FDA Reviews Clinical Research Approval Process
November 28, 2018 | FDA | Legislation and Public Policy | Pharmaceuticals

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

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Allergy Practice Discloses Patient Info to Reporter, Pays $125,000
November 27, 2018 | Rivkin Rounds Staff | HIPAA | Litigation

An article in Bloomberg Law’s Health Law & Business, “Allergy Practice Discloses Patient Info to Reporter, Pays $125,000,” discussed a recent HIPAA settlement arising out of a physician’s disclosure of a patient’s protected health information (PHI) to a television reporter. Rivkin Radler’s Eric Fader was quoted in the article.

The settlement was announced on November 26

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CMS Finalizes Reimbursement for New Virtual Services
November 21, 2018 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Telehealth

The final 2019 Medicare Physician Fee Schedule released on November 1, 2018 by the Centers for Medicare & Medicaid Services (CMS) includes a section entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.” Effective January 1, 2019, physicians may be reimbursed for certain virtual interactions with patients using several new billing codes.

One new

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Deadline Approaches to Certify Compliance Programs
November 20, 2018 | Ashley Algazi | Fraud and Abuse | Hospitals | Medicare and Medicaid

The December 31 deadline for certain Medicaid providers and third-party billers to certify as to the effectiveness of their compliance program is fast approaching.

New York State Medicaid providers and third-party billing companies who claim, bill, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program or Managed Medicaid payors

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Dental Clinics are First on OIG’s “High Risk” List
November 16, 2018 | Margarita Christoforou | Fraud and Abuse | Litigation | Medicare and Medicaid

Two dental care companies are the first entities to be placed on the new High Risk – Heightened Scrutiny list created by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) for providers that pose a significant risk to federal healthcare programs and beneficiaries.  Each of the companies settled with the

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NJ Insurance Commissioner Confirms State Law Trumps Changes to ACA
November 14, 2018 | Eric D. Fader | Affordable Care Act | Legislation and Public Policy | Private Insurers

On October 29, 2018, the Commissioner of the New Jersey Department of Banking and Insurance issued two bulletins confirming that recent federal changes affecting the Affordable Care Act (ACA) don’t supersede New Jersey state law.

Bulletin No. 18-12, captioned “Short-Term, Limited Duration Insurance,” confirms that short-term, limited-duration health insurance plans, which never comply with New

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CMS to Pay Home Health Providers for Remote Monitoring
November 12, 2018 | Eric D. Fader | Home Health | Legislation and Public Policy | Medicare and Medicaid | Telehealth

On Oct. 31, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update the payment system for home health agencies and improve access to remote patient monitoring technology. The rule will allow home health providers to build the costs of remote monitoring technology into their Medicare reimbursement beginning Jan. 1, 2020.

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CMS Delays Implementing Revised E/M Visit Policies
November 8, 2018 | Margarita Christoforou | Electronic Health Records | Legislation and Public Policy | Medicare and Medicaid

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that certain policy changes in the Medicare Physician Fee Schedule relating to the documentation, coding and payment structure of Evaluation and Management office/outpatient visits will now be delayed until 2021. The changes were originally set to go into effect on January 1,

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HHS Ordered to Eliminate Medicare Appeals Backlog
November 7, 2018 | Hospitals | Litigation | Medicare and Medicaid

Healthcare facilities waiting to hear back on Medicare appeals received good news on November 1, when the U.S. District Court for the District of Columbia ordered the U.S. Department of Health and Human Services (HHS) to eliminate its backlog of 426,594 Medicare appeals by 2022. The order, in American Hospital Association, et al., v. Azar,

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340B Program Changes Finally on the Fast Track
November 6, 2018 | Ada Janocinska | Legislation and Public Policy | Pharmaceuticals

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from

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