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Latest Top (4) News

HHS Proposes to Revise ACA Section 1557 Rule to Enforce Civil Rights in Healthcare, Conform to Law, and Eliminate Billions in Unnecessary Costs

Today, the U.S. Department of Health and Human Services (HHS) proposed regulatory reform related to regulations issued under Section 1557 of the Affordable Care Act (ACA). The proposed rule would maintain vigorous civil rights enforcement on the basis of race, color, national origin, disability, age, and sex, while revising certain provisions of the current Section 1557 rule that a federal court has said is likely unlawful. The proposal also would relieve the American people of approximately $3.6 billion in unnecessary regulatory costs over five years.

Conforming to the Text of our Laws

In Section 1557 of the ACA, Congress directed HHS to apply existing civil rights laws and regulations to healthcare and the ACA Exchanges, including a 1972 law (Title IX) prohibiting discrimination on the basis of sex in certain federally funded programs. In 2016, HHS issued a new rule that redefined discrimination “on the basis of sex” to include termination of pregnancy and gender identity which it defined as one’s internal sense of being “male, female, neither, or a combination of male and female.”

In response to a subsequent lawsuit by several states and healthcare entities, on December 31, 2016, a federal court preliminarily enjoined the rule’s gender identity and termination of pregnancy provisions on a nationwide basis, finding them contrary to the applicable civil rights law, the Religious Freedom Restoration Act, and the Administrative Procedure Act. A second federal court agreed. Because the preliminary injunction continues to be in effect, HHS cannot, and has not since the date of the injunction, enforced the rule’s provisions the court said are likely unlawful. The proposed rule would revise the provisions subject to those injunctions to conform with the plain understanding recognized by the court.

“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said OCR Director Roger Severino. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives,” said Severino. “The proposed rule would accomplish both goals.”

Continued Robust Enforcement of Civil Rights Law

Under the proposed rule, HHS would continue to vigorously enforce prohibitions of discrimination on the basis of race, color, national origin, disability, age, and sex in healthcare, as Section 1557 provides. The proposed rule would also retain protections under the 2016 regulation that ensure physical access for persons with disabilities to healthcare facilities, and appropriate communication technology to assist persons who are visually or hearing-impaired. HHS’s proposed rule would also retain protections for non-English speakers, including the right to meaningful language access to healthcare, qualification standards for translators and interpreters, and limitations on the use of minors and family members as translators in healthcare settings. Regulated entities would also continue to be required to provide written assurance to the Department that they will comply with Section 1557’s civil rights provisions and the proposed regulation.

“We are committed to full enforcement of civil rights laws before, during, and after any rulemaking,” said Severino. “We are also committed to the elimination of regulations that contradict law or raise the costs of healthcare without achieving intended results.”

Removing Costly and Unnecessary Regulatory Burdens

The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the 2016 rule. Covered entities report that the 2016 rule requires them to send billions of “tagline” notices each year informing patients and customers of their ability to have “significant documents” translated in at least 15 languages. When HHS adopted the 2016 rule, it projected notice and taglines costs of about $7.2 million in the first five years. Because the 2016 rule did not fully account for printing and mailing costs associated with these notices and taglines, it underestimated the burden of these requirements by over three billion dollars over five years. Instead of requiring regulated health companies to mail billions of paper taglines to mostly English speakers, the money saved could be used to more effectively address individual needs of non-English speakers such as by providing increased access for translators and interpreters.

The proposed Section 1557 rule estimates an additional savings of approximately $400 million over five years by eliminating duplicative requirements and reverting to well-established language access guidance, resulting in a total savings of approximately $3.6 billion in the first five years after finalization.

“As a child of Hispanic immigrants, I know how vitally important it is that people receive quality healthcare services regardless of the language they speak, and this proposal grants providers the needed flexibility for achieving that goal,” said Severino. “The American people are tired of unnecessary regulations getting in the way of access to affordable healthcare, and today’s proposal would remove $3.6 billion in regulatory burdens that are ultimately being passed down to patients,” Severino concluded.

Click to read the Proposed Regulation on Section 1557.

Click to read the proposed regulation Factsheet on Section 1557.


*A Spanish version of this press release and the Factsheet will be provided in the near future.

