Articles Posted in Health Law News

Small health care data breaches – those affecting fewer than 500 patients – that occurred in the 2019 calendar year must be reported to the Department of Health and Human Services’ Office for Civil Rights (OCR) by February 29, 2020.

The HIPAA Breach Notification Rule requires HIPAA-covered entities to report small data breaches either as they occur or within 60 days of the end of the applicable calendar year. Breaches affecting 500 or more patients must be reported to OCR at the time of patient and media notification.

Breaches can be reported online here.

Senate Bill 340, which would allow ‘remote pharmacies’ that are not staffed by an on-site pharmacist, cleared Michigan Legislature Wednesday, January, 8, 2020 on a 32-5 Senate vote. The bill is now waiting for Governor Gretchen Whitmer’s signature in order to be passed as law.

SB 340 would allow the use of telecommunication to permit a pharmacist at a ‘parent pharmacy’ to oversee up to two remote pharmacies. Pharmacists at the parent pharmacy would utilize real-time audio and visual connections in order to supervise the remote locations. However, the bill would only permit a remote pharmacy in a location if it is more than 10 miles from a regular pharmacy, unless the state waives the requirement due to evidence of other factors limiting local patient access to pharmacy services.

This bill, proposed by Michigan Senator Curt VanderWall and backed by the Michigan Pharmacists Association and major drug distributor Cardinal Health, aims to expand patient access to pharmacy services in rural and underserved areas. If passed, Michigan would become the 24th state to allow remote pharmacies staffed only by pharmacy technicians.

Due to the high volume of tips and complaints the Department of Health and Human Services (HHS) Office of Inspector General (OIG) receives – approximately 115,000 each year – the need for an efficient means of capturing these complaints was vital for OIG. Released to the public November 14, 2019, the newly redesigned OIG Hotline website is now the preferred method for users to submit tips or complaints.

The site has been completely revamped to include user-friendly updates such as guided questions and options for users to provide supplementary documentation for their submission. Furthermore, the addition of mobile compatibility for the site increases the options for access individuals previously had.

“The Hotline is the public face of the Health and Human Services Inspector General,” said Nenette Day, Assistant Special Agent in Charge, Office of Investigations.

New York Governor Andrew Cuomo signed legislation on October 17, 2019 further reinforcing New York’s Surprise Medical Bill Law, originally enacted in 2014. That bill, the first of its kind in the nation, is intended to comprehensively protect New York consumers from surprise medical bills for services rendered by out-of-network providers at in-network hospitals. With the October 17th legislation, the bill has now been extended to include emergency services, as well as inpatient services following an emergency room visit.

New York Assembly Member Kevin Cahill commented: “Relieving consumers of the aggravation associated with billing disputes between health care providers and insurance companies is one step closer to completion.” New York Senator Liz Krueger added, “This new law will protect New York families from outrageous surprise medical bills and help keep overall medical costs down.”

Under this legislation, health insurance companies are now required to ensure that patients will not incur greater out-of-pocket costs from services administered by a non-participating provider than they would have incurred from a participating provider. “In an emergency, every second counts and it’s ridiculous to expect someone facing a potential life or death situation to first check and see if a hospital is part of their health insurance network,” said Governor Cuomo.

“We serve patients poorly when government regulations gather dust in the attic: they become even more stale and liable to wreak havoc throughout the health care system. Administrative costs are driving up the cost of health care in America – to the tune of hundreds of billions of dollars. The Stark proposed rule is an important next step in President Trump’s health care agenda for Americans. We are updating our antiquated regulations to decrease burden for providers and helping bring down these increasingly escalating costs.”

– Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma.

The Department of Health and Human Services (HHS) announced today the release of several proposed changes to the regulations that interpret the Physician Self-Referral Law (the Stark Law), the Civil Monetary Penalty Law (CMP), and the Federal Anti-Kickback Statute (AKS). The proposed revisions are intended to provide greater clarity to health care professionals.

By Adrienne Dresevic, Esq. and Carey Kalmowitz, Esq. of The Health Law Partners, P.C.

The Centers for Medicare & Medicaid Services (CMS) issued a final rule that strengthens the agency’s ability to stop fraud by barring unscrupulous providers out of federal health insurance programs. This rule is unlike past rules in that it stops providers before they get paid. This is a momentous step on CMS’s part to end “pay and chase” in federal health care fraud efforts and replace it with proactive measures.

