Healthcare Law Blog

Shaping the World of Healthcare Law

“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…
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.”…
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…
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…
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…
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.…
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”)…
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.…
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…
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…