Marketing, HIPAA, Rules & Exceptions

---Terri Bernacchi, PharmD, MBA,  President, Cambria Health Advisory Professionals

Health Care Reform (the ACA, PPACA, “Obamacare” or whatever you want to call this hot mess) was basically an outline or framework.  Along with ACA, there have been  myriad other bills and regulatory or administrative rules which have come out piecemeal since 2009 that---combined---make it very difficult to assimilate, plan, or manage changes in business operations for many businesses directly or indirectly involved in the US Health Care Sector. 

One of these—HITECH---contains some rules that impact what is considered prohibited in terms of “marketing” drugs directly to patients, citing HIPAA and other related privacy rules. 

In 2009, the HITECH Act was signed into law as part of the American Recovery and Reinvestment Act. (ARRA) One effect of HITECH was to reduce the range of permitted communications with patients.  It declared that a communication “about a product or service . . . that encourages recipients of the communication to purchase or use the product or service shall not be considered a health care operation” if the covered entity receives direct or indirect payment in exchange for making the communication.

As is common with federal regulations or laws, there were various limited exceptions to the rules, but the net result of this specific provision is that payments to covered entities (such as pharmacies) to provide particular types of communications to patients on behalf of a pharmaceutical company would be considered marketing and thus excluded under HIPAA permitted “TPO” (treatment, payment or operations activities.)  The HITECH Act did not, however, state whether some communications (done for compensation) might be considered “treatment,” and thus, excluded from the “marketing” label.

Health and Human Services undertook rulemaking (recently released) in the Final Rule.  Permissible communications that are not considered marketing (e.g., refill reminders) should have been clarified by the Final Rule. 

If covered entities receive any financial (direct or indirect payment) remuneration in exchange for making the treatment-related or health care operations-related communication, the communication is now thus considered marketing. If the same activity goes on without remuneration, it is okay. 

Importantly, this represents a striking departure from past law and guidance and common practice.  The rule also dropped the opt-out requirement under which a patient may choose to “opt out”.  

There are more details in the Final Rule, including the exception for “face-to-face” versus electronic, telephone or written messaging.  HHS announced that it would not enforce the restriction on financially remunerated prescription refill reminders until November 7, 2013.  That means that these rules are currently in place, and enforceable.

• Interested parties can download a copy of an excellent analysis here supplied by Arnall Golden Gregory.  LLP http://www.agg.com/The-HIPAAHITECH-Final-Rule-Pharmaceutical-Manufacturers-Required-to-Thread-the-HIPAA-Marketing-Needle-12-03-2013/
• A copy of the final rule is at this link:  http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf
• And a copy of the guidance summary can be found here:  http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/marketingrefillreminder.html

 

Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

NCPDP Releases New White Paper on E Prescribing & Formulary Compliance

---Terri Bernacchi, PharmD, MBA,  President, Cambria Health Advisory Professionals

 

For the past 3 years, two workgroups associated with the National Council of Prescription Drugs has worked on a white paper to inform readers about the positive benefits (and related challenges) of the new “electronic prescribing” process.  I worked with this group personally.

The benefits of better record keeping, greater efficiencies and fewer errors due to physician handwritten prescriptions are associated with a technology that has also generated some new challenges.  For example, the group focused this paper on challenges relating to current processes between pharmaceutical companies who pay rebates based upon how formularies are implemented by health plans to offset costs. 

Interested parties will want to stay informed and work toward continued improvement in these processes, promoting a greater understanding regarding how this technology can be used to improve patient care, product selection, and still support business relationships. 

Just this week, NCPDP has released this daunting, but collaborative effort describing the following about e prescribing, formulary compliance and the manufacturer-payer trading partner relationships:   

ü  How the actual process of e prescribing works and the parties involved in the process. 

ü  That the contract language between manufacturers and payers is generally loose and proprietary.  This has fostered variability in some components of data exchanged in support of the invoicing and payment processes.

ü  That contracts between parties often establish rebate/discount eligibility based upon how therapy options are depicted in a formulary drug class, offering differential discounts based on whether rules have been properly applied in the formulary. (For example, a higher rebate is applied if the product is one of two in a preferred category, versus one of three.)

