Tag archives: hospitals and health systems

Court of Appeals upholds 340B Reductions

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in News from DC

On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.… Continue reading

CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 4, 2020 Posted in Enforcement, News from DC, Regulatory

All three of these Medicare payment final rules will become effective on October 1, 2020.… Continue reading

Withdrawal of life support from child in his best interests (UK)

By Sandra Sithole (ZA) on September 21, 2016 Posted in International

The mother of a 2-year old child who suffered grave injuries in a road traffic accident appealed against the court order obtained by the grandmother to withdraw all respiration and to treat the child only with pain relief, sedation and nursing as appropriate.… Continue reading

Australia trials “Health Care Homes”, a new model of primary health care

By Rohan Sridhar (AU) on August 15, 2016 Posted in International

Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People … Continue reading

CMS proposed rule revises conditions of participation for hospitals and CAHs

By Thomas Dowdell (US) and Mark Faccenda (US) on June 14, 2016 Posted in Regulatory

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

By Yvonne Puig (US) and Mark Faccenda (US) on June 10, 2016 Posted in News from DC, Regulatory

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

By Nerushka Bowan and Rakhee Bhikha on June 7, 2016 Posted in International

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

By Thomas Dowdell (US) and Mark Faccenda (US) on May 24, 2016 Posted in News from DC, Regulatory

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

By Tamsen Barrett (US) on May 9, 2016 Posted in Regulatory

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

By Frances Morgan (US) on May 3, 2016 Posted in News from DC, Regulatory

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

By Thomas Dowdell (US) on May 3, 2016 Posted in Regulatory

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

By Thomas Dowdell (US) and Mark Faccenda (US) on April 28, 2016 Posted in Regulatory

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

By Yvonne Puig (US) and Mark Faccenda (US) on April 11, 2016 Posted in News from DC, Regulatory

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

D.C. Health Department issued proposed regulation establishing rules for telemedicine in the district

By Mark Faccenda (US) on March 22, 2016 Posted in Regulatory

Late last month, the Washington D.C. Health Department issued a four-page proposed D.C. municipal regulation on the practice of telemedicine. Until now, providers in Washington D.C. have relied on a policy statement on telemedicine that was issued in November of 2014. … Continue reading

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

By Yvonne Puig (US) and Mark Faccenda (US) on March 3, 2016 Posted in FDA & Food Safety

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

By on January 5, 2016 Posted in International

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

Free introductory visits by home health provider are not a kickback, says OIG

By on August 19, 2015 Posted in Regulatory

A home health provider may offer free “introductory visits” to new patients without fear of implicating the Anti-Kickback Statute or Civil Monetary Penalties law, so long as those patients have already chosen it as their home health provider, OIG said late last week. OIG concluded that these introductory visits “are a logical and reasonable first … Continue reading

Health Ethics Trust – call for submission for best compliance practices

By on August 11, 2015 Posted in Regulatory

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

Judge sides with government on FCA 60-day overpayment rule

By Carol Poindexter (US) on August 6, 2015 Posted in Enforcement

In the first decision interpreting the 60-day overpayment rule of the False Claims Act (”FCA”), Judge Edgardo Ramos of the Southern District of New York held that an overpayment has been “identified” for purposes of starting the 60-day overpayment refund clock when “a provider has been put on notice of a potential overpayment, rather than … Continue reading

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

By Thomas Dowdell (US) and Mark Faccenda (US) on August 3, 2015 Posted in Regulatory

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

By Mark Faccenda (US) on August 3, 2015 Posted in Regulatory

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

By Debbi Johnstone (US), Stacey Murphy (US) and Joseph Keillor (US) on July 13, 2015 Posted in Regulatory

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

By on July 6, 2015 Posted in Regulatory

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

By on July 2, 2015 Posted in Enforcement

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