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Insights on Health Care

1112 total results. Page 37 of 45.

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        Health Care Counsel Blog
        New OCR HIPAA Audit Protocol Can Assist Providers with Preparing for Phase 2 Audits
        May 17, 2016
        Douglas A. Grimm, Thomas E. Jeffry, Jr., Jill A. Steinberg, Stephanie Trunk

        The Office for Civil Rights (OCR) recently began its second round of audits of covered entities and business associates for compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule (the “Phase 2” audits).

        The Fine Print
        Heading for the Breaches: California Recommends Data Security Measures
        May 16, 2016

        The California Office of the Attorney General (OAG) recently released a report detailing a comprehensive analysis of the data breaches reported to the OAG between 2012 and 2015.

        Health Care Counsel Blog
        CMS Proposes New Requirements for Stark Self-Disclosures
        May 12, 2016

        On May 6, 2016, CMS published in the Federal Register a request for comments on proposed revisions to the information to be collected pursuant to the CMS Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP).

        Health Care Counsel Blog
        Office of Inspector General Evaluates the Enhanced Enrollment Screening of Medicare Providers
        May 11, 2016
        Lowell C. Brown, Douglas A. Grimm, Annie Chang Lee

        In March 2012, the Centers for Medicare & Medicaid Services (CMS) enhanced its Medicare enrollment screening for new and existing enrollees to the Medicare program. Providers not meeting CMS’s enhanced enrollment screening risk denial, revocation, or deactivation of Medicare billing privileges.

        News
        Arent Fox Partner Linda Baumann Comments on Pay-for-Quality Arrangements for Physicians As It Relates to Self-Referral Law
        May 11, 2016

        Arent Fox Health Care partner Linda A. Baumann was quoted extensively in Bloomberg BNA’s Health Care Fraud Report in an article on recent concerns surrounding the Stark Law that prohibits physician self-referrals.

        Health Care Counsel Blog
        Texas Adopts NADAC and Eliminates Some Manufacturer Reporting
        May 10, 2016
        Stephanie Trunk

        Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug Acquisition Cost (NADAC) to establish Medicaid ingredient cost reimbursement instead of utilizing manufacturer-reported prices.

        Health Care Counsel Blog
        False Claims Act Penalties Set to Double, Far Exceeding Expected Increase
        May 6, 2016
        David S. Greenberg, D. Jacques Smith

        In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

        Health Care Counsel Blog
        Don’t Discount the Discounts: Pfizer and Wyeth Reach Settlement Over Medicaid Drug Pricing Allegations
        May 4, 2016
        Stephanie Trunk, Hillary M. Stemple

        The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

        News
        Supreme Court Weighs FCA Implied Certification Theory
        April 27, 2016
        D. Jacques Smith, David S. Greenberg

        Partners Jacques Smith and David Greenberg spoke with AHLA Weekly after the US Supreme Court heard oral argument on April 19 in a major False Claims Act case that has far-reaching implications for the health care industry and other highly-regulated sectors reliant on government funding.

        Health Care Counsel Blog
        New VA Policy: All Covered Drugs, Regardless if Compliant with the Trade Agreements Act, Must Be Offered
        April 26, 2016
        Stephanie Trunk

        VA recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract.

        Health Care Counsel Blog
        Secure Yourself: NIST Releases Final Version of the Cryptographic Standards and Guidelines Development Process
        April 25, 2016
        Thomas E. Jeffry, Jr.

        Covered entities and business associates subject to HIPAA Security Rule are closer to getting a benchmark for encryption standards with the release of the Standards and Guidelines Development Process in late March by the National Institute of Standards and Technology (NIST).

        Health Care Counsel Blog
        Guidance to Pharma from CMS: How to Calculate the New Inflation-Based Additional Rebate for Generic Drugs
        April 22, 2016
        Stephanie Trunk

        The Program Notice provides some guidance on how generic drug manufacturers are to calculate the new Additional Discount on generic drugs that will become part of the rebate due state Medicaid programs under the Medicaid Drug Rebate Program.

        Health Care Counsel Blog
        Stricter European Privacy Rules: Think Twice Before Marketing Health Care Goods and Services Across the Atlantic
        April 21, 2016
        Thomas E. Jeffry, Jr.