ü  These contracts may also employ language that spells out requirements regarding how the product should be displayed to the prescriber.

ü  That the process involves dynamic data used to illustrate, for any point in time, an accurate depiction of how a product or many products are depicted in any version of a Formulary, as well as how the patient’s benefit and coverage rules (including out-of-pocket, copay or co-insurance amounts) are impacted by the formulary.

ü  That formulary information is made available to EHR/electronic prescribing vendors with various levels of data elements supplied by processors/payers and plans, and at variable intervals.

ü  That formulary information is displayed in different ways by the vendors that support the electronic prescribing process. 

 

Interested parties can download a copy of the whitepaper here:  http://www.ncpdp.org/Whitepaper.aspx  

 

Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

 

Advocating for the Individual in a World of RWE and CER

---Terri Bernacchi, PharmD, MBA,  Senior Partner, Valiant Health

The history of the Federal Food and Drug Administration is a fascinating story that balances the federal government’s actions in support of keeping the citizenry safe from snake oil salesman selling poison and the food and drug supply “pure” against the capitalist that drives innovation in the area of health care improvement.  The story of the FDA is one that will never be over but unless someone actually understands what has happened in the past and WHY certain official positions have been imposed, the beneficial nuances can be completely lost in the jargon.

For example, the FDA was charged with assuring that a manufacturer wishing to market a health, food, or cosmetic product in this country was SAFE.  Later, impositions regarding proving the “efficacy” of the product, in line with the manufacturer’s claims, were added.  This became of particular interest as health care financial risk was born by third parties, including the Government under Medicare and Medicaid payments. 

Now, CER (Comparative Effectiveness Research”) has taken the FDA’s scope of authority yet farther as the research manufacturers must assume before and after a product is launched involves establishing more than just, “Can I prove that this product is more effective than a placebo?”  Defined in various ways, CER is described by the IOM as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or improve the delivery of care. The purpose of the research is to help consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”

The American Recovery and Reinvestment Act of 2009 (ARRA) and the ACA reignited the federal government’s interest in CER.

There is a cost (which is not surprisingly added to the cost of the product) to prove safety and a cost to prove efficacy.  When you go to prove comparative efficacy, you are risking that you will lose.  It’s tantamount to betting your bank account at the craps table in Las Vegas because you cannot really be sure which way it will turn out. 

In fact, this CER craps table, has become part of the requirement under new federal requirements but sometimes the forest is lost for the trees.   For example, the Forbes article linked below cites TWO studies on diabetes drugs that concentrated on Safety (being no worse than placebo) but said nothing about effectiveness.  At what cost?    The author concludes, “Rather than mandating narrow studies of cardiovascular studies, we should be encouraging studies that let us know which regimen is best for which patients, based on what they actually do for patients.” 

He does not recommend ignoring safety, he’s just looking for an equally important conclusion.  I am sure there are also CER studies underway to answer his question.  

http://www.forbes.com/sites/harlankrumholz/2013/09/03/is-no-worse-than-placebo-good-enough-for-new-diabetes-drugs/

The other perspective on this is from the Heritage article linked below, referencing that this concept in the UK resulted in a system whereby CER was used to reject certain treatments for mostly budgetary reasons.

“CER use in the U.K. has been a far cry from what is implied by the rhetoric used to promote PCORI. Rather than focusing on the individual needs of patients, the United Kingdom’s National Health Service (NHS) uses comparative and cost-effectiveness information to limit options as a budgetary tool.

The NHS offers health coverage to all British citizens and determines which treatments will be covered and paid for, and under which circumstances. Decisions are based on “recommendations” by the National Institute for Health and Clinical Excellence (NICE), who’s stated purpose is to create clinical guidelines and standardize care using cost-effectiveness information, but the NHS is required to adhere to all of the recommendations made by NICE.

