Innovations in Health Care Delivery

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After July 1, 2017, optometrists and ophthalmologists (“Ophthalmic Providers”) in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship “by an examination through face-to-face interactive, two-way, real-time communication” or through “store-and-forward technologies.” Licensed Ophthalmic Providers may establish a provider-patient relationship so long as the provider conforms to the in-person standard of care.  To the extent that an Ophthalmic Provider actually writes a prescription, the Ophthalmic Provider must also obtain an updated patient medical history and make a diagnosis at the time of prescribing.  However, like most telehealth laws in other states, the Virginia law prohibits issuing a prescription solely by use of an online questionnaire.

By comparison to other telehealth laws, the Virginia law is progressive not only because it permits Ophthalmic Providers to establish a valid provider-patient relationship through store-and-forward technologies, but that it addresses the need for telehealth laws that specifically apply to Ophthalmic Providers. As of July 1, Ophthalmic Providers in Virginia can begin prescribing eyeglasses or contact lenses using real time and store-and-forward telehealth modalities. Since Virginia already has remote prescribing and parity laws in place, Ophthalmic Providers should feel free to immediately begin using these technologies to prescribe in accordance with the new law.  While it is hard to say how many Ophthalmic Providers are ready to immediately incorporate these technologies into their practices, telehealth optometry will most certainly expand patient access to eye care services in Virginia.

This post was written with assistance from Lauren Farruggia, a 2017 Summer Associate at Epstein Becker Green.

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called “superbugs,” estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the same study projected 8.2 million deaths from cancer, and 1.2 million deaths from traffic accidents by 2050.  Legislative efforts to address antimicrobial resistance span from encouraging development of new pathways to market for antimicrobial drugs to expanding data collection and monitoring efforts to better understand the scope of the problem.  The combination of new data and less-restrictive pathways to market simultaneously provide pharmaceutical companies with a faster entry into the market for antimicrobial drugs and a better understanding by local health departments and hospitals of the need for new drugs to combat resistant strains of microorganisms.

Federal Initiatives

On the federal side, the 21st Century Cures Act (the “Act”), signed into law by President Obama on December 13, 2016, includes several measures related to antimicrobial resistance.  For example, the Act creates a new approval pathway for “limited population drugs,” which are antibacterial or antifungal drugs “intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs.” While the Act allows FDA to approve limited population drugs with less data than typically would be required, the approval is restricted to “the intended limited population,” and the manufacturer must meet additional labeling requirements to inform physicians of the drug’s limited approved use.  In addition, manufacturers of drugs approved through this pathway are required to submit any promotional materials to FDA at least 30 days before they plan to use them.

While adding specific labeling requirements for new drugs approved for limited populations, the Act also changes labeling requirements for susceptibility test interpretive criteria. Susceptibility test interpretive criteria includes the myriad of testing options used to determine whether a patient is infected with a specific microorganism or class of microorganism that can effectively be treated by a drug.  The Act requires pharmaceutical manufacturers to replace the currently existing susceptibility test interpretive criteria from the drug’s packaged insert or labeling with a reference to a FDA website to be built where such criteria for all drugs will be held.  Manufacturers have one year from the day the website is established to move its susceptibility test interpretive criteria to the so-called “Interpretive Criteria Website.”

The Act also increases monitoring and reporting of antimicrobial drug use and antimicrobial resistance at federal healthcare facilities, like VA hospitals and facilities run through the Indian Health Service or the Department of Defense. Further, it requires annual federal data reporting on aggregate national and regional trends related to antimicrobial resistance. A broad base of reliable data on antimicrobial resistance and the associated morbidity and mortality does not currently exist. However, along with the federal government, certain states are also making efforts to improve data collection in this space.

State Initiatives

Many states receive funding from the Centers for Disease Control (CDC) to collect data about patients with extremely resistant strains of microoganisms, like carbapenem-resistant Enterobacteriacea, or “CRE” – a bacteria that kills an estimated 600 Americans each year. The Illinois Department of Health, for example, developed a registry in 2014 that tracks positive lab tests for extremely drug-resistant organisms, including CRE.  Illinois began tracking this information following a deadly outbreak of CRE in 2013.  Health care facilities participating in the registry receive alerts when an infected patient is transferred in and must report CRE-positive culture results of patients within seven calendar days.  The most recent annual report shows a 7% increase in overall cases; however, a recent article posits that the increase may be somewhat attributable to better reporting efforts by hospitals gaining experience identifying CRE.  Similar programs exist in many states, but these programs typically do not track the outcomes of CRE cases.

A recently proposed bill in California (California Senate Bill 43) would require hospitals to include information within death certificates that identifies whether “any antimicrobial-resistant infection…was a factor in the death.”  Specifically, the bill would require the “attending physician [who] is legally obligated to file a certificate of death” to determine whether, in the physician’s professional judgment, an antimicrobial-resistant infection was a factor in the patient’s death.  State law already mandates tracking of over 80 communicable diseases, like HIV and Hepatitis (A-E), but only tracks antibiotic-resistant infections of VRE and MRSA if they are contracted while a patient is already in the hospital.

