Tag archives: hospitals and health systems

CMS proposed rule revises conditions of participation for hospitals and CAHs

On June 13, 2016, CMS published a proposed rule intended to revise the conditions of participation (CoPs) required for hospitals and critical access hospitals (CAHs) to participate in the Medicare and Medicaid programs, with a focus on quality of care. Highlights from the proposed rule are outlined in further detail below.… Continue reading

Senators urge HHS to further expand patient access to opioid drug treatment

On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act.  MAT involves the use of medication in combination with certain behavioral … Continue reading

Medical technology initiatives announced in Health Minister’s budget speech

The use of technology in the health sector is on the rise.  The intersection of these two industries leads to interesting legal questions relating to digital risk, including big data analytics, data security and privacy. In his budget speech on 10 May 2016, Minister Aaron Motsoaledi discussed the following interesting medical technology initiatives being undertaken … Continue reading

House bill addresses reduced payments to new off-campus hospital outpatient departments

On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).… Continue reading

New USPTO subject matter eligibility (35 USC § 101) examiner guidance and life science examples

On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences).  These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter … Continue reading

May 1st letter from CMS temporarily extends Texas’ 1115 Transformation Waiver

The Texas Health and Human Services Commission (“HHSC”) has been actively trying to reach an agreement with the Centers for Medicare and Medicaid Services (“CMS”) to extend or renew the Texas 1115 Transformation Waiver (the “Waiver”)since March 2015, when HHSC submitted its first iteration of a transition plan focused on a 5-year renewal. The result … Continue reading

CMS announces final rule on fire safety requirements for certain health care facilities

On May 4th, the Centers for Medicare & Medicaid Services (CMS) will publish a final rule to update health care facilities’ fire protection guidelines to improve protections for all Medicare beneficiaries in facilities from fire. This final rule applies to certain providers, including hospitals, critical access hospitals, ambulatory surgery centers, long term care facilities, and … Continue reading

FY 2017 Medicare Acute Care Hospital IPPS and LTCH PPS proposed rule policy highlights

On April 27, 2016, CMS published the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule for fiscal year (FY) 2017 in the Federal Register. Highlights from the proposed rule are explained in further detail below. Completion of Medicare Severity-Diagnosis Related Group (MS-DRG) $11 Billion Overpayment Recoupment … Continue reading

Joint Commission revises deemed status accreditation requirement for psychiatric hospitals

On March 25, 2016, the Joint Commission revised an accreditation requirement related to written patient care plans for psychiatric hospitals that use Joint Commission accreditation for deemed-status purposes.  Psychiatric hospitals may achieve deemed status through Joint Commission surveys that meet or exceed the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoP). Specifically, … Continue reading

FDA issues guidance on screening blood and tissue donors for the Zika Virus

On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA’s guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the … Continue reading

Australia – ehealth amendments

As part of the Australian Government’s digital health agenda, the Health Legislation Amendment (eHealth) Act 2015 (the Act) has recently been assented to.  The personally controlled electronic health record (PCEHR) system was launched in July 2012.  eHealth records are an online summary of an individuals’ health information.  The individual controls what is included in the … Continue reading

Health Ethics Trust – call for submission for best compliance practices

Please consider submitting your organization’s compliance practices for recognition at this year’s Healthcare Best Compliance Practices Forum. The Health Ethics Trust’s Best Practices process assigns evaluation of submitted practices to independent panels of compliance professionals. The Health Ethics Trust has recognized 164 practices as Best Practices.  We invite our clients to submit their own practices … Continue reading

CMS publishes rehabilitation, psychiatric, SNF and hospice final rules for fiscal year 2016

On July 30 and 31, 2015, the Centers for Medicare & Medicaid Services (CMS or the agency) made publicly-available pre-publication copies of the inpatient rehabilitation facilities, inpatient psychiatric facilities, skilled nursing facilities, and hospice wage index and payment rate update and hospice quality reporting requirements FY 2016 final rules. The inpatient rehabilitation facility (IRF) final … Continue reading

CMS publishes 2016 inpatient prospective payment system and long term care hospital final rule

On July 31, 2015, the Centers for Medicare and Medicaid Services issued a pre-publication copy of the inpatient prospective payment system final rule for fiscal year 2016. The final rule, effective on October 1, 2015, reflects the continuing shift from volume to value-based payments. The final rule features a 0.9% increase in Medicare reimbursement for … Continue reading

CMS proposes Stark Law liberalizations

On July 8, CMS proposed significant changes to the Stark Law via a far-reaching proposed rule and commentary that would—and in a few cases may already—eliminate numerous technical traps under the current regulatory scheme. From eliminating time limitations in connection with ‘holdovers’ of existing arrangements, to affording greater flexibility in signature timing, to clarifying that … Continue reading

CMS proposes changes to the 2-midnight rule and updates to Medicare outpatient payments for CY 2016

On July 1, the Centers for Medicare & Medicaid Services (CMS) issued the proposed calendar year (CY) 2016 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule (collectively, OPPS rule). In the proposed OPPS rule, CMS (1) provides changes to its inpatient short hospital stay policy known as the 2-midnight … Continue reading

$237 million judgment against Tuomey stands

Tuomey Healthcare System Inc. owes the government $237.4 million after losing its Fourth Circuit appeal of a judgment imposed after a jury found the hospital liable for violations of the Stark self-referral law and the False Claims Act. Tuomey has stated that it would likely need to file for bankruptcy based on the damages imposed in … Continue reading

CMS releases 2014 Sunshine Act data

On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals.  The data covers 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals. Join us on July 8 or July 14 for a … Continue reading

Obamacare saved by Supreme Court

In a 6-3 decision credited with saving Obamacare, the Supreme Court ruled on Thursday that the premium subsidies offered to qualifying enrollees of insurance plans offered on federal exchanges, which help more than 6 million Americans pay for their health plans under Obamacare, are legal. The Court declined to apply Chevron [i] deference to an IRS … Continue reading
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