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Advice to Law Students

October 25, 2015 Leave a comment

When I graduated law school in 1981, health law was pretty much nonexistent.  Now, to be relevant, most law schools offer some health law courses.

Because?  Health law is hot.  It was hot before Obamacare, and it will remain hot.

Harvard Law School has its health blog, Bill of Health.  Yale Law School is opening its new Solomon Center for Health Policy and Law next month. U.S. News ranks the country’s top health law programs.

Getting healthy and staying that way is a passion for most Americans. Obamacare has changed the way the country thinks about dispensing health care.  But there will always be sick people. New drugs will be invented, and new procedures adopted.  All to make us healthier or to make us more comfortable in our sickness.  Health care is big business, and, by necessity, will remain heavily regulated.   After all, there will always be patients and providers who will try to game the system.

So, law students, if you don’t know what path to follow, you could do a lot worse than health law

CMS Proposes Significant Changes to the 2016 Medicare Physician Fee Schedule, including to Stark

August 16, 2015 Leave a comment

CMS Factsheet:

“On July 08, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that updates payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after January 1, 2016. This year, CMS is proposing a number of new policies, including several that are a result of recently enacted legislation. The rule also finalizes changes to several of the quality reporting initiatives that are associated with PFS payments, including the Physician Quality Reporting System (PQRS), the Physician Value-Based Payment Modifier (Value Modifier), and the Medicare Electronic Health Record (EHR) Incentive Program, as well as changes to the Physician Compare website on Medicare.gov.”

The proposed rule includes provisions relating to the following;

  • physician quality reporting system
  • “Physician Compare”
  • EHR incentive program
  • Medicare shared savings
  • advance care planning
  • payment provisions on Part B drugs, misvalued codes, RVU reductions, “incident to” services, physician value-based payment modifier, etc.

Perhaps most significant in the area of healthcare business transactions are the physician self-referral (Stark law) updates:

  • expansion of recruitment and retention provisions to NPPs
  • updating physician-owned hospital requirements
  • reducing burdens of technical noncompliance through more reasonable regulations in a number of areas (based on information learned from self-dsiclosures and the rersults of recent cases)

The complete proposed rule as published in the Federal Register on July 15 can be found here.

Comments will be accepted by CMS on the proposed rule until September 8, 2015.

OIG Fraud Alert on Physician Compensation — Why Is No One Listening?

July 11, 2015 1 comment

A few weeks ago, the OIG published another one of its fraud alerts.  This one was entitled, “Physician Compensation Arrangements May Result in Significant Liability.”

Everyone knows (don’t they?) that business arrangements in healthcare have to meet several legal requirements, including: (1) it cannot be based on the value or volume of referrals, (2) it must be at arms’ length, and (3) it must be commercially reasonable.  When a healthcare provider enters into a transaction that violates any of these three requirements, he may have violated the anti-kickback statute or physician self-referral/Stark law or both, and any claim arising from the transaction that is submitted to the federal government for payment may be a false claim.  Healthcare lawyers have long been warning their clients to be cautious about how they pay (and recruit) physician employees and contractors in order to avoid violations of the kickback, self-referral, and false claims laws. Violations carry stiff penalties and in some cases criminal sanctions.

There is nothing new in this recent Fraud Alert.  Many similar fraud alerts and OIG advisory opinions and actual court cases have passed on the same message.  And there is nothing surprising other than that the facts described in this Fraud Alert so obviously violate these healthcare laws that you have to ask, why is no one listening?

