Day 3 Notes at the 2020 J.P. Morgan Healthcare Conference

Eric KleinAytan DahukeyBy Eric Klein and Aytan Dahukey on Posted in Healthcare Industry News

CMI, CMMI, and Changing the Consumer Experience in the U.S. and China

Case Mix Index: Sitting in multiple hospital, payor and physician organization presentations at the J.P. Morgan healthcare conference this year, it is clear that the healthcare market continues to move ahead with the shift toward value and risk-based reimbursement. But, the number one target for healthcare savings in a value or risk-based reimbursement model is the reduction of hospital inpatient admissions and bed days where clinically appropriate, which likely will reduce hospital revenue and perhaps profitability unless proactive responses are taken. Yet, at this year’s conference only a minority of the hospitals presenting spoke to a critical indicator for their financial wellbeing that will become even more important for hospitals’ survival in a risk-based environment. Continue Reading

FDA Year in Review: A Shifting Regulatory Landscape

Allison FultonBy Allison Fulton on Posted in FDA

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas. Continue Reading

Day 2 Notes at the 2020 J.P. Morgan Healthcare Conference

Eric KleinAytan DahukeyBy Eric Klein and Aytan Dahukey on Posted in Healthcare Industry News

The Big Cost; Cancer is the Answer; and SDOH Evolves

The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a bad diagnosis (I’m sorry, you’ve got….) – or the beginning of what will be a life changing chronic condition, we each day are living our lives, making unconscious calculations about our risks and our choices that can lead to these risks. The easier ones are things like “do I want to wear that seatbelt,” “what will eating that (fill in your favorite comfort food) do to me,” or “I know I need to exercise, but…”

The more interesting risk choices – and that’s what we’re talking about, the fact that every day each and every one of us, and every business that provides healthcare insurance to its employees, is making choices as to what risks are tolerable, foreseeable or not acceptable – are those that are not clearly foreseeable but definitely will have consequences in the foreseeable future. For example, if you’re an employer or an insurer, you know that a significant portion of your employees or members have either genetic disposition to certain diseases or are more likely to suffer from certain diseases due to social determinants of health. We also wonder at the development of new drugs that can cure or successfully treat conditions that never before could be addressed successfully, like childhood leukemia, sickle cell anemia, hemophilia, spinal muscular atrophy or inherited retinal dystrophy – many of which wonder drugs also carry eye-watering prices in the millions per treatment. Families can’t afford those costs, nor can individual employers. Continue Reading

Day 1 Notes at the 2020 J.P. Morgan Healthcare Conference

Eric KleinAytan DahukeyBy Eric Klein and Aytan Dahukey on Posted in Healthcare Industry News, Healthcare Information

If I printed a tee shirt for the 2020 J.P. Morgan Healthcare Conference, what would it say? In past years, it would have been “Big Data,” Analytics, Artificial Intelligence, ACA, Risk, Medicare Advantage or Quality. This year, I’d have to say it was: diversification, organic growth and scale. Almost every presentation we attended used those terms, to the point where I wanted to jump up and yell “Bingo! I got it already.” But the message that came through loud and clear this year is that the healthcare industry has figured out what it needs to do and where it needs to go – and that it is creating positive impact for patients while generating good profits by doing so. Continue Reading

2019 Year in Review: Notable Changes in Law, Policy, and Enforcement of HIPAA

Vinay BhupathyDaniel EliavBy Vinay Bhupathy and Daniel Eliav on Posted in HIPAA

According to a December 20, 2019 Report by HIPAA Journal, nearly 39 million health care data breaches had been reported to the U.S. Department of Health and Human Services (“DHHS”), Office of Civil Rights (“OCR”) by the end of November 2019. This is a staggering number, especially considering that this is more than double what was reported in all of 2018. This appears to be part of an exponentially growing number of breach reports since, as we reported last year, 2018’s breach reports were already three times greater than what was reported in 2017.