Friday, May 24, 2019 - 08:45

New HHS Fact Sheet On Direct Liability of Business Associates under HIPAA

The HHS Office for Civil Rights (OCR) has issued a new fact sheet that provides a clear compilation of all provisions through which a business associate can be held directly liable for compliance with certain requirements of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. In 2013, under the authority granted by the HITECH Act, OCR issued a final rule that, among other things, identified provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable.

OCR has authority to take enforcement action against business associates only for those requirements and prohibitions of the HIPAA Rules that appear on the following list. 

  1. Failure to provide the Secretary with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance.
  2. Taking any retaliatory action against any individual or other person for filing a HIPAA complaint, participating in an investigation or other enforcement process, or opposing an act or practice that is unlawful under the HIPAA Rules.
  3. Failure to comply with the requirements of the Security Rule.
  4. Failure to provide breach notification to a covered entity or another business associate.
  5. Impermissible uses and disclosures of PHI.
  6. Failure to disclose a copy of electronic PHI to either the covered entity, the individual, or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity’s obligations regarding the form and format, and the time and manner of access under 45 C.F.R. §§ 164.524(c)(2)(ii) and 3(ii), respectively.
  7. Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
  8. Failure, in certain circumstances, to provide an accounting of disclosures.
  9. Failure to enter into business associate agreements with subcontractors that create or receive PHI on their behalf, and failure to comply with the implementation specifications for such agreements.
  10. Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement.

“As part of the Department’s effort to fully protect patients’ health information and their rights under HIPAA, OCR has issued this important new fact sheet clearly explaining a business associate’s liability,” said OCR Director Roger Severino.  “We want to make it as easy as possible for regulated entities to understand, and comply with, their obligations under the law.”

The new fact sheet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/business-associates/index.html along with OCR’s guidance on business associates.

Friday, May 24, 2019 - 13:15

HHS Secretary Azar Statement on Personnel Promotion and Departure

The Department of Health and Human Services announced today that HHS Secretary Azar’s Chief of Staff, Peter Urbanowicz, will be leaving the department in June, with Deputy Chief of Staff Brian Harrison promoted to the Chief of Staff position.

Secretary Alex Azar released the following statement regarding Mr. Urbanowicz’s service and Mr. Harrison’s promotion:

“Earlier this year, Peter advised me of his intention to return to his home in Texas this summer. Peter has been a key leader in HHS’s success over the past year and a half, and has played a vital role in our work to lower prescription drug prices, advance value-based care, and improve rural healthcare access. As Chief of Staff, he built a highly engaged team, governed by a disciplined management culture, which laid out an ambitious strategic vision and executed on its goals. He has inculcated a strategic mindset and a culture of professional development among the agency’s leaders, and emphasized high standards of integrity for all employees. Peter’s service to the department and the American people is deeply appreciated, and he will be greatly missed.

“I have known Peter and Brian for a combined time of more than 30 years, and we could not have accomplished what we have without the strong team they formed. In his role as Deputy Chief of Staff, Brian has demonstrated remarkable leadership and managerial talents, and I am proud to promote him to a new role where he will continue to lead.”

Mr. Urbanowicz issued the following statement:

“It has been a great honor to work for Secretary Azar and President Trump and serve the American people. The entire HHS team has made important progress on our shared goals, including improving the quality and affordability of healthcare and tackling pressing public health challenges. I am lucky to have had two wonderful tours at HHS and I am proud to have had the privilege to work alongside the thousands of HHS employees who demonstrate daily their devotion to the health and well-being of all Americans. I will always cherish the time I have spent here.”

Mr. Harrison issued the following statement:

“It is a privilege to continue the important work that has begun, and build upon the successes that have been achieved, at HHS over the past year and a half. The entire team will miss Peter’s leadership, and I personally will miss his friendship. I am humbled by Secretary Azar’s confidence in me and look forward to diligently serving the President, Secretary, and department in this new role. It has been and will be an honor to help lead the men and women of our department in advancing the mission of HHS and delivering results for the American people.” 