I have a three explanations:

  • The false claims act was passed during the Civil War and was aimed at stopping corruption in how defense contractors were paid.  The law made sense.  There was a direct relationship between the defense contractor and the government dollars received.  However, the false claims act makes no sense in healthcare — treating a patient is so separated from payment; the provider at the time of care may not know who is paying — government, commercial, the patient, or no one.
  • The healthcare laws are so contrary to the economic rules that apply to other businesses and so counter-intuitive as to make them offensively ridiculous and begging to be ignored (which they are).
  • As we move to a pay for performance, quality-based healthcare reimbursement system, these laws become even more irrelevant.  Case in point — Accountable Care Organizations — a critical foundation for healthcare reform under the Accountable Care Act.  ACOs could not operate unless waivers to these healthcare laws were implemented.  Every healthcare provider is not in an ACO, but many are developing clinically integrated networks and other arrangements to oversee quality and utilization in order to compete more effectively with large healthcare systems and negotiate with payors in keeping with the goals of healthcare reform.  They are forced to act as if the waivers applied to them also.  In fact many consultants advise that the waivers DO apply to non-ACO networks.

It is time for a thoughtful review (and repeal) of these antiquated and economically debilitating laws in how they apply to healthcare providers.  It is time to stop calling business sensible healthcare transactions fraudulent and punishing the participants.

These laws allow regulators to be lazy and stupid. Anyone can enforce laws based an strict liability or ones that have lines so faint that crossing them is unavoidable.

Seriously, who cares if someone pays a fee for referring a patient for care?  Liability should be based on the quality and necessity of the care.  Providing care not needed or charging for care not given — those actions should be punished.  But that’s harder for regulators, so we continue to vilify healthcare providers and impose burdens on them that are far tougher than the benefits derived.

Setting Value-Based Payment Goals — HHS Efforts to Improve U.S. Health Care — NEJM

February 1, 2015 Leave a comment

Setting Value-Based Payment Goals — HHS Efforts to Improve U.S. Health Care — NEJM

This article (reproduced in full below) in the New England Journal of Medicine, online January 26, 2015,  is by Sylva M. Burwell, Secretary of Health and Human Services.  It discusses the important concepts of efficiency, quality, waste, and rationing and their intersection with the delivery of healthcare.  References can be found at the online article.

* * * * * * * *

Now that the Affordable Care Act (ACA) has expanded health care coverage and made it affordable to many more Americans, we have the opportunity to shape the way care is delivered and improve the quality of care systemwide, while helping to reduce the growth of health care costs. Many efforts have already been initiated on these fronts, leveraging the ACA’s new tools. The Department of Health and Human Services (HHS) now intends to focus its energies on augmenting reform in three important and interdependent ways: using incentives to motivate higher-value care, by increasingly tying payment to value through alternative payment models; changing the way care is delivered through greater teamwork and integration, more effective coordination of providers across settings, and greater attention by providers to population health; and harnessing the power of information to improve care for patients.

As we work to build a health care system that delivers better care, that is smarter about how dollars are spent, and that makes people healthier, we are identifying metrics for managing and tracking our progress. A majority of Medicare fee-for-service payments already have a link to quality or value. Our goal is to have 85% of all Medicare fee-for-service payments tied to quality or value by 2016, and 90% by 2018. Perhaps even more important, our target is to have 30% of Medicare payments tied to quality or value through alternative payment models by the end of 2016, and 50% of payments by the end of 2018. Alternative payment models include accountable care organizations (ACOs) and bundled-payment arrangements under which health care providers are accountable for the quality and cost of the care they deliver to patients. This is the first time in the history of the program that explicit goals for alternative payment models and value-based payments have been set for Medicare. Changes assessed by these metrics will mark our progress in the near term, and we are engaging state Medicaid programs and private payers in efforts to make further progress toward value-based payment throughout the health care system. Through Healthy People 2020 and other initiatives, we will also track outcome measures that reflect changes in Americans’ health and health care.

To drive progress, we are focusing on three strategies. The first is incentives: a major thrust of our efforts is to create an environment in which hospitals, physicians, and other providers are rewarded for delivering high-quality health care and have the resources and flexibility they need to do so. The ACA creates a number of new institutions and payment arrangements intended to drive the health care system in this direction. These include alternative payment models such as ACOs, advanced primary care medical-home models, new models of bundling payments for episodes of care, and demonstration projects in integrated care for beneficiaries dually eligible for Medicare and Medicaid.

