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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

Interpreting Fiorina’s Comments on Vaccination Law

August 16, 2015 Leave a comment

Last Week’s Big Healthcare Law Stories

May 30, 2015 Leave a comment

As healthcare providers and their lawyers know, things happen fast in healthcare.  Business deals, enforcement activity, new inventions and discoveries.

Here are a few headlines from last week in no particular order:

  • OIG Mid-Year 2015 Work Plan Mid-Year Update — The OIG published its 86 page mid-year update to its 2015 Work Plan. “This edition of the Work Plan, effective as of May 2015, describes OIG audits, evaluations, and certain legal and investigative initiatives that are ongoing. In response to adjustments made to our Work Plan, this mid-year update removes items that have been completed, postponed, or canceled and includes new items that have been started since October 2014. The word “new” before a project title indicates that the project did not appear in the previous Work Plan. For each project, we include the subject, primary objective, and criteria related to the topic. At the end of each description, we provide the internal identification code for the review (if a number has been assigned) and the year in which we expect one or more reports to be issued as a result of the review. This edition also forecasts areas for which OIG anticipates planning and/or beginning work in the upcoming fiscal year and beyond. Typically, these broader areas of focus are based on the results of OIG’s risk assessments and have been identified as significant management and performance challenges facing HHS. In FY 2015 and beyond, we will continue to focus on emerging payment, eligibility, management, and information technology systems security vulnerabilities in health care reform programs, such as the health insurance marketplaces. OIG plans to add to its portfolio of work on care quality and access in Medicare and Medicaid, as well as on public health and human services programs. OIG’s examination of the appropriateness of Medicare and Medicaid payments will continue, with possible additional work on the efficiency and effectiveness of payment policies and practices in inpatient and outpatient settings, for prescription drugs, and in managed care. Other areas under consideration for new work include, for example, the integrity of the food, drug, and medical device supply chains; the security of electronic data; the use and exchange of health information technology; and emergency preparedness and response efforts.”
  • CMS Proposes New Rule for Medicaid Managed Care — “This proposed rule would modernize the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The proposed rule would align the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implement statutory provisions; strengthen actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; and promote the quality of care and strengthen efforts to reform delivery systems that serve Medicaid and CHIP beneficiaries. It would also ensure appropriate beneficiary protections and enhance policies related to program integrity. This proposed rule would also require states to establish comprehensive quality strategies for their Medicaid and CHIP programs regardless of how services are provided to beneficiaries. This proposed rule would also implement provisions of the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.”
  • Florida Senate Tweaks Health Exchange Plan For Fast Action — “The new Senate plan would jettison an initial proposal to expand Medicaid this summer, but instead would still rely on federal money linked to President Barack Obama’s health care overhaul. Low-income Floridians would be eligible to purchase coverage through a new state-run exchange, but they would have to pay premiums and they would be required to work. The new health coverage plan would require federal approval and would not kick in until January.  It would also allow consumers who are currently getting insurance through the federal exchange to continue doing so instead being bumped to an expanded Medicaid program — something the House criticized in the initial proposal.”
  • New York Assembly Passes Universal Health Care Bill — The New York Assembly passed the New York Health Act, which is seen largely as a symbolic gesture and not likely to be passed by the Republican New York Senate.  The bill’s Economic Analysis stated “This report analyzes the economic effects of the New York Health Act …, which would establish a comprehensive, universal health insurance program for all New Yorkers. The Act would replace the current multi-payer system of employer-based insurance, individually acquired insurance, and federally sponsored programs (e.g., Medicare and Medicaid) with a single billing pipeline funded by broad-based progressively graduated assessments collected by the State and based on income and ability to pay, thereby reducing administrative bloat and monopolistic pricing and dramatically reducing the cost of health care to New Yorkers even while extending and improving the provision of care.”
  • 21st Century Cures Act: A Call to Action — “The House Energy and Commerce Committee recently approved the 21st Century Cures Act with a vote of 51-0. The nonpartisan legislation will help to modernize and personalize health care, encourage greater innovation, support research, and streamline the system to deliver better, faster cures to more patients.”
  • FTC Commissioner Calls For War On Hospital Construction Laws — Law360 reported yesterday that “Federal Trade Commissioner Maureen K. Ohlhausen on Friday urged the antitrust agency to put pressure on state legislatures around the country to scrap laws requiring state approval for the construction of new hospitals, saying the laws are ‘anti-competitive’ in nature and create barriers for new market entrants.”
  • Two Cardiologists To Pay Over $3.6 Million For Fraud — “Jasjit Walia and Preet Randhawa and their New Jersey-based cardiology practice Garden State Cardiovascular Specialists will pay the amount to resolve allegations that they submitted claims to federal insurance program Medicare for various cardiology diagnostic tests and procedures. The tests included stress tests, cardiac catheterizations and external counterpulsation, which were not medically necessary, US Attorney Paul Fishman for the District of New Jersey said.”
  • Florida’s Medical Marijuana Rules Upheld — “Florida Administrative Hearings Judge David Watkins rejected claims by an Orange County nursery that the state’s proposed rules and regulations were unfairly developed to give advantage to bigger, politically connected nurseries to win the five regional medical-marijuana-growing licenses the law allows. … Florida may now start creating a statewide medical-marijuana program that so far has only been proposed. The program, as written, allows five companies to grow low-THC marijuana, extract an oil and sell it as medicine for people who suffer from intractable epilepsy and several other debilitating conditions.”

