Reconsideration of Certificate of Need in Virginia

In a joint statement issued by the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice (collectively, the “Agencies”) late last month, the Agencies suggested Virginia’s Certificate of Public Need Work Group (“Work Group”), currently convened, consider repealing or retrenching Virginia’s Certificate of Public Need (“COPN”) law.[1] Continue Reading

The Next Rx: New Medicare Part D Initiative Advances Role of Medication Management in Reform

Medicare Part D’s Medication Therapy Management (MTM) program intends to optimize clinical benefits and avoid drug-related problems among eligible beneficiaries. MTM services—involving pharmaceutical and clinical interventions—are offered at no cost to beneficiaries who meet criteria related to annual Part D drug costs, the prevalence of chronic diseases and number of prescription drugs.[1] Continue Reading

Home Care Associations Seek Stay by SCOTUS of New Wage-and-Hour Rules, As the Effective Date of DOL Wage-and-Hour Regulations Quickly Approaches

Recently, the D.C. Circuit Court of Appeals ruled in Home Care Association of America, et al. v. Weil, that the Department of Labor’s (“DOL”) regulations about the inapplicability of certain statutory exemptions for third-party employers of home care workers are enforceable and that the federal minimum wage and overtime rules will apply to these types of home care workers. As a result, unless the Rule’s application is stopped or otherwise delayed, those acting in the home care industry need to be aware of changes soon to take effect, and employers in particular must be ready to meet their new obligations, as of October 15, 2015. Continue Reading

CMS Proposes Mandatory Hospital Participation in New Bundled Payment Program for Hip and Knee Replacements

On July 14th, 2015, the Centers for Medicare and Medicaid’s (CMS) latest proposed rule (Rule) introduced a new alternative payment model. The Rule proposes CMS’ latest alternative payment model known as the Comprehensive Care for Joint Replacement (CCJR) Model. The model is targeted at hospitals that do not currently participate in the CMS Bundled Payments for Care Improvement (BPCI) Initiative for BPCI episodes covering hip and knee replacements.[1] Under the CCJR Model, select hospitals in 75 predetermined geographic areas across the United States would be mandated to participate.  All participating hospitals would be held financially accountable for the quality and cost of an “episode” of care related to each hip or knee replacement performed for a Medicare Fee For Service (FFS) beneficiary.[2] The proposed rule is the latest in a series of efforts by CMS to shift payment models away from fee-for-service to alternative payment models to advance quality and efficiency of care.[3] Continue Reading

CMS Proposes to Modify—but Continues to Stand Behind—its “Two-Midnight” Rule

The “Two-Midnight” rule is a Centers for Medicare and Medicaid Services (“CMS”) billing policy which bases the appropriateness of payments for inpatient services under Medicare Part A versus Part B on provider expectations regarding length of stay.  It has been a source of controversy since its inception in 2013.  In addition to receiving an extended enforcement delay through September 30, 2015, the rule has been debated in Congress on multiple occasions including a House Ways and Means Committee Health Subcommittee hearing on hospital issues in May 2014 and a Senate Special Committee on Aging Hearing in July 2014. Last week CMS responded via a proposed rule that seeks to improve the applicability of the policy and simultaneously demonstrates that the agency continues to stand behind it.[1] Continue Reading

The Supreme Court Upholds The Availability Of Subsidies On The Federal Exchange—Where Do We Go From Here?

One of the most highly anticipated decisions of the term—at least among the Sheppard Mullin Healthcare team—was issued today by the Supreme Court: King v. Burwell.[1]   Six of the justices, including Chief Justice Roberts, voted to uphold the Administration’s interpretation of the law, leaving the availability of tax credits to people insured on the federal exchange and the current status quo in place.

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Thirteen Years of the Same Rules and Now Big Proposed Changes to the Regulation of Medicaid Managed Care Plans

On June 1, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a newly proposed rule that would change the way the agency regulates Medicaid managed care plans, the first regulation of its kind since 2002.  The proposed rule seeks to address issues related to the healthcare experience of Medicaid and Children’s Health Insurance Program beneficiaries, including quality of care and program administration, as well as improve program integrity, efficiency, and alignment.  Specifically, the following areas are covered by the proposed rule: Continue Reading

Proposed Managed Care Rules Leave State Obligations for CHIP Largely Unchanged

The Centers for Medicare & Medicaid Services’ (CMS) proposed rule (“Rule”) that updates Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems, leaves state obligations largely unchanged for the Children’s Health Insurance Program (“CHIP”).[1] Published on June 1, 2015, the proposed rule would codify statute and guidance that has applied to CHIP since 2009, as implemented by State Health Official (“SHO”) letters released in 2009. Continue Reading

There Is Potential Federal Inconsistency Over ACOs

On June 4, 2015, the Centers for Medicare & Medicaid Services issued final revisions to regulations governing accountable care organizations participating in the Medicare Shared Savings Program (“MSSP”). Among them is one explicitly requiring the formation of an ACO as a formal, separate legal entity for governance purposes whenever there are two or more ACO participants with unique tax identification numbers.[1] In its revised state, CMS’ requirement now appears to be at odds with certain positions taken by the Federal Trade Commission and U.S. Department of Justice.

Click here to read the full article originally published by Law360.