If a treatment is not covered, patients are able to go outside the NHS and receive it privately without regulatory or statutory obstacles—if they are able to afford this. (Because of Medicare’s restrictions on private contracting, American seniors would not have this same option.)” 
http://www.heritage.org/research/reports/2012/04/comparative-effectiveness-research-under-obamacare-a-slippery-slope-to-health-care-rationing

Thus, the benefits of CER (which may derive clarity for the practitioner to apply to individual patients) must be weighed against the need to treat each patient as an INDIVIDUAL whose needs, wants, and situations may require the flexibility which a system conformed to the latest CER may not allow. 

  Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

Seeing 2014 Through the Fog: Anticipating the Impact of Personal Incentives Under Obamacare

---Terri Bernacchi, PharmD, MBA,  Senior Partner, Valiant Health

So what is it?  Will premiums go up by double digits or will they go down?  Is it possible that for a small group of people in some states, premiums will go down, but for a larger group of people on some exchanges or in some states, the premiums may be fairly criticized as “sky-rocketing”? 

It’s really hard to understand if any side in the health care debate is completely lying when the news headlines on what is coming are so completely polar opposites.  Is it possible that recent media “spin” on Obamacare’s health exchanges are fairly characterized as “lies, deceit and untruth”?  The political stakes are high, to be sure, but as people ask you for advice on what to do in their own personal situation, it would certainly be nice to be able to go somewhere and actually “see through the fog” on their behalf.   My premise is this:  people will do what is in their best interest, assuming they can see it. 

On Friday, Senator Harry Reid admitted to a PBS audience in Nevada, that the Accountable Care Act was always just a step toward a public system, getting there by pushing private health care insurers out of business.   At least now, the truth seems to be coming out as some portions of the new law (widely panned by experts and consultants on all sides of the political spectrum as a failure in process.)

An article by CNN Money noted that under the health care reform act, insurers must offer a package of essential benefits -- including maternity, mental health and medications -- and they must cover all who apply. The imposition of these richer benefits will cause price hikes in some states where a lower cost, bare bones policy may have been sufficient for coverage for young, healthy people in the past. Isn’t it logical then, for a primitive student of human behavior, to predict that some young, healthy people won’t want to take on the increased cost because they don’t “need” the additional benefit or the additional cost?  They’ll pay the $95 per year or 1% of their income to avoid a cost that may be $3,000 per year or more. 

• “Our analysis found that 21-year-old men will pay a lot more for an exchange plan, but 42-year-old women and 62-year-old men will shell out less for a silver-level plan that comes with a $2,500 deductible and a roughly $25 co-pay for office visits.”

It may be that part of what must happen as this mess unravels is that we must better understand what happens in terms of individual incentives.  If a premium increase is unaffordable and if the individual has other alternatives (including doing nothing), then young, healthy people can be expected to forego coverage, and older/unhealthy people will sign up for lower cost coverage.  Predictably, then the exchanges will fail under the weight of insufficient premium to cover incalculable risk.  And people will be begging for something to be done. 

Is this, therefore, given Harry Reid’s recent comments, an unintended consequence of a well-meaning public policy or is it the success that was anticipated all along, leading the country to a federally controlled, single-payer system?  

Link:  http://finance.yahoo.com/news/where-obamacare-premiums-soar-095700316.html?CFID=24988291&CFTOKEN=70696857&jsessionid=2e302825861375967192417   

http://www.forbes.com/sites/theapothecary/2013/08/10/sen-harry-reid-obamacare-absolutely-a-step-toward-a-single-payer-system/

Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

Health Care Reform as a Technology Innovation Stimulus

---Paul Dausman, CEO, Valiant Health  See also http://www.valianthealth.com/blog/health-care-reform-as-a-technology-innovation-stimulus/

The regulatory and compliance requirements emanating from the Affordable Care Act, coupled with incentives for providers to move manual processes to automated ones has stimulated the growth of technology and service vendors to enable health care businesses to stay in the game.  Some entrepreneurial vendors are aiming their innovative solutions at the patient; others are focused on the doctor’s office and the information which is needed while care is being rendered.  Many are focused on cost management, fraud detection, or waste reduction at the population health or plan level.    

It has occurred to me, however, that solutions that consume the publicly available data and that data gathered by the doctor or member at the point of care will afford only a part of what is needed. 