Looking ahead, we plan to develop and test new payment models for specialty care, starting with oncology care, and institute payments to providers for care coordination for patients with chronic conditions. Three years ago, Medicare made almost no payments through these alternative payment models,1 but today such payments represent approximately 20% of Medicare payments to providers, and as noted above, we aim to increase this percentage. As part of this work, we also recognize the need to continue to reach consensus on the quality measures used and address issues related to risk adjustment in these new models.

Second, improving the way care is delivered is central to our reform efforts. We have put in place policies to encourage greater integration within practice sites, greater coordination among providers, and greater attention to population health. Through the Partnership for Patients, we have engaged U.S. hospitals in learning networks to focus on high-priority risks to patient safety and have already seen significant improvement. There is now a national program to reduce hospital readmissions within 30 days after discharge, which encourages hospitals to improve transitional care and coordinate more effectively with ambulatory care providers. Readmission rates are decreasing nationwide.2 Through the Transforming Clinical Practice Initiative, we will invest up to $800 million in providing hands-on support to 150,000 physicians and other clinicians for developing the skills and tools needed to improve care delivery and transition to alternative payment models. New Medicaid health homes, patient-centered medical homes, and efforts to reorganize care for people eligible for both Medicare and Medicaid are all designed to foster greater integration and coordination.

Third, we aim to accelerate the availability of information to guide decision making. The Obama administration has led a major initiative in health information technology (IT), focusing on the adoption of electronic health records (EHRs) and their meaningful use as a central avenue for transforming care. The proportion of U.S. physicians using EHRs increased from 18% to 78% between 2001 and 2013, and 94% of hospitals now report use of certified EHRs.3 Ongoing efforts will advance interoperability through the alignment of health IT standards and practices with payment policy so that patients’ records are available when needed at the point of care to permit informed clinical decisions to be made in a timely fashion.  HHS has made a commitment to enhancing transparency in the health care market. For example, the Medicare website enables consumers to compare data on the costs and charges for hundreds of inpatient, outpatient, and physician services. Information is available on the quality of hospitals, physicians, nursing homes, and other providers, enabling consumers to make better-informed choices when selecting providers and health plans.

The ACA established the Patient-Centered Outcomes Research Institute (PCORI), dedicated to generating information that can guide doctors, other caregivers, and patients as they address important clinical decisions; PCORI is working with the Agency for Healthcare Research and Quality to disseminate this information. In the years ahead, the research findings from PCORI, disseminated in part through EHRs, can bring critical clinical information to providers and patients when they need it most, at the point of care.

Although we have much to celebrate regarding increased access and quality and reduced cost growth, much of the hard work of improving our health care system lies ahead of us. Care delivered in hospitals was much safer in 2013 than it was in 2010: there were 1.3 million fewer adverse events between 2011 and 2013 than there would have been if the rate of such events had remained unchanged, and an estimated 50,000 deaths were averted. Still, far too many hospitalized patients — nearly 1 in 10 — have adverse events while hospitalized, and many people do not receive care that they should receive, while others receive care that does not benefit them. Growth of health care spending is at historic lows: Medicare spending per beneficiary increased by approximately 2% per year from 2010 to 2014 — a rate far below both historical averages and the growth rate of the gross domestic product.4 Survey data show that more than 7 in 10 people who signed up for insurance in the new health insurance marketplace last year say the quality of their coverage is excellent or good.5 However, it will take additional effort to sustain and augment the positive changes we have seen so far.

We are dedicated to using incentives for higher-value care, fostering greater integration and coordination of care and attention to population health, and providing access to information that can enable clinicians and patients to make better-informed choices. We believe that, by working in partnership across the public and private sectors, we can accelerate these improvements and integrate them into the fabric of the U.S. health system.

