the bill and passage is expected this year. 32
  • Corporate Inversions – The Senate Finance Committee and House Ways and Means are expected to address corporate inversions that have allowed US drug manufacturers to avoid US taxes. 33

What’s all this mean?

  • It means the federal government is playing a larger role in oversight in every sector of U.S. healthcare.
  • It means healthcare will get significant media attention in 2016 as court rulings and guidance are released.
  • It means navigating regulatory compliance and managing an organization’s risk will be tougher.
  • It means candidates in Campaign 2016 will be addressing health reforms in their platforms.
  • It means management teams across the spectrum of healthcare must be attentive to regulatory compliance risk to avoid financial penalties and protect reputations.

2016 will be busy in regulatory compliance activities for every organization in healthcare. Boards of directors must be educated about the issues and penalties for non-compliance for the organizations they serve. Management teams must be prepared to demonstrate compliance to regulators. Legislators and policymakers must be diligent and circumspect in understanding the intended and unintended consequences of their actions. And the public will be watching.

Healthcare is not government run, but it is, indeed, government regulated. 2016 promises to bring more guidance, more laws and more risk to every sector in U.S. healthcare!

 

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The Year of the Hacker

flying cadeucii2015 was the year health care got serious about cyber security.
Hackers gave the industry no other choice.

The year started with a massive data breach at Indianapolis-based Anthem Inc., which the health insurer revealed on Feb. 4. Hackers roamed around in Anthem’s computers for six weeks and stole personal and financial information of 78.8 million customers, as well as the information of 8.8 million customers at Blue Cross and Blue Shield plans not owned by Anthem.

There have been 269 data breaches at health care organizations this year, according to statistics collected through Dec. 22 by the Identity Theft Resource Center. That’s actually down from 2014, when health care organizations suffered 333 breaches.

But the number of records stolen has soared to 121.6 million records stolen, up from less than 8.4 million records in 2014. Even without the Anthem breach, there were still 34 million records stolen this year from health organizations.
The health care industry accounted for one out of every three breaches recorded by the Identity Theft Resource Center.

“They can and are trying to break into everything,” Doug Leonard, president of the Indiana Hospital Association, said of hackers. He added, “It’s really on everybody’s radar screen in the health care industry.”

In a survey released in August by consulting firm KPMG, 81 percent of health care executives said their organization had suffered a cyber attack in the previous two years and 13 percent said they were being attacked daily.

In late November, the bond rating service Moody’s said it would now consider cyber risk in its evaluation of health insurers and hospitals, among other businesses. Moody’s will not evaluate the cyber security readiness of the individual companies it rates, but it could use cyber security in stress-tests of companies, much as it does now with weather disasters or acts of terrorism.

“As cyber risk becomes more pervasive, it will take a higher priority within our analysis,” said Jim Hempstead, an associate managing director at Moody’s who was the lead author of a Moody’s cyber security report released Nov. 23.

The risk of a data breach are far higher now for health care providers since the 2009 stimulus act funneled more than $30 billion to help the industry digitize its patients’ medical records. Now the federal government actually penalizes health care providers if they don’t use electronic medical records.

Also, Moody’s noted, more and more medical equipment uses the Internet to send and receive information, making that equipment vulnerable to hacking—and possibly to patient harm or disruption of services.

“We believe the sector’s risk awareness is high, a credit positive,” Hempstead wrote in the Moody’s report. “Most hospitals have completed or are in the process of installing expansive, new patient information systems which likely have better safeguarding features than prior technology.”

Leonard, the president of the Indiana hospital association, said his organization purchased cyber security insurance for the first time this year, because the association receives some sensitive information from its members. It also organized some teleconferences on cyber security for hospitals around the state.
Still, he said, no one really feels adequately protected from hackers, who even breached the federal Office of Personnel Management this year and stole employment records of millions of federal employees, including CIA spies.

“They are probably all suitably worried that they are taking all the precautions they know how to take,” Leonard said, “but with the sophisticated attacks going on, I don’t think anybody feels adequately protected.”

Indeed, in an October simulation of a cyber attack among 12 health insurers, conducted by the HITRUST Alliance industry group, only two companies even consulted their pre-prepared incident report plans.

“I’ve seen a dramatic improvement,” Ray Biando, chief information security officer at Illinois-based Health Care Service Corp., told the FierceHealthPayer news service, “but we still have a lot of work ahead of us.”

<em>J.K. Wall is a health care reporter at the Indianapolis Business Journal and writes The Dose blog on the business of health care.</em>

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The Five Most Popular Posts of 2015

Dear joyous reader, happy (almost) 2016! This past year, I and the joyous team published just over 156 posts, recipes and videos. Over the next couple of weeks, we’re going to reveal which posts, recipe and video’s made our top five for most popular throughout the year. Today we’re starting with our top posts for 2015, and based on what made the list, it looks like you were all very interested in digestion and babies, but hopefully not digesting babies, because that would just be weird. So here you go – the most popular posts of 2015!

