Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Department of Health and Human Services. Show all posts
Showing posts with label Department of Health and Human Services. Show all posts

Friday, February 3, 2023

Contraceptive Coverage Expanded: No More ‘Moral’ Exemptions for Employers

Ari Blaff
Yahoo News
Originally posted 30 JAN 23

Here is an excerpt:

The proposed new rule released today by the Departments of Health and Human Services (HHS), Labor, and Treasury would remove the ability of employers to opt out for “moral” reasons, but it would retain the existing protections on “religious” grounds.

For employees covered by insurers with religious exemptions, the new policy will create an “independent pathway” that permits them to access contraceptives through a third-party provider free of charge.

“We had to really think through how to do this in the right way to satisfy both sides, but we think we found that way,” a senior HHS official told CNN.

Planned Parenthood applauded the announcement. “Employers and universities should not be able to dictate personal health-care decisions and impose their views on their employees or students,” the organization’s chief, Alexis McGill Johnson, told CNN. “The ACA mandates that health insurance plans cover all forms of birth control without out-of-pocket costs. Now, more than ever, we must protect this fundamental freedom.”

In 2018, the Trump administration sought to carve out an exception, based on “sincerely held religious beliefs,” to the ACA’s contraceptive mandate. The move triggered a Pennsylvania district court judge to issue a nationwide injunction in 2019, blocking the implementation of the change. However, in 2020, in Little Sisters of the Poor v. Pennsylvania, the Supreme Court, in a 7–2 ruling, defended the legality of the original Trump policy.

The Supreme Court’s overturning of Roe v. Wade in June 2022, in its Dobbs ruling, played a role in HHS’s decision to release the new proposal. Guaranteeing access to contraceptions at no cost to the individual “is a national public health imperative,” HHS said in the proposal. And the Dobbs ruling “has placed a heightened importance on access to contraceptive services nationwide.”

Thursday, June 6, 2019

What's Behind A Rise In Conscience Complaints For Health Care Workers?

Selena Simmons-Duffin
NPR
Originally posted May 9, 2019

When health care workers feel they have been forced to do something they disagree with on moral or religious grounds, they can file complaints with the Department of Health and Human Services' Office for Civil Rights. Some high-profile cases have involved nurses who objected to providing abortion services.

For a decade, the agency got an average of one of these complaints of conscience violations each year. The complaints can include doctors, nurses or other health care workers who feel a hospital or clinic that receives federal funds has discriminated against them because of their moral position. Groups of health care providers also can file complaints.

Last year, the number of complaints jumped to 343.

That increase was cited by the Office of Civil Rights as one reason for issuing a new rule designed to protect conscience rights, unveiled publicly last week. HHS estimates that implementing and enforcing the rule will cost taxpayers $312 million in its first year.

But why did the number of complaints increase?

HHS declined to offer any specifics on the 343 complaints, such as where they were from or what might be behind the sudden increase over past years.

The info is here.

Thursday, January 31, 2019

HHS issues voluntary guidelines amid rise of cyberattacks

Samantha Liss
www.healthcaredive.com
Originally published January 2, 2019

Dive Brief:

  • To combat security threats in the health sector, HHS issued a voluminous report that details ways small, local clinics and large hospital systems alike can reduce their cybersecurity risks. The guidelines are voluntary, so providers will not be required to adopt the practices identified in the report. 
  • The four-volume report is the culmination of work by a task force, convened in May 2017, that worked to identify the five most common threats in the industry and 10 ways to prepare against those threats.  
  • The five most common threats are email phishing attacks, ransomware attacks, loss or theft of equipment or data, accidental or intentional data loss by an insider and attacks against connected medical devices.

Friday, May 25, 2018

The $3-Million Research Breakdown

Jodi Cohen
www.propublica.org
Originally published April 26, 2018

Here is an excerpt:

In December, the university quietly paid a severe penalty for Pavuluri’s misconduct and its own lax oversight, after the National Institute of Mental Health demanded weeks earlier that the public institution — which has struggled with declining state funding — repay all $3.1 million it had received for Pavuluri’s study.

