Health Law Advisor Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Category Archives: Quality of Health Care

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New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

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 … Continue Reading

Network Adequacy: A Multimarket Recap of 2015 and Looking Ahead

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”).  Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often … Continue Reading

Higher Bar for “Good Faith Compliance” in Second Year of Exchange Operations

The Centers for Medicare & Medicaid Services (“CMS”) expects Qualified Health Plan (“QHP”) Issuers to be more familiar with Marketplace requirements and better reflect those standards in Issuers’ written policies and procedures, officials stated at the recent 2015 QHP Certification Conference held at CMS Headquarters in Baltimore, Maryland.

Twenty-three Issuers across fifteen Federally-facilitated Marketplace (“FFM”) States were audited for compliance with Federal QHP requirements during 2014.  The audits focused largely on QHP’s policies and procedures relating to FFM operations, including oversight of first tier, downstream and related entities (“FDRs).  While CMS held to its previously announced policy to not pursue … Continue Reading

HHS Announces Goals for Moving Medicare from Volume to Value Payments.

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 … Continue Reading

DC Circuit Will Rehear Halbig

By Stuart Gerson

As we noted in our various blogs and communications on the subject (HEAL Advisory and HEAL Blog), the United States Court of Appeals for the District of Columbia Circuit’s action today, to rehear in December the Halbig case (Halbig v. Burwell, D.C. Cir., No. 14-508 ), challenging  Obamacare subsidies in the federal health exchange, is not unexpected given the current makeup of the Court. This development now makes it more likely that the Supreme Court will not take action on the King cert petition (King v. Burwell, U.S. 4th Circuit … Continue Reading

Complimentary Webinar to Examine Population Health Strategies for Employer-Based Coverage

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in August on emerging trends in value-based purchasing in health care. The session, Population Health Strategies for Employer-Based Coverage, will assess how employers and other health plan sponsors are developing new programs to promote enhanced clinical and financial outcomes for the groups and populations they manage. In particular, speakers will highlight how the Affordable Care Act (ACA) is influencing population health management strategies for employer-based coverage.

The webinar, scheduled for August 26, 2014, at 12:00 p.m. ET, … Continue Reading

Complimentary Webinar to Focus on the Role of Patient Engagement Strategies

Epstein Becker Green and EBG Advisors, as part of their Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in July on emerging trends in population health. The webinar—What Role Do Patient Engagement Strategies Play in Promoting Population Health?—will examine different approaches to target, engage, and modify individual behaviors to lead a healthier lifestyle. Key thought leaders in population health will share examples of ways to engage high-risk and chronically ill groups so as to achieve meaningful clinical and financial outcomes.

This webinar, scheduled for July 31, 2014, at 12:00 p.m. ET, will be led … Continue Reading

CMS Gets the Message – Updated Governance Changes to the Medicare Conditions of Participation

By Arthur J. Fried

The Controversy – 2012 Rulemaking Attempts

Roughly two years ago, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services (“CMS”) published final regulations announcing two controversial rule changes addressing hospital governance.  The industry was taken by surprise, to say  the least, as neither of these requirements had been in the proposed rule.  The changes, promulgated as amendments to the Governing Body Condition of Participation (CoP) included (i) the requirement that a hospital’s board include at least one member of its medical staff; and (ii) a statement in the preamble interpreting … Continue Reading

The Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for reporting information and making that information available online to the public, it has yet to … Continue Reading

Patient-Centered Outcomes Research Institute Begins Process to Fund Clinical Effectiveness Research Grants

by Jason B. Caron

On May 22, 2012, the Patient-Centered Outcomes Research Institute (“PCORI”), a private nonprofit entity established by the Patient Protection and Affordable Care Act of 2010, announced that it will be seeking applications to fund an initial $96 million in grants for innovative research projects in clinical effectiveness research. These grants will be awarded in four areas recently identified in PCORI’s National Priorities Research Agenda.

Read the full alert here

Adam L. Zavadil, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green’s Washington, DC, office, contributed significantly to the preparation of this Continue Reading

Medicare ACOs: Financial and Clinical Integration

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 … Continue Reading

Five Wishes for the Medicare Shared Savings Program Regulations

As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:

 

 

1. Flexibility. 

 

 "Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande’s advice and avoids being too proscriptive in launching the Share Savings Program. To me, the biggest risk to the program is being deemed a failure for having gone down too narrow a path that turns out to be unsuccessful.

 

Useful approaches have been suggested for tiering ACOs and … Continue Reading

The Timeline for Accountable Care

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let’s look at the rollout of the accountable care provisions–i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in the BNA’s Health Law Reporter.  Click here to read the full article Continue Reading

Payment and Delivery System Reform – It’s Only a Matter of Time

In my most recent article in the series I have been writing for the BNA’s Health Law Reporter on payment and delivery system reform, accountable care organizations and bundled payments, I comment on where things are now that federal reform has stalled. The article, titled "Payment and Delivery System Reform: It’s Only a Matter of Time," argues that changes in payment and delivery are on the horizon regardless of the pace of federal reform and that providers (and payers as well) should continue their efforts toward accountable care to meet the cost and quality challenges that are no less daunting today than they were a … Continue Reading

Health Care Delivery System Reform Provisions in the Baucus Bill

In addition to the many hotly contested insurance and access-related provisions in the America’s Healthy Future Act of 2009, the Chairman’s Mark from Senator Baucus on behalf of the Senate Committee on Finance, released Wednesday, there is in the bill a section that addresses in a substantive way reform of the health care delivery system with a focus on quality.  Much of the underlying thinking in Title III of the bill, entitled "Improving the Quality and Efficiency of Health Care," draws from the Institute of Medicine’s seminal publication in 2001 of Crossing the Quality Chasm.  Especially in Subtitle A, … Continue Reading