1. HEALTH BENEFITS OF LEMON AND WATER

Health Benefits of Lemon and Water For as long as I can remember, even before I became a certified nutritionist I’ve been recommending this morning habit. It’s my daily ritual and something that I always recommend. Drinking freshly squeezed lemon and water first thing in the morning, on an empty stomach has many benefits. Learn about them in my video and I’ve written them out below. Read more

2. MY BIRTHING STORY

My-Birthing-Story As I sit down to write this, our baby girl Vienna is sitting on my lap sucking her fingers, wrapped up in the most comfy looking swaddle. On a side note, I think they need to make these for adults – I wouldn’t mind being swaddled hehehe. Read more

3. NATURAL SOLUTIONS FOR INFLAMMATION

Inflammation 101 There have been times throughout my life where I’ve felt very inflamed. When I was training for a half marathon in Miami several years ago I wasn’t eating as well as I do now or taking any supplements to combat the effects of all the exercise was doing. Looking back at photos of myself, despite being able to run an hour and a half with no problem, I was the fattest I’ve ever been and I looked puffy. Even my boobs were gigantic! Read more

4. HEAL YOUR GUT IN 5 STEPS

Heal-Your-Gut Healthy digestion is the foundation of great health. It’s estimated that over 80% of our immune system resides in our gut lining, so it’s only logical that we would want to keep it functioning as optimally as possible. Read more

5. POST LABOUR RECOVERY REMEDIES

Lady-Part-Love When I first became pregnant with Vienna I read as much as I possibly could about having a healthy pregnancy. Then in my third trimester I was very focused on having a positive birthing experience, which is why I took a hypnobirthing course. I knew NOTHING about recovery of my lady parts post labour and delivery. Read more So there you have it – the 5 most popular posts of 2015! Stay tuned for the most popular recipes of 2015.

Joy McCarthy

Joy McCarthy is the vibrant Holistic Nutritionist behind Joyous Health. Author of JOYOUS HEALTH: Eat & Live Well without Dieting, professional speaker, nutrition expert on Global’s Morning Show, Faculty Member at Institute of Holistic Nutrition and co-creator of Eat Well Feel Well. Read more…

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Why Meaningful Use Has to Go

flying cadeuciiWe don’t win anymore in health care. After repeatedly drilling in our heads that America’s sick care system is a disaster, that those who care for the sick are incompetent and stupid, and that the sick themselves are losers, Meaningful Use was advertised as the means by which technology will make health care great again. The program has been in place for 5 years and the great promise of Meaningful Use is just around the same corner it was back in 2011. The only measurable changes from the pre Meaningful Use era are the billions of dollars subtracted from our treasury and the minutes subtracted from our time with our doctors, balanced only by the expenses added to our medical bills and the misery added to physicians’ professional lives.

Meaningful Use, a metastasizing web of mandates, regulations, exclusions, incentives and penalties, is conveniently defined in the abstract as a set of indisputably wholesome aspirational goals for EHR software and its users, which stands in stark contrast to the barrage of bad news flooding every health related publication, every single day. Health care in America used to be the best in the world, but now our health care is crippled. Meaningful Use of EHR technology will improve quality, safety, efficiency, care coordination, and public and population health. It will engage patients and families, and it will ensure privacy and security for personal health information. With Meaningful Use leading the way, health care will be winning so much that your head will be spinning. You won’t believe how much we’ll be winning.

Be afraid, be very afraid

Bombastic? Laughable? Easily dismissible by educated people? Not so fast. According to Dr. David Blumenthal, president of the Commonwealth Fund, and former National Coordinator for Health IT, “we probably have the worst primary care system in the world”. Yes, worst system in the whole wide world, worse than Niger, Malawi and Somalia. Probably. According to a hobbyist “study” that extrapolates its “results” from a handful of other studies based on an admittedly inaccurate tool intended for different purposes, 440,000 people are killed in hospitals due to preventable errors each year – “that’s the equivalent of nearly 10 jumbo jets crashing every week”. Or, with a little more math, half of all hospital deaths, and one in six US deaths, are due to negligent homicide perpetrated by psychopathic doctors and nurses.

How is that for buffoonery? I suspect that the beautiful minds appalled at populist or outright racist fear mongering rhetoric claiming that thousands of Muslims were dancing on rooftops on 9/11 in New Jersey, have zero problems with self-servingly stating that “hospitals are killing off the equivalent of the entire population of Atlanta one year, Miami the next, then moving to Oakland, and on and on”, based on equally valid he-said-she-said evidence. Both virulent strains of outlandish demagoguery are insisting that they, and only they, can keep us safe from things that go bump in the night. Supersizing the ghoulies and ghosties and long-leggedy beasties makes us more likely to relinquish control of our lives to those who might deliver us from terror.