In issuing the rare rebuke, federal officials concluded that Pavuluri’s “serious and continuing noncompliance” with rules to protect human subjects violated the terms of the grant. NIMH said she had “increased risk to the study subjects” and made any outcomes scientifically meaningless, according to documents obtained by ProPublica Illinois.

Pavuluri’s research is also under investigation by two offices in the U.S. Department of Health and Human Services: the inspector general’s office, which examines waste, fraud and abuse in government programs, according to subpoenas obtained by ProPublica Illinois, and the Office of Research Integrity, according to university officials.

The article is here.

Friday, December 8, 2017

University could lose millions from “unethical” research backed by Peter Thiel

Beth Mole
ARS Technica
Originally published November 14, 2017

Here is an excerpt:

According to HHS records, SIU (Southern Illinois University) had committed to following all HHS regulations—including safety requirements and having IRB approval and oversight—for all clinical trials, regardless of who funded the trials. If SIU fails to do so, it could jeopardize the $15 million in federal grant money the university receives for its other research.

Earlier, an SIU spokesperson had claimed that SIU didn’t need to follow HHS regulations in this case because Halford was acting as an independent researcher with Rational Vaccines. Thus, SIU had no legal responsibility to ensure proper safety protocols and wasn’t risking its federal funding.

In her e-mail, Buchanan asked for the “results of SIU’s evaluation of its jurisdiction over this research.”

In his response, Kruse noted that SIU was not aware of the St. Kitts trial until October 2016, two months after the trial was completed. But, he wrote, the university had opened an investigation into Halford’s work following his death in June of this year. The decision to investigate was also based on disclosures from American filmmaker Agustín Fernández III, who co-founded Rational Vaccines with Halford, Kruse noted.

The article is here.

Wednesday, January 13, 2016

Your health records are supposed to be private. They aren’t.

By Charles Ornstein
The Washington Post
December 30, 2015

Here is an excerpt:

In each story, a common theme emerged: HIPAA wasn’t working the way we expect. And the agency charged with enforcing it, the HHS office for civil rights, wasn’t taking aggressive action against those who violated the law.

We all know HIPAA, whether we recognize the acronym or not. It’s what requires us to stand behind a line, away from other customers, at the pharmacy counter or when checking in at the doctor’s office. It is the reason we get privacy declaration forms to sign whenever we visit a new medical provider. It is used to scare health-care workers, telling them that if they improperly disclose others’ information, they could pay a steep fine or even go to jail.

But in reality, it is a toothless tiger. Unless you’re famous, most hospitals and clinics don’t keep tabs on who looks at your records if you don’t complain. And even though the civil rights office can impose large fines, it rarely does: It received nearly 18,000 complaints in 2014 but took only six formal actions that year. A recent report from the HHS inspector general said the office wasn’t keeping track of repeat offenders, much less doing anything about them.

The story is here.

Monday, March 9, 2015

Debate heats up over safety of electronic health records

Jayne O'Donnell and Laura Ungar
USAToday
Originally posted February 3, 2015

Department of Health and Human Services officials said Tuesday that the safety benefits of electronic health records far outweigh any potential problems, but critics say regulators are pushing health care providers to use them while downplaying the risks to patients.

"This transition to electronic health records has led to far better safety than (it has) created new problems," said Andy Gettinger, an physician who heads health information technology (HIT) safety at HHS, at a government-sponsored conference here.

The entire article is here.

Tuesday, July 22, 2014

Crack Down on Scientific Fraudsters

By Adam Marcus and Ivan Oransky
The New York Times
Originally published July 10, 2014

DONG-PYOU HAN needed impressive lab results to help his team at Iowa State University move forward with its work on an AIDS vaccine — and to continue receiving millions of dollars in federal grants. So Dr. Han did what many scientists are probably tempted to do, but don’t: He faked the tests, spiking rabbit blood with human proteins to make it appear that the animals were responding to the vaccine to fight H.I.V.

The reason you’re reading about this story, and not about the glowing success of the therapy, is that Dr. Han was caught.

The entire story is here.

