Archives: Hospitals

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Supreme Court To Decide If HHS May Skip Notice And Comment Requirements For Certain Payment Rules

On September 27, 2018, the U.S. Supreme Court agreed to review a D.C. Circuit Court of Appeals decision that had tossed out a new calculation method, employed by the U.S. Department of Health and Human Services (“HHS”), which had cut Medicare payments to hospitals. Azar v. Allina Health Services (“Allina Health”). HHS itself estimated that … Continue Reading

Unauthorized TV Cameras in Hospitals Yield Costly HIPAA Penalties of $999,000

For the second time in as many years, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into settlement agreements with and levied hefty fines on three hospitals that allegedly impermissibly disclosed patients’ protected health information to ABC News in the course of filming a television network documentary series.  OCR announced … Continue Reading

House Panel Examines 340B Legislative Reforms

On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading

DC Circuit Rejects HHS Rule Barring Hospital Medicare Appeals Challenging Longstanding Erroneous “Predicate Facts”

On June 29, 2018, the DC Circuit ruled that HHS could not apply in PRRB appeals a 2013 “reopening” regulation, which purports to bar the adjudication of “predicate facts” beyond 3 years after the facts had been determined. St. Francis Medical Center v. Azar (D.C. Cir. June 29, 2018). The court held that the agency’s … Continue Reading

Texas Hospital Loses Bid to Keep Secret its Reimbursement Rates

The Texas Supreme Court recently held that North Cypress Medical Center Operating Co., Ltd. cannot keep secret its private insurance and public payer reimbursement rates in litigation brought by an uninsured patient who alleges that she was overcharged for treatment. In re North Cypress Medical Center Operating Co., Ltd., No. 16-0851 (Tex. 2018) (majority opinion … Continue Reading

Recent UK hospitals merger clearance confirms recent high degree of willingness to accept efficiencies/customer benefits arguments in hospitals merger reviews

The UK’s Competition and Markets Authority (CMA), has recently cleared a second hospital merger after only a Phase 1 review (involving an initial 40-day review period) based on the parties’ efficiencies/customer benefits arguments, despite the fact that the CMA believed that the merger may result in a substantial lessening of competition (SLC). It is quite … Continue Reading

District Court Requires Specific Claim and ERISA Plan Allegations In ERISA Complaint

Recently, a federal district court dismissed a hospital’s complaint against an ERISA plan administrator as inadequately pled and outlined the minimum degree of specificity required in similar cases.  In Polk Med. Ctr., Inc. v. Blue Cross & Blue Shield of Ga., Inc., the plaintiff hospital alleged that the defendant administrator was employing various tactics to … Continue Reading

Reduced 340B Reimbursements? Nonprofit Institutions Act May Provide New Possibilities

A recent Centers for Medicare & Medicaid Services (CMS) final rule reduces some Medicare reimbursements to hospitals in 2018, paying 28 percent less for certain “specified covered outpatient drugs” (SCODs) purchased at a discount through the 340B Drug Pricing Program (340B). Although hospitals recently lost a challenge to the lower CMS rates in American Hospital Association … Continue Reading

Comment Dates Set For Federal Communications Commission Rulemaking On $400 Million Rural Health Care Program

The FCC’s Notice of Proposed Rulemaking (NPRM) to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP), has now been published in the Federal Register. Interested parties may submit initial comments on the FCC’s proposals by February … Continue Reading

FCC Focuses on Critical Role of $400 Million Rural Health Care Program

Noting that technology and telemedicine are assuming an increasingly critical role in healthcare delivery, the FCC has initiated a proceeding to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP). These changes would potentially affect existing as … Continue Reading

Recent Federal District Court Ruling Considers Who May Bring EMTALA Claims

The United States District Court for the Northern District of Georgia recently granted several defending healthcare insurers’ motions to compel arbitration and (in part) to dismiss claims alleging improper reimbursement practices brought under the Emergency Medical Treatment and Labor Act (“EMTALA”), Affordable Care Act (“ACA”), COBRA, and various Georgia state law theories.  The order, styled … Continue Reading

CMS to Reduce 340B Drug Payments to Hospitals by $1.6 Billion

On November 13, CMS published the final rule revising the Medicare hospital Outpatient Prospective Payment System for 2018.  Among a number of changes, the final rule dramatically reduces Medicare Part B payments to hospitals for separately payable drugs purchased through the 340B Program.  Currently, Medicare pays hospitals the Average Sales Price (ASP) plus 6% for … Continue Reading

