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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
On June 7, the House passed H.R. 5273, the Helping Hospitals Improve Patient Care Act of 2016 which, in part, modifies the Medicare payment rules for certain hospital outpatient departments (HOPDs) which were adopted as part of the “site-neutral” payment provisions under Section 603 of the Bipartisan Budget Act of 2015 (Pub. L. No 114017). … Continue Reading
In a move that could affect all hospitals reimbursed by Medicare, the American Hospital Association (AHA) this week renewed strenuous objections to various aspects of ongoing hospital compliance reviews conducted by the Department of Health and Human Services (HHS) Office of Inspector General (OIG). AHA’s most recent correspondence references the “numerous legal defects” it had … Continue Reading