Friday, February 21, 2014

HIPAA data breaches climb 138 percent

By Erin McCann
Healthcareitnews.com
Originally posted February 6, 2014

When talking HIPAA privacy and security, the numbers do most of the talking.

Take 29.3 million, for instance, the number of patient health records compromised in a HIPAA data breach since 2009, or 138 percent, the percent jump in the number of health records breached just from 2012.

These numbers, compiled in a February 2014 breach report by healthcare IT security firm Redspin, though, don't tell the whole story, as these are numbers reported to the U.S. Department of Health and Human Services by HIPAA covered entities.

The entire article is here.

Wednesday, August 21, 2013

The Army's hidden child abuse epidemic

By Richard Sandza
Army Times
Originally published July 29, 2013

Here is an excerpt:

When the Army suspects child abuse or neglect, Campbell said, “we’ll investigate and prosecute and try to make sure we have the right program in place to take care of the soldiers and their families and do what’s right there.”

Of the 29,552 cases of child abuse and neglect in active-duty Army families from 2003 through 2012, according to Army Central Registry data, 15,557 were committed by soldiers, the others by civilians — mostly spouses.

The Army’s rate of child abuse was 4.5 cases per 1,000 children for 2011. The civilian rate was 27.4 per 1,000 children, according to the Children’s Bureau of the Department of Health and Human Services.

But the number of Army cases has spiked 28 percent between 2008 and 2011, while the number of civilian cases has increased by 1.1 percent.

The entire story is here.

Thursday, July 11, 2013

WellPoint to pay $1.7 million HIPAA penalty

By Rachel Landen and Joseph Conn
ModernHealthcare.com
Published July 11, 2013

WellPoint, which serves nearly 36 million people through its affiliated health plans, has agreed to pay a $1.7 million penalty to HHS for potential violations of the privacy and security rules under the Health Insurance Portability and Accountability Act of 1996.

Between Oct. 23, 2009, and March 7, 2010, access to personal data for 612,402 people—their names, dates of birth, addresses, Social Security numbers, telephone numbers and health information—was made available to unauthorized users as the result of online security weaknesses, HHS said Thursday.

During an investigation of WellPoint's information systems, HHS' Office for Civil Rights found that the Indianapolis-based insurer had not enacted appropriate administrative, technical and physical safeguards for data as required by HIPAA.

The entire story is here.

Medicare fraud outrunning enforcement efforts

By Fred Shulte
The Center for Public Integrity
Originally published on July 1, 2013

Citing massive budget and staff cuts, federal officials are set to scale back or drop a host of investigations into Medicare and Medicaid fraud and abuse — even though cracking down on government waste and cutting health care costs have been top priorities for the Obama administration.

The Department of Health and Human Services Office of Inspector General is set to lose a total of 400 staffers that are deployed nationwide as a primary defense against health care fraud and abuse. Though agency officials have yet to decide which investigations will be shelved as staff dwindles, the existing staff is already stretched so thin that the agency has failed to act on 1,200 complaints over the past year alleging wrongdoing — and expects that number to rise. The OIG began shedding staff at the beginning of the year.

The budget crunch surfaced during questioning at a June 24 hearing of the Senate Committee on Homeland Security and Governmental Affairs. The hearing was called to examine prescription drug abuse in Medicare.

Gary Cantrell, Deputy Inspector General for the OIG Office of Investigations, said at the hearing that his unit “is shrinking” even as the federal Medicare and Medicaid programs grow in size and complexity. “We’re set to lose roughly 400 bodies out of a total of 1,800 at our peak in 2012. That’s really limiting our ability to expand our oversight in some of these areas,” he said.

Stuart Wright, Deputy Inspector General for the OIG Office of Evaluations and Inspections, added that 200 of those staffers will have departed by the end of this year and 200 more are out the door by the end of 2015.

The entire story is here.

Wednesday, June 26, 2013

Committee supervises ethics of human testing

By Madison Pauly
The Dartmouth
Published on Monday, February 25, 2013

From new cardiology studies to students that go overseas and want to interview people, the Committee for the Protection of Human Subjects answers ethical questions about human research at Dartmouth. The committee is an interdisciplinary group of experts and community members who analyze the risk posed to participants by Dartmouth-affiliated researchers’ studies.

