Part C and Part D Quality Rating System

The November 1, 2018 proposed rule issued by the Centers for Medicare & Medicaid Services (“CMS”) includes enhancements and substantive changes to the Star Rating System in order to increase the stability and predictability of the Medicare Advantage program (aka “Part C”) and the Medicare Prescription Drug Benefit program (aka “Part D”) Star Ratings.

Measure Level Star Ratings.

CMS’ Star Ratings proposals are intended to eliminate some of the volatility and unpredictability of the calculation methodology, which is a welcome change for Medicare Advantage organizations (“MAOs”) and Part D plan sponsors. Based on stakeholder feedback and analyses of the data, CMS proposes two enhancements to the current hierarchical clustering methodology that is used to set cut points for non-Consumer Assessment of Healthcare Providers and Systems (“CAHPS”) measures:
Continue Reading Blog Series Part 7: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for 2020 and 2021

A single, multidisciplinary entity, like a university, may include certain departments that use PHI, and other departments that do not. Such institutions are eligible to (and should) self-identify as “hybrid entities” to better manage HIPAA compliance risk.

The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) mandates privacy and security safeguards for information about an individual’s health status, care, or payment for care. Individuals, organizations, and agencies that meet the definition of a “covered entity” or “business associate” under HIPAA must comply with its requirements.
Continue Reading Are You a “Hybrid Entity” under the Health Insurance Portability and Accountability Act of 1996? The $4,348,000 Question

As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.”

On May 7, 2018, the Opioid Crisis Response Act of 2018 (the “Bill”) was placed on the Senate Legislative Calendar after a unanimous vote out of the Senate Health, Education, Labor and Pensions Committee just weeks before on April 24. A showing of legislative commitment and intent, the Bill begins to tackle many of the key issues underlying and exacerbating the epidemic, though stakeholders remain concerned as to whether it goes far enough in light of the magnitude and complexity of the crisis.
Continue Reading In a Unanimous Vote, the Opioid Crisis Response Act of 2018 Makes it Onto the Legislative Calendar

Summer is almost here. For some, that means planning vacations to the beach, hitting the gym to shed that winter weight, or perhaps hitting the golf course—but for us at the Sheppard Mullin Healthcare Law Blog and the False Claims Act Defense Blog, summer signals the anniversary of the Supreme Court’s seminal decision in Universal Health Services, Inc. v. United States ex rel. Escobar
Continue Reading What Have We Learned About False Claims Act Litigation in the Two Years Since Universal Health Services, Inc. v. United States ex rel. Escobar? Quite a Lot, Actually

On March 21, 2018, a representative from the Hospital and Ambulatory Policy Group at the CMS, held a listening session regarding proposed updates to documentation guidelines for Evaluation and Management (“E/M”) Services. The purpose of this listening session was for the agency to obtain stakeholder feedback in order to develop policy proposals for upcoming notice and comment rulemaking, which, according to the CMS, will require a multi-year, collaborative effort among the agency and providers. Despite the warning of a Sisyphean task ahead, the CMS seems focused on reducing the burdens associated with the documentation requirements, which date back to 1995. Perhaps the effort will be moot as documentation as the driver of reimbursement will be replaced with clinical and quality outcomes. While the industry is certainly on this path – moving from “if it is not documented, it has not been done” to “if there is no value, it has not been done,” coding remains key and the 20 year old guidelines must be re-visited in light of the current state of the practice of medicine, especially the wide-spread use of electronic health records (“EHRs”).  
Continue Reading Take-Aways from CMS’ Recent Listening Session Regarding E/M Services: Documentation Guidelines and Burden Reduction

We reported, in early 2017, on what was then the latest legislative effort to repeal the Affordable Care Act’s amendment to the Stark Law’s whole hospital exception, which amendment has effectively prevented new physician-owned hospitals from participating in the Medicare program. (You can visit—or revisit—that post, which explores arguments in favor of and in opposition to the restriction, here.)

While the Patient Access to Higher Quality Health Care Act of 2017, introduced in the House in February 2017 and, in May 2017, the Senate, did not pass, recent rumblings suggest that repeal efforts are far from exhausted; rather, proponents of physician hospital ownership may be targeting a new tactic: regulation.
Continue Reading Lifting the Limits on Physician-Owned Hospitals: Can Regulators Prevail Where Legislators Have Stalled?

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and the federal False Claims Act (United States ex rel. Greenfield v. Medco Health Solutions, Inc. et al., No. 17-1152.). The court held that the relator, a former vice president of the specialty pharmacy, failed to link the pharmacy’s alleged kickback scheme to the actual submission of claims to Medicare. The decision is important because it stands for the proposition that to be liable under the False Claims Act a relator must allege more than the defendant was submitting claims for federal health care program beneficiaries while engaging in kickbacks. Rather, it must allege that at least one claim was submitted for services that were provided in violation of the Anti-Kickback Statute.
Continue Reading Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

In a year when the Department of Justice recovers $2.5 billion from the healthcare industry in False Claim Act judgements and settlements, can there really be a silver lining?

Every December, the Department of Justice (DOJ) releases its annual False Claims Act (FCA) recovery statistics for the preceding fiscal year. The recovery statistics, as they have for the past several years, indicate the DOJ considers the healthcare industry to be the number one target for FCA enforcement activity. Of the $3.7 billion in judgments and settlements recovered by the DOJ in 2017, $2.5 billion of that came from the healthcare industry. That is a tremendous number and indicates that the DOJ’s enforcement priority continues to be healthcare—as it has been for the last several years. In 2016, the DOJ recovered $2.6 billion from the healthcare industry. And in 2015, the DOJ recovered $2.2 billion from the healthcare industry. Healthcare has been a focus of DOJ’s FCA enforcement strategy for several years—and it shows no signs of changing any time soon. 
Continue Reading The 2017 Department of Justice False Claims Act Recovery Statistics:

As 2017 drew to a close, some health plans and healthcare providers across the country were still busy trying to finalize contracts for in-network services for 2018 and beyond. A number of negotiations made the headlines in 2017, highlighting ongoing and emerging issues affecting network contracting.

We recap for you some complex deals: in June, UnitedHealthcare and University of Chicago Medicine reached an agreement just a few weeks before the provider was scheduled to go out-of-network;[1] in September, CarePoint Health and Horizon Blue Cross Blue Shield of New Jersey (“Horizon”) reached an agreement to bring CarePoint in-network, putting an end to CarePoint Health’s federal lawsuit against Horizon for $76 million in unpaid out-of-network bills;[2] after months of negotiations, and a failure to meet an October 1 deadline to keep services in-network, Anthem and Hartford HealthCare reached an agreement in November to continue in-network services at Hartford’s Connecticut medical centers;[3] and, at the beginning of December, Mission Health and Blue Cross Blue Shield of North Carolina reached a new in-network agreement after a six-month long dispute.[4]
Continue Reading ‘Twas the Season to Contract? A Year-End Review of Network Negotiations and Billing Disputes