Squire Patton Boggs

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Resurrection of the 340B Mega Rule

In November 2014, we provided an update, which noted that the Health Resources and Services Administration (HRSA) had halted publication of the 340B Mega Rule.  HRSA, however, has now resurrected the Mega Rule having recently submitted the “340B Program Omnibus Guidelines” to the Office of Management and Budget, which is pending review. The substantive contents … Continue Reading

Capital Thinking: Health Care Legislative Update

Congressional Committees Consider Veterans’ Health, Chronic Conditions Several hearings this week will focus on veterans’ health topics. Both the House and the Senate will discuss the implementation of the Veterans Choice Program early in the week, with the Senate holding a hearing on Tuesday, May 12, and the House following on Wednesday, May 13. On … Continue Reading

The Next Generation ACO — The Yellow Brick Road to Capitation

The Centers for Medicare & Medicaid Services (CMS) recently announced its Better, Smarter, Healthier initiative, part of which plans on tying “30 percent of traditional, or fee-for-service, Medicare payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and tying 50 percent of … Continue Reading

Board Members Should Heed OIG Compliance Guidance

Board members for organizations of all sizes need to be familiar with the OIG’s recent publication of Practical Guidance for Health Care Governing Boards on Compliance Oversight. This informative guide is intended to assist the Board member of any health care organization fulfil compliance obligations with the myriad of health care laws and regulations.  Although … Continue Reading

Capital Thinking: Health Care Legislative Update

House and Senate Consider Medical Modernization Capitol Hill focuses on the future of health care this week. The Senate Committee on Health, Education, Labor, and Pensions (HELP) will conduct a discussion on medical advancement and improvement on Tuesday with a hearing titled “Continuing America’s Leadership: The Future of Medical Innovation for Patients.” Dr. Christopher P. … Continue Reading

Capital Thinking: Health Care Legislative Update

Legislative Activity Last Thursday, President Obama signed H.R. 2, the Medicare Access and CHIP Reauthorization Act, into law. Also known as the Sustainable Growth Rate (SGR) package or the “permanent doc fix,” the bill permanently repealed Medicare’s often-criticized physician payment system. The House and Senate each drew support from both sides of the aisle to … Continue Reading

Capital Thinking: Health Care Legislative Update

With both chambers returning from recess this week, attention is focused on Senate consideration of the House-passed bill to permanently repeal Medicare’s physician payment system. While the last “doc fix” expired March 31, the Centers for Medicare and Medicaid Services (CMS) indicated it would hold claims for two weeks to allow Congress to return from … Continue Reading

Thinking About Cybersecurity – How to Get Organized & Better Manage Risk

Another month, another round of data breaches – seem like a familiar refrain when healthcare providers, health plans and their counsel think about cybersecurity?  But what if instead we could get organized and manage this growing business risk in a more proactive manner? It sounds like a good idea, but for many counsel, who view … Continue Reading

Capital Thinking: Health Care Legislative Update

Lawmakers Continue Negotiations on Doc Fix Package, Working Framework Announced With the current patch expiring on March 31, lawmakers continued over the weekend to negotiate a legislative package to permanently repeal Medicare’s automatic payment cut to physicians. H.R. 1470 is very similar to the bipartisan legislation that key committees in both chambers approved last year. … Continue Reading

Capital Thinking: Health Care Legislative Update

Congressmen Negotiate SGR Package Lawmakers on the House side of the Capitol continue to negotiate a package that would prevent an anticipated cut to Medicare physician payments and include a permanent repeal of payment system. Bipartisan leaders on the House Committee on Ways and Means and the House Committee on Energy and Commerce released joint … Continue Reading

US Supreme Court Oral Argument on Tax Subsidies for Federal Exchange

This morning, the U.S. Supreme Court heard oral argument in King v. Burwell, which raises the issue of whether the federal government can provide tax subsidies to people who buy insurance on the federal exchange because their state declined to establish its own insurance exchange.  Our earlier post details  the arguments at play.  SCOTUS Blog … Continue Reading

CMS delays identifying overpayments. Can you?

The Centers for Medicare and Medicaid Services (CMS) continues to mull over the knotty problem of what it means to identify an overpayment from the government.  Healthcare providers do not have the same luxury. Five  years ago, the Affordable Care Act required a provider that received an overpayment from the government to report and repay it within 60 days of identifying the … Continue Reading

Anthem Data Breach: A Dramatic Reminder about Data Security

News of the data breach suffered by Anthem continues to dominate the news (here, here, and here for example).  And, further raising the stakes, class action lawsuits from individuals whose information has potentially been compromised are beginning to roll into courthouses across the country (California, Alabama, Indiana, Georgia, California (again), and California (again)).  Because health care data is such a … Continue Reading

FDA Rethinks Consumer-Directed Print Ads for Drugs

In 2004, the FDA promulgated requirements for drug print advertisements.  FDA, 69 Fed. Reg. 6307 (May 10, 2004).  Those regulations required “the entire risk-related sections of the FDA-approved professional labeling.”  The FDA is now significantly changing its course because of  “recent social science research” indicating that non-material information should be omitted from drug advertisements in print … Continue Reading

This Week's Legislative Activity and Hearings

Legislative Activity With the midterm elections now over, the attention of the health policy community has shifted to the Affordable Care Act’s open enrollment period, which began on November 15. Due to last year’s bungled rollout, as well as recently disclosed statements made by economist and White House consultant Jonathan Gruber, a renewed focus on … Continue Reading

Legislative Activity

 This Week’s Hearings: Wednesday, November 12: The Senate Committee on Appropriations will hold a hearing titled “The U.S. Government Response to the Ebola Outbreak.” Thursday, November 13: The House Committee on Foreign Affairs will hold a hearing titled “Combating Ebola in West Africa: The International Response.” The House Committee on Veterans’ Affairs will hold a … Continue Reading

Supreme Court Will Hear Another ACA Case

The Affordable Care Act has once again made its way onto the Supreme Court’s calendar.  On Friday, the Justices voted to accept King v. Burwell for hearing this term.  The issue this time is whether tax subsidies may be given to individuals who purchase insurance through the federal exchange, rather than an insurance exchange run … Continue Reading

Release of the 2015 OIG Work Plan

Happy Halloween!  In addition to costumes and candy, October 31 saw the release of the 2015 Work Plan by the Office of Inspector General for Health and Human Services.  Always a lengthy document, the Work Plan can indicate areas that providers and suppliers want to monitor closely, as they are areas receiving attention from the government.  In … Continue Reading

Hardship Exception Applications to Avoid the 2015 Medicare Payment Adjustment Due November 30, 2014

Last week, CMS announced that it intends to reopen the submission period for hardship exception applications for eligible professionals and eligible hospitals to avoid the 2015 Medicare payment adjustments for not demonstrating meaningful use of Certified Electronic Health Record Technology (CEHRT).  This reopening process will be addressed through future rulemaking.  Previously, the hardship exception application … Continue Reading

The Yellow Brick Road to Medicare Provider Reimbursement Appeal

Over the years, various instruments have narrowed and darkened providers’ appellate rights relating to Medicare underpayment and recoupments. Recent court decisions, however, may put providers’ Medicare appeal rights back on the yellow brick road. On August 6th, the U.S. District Court for the District of Columbia issued three injunctions, each prohibiting HHS, the PRRB and … Continue Reading
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