As Dartmouth’s incarnation of a federally-mandated institutional review board, the committee analyzes proposals for research on human subjects from Dartmouth-Hitchcock Medical Center and the Veterans Affairs Medical Center in White River Junction, as well as the College’s graduate and undergraduate departments.

While all studies involving human participants are subject to review by the committee, those that receive funding from sources other than the government must pay a review fee to the committee office.

A division of the Provost’s Office, the committee is financed in part by federal funds allocated to Dartmouth for research. Accordingly, its review process follows federal policies to ensure “respect for persons, beneficence and justice,” according to a Department of Health and Human Services report.

Major areas of ethical concern include the research’s medical relevance, involvement of vulnerable populations, its informed consent process and use of deception, said assistant provost for research Liz Bankert, a member of the committee.

The current federal regulations were last revised in 1991 and often fail to give adequate ethical guidance on modern research questions, said Bankert, who also serves on a national research ethics advisory committee.

The entire story is here.

Tuesday, June 4, 2013

Electronic Health Data Gaining Favor

By LOUISE RADNOFSKY
The Wall Street Journal
Originally posted on May 22, 2013

More than half of U.S. doctors have switched to electronic health records and are using them to manage patients' basic medical information and prescriptions, according to federal data set to be released Wednesday.

The Department of Health and Human Services says it has reached a tipping point as it seeks to steer medical providers away from paper records. Advocates for electronic health records say they have the potential to make medical care safer and more efficient. In 2015, the federal government will start penalizing providers that haven't begun using electronic health records in reimbursements they get for treating patients.

But some doctors have been cautious about changing long-standing practice, saying that typing into a computer while talking with patients requires more attention than taking notes by hand. Others are concerned that electronic systems don't allow for enough family history or fail to highlight the important parts of a patient's medical record. Some critics also cite privacy concerns.

The entire story is here.

Thursday, May 23, 2013

Doctors and nurses among nearly 100 charged in $223 million Medicare fraud busts in 8 cities

By Associated Press
Originally published May 14, 2013

Nearly 100 people, including 14 doctors and nurses, were charged for their roles in separate Medicare scams that collectively billed the taxpayer-funded program for roughly $223 million in bogus charges in a massive bust spanning eight cities, federal authorities said Tuesday.

It was the latest in a string of similar announcements by Health and Human Services Secretary Kathleen Sebelius and Attorney General Eric Holder as federal authorities crack down on fraud that’s believed to cost the program between $60 billion and $90 billion each year. Stopping Medicare’s budget from hemorrhaging that money will be key to paying for President Barack Obama’s health care overhaul. Sebelius and Holder partnered in 2009 to increase enforcement by allocating more money and staff and creating strike forces in fraud hot spots around the country.

The entire story is here.

Monday, February 25, 2013

U.S. proposes scrapping some obsolete Medicare regulations

By Reuters
Originally published February 13, 2013

The Obama administration on Monday proposed eliminating certain obsolete Medicare regulations, a move it said would save hospitals and other healthcare providers an estimated $676 million a year, or $3.4 billion over five years.

The Department of Health and Human Services described the targeted regulations as unnecessary or excessively burdensome and said their proposed elimination would allow greater efficiency without jeopardizing safety for the Medicare program's elderly and disabled beneficiaries.

"We are committed to cutting the red tape for healthcare facilities, including rural providers," Health and Human Services Secretary Kathleen Sebelius said in a statement.

"By eliminating outdated or overly burdensome requirements, hospitals and health care professionals can focus on treating patients," she added.

Industry representatives largely welcomed the changes, saying the proposed rule would help hospitals free up more resources for patient care.

"There are a number of particularly meaningful provisions in the proposed rule," said Chip Kahn of the Federation of American Hospitals.

The American Hospital Association, though, said it was disappointed the administration did not allow "hospitals in multi-hospital systems" to have single integrated medical staff structures.

"Hospitals are delivering more coordinated, patient-centered care and (the administration) should not let antiquated organizational structures stand in the way," AHA President Rich Umbdenstock said in a statement.