Monday, June 3, 2019 - 09:45

U.S. Departments of Health and Human Services, Labor, and the Treasury Expand Access to Quality, Affordable Health Coverage Through Health Reimbursement Arrangements

Today, the U.S. Departments of Health and Human Services, Labor, and the Treasury issued a new policy that will provide hundreds of thousands of employers, including small businesses, a better way to provide health insurance coverage, and millions of American workers more options for health insurance coverage. The Departments issued a final regulation that will expand the use of health reimbursement arrangements (HRAs). When employers have fully adjusted to the rule, it is estimated this expansion of HRAs will benefit approximately 800,000 employers, including small businesses, and more than 11 million employees and family members, including an estimated 800,000 Americans who were previously uninsured.

“Too many Americans today have little say in how their healthcare is financed,” said HHS Secretary Alex Azar. “President Trump has promised Americans that he will put them in control of their healthcare, and this expansion of health reimbursement arrangements will help deliver on that promise by providing Americans with more options that better meet their needs. This rule and other Administration efforts are projected to provide almost 2 million more Americans with health insurance.”

“By continuing to offer diverse health coverage choices, the Trump Administration ensures America has a healthy workforce,” said Labor Secretary Alex Acosta. “The HRA final rule offers millions of American workers more health coverage choices and portability. HRAs create a great opportunity for job creators to support their employees and for those employees to be empowered to make the best healthcare decisions for their families.”

“President Trump is delivering on his promise to offer Americans more health coverage choices and lower healthcare costs. This new rule gives businesses a better way to offer health insurance to employees and allows workers to select coverage that best fits their and their families’ needs,” said Treasury Secretary Steven T. Mnuchin. “I am proud of this Administration’s efforts to curb the cost of healthcare for American workers and small businesses by expanding coverage options and spurring competition.”

Under the rule, starting in January 2020, employers will be able to use what are referred to as individual coverage HRAs to provide their workers with tax-preferred funds to pay for the cost of health insurance coverage that workers purchase in the individual market, subject to certain conditions. These conditions strike the right balance between employer flexibility and guardrails meant to protect the individual market against adverse selection, and include a notice requirement to ensure employees understand the benefit. Individual coverage HRAs are designed to give working Americans and their families greater control over their healthcare by providing an additional way for employers to finance health insurance.

This regulation is in response to President Donald J. Trump’s Executive Order on “Promoting Healthcare Choice and Competition Across the United States,” and is part of the Trump Administration’s work to deliver more health coverage choices and lower healthcare costs for Americans. Full implementation of the HRA rule, the Association Health Plan rule, and the short-term, limited-duration insurance rule is projected to provide insurance to nearly 2 million people, on net, who would otherwise be uninsured.

Many businesses have struggled with the high costs and complex bureaucracy of providing health insurance coverage, leading to less coverage for workers. Over the last decade, a significant number of small businesses have stopped offering any health insurance to their employees. As a result, a smaller percentage of Americans working in small businesses are being covered by employer health benefits, and many are left uninsured. Moreover, 80 percent of employers that provide coverage only offer one type of health plan to their employees, leaving workers and their families with no choices and plans that may not meet their needs.

The HRA rule makes it easier for small businesses to compete with larger businesses by creating another option for financing worker health insurance coverage. The rule enables businesses to better focus on serving their customers and growing their businesses—and not on navigating and managing complex health benefit designs.

The HRA rule also increases workers’ choice of coverage, increases the portability of coverage, and will generally improve worker economic well-being. This rule will also allow workers to shop for plans in the individual market and select coverage that best meets their needs. Because HRAs are tax-preferred, workers who buy an individual market plan with an HRA receive the same tax advantages as workers with traditional employer-sponsored coverage. Further, by increasing employee options and empowering more people to shop for health plans in the individual market, the final rule should spur a more competitive individual market that drives health insurers to deliver better coverage options to consumers.

In addition to allowing individual coverage HRAs, the HRA rule creates an excepted benefit HRA. In general, this aspect of the rule permits employers that offer traditional group health plans to provide an excepted benefit HRA of up to $1,800 per year (indexed to inflation after 2020), even if the employee doesn’t enroll in the traditional group health plan, and to reimburse an employee for certain qualified medical expenses, including premiums for vision, dental, and short-term, limited-duration insurance. This provision will also benefit employees who have been opting out of their employer’s traditional group health plan because the employee share of premiums is too expensive.

Read the final rule and find out more information from FAQs about new health coverage options for employers and employees.*

* People using assistive technology may not be able to fully access information in this file. For assistance, contact digital@hhs.gov.

Thursday, June 13, 2019 - 15:45