Given the magnitude of the potential threat, it is reassuring that legislative initiatives are showing an increased focus on antimicrobial resistance. New pathways to market for antimicrobial drugs and increased public awareness of the rising threat of “superbugs” should lead to additional innovation by drug manufacturers.  The limited population pathway may also cause some manufacturers to reassess their pipelines and strategies to market drugs toward limited populations.  For manufacturers facing expensive and burdensome FDA requirements to market new antimicrobials to a general population, the limited population pathway may provide a cheaper and faster entry into the market.  Early entry into the market can then fund additional efforts expand the label beyond a limited population.

Telemental/telebehavioral Health SurveyEpstein Becker Green has just released the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.

While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care.

Compiled by attorneys in Epstein Becker Green’s Telehealth practice, the survey details the rapid growth of telemental health—mental health care delivered via interactive audio or video, computer programs, or mobile applications—and the increasingly complex legal issues associated with this trend. Additionally, the survey provides one source for state-by-state coverage of legal issues related to telemental health, such as:

  • Definitions of “telehealth” or “telemedicine”
  • Licensure requirements
  • Governing bodies
  • Reimbursement and coverage issues
  • The establishment of the provider-patient relationship
  • Provider prescribing authority
  • Accepted modalities for delivery (e.g., telephone, video) to meet standards of care

Read the firm’s full announcement and click here to download the complimentary survey.

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable Care Organizations, Patient Centered Medical Homes, and Bundled Payments.  Like the Affordable Care Act itself, HHS believes that its initiative will unleash an even stronger movement in the private sector towards alternative payment methodologies, and is establishing the “Health Care Payment Learning & Action Network” to promote this public-private partnership, to be kicked-off in March.

While some reports regarding these approaches have shown mixed results, Secretary Burwell cited data showing savings of $116 billion from previous trends, and anticipates even further inroads into the cost curve with Monday’s announcement.  Various national provider associations were supportive of the initiative. Others noted, however, that physicians need flexibility in the way payments are administered and that continued reductions in payments to hospitals could impair their ability to invest in delivery reforms.  Some urged HHS to recognize the value of new treatment and pharmacological advances in the developing payment methodologies.

Whatever the outcome of these initiatives, this announcement signals that government payment policies will continue to strongly influence the transformation of the American health care system for the foreseeable future. Indeed, almost immediately, several large hospital systems and payors likewise announced significant goals for quality and cost incentives in their contracts.

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled The Impact of Value-Based Purchasing and Other Employee Initiatives on Population Health.  This session will discuss several approaches for population health managers to reduce costs and improve health care.

The webinar, scheduled for November 20, 2014, at 12:00 p.m. ET, will be led by Laurel Pickering, MPH, President & CEO of Northeast Business Group on Health, and David Lansky, PhD, President & CEO of Pacific Business Group on Health. Adam Solander of Epstein Becker Green will moderate the session.

For more information, click here.  To register, click here.

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled Moving to an Integrated Population Health Management Model. This session will highlight several approaches to help manage populations to promote better clinical outcomes, more cost savings and enhanced patient satisfaction.

The webinar, scheduled for October 30, 2014 at 12:00 p.m. ET, will be led by Sarika Aggarwal, MD, Senior Vice President and Chief Medical Officer of Fallon Community Health Plan, and Julie O’Brien, RN, BSN, MS, Senior Vice President and Chief Operating Officer of Alicare Medical Management, and moderated by Mark Lutes, Chair, Epstein Becker Green.

For more information, please click here.  To register, please click here.

 

Epstein Becker Green today announced that Lynn Shapiro Snyder and Tanya Cramer have written a newly released topical Portfolio for Bloomberg BNA on provider risk sharing arrangements entitled, “Accountable Care Organizations and Other Provider Risk Sharing Arrangements, 2nd edition.” The Portfolio discusses the federal and state regulatory schemes for accountable care organizations (ACOs), integrated delivery systems, and other provider organizations that assume some or all of the financial risk for providing covered health care benefits to patients.  For more information, click here.

 

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar on September 30, 2014 on emerging trends in value-based purchasing in health care. The next session will feature a former key official from the U.S. Department of Health and Human Services (HHS), Gary Cohen, JD, who played a central role in the implementation of the Affordable Care Act over the past several years and is moderated by Lynn Shapiro Snyder, Senior Member, Epstein Becker Green.  The session, The Impact of the Affordable Care Act on Population Health Management, will assess how much progress the federal and state governments have made expanding health care coverage and bending the cost curve.  Specific insurance reforms to the individual and small group markets will be examined along with emerging trends such as the role of accountable care organizations (ACOs), patient accessibility issues, and the drive towards integrated population health solutions.