In fact, the change (as described in the New York Times Opinion piece link below) that is coming will require a complete re-engineering from the top to the bottom of the existing health plan and provider care models.  Healthcare Performance Management (HCMP) systems will enable all parties within a program to be on the same page in terms of developing priorities and sound action plans. 

Thomas L. Friedman noted in his NYT article that while the US has had the best but most expensive health care in the world, the goal of the new health care law is to “flip this fee-for-services system (which some insurance companies are emulating) to one where the government pays doctors and hospitals to keep Medicare patients healthy and the services they do render are reimbursed more for their value than volume.”

Proving that the “flip” is successful or just “cheaper” is going to require data, fed into HCMP systems that will shine a light on what health care organizations need to do first and whether or not they are risking failure over the course of time in any specific measurable area or for any specific patient.

http://www.nytimes.com/2013/05/26/opinion/sunday/friedman-obamacares-other-surprise.html?ref=thomaslfriedman&_r=1&

Paul Dausman is the CEO of Valiant Health, LLC, and has an extensive history as an entrepreneur in the health care and information technology areas.

Dueling Data Games: Demographics vs. Provider Patterns?

---John Campo, Vice President, Business Development, Valiant Health  (see also http://www.valianthealth.com/blog/dueling-data-games-demographics-vs-provider-patterns1/)

Various forums like Health IT, academia, and the health care bloggers are abuzz with a fascinating, but controversial study released on May 28, 2013 that addresses the long held belief that some regions have wasteful medical practice patterns. The new paper concludes that individuals’ health differences around the country explain between 75 percent and 85 percent of the cost variations.  When the primary author, Dr. Patrick Romano, noted that “People really are sicker in some parts of the country,” he set in motion a debate with the conventional wisdom against the work of the Dartmouth Institute for Health Policy & Clinical Practice.  Dartmouth’s three decades of research has propagated a theory that regional differences in Medicare spending is mostly due to the aggressiveness of the medical community (and attributing it mostly to individual profit incentives).

The answer to this question is critical because it is driving CMS strategies to reduce Medicare spending.  The Institute of Medicine, at the request of Congress, is continuing to investigate the question.  

Regardless of whether the new study turns out to be correct or if the IOM substantiates the findings of the Dartmouth group, it makes for an interesting debate with high stakes in terms of CMS payment strategies.  Plans, ACOs, and all types of providers will be involved in looking at data in various ways like local/provider specific analyses to regional/national benchmarks.  Providers should expect to conduct patient and population level analyses and measure results, comparing them to expected norms and explaining the variances.

 This will be particularly important as providers and plans engage in any kind of pay-for-performance or risk sharing arrangements, such as those expected under Accountable Care Organizations.  They must have systems in place to offer point-counter-point perspectives that establish quality results and justify the occasional outlier.  Link for different perspectives:   

• http://www.healthcareitnews.com/news/pop-health-explains-medicare-disparities?topic=04,28,19
• http://www.kaiserhealthnews.org/Stories/2013/May/28/medicare-state-geographic-variation-costs.aspx

John Campo is responsible for Valiant Health’s growth, including client engagement and satisfaction. He brings over 15 years of diversified healthcare experience to Valiant Health. Prior to joining our leadership team, John founded and owned the CAMPO Group: Strategic Managed Care Consultants where he engaged leading pharmaceutical, biotechnology, specialty pharmacy, and health insurance clients. John’s background includes healthcare contracting, trade relations, reimbursement, specialty pharmacy distribution, quality improvement and Medicare. His leadership background includes working for a Fortune 500 PBM, HMO, and Specialty Pharmacy organization in leadership roles as well as being responsible for Managed Markets National Account Management for a large ethical US Pharmaceutical firm. He holds a BS in Business from Brescia University. 

Hospital Readmission Penalties Create Continued Policy Debate

---Terri Bernacchi, PharmD, MBA,  Senior Partner, Valiant Health (See also:  http://www.valianthealth.com/blog/hospital-readmission-penalties-create-continued-policy-debate/ )

 

A by-product of CMS’ cost reduction efforts associated with payment (or penalty) for quality results, is the much vilified Star Rating measure on All-Cause Hospital Readmissions. These efforts hit the Medicare Advantage plan’s Star Ratings results but also impact hospitals Medicare reimbursement rates directly. 

