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Latest Top (4) News


Trump Administration Announces Historic Price Transparency Requirements to Increase Competition and Lower Healthcare Costs for All Americans

As directed by President Trump's Executive Order on Improving Price and Quality Transparency in American Healthcare, today the Department of Health and Human Services is announcing that the Centers for Medicare & Medicaid Services (CMS) is issuing two rules that take historic steps to increase price transparency to empower patients and increase competition among all hospitals, group health plans and health insurance issuers in the individual and group markets. One of the rules is the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule. The second rule is the Transparency in Coverage Proposed Rule. Both the final and proposed rules require that pricing information be made publicly available.

"President Trump has promised American patients 'A+' healthcare transparency, but right now our system probably deserves an F on transparency. President Trump is going to change that, with what will be revolutionary changes for our healthcare system," said HHS Secretary Alex Azar. "Today's transparency announcement may be a more significant change to American healthcare markets than any other single thing we've done, by shining light on the costs of our shadowy system and finally putting the American patient in control."

Consistent with the Executive Order on price and quality transparency, the Trump Administration is taking action toward making sure that insured and uninsured Americans alike have the information necessary to get an accurate estimate of the cost of the healthcare services they are seeking before they receive care.

"Under the status quo, healthcare prices are about as clear as mud to patients," said CMS Administrator Seema Verma. "Thanks to President Trump's vision and leadership, we are throwing open the shutters and bringing to light the price of care for American consumers. Kept secret, these prices are simply dollar amounts on a ledger; disclosed, they deliver fuel to the engines of competition among hospitals and insurers. This final rule and the proposed rule will bring forward the transparency we need to finally begin reducing the overall healthcare costs. Today's rules usher in a new era that upends the status quo to empower patients and put them first."

In response to the Executive Order, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments) are issuing a proposed rule, "Transparency in Coverage" that would require most employer-based group health plans and health insurance issuers offering group and individual coverage to disclose price and cost-sharing information to participants, beneficiaries, and enrollees up front. With this information, patients will have accurate estimates of any out-of-pocket costs they must pay to meet their plan's deductible, co-pay, or co-insurance requirements.  This will make previously unavailable price information accessible to patients and other stakeholders in a standardized way, allowing for easy comparisons.

If finalized, the proposed Transparency in Coverage rule would require health plans to:

  • Give consumers real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer's request. This requirement would empower consumers to shop and compare costs between specific providers before receiving care.
  • Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry. Making this information public directly helps the consumer, but, more importantly, creates new opportunities for researchers, employers and other developers to build new tools to help consumers.

The proposed rule would also encourage health insurance issuers to offer new or different plan designs that incentivize consumers to shop for services from lower-cost, higher-value providers by allowing issuers to take credit for "shared savings" payments in their medical loss ratio (MLR) calculations.

In addition, the Administration is finalizing a rule that will require hospitals to provide patients with clear, accessible information about their "standard charges" for the items and services they provide, including through the use of standardized data elements, making it easier to shop and compare across hospitals, as well as mitigating surprises. The final rule will require hospitals to make their standard charges public in two ways beginning in 2021:

  • Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
  • Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common shoppable services in a manner that is consumer-friendly and update the information at least annually.
    • Shoppable services are services that can be scheduled by a healthcare consumer in advance such as x-rays, outpatient visits, imaging and laboratory tests or bundled services like a cesarean delivery, including pre- and post-delivery care.
    • The requirements for the consumer-friendly file are that the information must be made public in a prominent location online that is easily accessible, without barriers, and it must also be searchable. Item and service descriptions must be in 'plain language' and the shoppable service charges must be displayed and grouped with charges for any ancillary services the hospital customarily provides with the primary shoppable service.

In order to ensure that hospitals comply with the requirements, the final rule provides CMS with new enforcement tools including monitoring, auditing, corrective action plans, and the ability to impose civil monetary penalties of $300 per day. In response to public comments, CMS is finalizing that the effective date of the final rule will be January 1, 2021 to ensure that hospitals have the time to be compliant with these policies.

For a fact sheet on the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public final rule (CMS-1717-F2), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2020-hospital-outpatient-prospective-payment-system-opps-policy-changes-hospital-price

For a fact sheet on the Transparency in Coverage Proposed Rule (CMS-9915-P), please visit: https://www.cms.gov/newsroom/fact-sheets/transparency-coverage-proposed-rule-cms-9915-p

The final rule (CMS-1717-F2) can be viewed here

The proposed rule (CMS‑9915‑P) can be viewed here



Fri, 15 Nov 2019 08:30:00 -0500


HHS Advances Development of Tests to Distinguish Bacterial from Viral Infections across Multiple Healthcare Settings

A novel diagnostics technology that reads gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determines the severity within minutes will receive advanced development support from the U.S. Department of Health and Human Services (HHS). The technology is being designed for use in outpatient and inpatient healthcare settings.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will support the advanced development of the new testing technology, known as host-response testing, under a 14-month, $6 million contract with Inflammatix Inc., of Burlingame, California.

