Archives: Physicians and Allied Health Professionals

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OIG Issues Favorable Advisory Opinion Regarding Health Plan’s Incentive Payment Program

On October 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a Medicaid managed care organization’s (Requestor) proposal to pay incentives to its network providers who meet benchmarks for increasing the amount of early and periodic screening, diagnostic, and treatment (EPSDT) services provided to Medicaid beneficiaries (Proposed Arrangement).…

Laws Affecting Health Care Entities in Connecticut Take Effect October 1, 2018

On October 1, 2018, a number of new laws affecting health care entities in Connecticut became effective. Below please find a brief description of some of the newly-effective provisions, as well as links to our analyses of the changes.…

Congress Considering Legislation Aimed at Curbing Surprise Medical Bills

The United States Senate is currently considering bipartisan legislation that would establish statutory limits on the financial exposure of certain patients to so-called “surprise” medical bills. The proposed legislation would amend the federal Public Health Service Act (at 42 U.S.C. § 300gg-19a) to prohibit surprise balance billing of patients receiving health care services in the following three situations: (1) Emergency services provided by a nonparticipating (i.e., out of network) provider in a nonparticipating facility; (2) Non-Emergency services following an emergency service at a nonparticipating facility; and (3) Non-Emergency services performed …

CMS Revises Hospital Inpatient Admission Order Documentation Requirements

On August 17, 2018, the Centers for Medicare & Medicaid Services (CMS) published its Hospital Inpatient Prospective Payment Systems final rule for Fiscal Year 2019 (Final Rule). The Final Rule contains a number of important updates to Medicare Part A that take effect October 1, 2018.

Among other provisions  in the Final Rule, CMS finalized its proposed update of the regulations that govern hospital admissions under Medicare Part A (42 C.F.R. § 412.3). Specifically, the Final Rule revises language in 42 C.F.R. § 412.3(a) to remove the current requirement that …

Medicare Proposes Revised Telehealth Services and Payments

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies.  The Proposed Rule contains several provisions that address the growing use of telehealth. CMS noted that it had received many suggestions regarding the expansion of access to telehealth as well as appropriate pay for the same, in response to its call for comments in the CY 2018 Medicare physician fee schedule (PFS) proposed rule.…

CMS Identifies “Pathway to Success” for Accountable Care in Proposed Rule that Would Significantly Change Shared Savings Program

On August 17, 2018, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule (Proposed Rule) that proposes a comprehensive overhaul of the Medicare Shared Savings Program (MSSP).  Among other changes, CMS proposes to:

  • replace the current three-track program with two options (Basic and Enhanced),
  • establish a ‘glide path’ that propels accountable care organizations (ACOs) towards acceptance of performance-based down-side risk,
  • update the benchmarking methodology to incorporate regional trends from the start of an ACO’s participation in the MSSP,
  • expand the use of telehealth services by ACOs, and

One-Two Punch: On Consecutive Days, DOJ Announces High Dollar Fraud and Abuse Settlements with Hospitals

The Department of Justice (DOJ) announced two significant False Claims Act (FCA) settlements in recent days that signal continued close government scrutiny of billing, coding and referral practices at hospitals.

On August 2, DOJ announced an $84.5 million dollar settlement with Michigan-based health system William Beaumont Hospital. The settlement resolves allegations of non-compliance with the Anti-Kickback Statute (AKS) and Stark Law arising from “improper relationships with eight referring physicians” that led to the submission of false claims to government health care programs.

DOJ alleged that the defendant provided compensation substantially …

Connecticut Enacts Law Revising Various Department of Public Health Statutes

On June 13, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-168 “An Act Concerning the Department of Public Health’s Recommendations Regarding Various Revisions to the Public Health Statutes” (PA 18-168). This legislation makes a number of changes to state laws concerning public health and the responsibilities of the Department of Public Health (DPH), including laws affecting advanced practice registered nurses (APRNs), advance directives, the scope of practice for podiatry, respiratory care, reportable events at nursing homes, and the supervision of physician assistants. …

FDA Approves Marijuana-Derived, CBD-Containing Drug Epidiolex to Treat Certain Epilepsy-Associated Seizures

On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, both of which are rare and severe forms of epilepsy. It is the first drug that FDA has approved for Dravet patients.…

Connecticut Legislature Again Addresses Opioid Crisis

On June 14, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-166 “An Act Concerning the Prevention and Treatment of Opioid Dependency and Opioid Overdoses in the State” (PA 18-166).

This legislation seeks to address the ongoing opioid crisis in Connecticut in part by: (i) implementing a new opioid overdose reporting requirement for hospitals and emergency medical services (EMS) personnel, (ii) establishing a statutory framework under which health care practitioners and pharmacists may partner with law enforcement or other government agencies, EMS providers, or …

Connecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

On June 1, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act 18-77 “An Act Limiting Auto Refills of Prescription Drugs Covered Under the Medicaid Program and Requiring the Commissioner of Social Services to Provide CHIP Data to the Health Information Technology Officer” (PA 18-77). This legislation allows the Department of Social Services (DSS) to prohibit pharmacies from automatically refilling certain prescription drugs for Medicaid beneficiaries and prohibits DSS from paying for refills of such drugs unless it receives a request for payment from the beneficiary …

Connecticut Legislature Revises DSS Provider Audit Processes

On June 1, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-76 “An Act Concerning Audits of Medical Assistance Providers” (PA 18-76), which makes several changes to the Medicaid provider audit process conducted by or on behalf of the Connecticut Department of Social Services (DSS). PA 18-76 is effective July 1, 2018.…

Connecticut Legislature Operationalizes New Health Oversight Agency: The Office of Health Strategy