The Meaningful Use program rests on a narrative where medicine is witchcraft, our doctors are murderers, our hospitals are cesspools teeming with death, our citizens are Lemmings unable to wipe their noses, and the machines of the illuminati are our only salvation. When the premise of an action is delusional, one cannot expect the outcomes to be anything but.

Smoke and mirrors

When you read “studies” advertising that Meaningful Use increased the rates of mammography by 90% in three months, you should assume that the only thing that was increased is the rate of ticking boxes for stuff that was not documented before, and practically no material changes have occurred. When you feel vindicated by the 99% rate of patients given a clinical summary after each visit, keep in mind that the vast majority of those summaries were posted to a portal that nobody uses, or just fake-printed to PDF, and the few actually given out were dutifully tossed in the recyclable trash bin. When you read about the billions of dollars in tax money successfully spent on Meaningful Use, you should understand that this is just the tip of the iceberg, and the indirect costs to each and single one of us are larger by orders of magnitude.

For most of us simpleton believers, who mistook fiery demagogues for brave-hearted visionaries, the disappointment is a throbbing daily humiliation, manifesting itself in polite low-energy petitions to powerful bureaucrats to take pity on us and roll back some of the most onerous aspects of the program. There are signs indicative of some forthcoming acts of mercy, but those are as disingenuous as the original false narrative of Meaningful Use. After five years of Meaningful Use of EHR technology, the initial hope has failed to translate into promised change. Or has it?

From its inception, the Meaningful Use program had two sets of requirements. One set defines what EHR vendors must build to stay in business, and another set specifies what doctors and hospitals must do to collect gratuity payments from Medicare. Over time these requirements sets began to diverge. Once clinicians became conditioned to compulsively collect data, overt reporting is being replaced with covert extraction through the backend (i.e. application programming interfaces, or APIs). The Certified EHR Technology mandated by the program was never intended to extend abilities of clinicians as much as it was designed to generate standardized measures of their performance. Administrators and regulators cannot control an industry from afar without incessant measurement and the power to reward and punish individual practitioners. Meaningful Use is designed to enable remote control of medicine, its doctors and the people they serve.

We are not alone

Back in 2001 our rulers identified another field where America was losing big time. Education was a disaster, a huge mess with rampant disparities and across the board low quality. Like health care, education of small children is an ideal place for intervention if your aim is to control populations and increase the value derived from each person. With overwhelming bi-partisan support the ruling class passed the No Child Left Behind Act, mandating that all children are above average by 2014. An avalanche of funding for computers, measurements of schools and teachers and incessant standardized testing of students descended upon our schools. For the last fifteen years, schools were engaged in life and death accountability games of reward and punishment, and our children became merely biometric indicators for school and teacher performance assessments.

As 2014 came and went, with many children still stubbornly below average, with multitudes of teachers still burnt out, and education morphing into a misnomer for the standardized testing doomsday machine consuming all but the rich and privileged, the federal government took a step back and passed the Every Student Succeeds Act of 2015. Leaving aside the downright idiotic terminology used for naming acts of Congress, the new legislation is reluctantly beginning a process to diminish federal control of schools. Considering the cumulative damage to our education system, perpetrated by toxic bureaucratic ineptitude which is  crowding out the ability of real educators to address real problems, this halfhearted attempt may very well be too little too late.

Failure is not inevitable

I don’t know about you, but I am getting tired of having to live up to Winston Churchill’s image of America. We don’t always have to try everything else before we do the right thing. We shouldn’t have to wait fifteen years before declaring that in retrospective Meaningful Use was meaningless. We know now that it is. Removing a few reporting requirements for physicians, while beefing up patient scoring measures, is not enough. Playing with reporting periods at the last minute and granting ad-hoc exclusions to make people shut up, is not enough either. Randomly linking physician fees to Meaningful Use EHRs may be enough, but it’s beyond disgusting.  The Meaningful Use program must end. Plain and simple. And most importantly, the underhanded EHR certification schemes must be halted immediately.

Standardization, quantification, computerization, gamification, engagement, and infantilization of the populace in general, do not produce better educated or healthier citizens. Education reform has failed us on a grandiose scale. Health care reform, to which Meaningful Use is foundational, is based on the same failed concepts as education reform. It will also fail in due course and spectacularly so. It is actually failing as we speak and with the exception of elite institutions, which are benefiting financially from as much health care reform as can possibly be inflicted on the rest of us, we all know it’s failing badly. 2016 presents the perfect opportunity to demonstrate to the entrenched perpetrators that in America accountability is a two way street, and value is a freely defined personal concept.

American health care has been hijacked by very bad people, and it’s time for us to quit being sad little losers who just sit there and bitch. It’s time to take our health care back and it’s high time to deliver to those horrible people the thorough schlonging they so richly deserve. It’s time to make American health care great again.

In 2016, resolve to go out and vote. Vote in the primaries, vote in local and general elections, ignore the propaganda, educate yourself and as old Harry Truman advised us all, vote for yourself, for your own interest, for the welfare of the United States, and for the welfare of the world.

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