This article explores some of the trends that can be attributed to the growing number of breaches and how the OCR has responded to the difficulties experienced by healthcare entities (“Covered Entities”) covered by the security and confidentiality requirements applicable to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act of 1996 and 45 CFR Parts 160 and 164, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) (collectively referred to hereinafter as “HIPAA”). Continue Reading

Congress Continues to Focus on Prescription Drug Pricing

Christine ClementsSusan IngargiolaBy Christine Clements and Susan Ingargiola on Posted in Drug and Pharmaceutical Law, Healthcare Industry News

The House and Senate continue to focus on prescription drug pricing though it is unclear whether any of the proposals currently pending in either chamber will become law. On December 6th, Senators Grassley and Wyden introduced an updated version of the bipartisan Prescription Drug Pricing Reduction Act (the “PDPRA”). Senate leadership, however, appears to be in no rush to vote on the bill. On December 12th, the House passed its own version of a prescription drug price reduction bill, H.R. 3, called the Elijah E. Cummings Lower Drug Costs Now Act, which was introduced by Speaker Pelosi. Senate leadership has already indicated the Senate will not take up the measure. While members of Congress on both sides agree that reducing prescription drug prices is a “must do,” they don’t agree on how to do it. Continue Reading

Update to Texas v. United States: Fifth Circuit Strikes Individual Mandate, Remands on Severability

Kenneth YoodJordan GrushkinMatthew GoldmanBy Kenneth Yood, Jordan Grushkin and Matthew Goldman on Posted in Affordable Care Act (ACA), Healthcare Reform

On December 18th, 2019, the Fifth Circuit Court of Appeals released a long-awaited decision on a significant challenge to the Affordable Care Act (“ACA”), affirming a lower-court ruling that we discussed in a previous post. In the lower-court ruling, the Federal District Court judge determined that the ACA’s individual mandate, which was reduced to $0 as a result of the Tax Cuts and Jobs Act of 2017, is no longer considered a tax and therefore Congress no longer has constitutional authority to enforce the mandate. Going one step further, the Federal District Court judge found that the individual mandate is not severable from the rest of the ACA, and thus held that the whole law is unconstitutional. Continue Reading

JUST IN: Fifth Circuit Court of Appeals Reaches Decision on Latest Case Involving Constitutionality of ACA

Kenneth YoodMatthew GoldmanJordan GrushkinBy Kenneth Yood, Matthew Goldman and Jordan Grushkin on Posted in Affordable Care Act (ACA), Healthcare Reform

Today the United States Court of Appeals for the Fifth Circuit reached its widely anticipated decision in Texas vs. Azar, ruling that the Affordable Care Act’s (ACA) individual mandate is unconstitutional as a result of the Tax Cuts and Jobs Act of 2017’s elimination of the mandate’s financial penalty. The Court has remanded the case to the District Court to further address the question (known as the “severability” question) of whether the remaining provisions of the ACA are lawful in light of the decision regarding the individual mandate. Continue Reading

Surprise Billing Initiatives Face Not-So-Surprising Resistance

Kathleen StrattonTheresa ThompsonBy Kathleen Stratton and Theresa Thompson on Posted in Healthcare Reform

“Surprise billing,” also known as “balance billing,” is one of few areas that garners bipartisan support. Surprise billing occurs when a patient inadvertently goes out of his or her insurer’s network, resulting in a “surprise bill” – often times when they had no choice in the matter. According to a recent analysis of 2017 national claims data by the Health Care Cost Institute, an independent, nonprofit research organization, emergency medicine specialists are the most likely to generate surprise bills. How does this play out? A patient goes to the emergency room at a hospital that is in-network, only to be provided services by a doctor staffing that emergency room who is out-of-network, with the patient having no idea about this billing dichotomy and no means to stop it. Continue Reading

340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information Collection Request

Kenneth YoodMelissa GertlerBy Kenneth Yood and Melissa Gertler on Posted in Hospitals, Medicaid, Medicare

Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”), submitted comments (“340B Comments”) to Seema Verma, the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), objecting to an announcement by CMS on September 30, 2019, which proposed an information collection request (“ICR”) to survey the drug acquisition cost data for hospitals participating in the 340B Program. Continue Reading

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