The entire article is here.

Saturday, February 2, 2013

HHS Releases Final HIPAA Privacy and Security Update Final Rule


U.S. Department of Health & Human Services
FOR IMMEDIATE RELEASE
Thursday, January 17, 2013

The U.S. Department of Health and Human Services (HHS) moved forward today to strengthen the privacy and security protections for health information established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The final omnibus rule greatly enhances a patient’s privacy protections, provides individuals new rights to their health information, and strengthens the government’s ability to enforce the law.

“Much has changed in health care since HIPAA was enacted over fifteen years ago,” said HHS Secretary Kathleen Sebelius.  “The new rule will help protect patient privacy and safeguard patients’ health information in an ever expanding digital age.”

The changes in the final rulemaking provide the public with increased protection and control of personal health information.  The HIPAA Privacy and Security Rules have focused on health care providers, health plans and other entities that process health insurance claims.  The changes announced today expand many of the requirements to business associates of these entities that receive protected health information, such as contractors and subcontractors. Some of the largest breaches reported to HHS have involved business associates. Penalties are increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation. The changes also strengthen the Health Information Technology for Economic and Clinical Health (HITECH) Breach Notification requirements by clarifying when breaches of unsecured health information must be reported to HHS.

Individual rights are expanded in important ways.  Patients can ask for a copy of their electronic medical record in an electronic form.   When individuals pay by cash they can instruct their provider not to share information about their treatment with their health plan.  The final omnibus rule sets new limits on how information is used and disclosed for marketing and fundraising purposes and prohibits the sale of an individuals’ health information without their permission.

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” said HHS Office of Civil Rights Director Leon Rodriguez.   “These changes not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a health care provider, or one of their business associates.”

The final rule also reduces burden by streamlining individuals’ ability to authorize the use of their health information for research purposes.  The rule makes it easier for parents and others to give permission to share proof of a child’s immunization with a school and gives covered entities and business associates up to one year after the 180-day compliance date to modify contracts to comply with the rule.

The final omnibus rule is based on statutory changes under the HITECH Act, enacted as part of the American Recovery and Reinvestment Act of 2009, and the Genetic Information Nondiscrimination Act of 2008 (GINA) which clarifies that genetic information is protected under the HIPAA Privacy Rule and prohibits most health plans from using or disclosing genetic information for underwriting purposes.

The Rulemaking announced today may be viewed in the Federal Register at https://www.federalregister.gov/public-inspection.


The final document is here.

Monday, January 28, 2013

New designs to make health records easier for patients to use

HHS.gov
U.S. Department of Health & Human Services
NEWS RELEASE
FOR IMMEDIATE RELEASE
January 15, 2013

Winning designs of printed health records to help patients better understand and use their electronic health records (EHRs) were announced today by Farzad Mostashari, M.D., the national coordinator for health information technology. The designs, created through a HHS Office of the National Coordinator for Health Information Technology (ONC) challenge contest, all met the goal of making EHRs valuable to patients and their family members.

“Patients that are engaged in their health care treatments have better outcomes in their health,” said Farzad Mostashari, M.D., national coordinator for Health Information Technology.  “The design challenge winners all proposed patient-friendly designs that will help to translate technical health information into easy-to-understand information that will help patients work closely with their doctors to manage their care.”
More than 230 submissions to the design challenge were submitted. Winners of the Health Design Challenge include:


  • Best Overall Design – “Nightingale” - Amy Guterman, Stephen Menton, Defne Civelekoglu, Kunal Bhat, Amy Seng, and Justin Rheinfrank from gravitytank in Chicago, Ill.
  • Best Medication Section – “M.ed” - Josh Hemsley from Orange County, Calif., presented a modern and intuitive design to help patients better understand how to properly adhere to their medication
  • Best Medical/Problem History – “Grouping by Time” – Mathew Sanders from Brooklyn, N.Y., aimed to provide more context by listing items in chronological order instead of grouping by functional type so cause and effect can be seen
  • Best Lab Summaries – “Health Summary” – Mike Parker, Dan McGorry, and Kel Smith from HealthEd in Clark, N.J., brought life to lab summaries through an aggregate health score and rich graphs of lab values
  • The Best Overall Design winner will receive $16,000, while the winners in the remaining categories will each receive $5,000.