12 Questions to Guide Physician Compensation Strategy

August 9, 2014 Leave a comment

From Healthcare Intelligence Network — essentially a sales promo for their book.  According to HIN, a successful physician compensation strategy includes organizational goals, governance, and physician engagement.  This is slanted from the healthcare organization viewpoint.

Nevertheless, still worth a look.

 


9 Measures of ACO Success

Via: Healthcare Intelligence Network

ACOs: The Least Agreed-Upon Concept in Healthcare? | Accountable Care Organizations

May 12, 2013 Leave a comment

Five common arguments against accountable care organizations, commentary from experts on each, and an update on Detroit Medical Center’s ACO.

1. In the grand scheme of healthcare spending, ACOs’ savings will be slight.

2. ACOs were designed on a premise that overestimated the level of integration in healthcare.

3. ACOs won’t work when healthcare still operates in a fee-for-service system.

4. ACOs will move patients out of hospitals and hurt hospitals’ revenue.

5. ACOs take healthcare back to the 1990s.

What will prove the ACO model?

The healthcare industry is still in a waiting game as far as ACOs’ results. Although a few mature ACOs like AdvocateCare (and it’s important to keep in mind that the term “mature” means that ACO is only about three years old) have reported hopeful results from its first year. Other newly launched ACOs are not yet able to disclose results. For Medicare savings, the industry has its eye on the Pioneer ACOs, and results from those 32 organizations are expected this summer.

See on www.beckershospitalreview.com

Christensen, Flier and Vijayaraghavan: The Coming Failure of ‘Accountable Care’

February 24, 2013 Leave a comment

In The Wall Street Journal, Clayton Christensen, Jeffrey Flier and Vineeta Vijayaraghavan say that the Affordable Care Act’s updated versions of HMOs are based on flawed assumptions about doctor and patient behavior.  See on online.wsj.com

Beware the nay sayers. ACOs and other accountable care measures can only succeed if there IS a change in physician behavior. Changing the way healthcare is done in this country is the basis (and only workable basis) for meaningful improvement in healthcare while controlling costs at the same time. No one ever thought it would be easy or quick.  

Can we learn something from America – Accountable Care Organisations

February 24, 2013 Leave a comment

It has become de rigueur on the left to regard the US healthcare system as the very incarnation of evil and therefore a country from which nothing of value can be learned for improving our NHS.  This might be about to change. There is now growing interest in the notion of the ‘Accountable Care Organisation’ (ACO) – or as it is tending to be termed over here, the Accountable Integrated Care System.

The Accountable Care Organisation concept is gathering pace in the US following the 2010 Patient Protection and Affordable Care Act, which included a pilot programme to explore ACO structures and processes. Under the new law, an ACO would agree to manage all of the healthcare needs of a minimum of 5,000 Medicare beneficiaries for at least three years. The ACO can gain extra money through sharing savings (with Medicare) resulting from collaborative efforts to provide care cost-effectively. Stringent governance conditions must be met, along with transparency and quality performance – Medicare ACOs will report on 33 different quality metrics.

In his recent ‘Green Paper’ speech on future Labour Party health policy, Andy Burnham spoke of the need for  “one service co-ordinating all of one person’s needs“, with the district general hospital “evolving over time into an integrated care provider from home to hospital“. Indeed, he went on to say:

“If we look to the US the best providers are working on that highly integrated basis, co-ordinating physical, mental and social care from home to hospital. We have got to take the best of that approach and universalise it here.”   See on www.sochealth.co.uk

From the Socialist Health Association of Scotland. I don’t want to think about the ramifications of having an important part of Obamacare endorsed by a socialist health organization. However, labels aside the ability to provide coordination of care in a private setting is a good thing, which is why ACOs are so critical to meaningful healthcare reform.

 

7 Big Data Solutions Try To Reshape Healthcare

January 3, 2013 Leave a comment

Skepticism is a two-edged sword. Not enough of it, and an IT manager might find himself duped into investing in software “solutions” that go nowhere. Too much of it, and skepticism can leave an IT department behind as it waits for enough proof to show a particular platform will improve outcomes beyond a reasonable doubt.