        On April 14, 2016, the European Union formally adopted a new scheme – known as the EU General Data Protection Regulation (GDPR) – to protect the personal data of European residents.

        Health Care Counsel Blog
        Health on the Move: FTC and HHS Release Guidance for Mobile Health App Developers
        April 20, 2016
        Thomas E. Jeffry, Jr.

        On April 5, 2016, Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of a new web-based tool to assist developers of mobile health apps in understanding what federal laws they must comply with.

        Health Care Counsel Blog
        HHS Re-Opens Comment Period on 340B Program Pricing and Penalty Rule
        April 19, 2016
        Stephanie Trunk

        Today, the Department of Health and Human Services announced that it is re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule).

        Health Care Counsel Blog
        The Move to Value-Based Payment Continues: CMS Announces Initiative to Transform Primary Care Delivery and Payment
        April 18, 2016
        David S. Greenberg, Douglas A. Grimm

        On April 11, 2016, the Centers for Medicare and Medicaid Services (CMS) announced its Comprehensive Primary Care Plus (CPC+) initiative.

        Health Care Counsel Blog
        Health Care Industry Braces for Major False Claims Act Case Before Supreme Court
        April 13, 2016
        David S. Greenberg

        The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

        Alerts
        Are You Safe? Providers Struggle to Contend with Surge in Ransomware Attacks
        March 31, 2016
        Stephanie Trunk

        In the wake of the recent ransomware attack on Hollywood Presbyterian Medical Center, news reports have emerged that at least three more medical centers and a large health care system have been the victims of these attacks.

        Health Care Counsel Blog
        Providers Prepare: OCR Launches Second Round of HIPAA Audits
        March 23, 2016
        Douglas A. Grimm, Thomas E. Jeffry, Jr., Jill A. Steinberg, Stephanie Trunk

        On March 21, 2016, the US Department of Health and Human Services Office for Civil Rights (OCR) announced it was beginning its next round of audits of covered entities and business associates for compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.

        Health Care Counsel Blog
        DOJ Attorneys Disclose Health Care Enforcement Trends for 2016
        March 17, 2016
        D. Jacques Smith

        Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

        Health Care Counsel Blog
        Alternative, Value Based Payment Models Reach Part B Drugs
        March 11, 2016
        Stephanie Trunk

        If finalized, the Proposed Rule would represent the most dramatic change in Part B Drug reimbursement since the enactment of the Medicare Modernization Act.

        Health Care Counsel Blog
        SAMHSA Proposes First Revisions to Substance Abuse Medical Record Privacy Rules in Almost Three Decades
        March 1, 2016
        Lowell C. Brown, Douglas A. Grimm, Thomas E. Jeffry, Jr.

        These proposed changes to the rules governing the confidentiality of substance abuse treatment records mark the first time the regulations have been subject to revision since 1987.

        Health Care Counsel Blog
        CMS Announces Stepped-Up Provider and Supplier Enrollment Screening
        February 24, 2016
        Lowell C. Brown, Douglas A. Grimm

        The Centers for Medicare and Medicaid Services (CMS) intend to strengthen provider and supplier enrollment screening – meaning, scrutinizing providers and suppliers more closely during enrollment – according to a February 22, 2016 post on its blog. 

        Health Care Counsel Blog
        Together We Stand(ard): CMS and AHIP Announce Standardization of Quality Measures for Physicians and ACOs
        February 24, 2016
        Douglas A. Grimm

        As pay-for-performance programs continue to expand in both scale and scope across the US health care system, the amount of administrative and clinical resources necessary to participate in these programs has correspondingly grown.

        Health Care Counsel Blog
        Administrative Law Judge Upholds Imposition of Civil Penalties on Health Care Provider for HIPAA Violations
        February 23, 2016
        Douglas A. Grimm, Thomas E. Jeffry, Jr., Jill A. Steinberg, Stephanie Trunk

        In a recent decision, a US Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) agreed with the HHS Office of Civil Rights (OCR) that Lincare, Inc. d/b/a United Medical had violated HIPAA.

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