For more information, please visit:  http://www.ebgadvisors.com/cciio-director-gary-cohen-address-key-health-care-reforms-impact-population-health-management/.

 

 

 

 

The Supreme Court Has Decided, But Can America Afford the Affordable Care Act? in Bloomberg BNA's Health Law Reporter

Most reasonably-well-informed citizens, and certainly everyone concerned with health care, is well aware that the Supreme Court concluded its most-recent term with the Chief Justice joining the Court’s so called “liberal” wing in National Federation of Independent Business v. Sibelius, in upholding essentially all of the Obama Administration’s Affordable Care Act (“ACA”), including its most controversial provision – the “individual mandate” —  not under the Commerce Clause, as its proponents argued, but under the tax power.  The Court’s majority also upheld, but limited, the controversial Medicaid expansion provision of the ACA. The expansion survives, but if a State declines to participate in the expansion, it can’t be constitutionally deprived of the federal Medicaid funding that it previously had received.

Victory proclamations and hand-wringing aside, one notes that the mere fact that the ACA  has passed judicial muster leaves open a myriad of milestones and questions. The Act, after all, runs on for hundreds of pages and most of them have nothing to do with the mandate or with the expansion of Medicaid. That said, Epstein Becker & Green is dedicating this blog to discussing the issues that are yet to be determined as the ACA regime goes forward.

The New Regime Already Has Begun: Many provisions of the ACA are already in effect including guaranteed access to insurance even if a person has a pre-existing condition, coverage for young adults, closing of the Medicare gap known as the "doughnut hole", small business tax credits and the imposition of a pharmaceutical manufacturer’s fee based on market share. This year saw the launch of Accountable Care Organizations, a part of the ACA that is intended to address quality and cost issues by allowing providers to organize and combine and then to share in savings achieved by meeting various performance targets.  Additional provisions will take effect through 2018, for example . . .

Hospital Value-Based Purchasing Program: Beginning on October 1, 2012, Medicare will implement a value-based purchasing program under which value-based incentive payments will be made in connection with discharges from hospitals that meet specified performance standards related to quality. Efficiency measures are to be added in 2014. Funding for these payments is to be generated through reducing Medicare IPPS payments to all hospitals (in an increasing amount each year), but all such reductions are returned to hospitals through incentive payments in the same year. The secretary will make the performance scores for hospitals on the measures publicly available. Also in 2012, there will be value-based purchasing demonstrations established for critical access hospitals and certain other hospitals excluded from the VBP program. The VBP program will require many regulations and the challenge to hospitals to maintain financial performance and efficiency will be great.

Hospital Readmissions Reduction Program: Also starting with discharges occurring on or after October 1, 2012, Medicare will reduce payments to hospitals (though some are exempted) that are determined to have an "excess readmissions ratio" as defined by the secretary. This is a complex provision that includes a formula for payment reductions that not only require substantial regulatory activity but likely will lead to controversy. 

And Beyond?: Certain knowledge about the ACA and the future will depend upon the outcome of the upcoming presidential and congressional elections and the determination of who will control the political agenda and the likely budget sequestration that will follow. For example, the “maintenance of effort” provisions of the law are already in effect. The question will be whether they stay in effect, or whether States are empowered to cut back on Medicaid and other eligibility. Litigation, which some consider our national sport, also is likely to test the many regulations that the Secretary must promulgate under the ACA.  Assuming that the ACA is not completely dismantled by the incoming Congress, and the probabilities do not favor that, much of the activity will be in the States. The primary concern will be the State’s difficulty (or, in some cases, inability) to afford even the modest increase in the State share of the Medicaid increase. We expect that almost every State ultimately will opt in but not until there are delays and administrative modifications negotiated with the federal government.  It is not unlikely that there will be caps on Medicaid expenditures imposed by State legislatures and the proliferation of Medicaid managed care programs, run on a capitated basis, to deal with the administration of the program to an increased eligible population.  Many are already asking whether the Supreme Court’s holding will allow a State to opt into the expanded Medicaid program but later to opt out while being guaranteed federal payments at the elevated level. We look forward to addressing that in future blog posts. The other State-based issue is that of the Exchanges. Some States are well along the way towards setting them up. Others have yet to begin. It is a certainty that there will be at least some federally administered exchanges which may likely become politically controversial as their proponents look to expand them into a quasi-public option.

Needless to say, there is plenty to talk and write about as the ACA moves forward. We look forward to discussing them and to hearing your comments and questions.

For more information, contact the author at sgerson@ebglaw.com.

Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 (there are 32 Pioneer Accountable Care Organizations and 6 Physician Group Practice Transition Demonstration organizations), we can see, 16 years later, how clinical and financial integration in fact go hand in hand.  Under these various accountable care arrangements, multi-providers entities contracting with the Centers for Medicare and Medicaid Services as ACOs are required to demonstrate both quality (i.e., delivery reform featuring clinical integration) and cost efficiency (i.e., payment reform featuring financial integration).

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