Two-thirds of hospitals are now facing readmission penalties totaling approximately $280 million in 2013, according to experts.  These 2,271 U.S. hospitals were found to have readmission rates higher than the CMS models predicted, and each of them will receive a penalty this year, as high as 1% of their reimbursement for Medicare patients. (Penalties will increase to 3% by 2015.)

The number of hospitals penalized is much higher than most observers would have anticipated on the basis of CMS's previous public reports, which identified less than 5% of hospitals as outliers.  (See NEJM Article by Drs. Karen E Joynt, MD & Ashish K. Jha, MD)  Path Forward on Medicare Readmissions at http://www.nejm.org/doi/full/10.1056/NEJMp1300122 )

The debate includes concerns that the safety-net hospitals caring for a higher proportion of members with socio-economic challenges are those least able to afford a penalty. Most agree, however, that setting a lower quality standard for these hospitals would not be ideal.   Many hospitals (and associated Medicare Advantage Plans) now have placed special focus on “helping patients make the transition from inpatient care to outpatient or community settings”.  A key part of this coordination is the ability to identify and intervene early in the hospitalization and post-discharge course.

See Links:  http://www.chrt.org/blog/the-aca-and-the-hospital-readmissions-policy-debate/

          http://www.nytimes.com/2013/03/30/business/hospitals-question-fairness-of-new-medicare-rules.html?pagewanted=all&_r=0

Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

Health Systems Around the World Could Learn From MA

John Campo, Vice President, Business Development, Valiant Health (See: http://www.valianthealth.com/blog/health-systems-around-the-world-could-learn-from-ma-plans/)

A new study by the Boston Consulting Group (BCG) suggests that health systems around the world can learn a lot from the care-delivery models used by private payers in U.S. Medicare Advantage plans. 

BCG concluded that Medicare Advantage plans, which impose classic managed care techniques to an elderly population, as compared to traditional Medicare fee-for-service plans, vary in a couple of key ways. 

1. Focused on mechanisms designed to encourage the delivery of cost-effective quality care
2. Identify  and focus on clinical best practices
3. Tap into a selective network of providers
4. Apply active care management strategies based on prevention to minimize expensive acute care

BCG’s study included an analysis of claims data for 3 million Medicare patients. They concluded that on three internationally accepted dimensions of health care quality—single-year mortality, recovery from acute episodes of care requiring hospitalization, and the sustainability of health over time—patients enrolled in Medicare Advantage plans had better outcomes than those participating in Medicare on a traditional fee-for-service basis.

Medicare Advantage plans in the US are under continued scrutiny to “prove” quality by meeting established benchmarks for various domains, including patient satisfaction, quality outcomes, access to care, and use of preventive services.  MA plan executives are faced with fee reductions if quality metrics are not met under “Star Ratings” programs imposed by CMS.

See Links:  http://finchannel.com/Main_News/Business/127573_Managed_Medicare_Advantage_Plans_Demonstrate_Better_Outcomes_for_Patients/
http://www.bcg.com/media/PressReleaseDetails.aspx?id=tcm:12-134145

John Campo is responsible for Valiant Health’s growth, including client engagement and satisfaction. He brings over 15 years of diversified healthcare experience to Valiant Health. Prior to joining our leadership team, John founded and owned the CAMPO Group: Strategic Managed Care Consultants where he engaged leading pharmaceutical, biotechnology, specialty pharmacy, and health insurance clients. John’s background includes healthcare contracting, trade relations, reimbursement, specialty pharmacy distribution, quality improvement and Medicare. His leadership background includes working for a Fortune 500 PBM, HMO, and Specialty Pharmacy organization in leadership roles as well as being responsible for Managed Markets National Account Management for a large ethical US Pharmaceutical firm. He holds a BS in Business from Brescia University.

Achieving 5 Stars on the Rx Side—The Secret?