The Health Design Challenge supports ONC’s efforts to engage consumers in their health through the use of technology, including the Blue Button, and is part of ONC’s Investing in Innovation (i2) Initiative. The i2 Initiative holds competitions to accelerate development and adoption of technology solutions that enhance quality and outcomes.

"This challenge was unique because it engaged professionals and students inside and outside of the health care industry to participate and propose real solutions," said Ryan Panchadsaram, presidential innovation fellow for ONC." We’ve assembled a showcase of top entries that challenged the status quo and inspired the health community."

More information about the winning submissions and other top entries can be viewed in the online gallery at http://healthdesignchallenge.com . For more information about health information technology, visit:  www.healthit.gov.

The release was posted here.


Saturday, January 5, 2013

New tools to help providers protect patient data in mobile devices

U.S. Department of Health & Human Services
Press Release
December 12, 2012

Launched by the U.S. Department of Health and Human Services (HHS) today, a new education initiative and set of online tools provide health care providers and organizations practical tips on ways to protect their patients’ protected health information when using mobile devices such as laptops, tablets, and smartphones.

The initiative is called Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information and is available at www.HealthIT.gov/mobiledevices.  It offers educational resources such as videos, easy-to-download fact sheets, and posters to promote best ways to safeguard patient health information.

“The use of mobile health technology holds great promise in improving health and health care, but the loss of health information can have a devastating impact on the trust that patients have in their providers.  It’s important that these tools are used correctly,” said Joy Pritts, HHS’ Office of the National Coordinator for Health Information Technology (ONC) chief privacy officer. “Health care providers, administrators and their staffs must create a culture of privacy and security across their organizations to ensure the privacy and security of their patients’ protected health information.”

Despite providers’ increasing use of using mobile technology for clinical use, research has shown  that only 44 percent of survey respondents encrypt their mobile devices.  Mobile device benefits—portability, size, and convenience—present a challenge when it comes to protecting and securing health information.

Along with theft and loss of devices, other risks, such as the inadvertent download of viruses or other malware, are top among reasons for unintentional disclosure of patient data to unauthorized users.

“We know that health care providers care deeply about patient trust and the importance of keeping health information secure and confidential,” said Leon Rodriguez, director of the HHS Office for Civil Rights. “This education effort and new online resource give health care providers common sense tools to help prevent their patients’ health information from falling into the wrong hands.”

For more information, tips, and steps on protecting and securing health information when using a mobile device visit www.HealthIT.gov/mobiledevices.

Wednesday, December 26, 2012

New Medicare fraud detection system saves $115 million

By By KELLI KENNEDY
Associated Press
Originally published December 15, 2012


A highly touted new technology system designed to stop fraudulent Medicare payments before they are paid has saved about $115 million and spurred more than 500 investigations since it was launched in the summer of 2011, according to a report released Friday.

Federal health officials said the projected savings are much higher. The savings so far, however, are minuscule compared with the estimated $60 billion lost each year to Medicare fraud. With the Obama administration and Congress desperately looking for savings to avoid a budget meltdown, denting Medicare fraud has the potential to save billions of dollars annually.

However, the Department of Health and Human Services' inspector general noted the report had some inconsistencies in its data and questioned the methodology for calculating some of the figures.

"In these cases, we could not determine the accuracy of the department's information, which impeded our ability to quantify the amount of the inaccuracies noted in this report," the inspector general's office said in a review of the report. Officials in the office said regardless of the glitches, they believe the new fraud system is a useful anti-fraud, too.

The $77 million technology system fights fraud in much the way credit card companies scan charges and can freeze accounts. It saved $32 million by kicking providers out of the program or refusing to pay suspicious claims. The report from the Centers for Medicare and Medicaid Services, obtained by The Associated Press, was unclear on how many actual providers were suspended or revoked from Medicare.

The entire story is here.