WHAT SAY YOU, NEW YORK? Now that Federal Antitrust Regulators Have Approved CVS’s Proposed Acquisition of Aetna, Attention Turns to New York State

By Kenneth Yood and Daniel Eliav on October 23, 2018 Posted in Healthcare Industry News

“I can stop the deal if it is reasonably necessary to protect New Yorkers.”
Superintendent Maria Vullo of the New York State Department of Financial Services

During a public hearing in New York City on Thursday, October 18, 2018, New York State regulators, including Superintendent Maria Vullo of the New York State Department of Financial Services (“DFS”), threatened to block CVS Health’s $69 billion merger with health insurer Aetna if (i) CVS would not agree to hold the line on rising insurance premiums for Aetna’s member population in New York State (approximately 1.1 million New Yorkers across the State); and/or (ii) CVS Health refused to submit its CVS/Caremark pharmacy benefits manager (“PBM”) business to State regulation. Continue Reading

Congress Passes “SUPPORT for Patients and Communities Act” — A Rare Example of Bi-Partisanship

By Kenneth Yood and Theresa Thompson on October 12, 2018 Posted in Healthcare Law

In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described in the Proclamation, the goal of Awareness Week is to “raise awareness about the prescription opioid and heroin epidemic and to consider concrete follow up activities.” Continue Reading

More Than 700 CEOs of Hospitals and Health Systems Write to Congress to Stop Cuts to the 340B Drug Pricing Program

By Matthew Goldman, Jordan Grushkin, Samuel Gilkeson and Melissa Gertler* on October 10, 2018 Posted in Hospitals, Medicaid, Medicare

On October 2, 2018, the CEOs of more than 700 hospitals and health systems representing healthcare providers in all fifty states sent a letter to Congress (the “Letter”) in a collective effort to protect the 340B Drug Pricing Program (the “340B Program”).[1] The CEOs expressed their view that recent governmental actions have reduced the reach of this vitally important program and that recently proposed legislation will undermine decades of bipartisan work to preserve access to prescription medication for the nation’s most vulnerable citizens. Continue Reading

The Merit-Based Incentive Payment System’s Targeted Review Deadline is Upon Us: Physicians, Groups, and other Clinicians have until October 15, 2018 to Identify and Report Errors in the Calculation of their 2017 MIPS Final Scores

By Amanda Zablocki and Kenneth Yood on October 5, 2018 Posted in MACRA

The Centers for Medicare & Medicaid Services (CMS) recently announced that it has several “prevailing concerns” regarding the accuracy of the 2017 Merit-Based Incentive Payment System (MIPS) scoring data that was used to set the 2019 MIPS payment adjustments. According to CMS, the concerns at issue relate to problems in the scoring logic used by CMS to generate the MIPS final scores for 2017. In light of these “prevailing concerns” and the identified errors, CMS went about the task of “addressing and correcting” the 2017 MIPS data. As a result, on September 13, 2018, CMS posted to the CMS Quality Payment Program (“QPP”) website the CMS revisions to the 2017 MIPS final scores and their associated 2019 MIPS payment adjustments.

Are You a “Hybrid Entity” under the Health Insurance Portability and Accountability Act of 1996? The $4,348,000 Question

By Kim Le on September 24, 2018 Posted in Health Insurance Portability and Accountability Act of 1996

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

Federal Antitrust Regulators Approve Cigna’s Proposed Acquisition of Express Scripts

By Jordan Grushkin and Cody Fierro on September 20, 2018 Posted in Antitrust, DOJ

On Monday, September 17, 2018, the Antitrust Division of the United States Department of Justice (the “DOJ”) cleared Cigna’s proposed $67 billion acquisition of Express Scripts, the country’s largest pharmacy benefit manager. While the transaction still needs the approval of certain state regulatory agencies, obtaining the DOJ’s approval was widely seen as the transaction’s most significant obstacle to overcome. Continue Reading

CMS’ Medicare Advantage Overpayment Rule: Arbitrary, Capricious, and Vacated

By Christine Clements, Erica Kraus and Michael Paddock on September 7, 2018 Posted in Medicare, Medicare Advantage

In a key case being watched by the industry, Judge Collyer of the United States District Court for the District of Columbia issued an opinion today granting UnitedHealthcare’s Motion for Summary Judgment in UnitedHealthcare Insurance Co. v. Azar, No. 16-157 (D.D.C.), which challenged CMS’ 2014 Overpayment Rule (the “Rule”). Judge Collyer’s decision vacated the Rule in its entirety, finding that, by effectively imposing a 100% accuracy requirement on the data that Medicare Advantage organizations (“MAOs”) report to CMS for risk adjusted payment purposes, the Rule violated the statutory mandate of “actuarial equivalence” between CMS payments for healthcare coverage under traditional Medicare and Medicare Advantage (“MA”). Moreover, the Court found that the Rule’s facilitation of False Claims Act liability for MAOs’ failures to engage in “reasonable diligence” overshot CMS’ statutory authority, and that its definition of when an overpayment is “identified” was finalized without adequate notice as required by the Administrative Procedure Act. These latter two holdings may also have significant implications in the context of CMS’ separate but similar overpayment rule for Medicare Part A and Part B providers. Continue Reading

The Blame Game: Senators Clash with the Trump Administration

By Jordan Grushkin and Patrick Callaghan on September 4, 2018 Posted in Prescription Drug Issues

Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has once again brought focus to the issue of prescription drug prices. According to the Administration, pharmacy benefit managers (“PBMs”) and drug distributors – who President Trump has dubbed as “middlemen” – are largely to blame for higher drug prices. However, Democratic Senators, PBMs, and drug distributors have recently pushed back against the Administration’s claims, arguing that the Administration’s claims are not supported by any evidence, and, in some cases, are contrary to the core functions of PBMs and drug distributors. Continue Reading

CMS Proposes Massive Changes to ACO Program – Pushing Providers to Accept Downside Risk

By Christine Clements, Vinay Bhupathy and Patrick Callaghan on August 16, 2018 Posted in Accountable Care Organization (ACO), Affordable Care Act (ACA)

On Thursday, August 9, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a Proposed Rule (the “Proposed Rule”)[1] regarding the Medicare Shared Savings Program (“MSSP” ) for Accountable Care Organizations (“ACOs”). The Proposed Rule would require ACOs to accept downside risk or shared losses sooner than under the current MSSP and would promote entities that have shown the greatest cost savings since implementation of the MSSP in 2012. Although not discussed in this article, the Proposed Rule also contains refinements to the methodology concerning ACO benchmarks and a modification to the current approach to risk adjustments, as well as changes to the MSSP’s claims-based assignment methodology and allowing beneficiaries to voluntarily align to ACOs in which their designated primary clinician is an ACO professional. Continue Reading

Reimbursement for and Documentation of Evaluation and Management Services: CMS Proposes Important Modifications

By Steven Chananie and Sophie Solomon on August 13, 2018 Posted in Federal Health Care Program Reimbursement, Medicare

On July 12, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) that would, among other changes: (1) reduce the documentation requirements with which physicians and other practitioners must comply in providing and billing for Evaluation and Management (E/M) services under the Medicare Physician Fee Schedule (“PFS”) on or after January 1, 2019; and (2) revise the current reimbursement methodology for E/M services under the PFS. CMS is seeking comment on the Proposed Rule through September 10, 2018. Continue Reading

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