---Terri Bernacchi, PharmD, MBA,  Senior Partner, Valiant Health (www.valianthealth.com )

http://www.valianthealth.com/blog/achieving-5-stars-on-the-rx-sidethe-secret/

To succeed in an increasingly challenging reimbursement environment, Medicare Advantage plans must work in close collaboration with physicians to identify at-risk populations and facilitate interventions that that improve quality and lower cost.  That is true for both the Part C & Part D portions of the program.

Some Medicare Advantage plans will thrive at the top of the quality ratings heap no matter what happens in the surrounding environment.  Those plans have some common elements that give them a weighty advantage in terms of statistics and actual results.  The common themes?  Cooperative providers, clean data management processes, enabled clinical teams and executive leadership, and a clear, prioritized plan.  In a phrase, they are able to exert maximal control over the variables that drive results which drive reimbursements.  

Kaiser Permanente, for example, attributes its success to “a deep understanding of the star measures along with internal and external organizational processes and protocols”.  They believe this has allowed the plan to achieve a Part D summary rating of 5 in 7 of the 8 regions. 

Matt Nye, the vice president of Pharmacy Care Support Services, National Pharmacy Programs and Services of Kaiser Permanente spoke at the Academy of Managed Care Pharmacy’s spring meeting in San Diego in April 2013.  His discussion included a brief company overview: coverage of 9 states and D.C. with 8.9 million members, 165,000 employees, 15,000 physicians, 36 hospitals and medical centers, and 1.05 million Medicare members. Nye noted that Kaiser’s program includes outpatient, inpatient, and ambulatory care pharmacies and services, home infusion, drug distribution, mail order and central fill operations, and centralized services.

Kaiser has some advantages in drug therapy management relating to its business model:  it is an integrated practice model.  He noted that they have placed an emphasis sharing accountability between physicians and pharmacists to ensure the appropriate use of medications. 

Even if a plan does not have the benefit of “owning” the full scope of clinical, distributive, and practice infrastructure, the lessons learned from Kaiser can still be applied.  Using technology and data management techniques, internal and organizational processes can be aligned to create common incentives and opportunities to maximize quality results to assure success in the current and future years.

Link:  http://www.ajmc.com/conferences/AMCP_Spring-2013/Optimizing-Care-Deliver-with-Medicare-Star-Ratings-The-Successes-and-Challenges-of-Managed-Care-Organizations

Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA. 

Cambria Health Advisory Professionals is proud to publish a new white paper!

Jumping New & Higher Hurdles--How US Pharmaceutical & Device Manufacturers Can Stretch Resources to Achieve Success in Today’s Post Health Reform Environment

---Terri Bernacchi, PharmD, MBA,  Cambria Health Advisory Professionals, Senior Partner, Valiant Health, & Managing Partner at Quo Magis Partners

Introduction

Pharmaceutical and Medical Device Manufacturers doing business in the United States are dealing with an unprecedented level of change. Even for seasoned managers, this requires ever greater attention to operational and compliance details at the very time when innovation and revenues are under extreme pressure.  This demands thoughtful and determined leadership, willing to consider “outside the box” ways to get things done.  This paper is intended to provide practical advice on ways to achieve results in today’s environment by engaging in flexible teaming, using large or small consultancies and service providers.

The Rules Have Changed

With health care reform and today’s economic chaos, factors outside your control are changing the rules of engagement, from how to get your product to market to how to report your results, to how to manage your people. 

Product commoditization and price pressures present critical challenges to the top line.  It’s not just you---it’s your customers.  Today’s health plans, hospitals, and medical communities are plagued with their own versions of “change hell”, with regulations coming out in thousands of pages, impossible to consume, much less to implement, in tight timelines.  Employers and consumers are just beginning to understand the implications of health reform and the regulatory environment.  Nothing was ever this hard before.  Quitting is not a good option for most of us,—and certainly some will find a way to thrive in the “new normal”.

Six Challenges That Rock Your Boat

In order to succeed, manufacturers need to think differently.  Today’s burdens emanate from at least 6 sources:

1)    Pressures on Revenue

2)    Access to the Market

3)    Cost of Operations

4)    Regulatory Overload & Unpredictability

5)    Customer “Shape-Shifting”

6)    Talent Acquisition & Retention

Given Today’s Reality, What Now? 