Big data analytics is at that tipping point right now in the healthcare industry. Several vendors promise better quality of care and reduced expenditures, but evidence to support those claims is somewhat tentative. Similarly, some critics of the big data movement say healthcare providers need to squeeze all the intelligence they can from small data sets before moving on to larger projects.

In a recent post in The Health Care Blog, for instance, consultants David C. Kibbe, M.D., and Vince Kuraitis argue that instead of succumbing to the allure of big data analytics, providers should focus on using small data better. In other words, concentrate on the clinical data already available in digitized form and use only those health IT tools that are directly applicable to care management.

Big data analytics, on the other hand, attempts to parse mounds of data from many disparate sources to discover patterns that could be useful in problem solving. For example, researchers are employing the big data approach to study genetic and environmental factors in multiple sclerosis to search for personalized treatments.

Some of this research might lead to exciting payoffs down the road, but IT companies are not waiting. As Kibbe and Kuraitis point out, technology firms are touting big data analytics as a must-have for healthcare systems and physician groups that aim to become accountable care organizations or make ACO-like arrangements with payers. As these ACOs and healthcare organizations try to profit under shared-savings or financial risk contracts, these proponents claim, big data can help them crunch the data for quality improvement and cost reductions.

Some providers are already using big data in patient care. According to BusinessWeek, “many [providers] are turning to companies such as Microsoft, SAS, Dell, IBM, and Oracle for their data-mining expertise.” And healthcare analytics is a growth business. Frost & Sullivan projects that half of hospitals will be using advanced analytics software by 2016, compared to 10% today.

Are healthcare providers ready for big data analytics, or should they be content with the more limited data analytics capabilities built into their EHR systems and relational databases to point the way to new policies and procedures?

When asked to weigh in on the big data/small data debate during a recent interview withInformationWeek Healthcare, David Blumenthal, former head of the Office of the National Coordinate of health IT, said, “It’s not an either/or choice. Big data starts with small data. As we have more information on health and disease and the patterns of care … that information will provide useful insights into what works, what doesn’t. What the natural history of disease is. It will enable us to do studies faster and more efficiently … But it’s going to take a while to figure out how to use the data.”

See on www.informationweek.com

Park Nicollet’s experiment with ACOs – TwinCities.com

September 23, 2012 Leave a comment

In 2005, Park Nicollet Health Services started participating in a pilot project that was the first to test the idea of “accountable care organizations” in the federal Medicare program.

Called the Physician Group Practice Demonstration Program, Park Nicollet was one of 10 large multi-specialty groups across the country that agreed to adopt a new payment relationship from Medicare for a portion of its patients.

The premise was straightforward: If Park Nicollet and other groups could provide care at a lower cost while meeting quality standards for patients, the groups would share the savings with Medicare.

But as a study published this month in the Journal of the American Medical Association shows, results from the Physician Group Practice, or PGP, project have been mixed. Overall, researchers found that the five-year pilot delivered only modest savings, although savings were larger for a subset of patients, many of whom have complex health problems.

“(Park Nicollet) received a bonus payment in only one year of the PGP,” said Carrie Colla, a researcher with the Dartmouth Institute for Health Policy and Clinical Practice. “But in the (subset), they saved quite a bit of money.”

Improving care while lowering costs for complex patients is one of the key challenges facing the nation’s health care system, said Dr. David Abelson, the chief executive officer at St. Louis Park-based Park Nicollet, during an August 2011 interview about the pilot project.

See on www.twincities.com

For an aggregation of other articles on Hot Topics in Healthcare Law, go to my magazine on Scoop.it – Hot Topics in Healthcare Law and Regulation and my newspaper on Paper.li – Hot Topics in Healthcare Law.

For an aggregation of other articles on improving healthcare, go to my internet magazine Scoop.it! Changing Health for the Better.

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