The final rule, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC), becomes effective November 4, 2019 and establishes novel revocation and denial authorities to buttress CMS’ efforts to stop waste, fraud and abuse. This rule is applicable to the entire provider community, including radiologists.

An Ashland, KY addiction treatment specialist, Dr. Rose O. Uradu, and her substance abuse treatment center, Ultimate Care Medical Services, LLC d/b/a Ultimate Treatment Center, have agreed to pay $1.4 million to resolve civil allegations that they violated the Controlled Substances Act, and defrauded the Medicare and Kentucky Medicaid programs.

The settlement resolved a civil lawsuit alleging that Ultimate Treatment Center, at the direction of Dr. Uradu, sought and received payments from Medicare and Kentucky Medicaid for services that were not actually provided to patients. According to the Complaint, between January 2013 and September 2014, defendants billed these government programs for “evaluation and management” services, purportedly provided to patients who visited the clinic to receive daily methadone doses. The United States alleged that Ultimate Treatment Center did not actually perform these services when patients received their methadone doses, but falsely documented the performance of these services, in the patients’ medical records, in order to create the false appearance that the reimbursement was justified.

The United States further alleged that, during the period July 2013 and December 2014, defendants billed Medicare and Kentucky Medicaid for complex urine testing that the clinic’s equipment was incapable of performing, therefore violating the False Claims Act.

On April 8, 2019, the American College of Physicians (“ACP”) released the clinical guideline, “Screening for Breast Cancer in Average-Risk Women: A Guidance Statement from the American College of Physicians” (the “Guideline”). The Guideline divides women into three categories based on age and offers breast cancer screening methodology guidance for each category. The Guideline offers the following guidance for women of average-risk:

  • Women aged 40-49: clinicians should discuss whether to screen for breast cancer with mammography, including a discussion on the benefits and harms of screening as well as the woman’s preference. The ACP notes that potential harms generally outweigh the benefits for most women in this category;
  • Women aged 50-74: clinicians should offer biennial screening for breast cancer with mammography;

In the recently released CY 2020 Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) introduced policies that, if finalized, would require hospitals to post a list of standard charges for items and services provided. This proposed rule updates the requirements set forth in the FY 2015 Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital (LTCH) final rule, which aimed to improve the transparency of hospital prices by requiring either standard charges to be posted online or compliance with patient requests for same. This rule was finalized on August 2, 2018 and came into effect on January 1, 2019. HLP previously wrote about the FY 2015 IPPS/LTCH rule here.

Following a June 24, 2019 Executive Order and several listening sessions and CMS-solicited comments, CMS offered numerous updates to its policy in the 2020 OPPS proposed rule. These changes would include defining several standard terms used in the policy, requiring the posting of 300 “shoppable services” to the hospital’s website, asking for payer-specific information, and penalizing noncompliant hospitals.

In order to ensure every hospital operating in the U.S. and in U.S. territories complies, CMS seeks to broadly define “hospital” as an institution in any State in which State or applicable local law provides for the licensing of hospitals and is either: licensed as a hospital pursuant to such law or, approved, by the agency of such State or locality responsible for licensing hospitals as meeting the standards established for such licensing. CMS does note that the rule would not apply to ambulatory surgical centers or nonhospital sites offering laboratory or imaging services but does encourage these facilities to comply with the policy. Furthermore, the rule would not apply to federally owned or operated hospitals, such as the U.S. Department of Veterans Affairs or hospitals operated by an Indian Health Program.

On July 30, 2019, a federal jury in Detroit, Michigan, found a patient recruiter guilty for his role in a scheme involving approximately $1.3 million in fraudulent Medicare claims for home health care that were procured through the payment of illegal kickbacks.

Following a six-day trial, Dominic Trumbo, 45, of Lexington, Kentucky, was found guilty of one count of conspiracy to pay and receive health care kickbacks and three counts of receipt of health care kickbacks.

According to evidence presented at trial, from 2009 to 2017, Trumbo, owner of Trumbo Consulting Agency, solicited and received kickbacks in exchange for referring Medicare beneficiaries to serve as patients at multiple home health agencies. These agencies then submitted claims to Medicare for home health services that were purportedly provided to those beneficiaries.