Manufacturers doing business in 2013 can still take a few steps forward:  

1)    Understand your budgetary certainties

2)    Choose your priorities, streamline operations

3)    Don’t expect miracles 

4)    Identify new ways to partner with each customer segment

5)    Use data to inform your decisions

Recruit talent to your teams.   The last few years may have created too much rapid turnover in some companies; the “old timers” with valuable experience and perspective that informs and trains the younger executives may be depleted.  An alternative way to meet your needs, yet maintain control is to optimize the use of short-term, experienced contractors/consultants or service organizations to get results on an ongoing basis.

Remember the "Fail Fast" Rule   If the project is going to be delayed, has the wrong scope, or is doomed from the outset, don’t pour money down a hole.  Similarly, if the contractor is a bad fit, end it quickly and seek a replacement.

Boutique vs. Big Box Partners? 

You can choose from a variety of consulting or service organizations---large or small, generalist or specialist.  If you are looking for results at the lowest price in the shortest timeframe, you may want to consider mixing it up a little---using both kinds of companies to extend your own teams. 

Included in this paper is a list of some example boutique firms with an edge on talent and experience that may be just what you need to make traction, with some suggestions on how to engage them.    Download the paper here, free of charge:  Jumping New & Higher Hurdles:  How US Pharmaceutical & Device Manufacturers Can Stretch Resources to Achieve Success in Today’s Post Health Reform Environment

Terri is the founder of Cambria Health Advisory Professionals and a Managing Partner at Quo Magis Partners, and a Senior Partner at Valiant Health. Among her current clients: a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders. a small special needs health plan as a 5 Star Consultant, and several other health related clients. The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Health Thought Leader colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007.  She has both a BS and a PharmD in Pharmacy and an MBA.

(UN)-Intended Consequences in Health Plan Consolidation

---Lowell T .Davies, Economist & Commentator

I should first acknowledge that I predicted a wave of consolidation in the health care industry as a response to the passing of the Affordable Care Act a few years ago. The fact that I predicted this shouldn’t illustrate any intelligence on my part; rather it shows the obvious true nature of Obamacare. In my opinion, one I share with many commentators, creating tumult in the insurance industry was an intended consequence of the legislation.

Consolidation, indeed, is just gaining momentum.  For example, in a recent article in Managed Health Care Executive, author James Burns outlines 5 potential issues raised by the potential merger of Wellpoint and Amerigroup, both large insurers. He explains that the Antitrust Division has made a second request for information on the merger, possibly inferring that they may not allow the deal. He goes on to say, however, that if the merger is allowed, the companies may encounter hurdles at the state level if politicians and regulators fear anticompetitive behavior. The article is informative on the subject, but what I took away from it is something of a wholly different nature. (See this excellent author’s work:  http://www.dickinson-wright.com/bdsfiles/News/d2f4dc06-6d34-4858-9f67-06c31bdb6656/Presentation/NewsAttachment/bc6d294b-54f3-4b81-8fe8-2f2019ea2439/MHEBurnsArticle.pdf)

This merger is likely to go through, as will others. It is my contention that the regulators behind enforcement of Obamacare would rather deal with a few behemoth insurers than a slew of smaller ones. 

While the insurance industry needs to consolidate to survive the measures enacted in the ACA, this is not a good thing for the average consumer. If competition leads to lowered prices, then the opposite is true of consolidation. From the standpoint of the Federal government however, if there are fewer companies to monitor then law and regulatory enforcement becomes that much easier. Furthermore, from the standpoint of this cynic, it also becomes easier to sway corporate leadership to act on behalf of said government’s interests; they do, after all, hold the most enticing bargaining chip that exists: control of the budgets of the largest payer sources in health care.

This all sounds conspiratorial and I’ll admit that it’s not crystal clear yet, but the pathway is set forth if you’ve read the bill. I hate to end on such a sour note, but I honestly fear that the march toward single-payer has officially begun and that we will, beginning here with insurers, see one domino after another fall in line.