On May 14, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-91 “An Act Concerning the Office of Health Strategy” (PA 18-91), a bill that operationalizes the Office of Health Strategy (OHS), a new health oversight agency in Connecticut. OHS is a division of the Department of Public Health (DPH) “for administrative purposes only” that was provisionally established by the Connecticut General Assembly within the budget implementer bill passed in a special session in late 2017 and accorded responsibility for developing and implementing a …

DOJ Enters Into Largest-Ever Civil Settlement with Hospital for Drug Diversion

On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million dollars.  The settlement with a Georgia hospital resolves allegations that the hospital “failed to provide effective controls and procedures to guard against theft and loss of controlled substances” that resulted in tens of thousands of 30mg oxycodone tablets being unaccounted for and believed to have been diverted for illegal uses over a four …

DOJ Intervenes in False Claims Act Case Against Insys Therapeutics

The Department of Justice (DOJ), recently intervened in a civil False Claims Act (FCA) case filed against Insys Therapeutics, Inc. (Insys) in the Central District of California that alleges FCA violations arising from the payment of kickbacks in violation of the Anti-Kickback Statute (AKS) as well as other fraudulent activities. Insys is an embattled Arizona-based pharmaceutical manufacturer of a highly-addictive sublingual opioid spray known as Subsys, and is currently the subject of a number of criminal and civil suits ongoing across the country (certain of which were consolidated into this …

US District Court Holds Medical Executive Committees Can Sue And Be Sued

On April 27, 2018, the United States District Court for the District of New Jersey held that the Medical Executive Committee (“MEC”) of a hospital, which is comprised of doctors that decide who is given privileges within the hospital, can sue and be sued. Nahas v. Shore Med. Ctr., 2018 U.S. Dist. LEXIS 70785.…

DOJ Announces Criminal Conviction of Physician for HIPAA Violation

On April 30, 2018 a Massachusetts physician was convicted of a criminal violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as one count of obstruction of a criminal health care investigation, in a Massachusetts federal court. The convictions relate to the purported sharing of confidential patient information by the physician with pharmaceutical sales representatives that allowed the pharmaceutical company to target patients with specific conditions (and to correspondingly facilitate the receipt of prior authorizations for the company’s drugs from patients’ insurers).…

Supreme Court Order Indicates Interest in Reviewing Campie, the False Claims Act Outlier of the Ninth Circuit

In an order issued on April 16, 2018, the U.S. Supreme Court invited the Solicitor General to file a brief “expressing the views of the United States” concerning the 2017 decision of the U.S. Court of Appeals for the Ninth Circuit in the False Claims Act (FCA) case U.S. ex rel. Campie v. Gilead Sciences, Inc. (see our previous analysis of the case here). The Campie case is noteworthy because it created a split among the circuit courts as to the scope of the “government knowledge” defense to materiality …

Private Equity Firm Named as Defendant in False Claims Act Case Targeting A Portfolio Company

A recent complaint filed by the United States Department of Justice against a private equity firms regarding an alleged kickback further illustrates new concerns private equity should be aware of in the healthcare arena and working with counsel to mitigate such concerns.  A February 23, 2018 press release from the DOJ regarding United States ex rel. Medrano and Lopez v. Diabetic Care Rx, LLC dba Patient Care America, et al., No. 15-CV-62617 (S.D. Fla.), available here, describes how the complaint was made against a pharmacy, several of its executives …

State Enforcement Actions Demonstrate Continued Scrutiny of Health Care Fraud

A series of criminal and civil enforcement actions announced in recent weeks demonstrate the continued attention that state regulators throughout the Northeast are placing on health care fraud. These actions, and the significant sanctions imposed by courts and the government, can serve as a reminder that violators of health care fraud laws are subject to scrutiny at both the federal and state levels (often simultaneously), and that such violations can create exposure to significant civil and criminal penalties.…

Recent Anti-Kickback Cases Emphasize Government Scrutiny of Speaker’s Bureaus and Lavish Meals Funded by Pharmaceutical and Device Manufacturers

The Department of Justice (DOJ) recently resolved two health care fraud cases – one criminal and one civil – that demonstrate the government’s continued scrutiny of lavish meals and “speaker’s bureaus” sponsored by pharmaceutical and device manufacturers as potential avenues for the payment of kickbacks to physicians for referrals of health care items and services. These cases indicate the criminal and civil risk that providing lavish meals or purported speaker’s bureau payment can pose, and the corresponding need to proactively assess the legitimacy of such programs and events.…

Escobar Compels Florida District Court to Overturn $350 Million Jury Verdict Arising from Claims of Inadequate Documentation

Last month, a U.S. District Court in the Middle District of Florida overturned judgments totaling $347,864,285 returned by a jury under the federal False Claims Act (FCA) and Florida’s state equivalent against the owners and operators of 53 specialized nursing facilities in Florida, determining that the plaintiffs’ allegations failed to satisfy the “demanding” and “rigorous” materiality standard endorsed by the Supreme Court in its 2016 Escobar decision. In an order released January 11, 2018, the District Court reversed the jury’s conclusions and granted the defendants judgment as a matter of …

CMS Announces Change to Student Documentation Requirement Intended to Reduce Burden on Teaching Physicians

On February 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released Transmittal 3971 (Change Request 10412), which revises a section of the Medicare Claims Processing Manual (Manual), that provides guidance regarding billing for Evaluation and Management (E/M) services involving students.  According to CMS, the Change Request is part of a broader goal to reduce the administrative burden on practitioners.…

CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D program.  CMS is particularly concerned with chronic overuse among beneficiaries taking high levels of prescription opioids (e.g., beneficiaries prescribed opioids with a 90 morphine milligram equivalent (MME) dose or higher per day), beneficiaries with multiple prescribers, and “opioid naïve” patients (i.e., patients newly prescribed opioids).

CMS’s strategies include consideration of a 7-day supply limit …

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