THE MEDICARE ACCESS AND CHIP REAUTHORIZATION ACT (a/k/a the Repeal of the SGR)

April 15, 2015 Leave a comment

There is great celebration in the healthcare community about the repeal of the Medicare Sustainable Growth Rate (“SGR”).  All the healthcare-related and other media are abuzz reporting on the jubilation:

among others.

In fact, the only comparable celebration that I can recall occurred on the death of the Wicked Witch in the Wizard of Oz. Actually, the repeal of the SGR and the witch’s death are more alike than different.

For years, the SGR has terrorized physicians.  Every December and into the following new year, physicians had to wait to see whether their reimbursement from Medicare would be reduced by some double-digit percentage.  Recently, physicians have been pawns for Democrats and Republicans trying to make points (perhaps “ping pong balls” is the better metaphor), with their livelihoods held hostage until some form of political rationality prevailed.

According to the summary/analysis of MACRA prepared by the Staffs of the House Energy and Commerce and Ways and Means Committees:

The legislation repeals the flawed Sustainable Growth Rate (SGR) formula and replaces it with the bicameral, bipartisan agreement to return stability to Medicare physician payments. The SGR formula is a cap on aggregate spending on physicians’ services where exceeding the cap resulted in punitive recoupments in subsequent years. The formula was passed into law in the Balanced Budget Act of 1997 to control physician spending, but it has failed to work. Since 2003, Congress has spent nearly $170 billion in short-term patches to avoid unsustainable cuts imposed by the flawed SGR. The most recent patch will expire on March 31st. Based on H.R. 1470, the bicameral, bipartisan unified Committee bill to replace the SGR, this policy removes the imminent threat of draconian cuts to Medicare providers and ensures a 5-year period of stable annual updates of 0.5 percent to transition to a new system. The new system moves Medicare away from a volume-based system towards one that rewards value, improving the quality of care for seniors.

The Medicare Access and CHIP Reauthorization Act, or MACRA for short, has been praised by President Obama who has  promised to sign it.  The 324-page Congressional print of MACRA does a lot of things in addition to repealing the SGR, including the following:

  • Extension of the Children’s Health Insurance Program (“CHIP”) for two years
  • Development of “alternative payment models” away from fee for service and toward quality of care
  • Strengthening of Medicare’s ability to fight fraud and build on existing program integrity policies
  • Additional $7.2 billion for community health centers
  • Increasing Medicare premiums for some seniors and elimination of Medigap policies starting in 2020 from covering Medicare deductibles for new beneficiaries

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.

The King Case and the Reach of State Legislatures

September 21, 2014 Leave a comment

On September 11, 2014, the Third Circuit Court of Appeals decided the case of King v. Governor of the State of New Jersey.

The King case deals with a New Jersey statute that prohibits licensed counselors from “sexual orientation change efforts” with clients under the age of 18.  The plaintiff-appellants, who provide licensed Christian-based counseling to minor clients seeking to reduce or eliminate same-sex attractions, challenged the N.J. statute as improperly violating their First Amendment freedoms of speech and religion.

The court affirmed the lower court’s upholding of the statute but on the basis of a much more conservative/protective analysis of the First Amendment rights.

The 3rd Circuit’s holding is in line with recent holdings from the 4th, 9th, and 11th Circuits that establish special rules for the regulation of speech that occurs pursuant to the practice of a licensed profession. (The 11th Circuit case dealt with the Florida gun-gag law on doctors.)

Though, unlike the other Circuits, the 3rd Circuit in King held that the statute must be subjected to “intermediate scrutiny” (as opposed to a more deferential review or no review) in order to “adequately protect the First Amendment interests inherent in professional speech.”

The take away here for me is that the reach of state legislatures has gotten bigger.  State legislatures are enacting laws that challenge/support the influence of religious groups (challenge, as in the King case) or political groups like the NRA (support, as in the Florida gun-gag case).  The Constitution has been a shield upholding intrusive laws that support very specific political agendas (e.g., pro-gay, pro-gun).  The politics of a state’s legislators, and the views of their supporters, will likely continue to trickle down to impact on what may be said to patients/clients by their counselors and by any other regulated professions.  I suspect that legislators will explore new ways to intrude on matters of individual choice and conscience that should be outside their interest or concern.

Harvard’s Bill of Health Blog: Contraceptive Mandates and Conscience – All Objections Are Not Equal

August 30, 2014 Leave a comment

The Harvard Law School Blog, Bill of Health, recently posted an article entitled “Contraceptive Mandates and Conscience – All Objections Are Not Equal.”

… studies show that medical professionals may object to services based on clinically false information. …  If medical professionals make decisions based on ignorance, one can suspect that lay employers and patients do as well.

This suggests that individuals often lack the information necessary to truly assess their stance on morally controversial services.  While the law does (and should) play a role in protecting conscience, it seems unsatisfying when such protection is granted to those holding underdeveloped views, and at the expense of (and detriment to) those seeking legal medical services.

This seems so simple and logical.  We do not let employers make other health-related decisions for their employees, why do we let some employers make reproductive decisions for their employees based on a religious view not shared by their employees?

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