Top 10 Provisions of CMS Proposed Rule: Medicare Advantage and Part D Programs for CY2021 and CY2022

As promised, here is a summary of some key provisions in CMS’ proposed rule relating to the Medicare Advantage and Part D programs for contract years 2021 and 2022.  CMS is soliciting comments on a number of issues and we urge stakeholders to take the opportunity to submit comments.  The deadline for comments is April 6, 2020. Continue Reading

ACA Medicaid Expansion Weakens: Trump Administration Unveils Optional Plan for Block Grants

January 30th, 2020 marked a dramatic change in Medicaid funding, as the Trump Administration and Centers for Medicare & Medicaid Services (“CMS”) showcased a plan, called the “Healthy Adult Opportunity,” that would permit states to cap Medicaid spending. This was a blow to the Medicaid expansion under the Affordable Care Act (“ACA”), which expanded federal spending for low income individuals that did not previously qualify for the program. Continue Reading

CMS Proposes Changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022

In an evening email that is sure to ruin the weekend for many, CMS announced on February 5, 2020, that it is proposing changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022. CMS will not issue a Call Letter for CY2021. The unpublished version of the proposed rule is available for inspection, and is scheduled to be published in the Federal Register on February 18, 2020. Comments are due April 6, 2020. Continue Reading

Health and Human Services Exchange Program Integrity Final Rule

On December 20, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on program integrity for Affordable Care Act (ACA) exchange plans.  This rule implements a number of provisions from the ACA, including the requirement that each state have the opportunity to establish an Exchange, as well as the steps the Secretary of Health and Human Services (HHS) may take to oversee Exchanges’ compliance with HHS standards, including ensuring their financial integrity, including conducting investigations and annual audits, and the requirement that the Secretary establish procedures to verify the accuracy of information provided by applicants, including eligibility to purchase qualified health plans (QHPs) through the Exchange and for advance payments of premium tax credit (APTC) and cost-sharing reductions (CSRs). Continue Reading

Why the Health Care Industry Should Be Concerned About Section 889 of the 2019 National Defense Authorization Act

On August 13, 2018, President Trump signed into law the National Defense Authorization Act (NDAA) of 2019. While the annual NDAAs are tracked, analyzed, and picked apart with great care by the federal contracting community, the health care industry typically pays them little mind. But ignoring the 2019 NDAA would be a big mistake, because tucked within its more than 1,000 sections is one that will have a significant impact on many health care industry players. It’s known as Section 889. Read our thoughts on Section 889’s impact on the Health Care industry here. Continue Reading

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

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

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

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

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

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

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