House Committee Chairman Asks HHS to Develop Health Care Cyber Risk Plan

Last week, the Chairman on the House of Representatives’ Committee on Energy and Commerce, Greg Walden (R-OR), sent a formal letter to the Dept. of Health and Human Services (“HHS”) requesting that HHS “develop a plan of action for creating, deploying, and leveraging [bill of materials] for health care technologies.” Walden gave HHS until December … Continue Reading

Ohio Expands Prescriptive Authority for Certain Advanced Practice Registered Nurses

On May 17, the Ohio Board of Nursing (the Board) adopted a new formulary which expands the prescriptive authority for certain of Ohio’s advanced practice registered nurses (APRNs). Specifically, this new “exclusionary” formulary applies to Ohio’s certified nurse practitioners, clinical nurse specialists and certified nurse midwives.  The new formulary was adopted pursuant to Ohio’s House … Continue Reading

Can DOJ Impose False Claims Act on States?

The immense power wielded by the Department of Justice (DOJ) under the False Claims Act (FCA) has limits according to United States District Judge Anna J. Brown in the District of Oregon. This month the court decided DOJ cannot force the Act to apply to an “arm of the state” simply by intervening in the suit. Although … Continue Reading

Court Rejects HHS’s Plea to Rescind Order to End Medicare Appeals Backlog

As reported last month, the US District Court for the District of Columbia issued an order in American Hospital Association v. Burwell for the US Department of Health and Human Services (HHS) to clear the enormous backlog of Medicare appeals at the administrative law judge (ALJ) level. US District Court Judge James E. Boasberg gave … Continue Reading

Court Directs CMS to Clear Medicare Appeals Backlog

On December 6, 2016, the US District Court for the District of Columbia issued an order in American Hospital Association v. Burwell giving CMS a four-year runway to clear the enormous backlog of appeals at the administrative law judge (ALJ) level. The Medicare Act requires ALJs to hold a hearing and to render a decision … Continue Reading

CMS Releases Final Rule Implementing Site Neutral Payment Rule for Hospital Outpatient Departments

On November 1, CMS released final rules implementing Section 603 of the Bipartisan Balanced Budget Act of 2015 (the Final Rule).  Section 603 effectively reduces Medicare compensation paid to certain off-campus hospital outpatient departments (HOPDs) beginning January 1, 2017 by eliminating their eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System (OPPS).  The Final … Continue Reading

FDA Working to Modernize Medical Device Reporting in Hospitals

Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals.  FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading

Rev. Proc. 2016-44 Greatly Expands Rev. Proc. 97-13 Safe Harbor for Management Contracts, Opening the Door for Long-Term Management Contracts (Repost)

On August 22, 2016, the IRS released new safe harbors from private business use of tax-exempt bond-financed facilities for management contracts that substantially change the prior safe harbors under Rev. Proc. 97-13. The new revenue procedure, Rev. Proc. 2016-44, provides more flexibility and appears to be more favorable than Rev. Proc 97-13. The new safe harbors … Continue Reading

CMS Finalizes 2017 Medicare Payment Rates: What Hospitals Need To Know

On August 2, 2016, CMS released its final rule to update the fiscal year (FY) 2017 Medicare payment rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (Final Rule). By law, CMS is required to update payment rates for IPPS hospitals annually, and to account for changes in … Continue Reading

HHS and Cuba’s Ministry of Public Health Sign a Historic MOU

Last month, the U.S. Department of Health and Human Services (HHS) entered into a historic Memorandum of Understanding (MOU) with Cuba’s Ministry of Public Health. The MOU establishes coordination across a broad spectrum of public health issues, including: Healthcare systems and public health management; Quality management and patient safety systems in hospitals and outpatient settings; … Continue Reading

CMS Releases Proposed Rules Implementing Section 603

On July 6, CMS released its long-awaited proposed rules implementing Section 603 of the Bipartisan Balanced Budget Act of 2015 (Proposed Rules).  As we’ve discussed previously, Section 603 effectively reduces Medicare compensation paid to certain off-campus hospital outpatient departments (HOPDs) beginning January 2017 by eliminating eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System … Continue Reading

Supreme Court Approves Implied False Certification Theory but Imposes “Demanding” Materiality Limitation

In a decision that will impact every provider who supplies goods and services to the federal government, the Supreme Court today approved the implied false certification theory as a basis for liability under the False Claims Act (FCA). Specifically, in Universal Health Services v. Escobar, the Court ruled that the FCA is violated whenever a … Continue Reading
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