This agreement can be extended to provide BARDA’s financial and technical support, up to a total of $64.9 million through 2027, for the company to complete the additional work needed to apply for U.S. Food and Drug Administration (FDA) clearance of the tests.

Inflammatix is developing three diagnostic tests for use on a point-of-care test system with results expected within 20-30 minutes. Rapid information on whether the infection is viral versus bacterial will help doctors make earlier, better-informed decisions about whether to treat the infection with or without antibiotics.

“Rapid diagnostics are a cornerstone of our strategy to protect Americans from many bacterial and viral infections; earlier diagnosis can empower patients to take action to reduce disease transmission,” said BARDA Director Rick Bright, Ph.D. “Antimicrobial resistance is a growing threat to public health and the health security of the United States, and diagnostics that can provide rapid results to patients and doctors will support stewardship of antibiotics and save lives.”

The first Inflammatix test, called HostDx Fever, is intended to help distinguish bacterial from viral infections in outpatient ambulatory settings; the second test, called HostDx Sepsis, is intended for inpatient hospital settings and also may determine whether a patient is likely to develop sepsis. The third test, HostDx FeverFlu, is intended for use in either setting during influenza season and combines rapid flu testing with host-response data.

In addition to the Inflammatix diagnostic test systems, BARDA, in collaboration with other federal partners, is supporting development of other diagnostic tests to identify bacterial pathogens and their susceptibility to specific antibiotics, along with improved tests to identify the risk of a patient becoming septic. These efforts are part of the HHS commitment to combat antimicrobial resistance and to support antibiotic stewardship.

To encourage antimicrobial stewardship further, ASPR also provides hospitals and health care coalitions with guidance and the latest information on antibiotic-resistant infections and new tools to combat them.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 52 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA accepts proposals for the advanced development of medical countermeasures through the Broad Agency Announcement, BARDA-BAA-18-100-SOL-00003, at https://www.fbo.gov.

Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov.



Thu, 14 Nov 2019 09:30:00 -0500


OCR Imposes a $1.6 Million Civil Money Penalty against Texas Health and Human Services Commission for HIPAA Violations

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has imposed a $1,600,000 civil money penalty against the Texas Health and Human Services Commission (TX HHSC), for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules between 2013 and 2017. TX HHSC is part of the Texas HHS system, which operates state supported living centers; provides mental health and substance use services; regulates child care and nursing facilities; and administers hundreds of programs for people who need assistance, including supplemental nutrition benefits and Medicaid. The Department of Aging and Disability Services (DADS), a state agency that administered long-term care services for people who are aging, and for people with intellectual and physical disabilities, was reorganized into TX HHSC in September 2017.

On June 11, 2015, DADS filed a breach report with OCR stating that the electronic protected health information (ePHI) of 6,617 individuals was viewable over the internet, including names, addresses, social security numbers, and treatment information. The breach occurred when an internal application was moved from a private, secure server to a public server and a flaw in the software code allowed access to ePHI without access credentials. OCR's investigation determined that, in addition to the impermissible disclosure, DADS failed to conduct an enterprise-wide risk analysis, and implement access and audit controls on its information systems and applications as required by the HIPAA Security Rule. Because of inadequate audit controls, DADS was unable to determine how many unauthorized persons accessed individuals' ePHI.

"Covered entities need to know who can access protected health information in their custody at all times," said OCR Director Roger Severino. "No one should have to worry about their private health information being discoverable through a Google search."

The Notice of Proposed Determination and Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/txhhsc/index.html



Thu, 07 Nov 2019 14:00:00 -0500


United States Files Patent Infringement Lawsuit Against Gilead Related to Truvada® and Descovy® for Pre-exposure Prophylaxis of HIV

Today, the United States, on behalf of the Department of Health and Human Services, filed a complaint in federal district court against Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention. Despite multiple attempts by HHS to license its patents, Gilead has refused.  In the complaint, HHS alleges that Gilead has willfully and deliberatively induced infringement of the HHS patents. The complaint further alleges that, as a result of such infringement, Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada® and Descovy®.

Gilead manufactures, markets, and sells Truvada® and Descovy® for PrEP. Originally, Gilead obtained FDA approval for the use of those products for post-infection HIV treatment in combination with other drugs. But after the Centers for Disease Control and Prevention’s (CDC) groundbreaking PrEP work and subsequent human trials, Gilead also obtained FDA approvals for Truvada®, and more recently Descovy®, to be used as PrEP regimens. Gilead now markets and sells Truvada® and Descovy® for use as the PrEP regimens that HHS has patented. Nevertheless, Gilead has repeatedly refused to obtain licenses for the use of the HHS patents.

“HHS recognizes Gilead’s role in selling Truvada® and Descovy® to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” said HHS Secretary Alex M. Azar II. “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”

Since the beginning of the AIDS epidemic in the early 1980s, researchers worldwide sought drug-based strategies to effectively prevent the spread of HIV. For over two decades, none succeeded. During that time, over 25 million people died due to AIDS.1 And the number of people living with HIV reached its highest level—about 40.3 million people.2

In the mid-2000s, researchers at the CDC succeeded where others had not. These scientists developed innovative two-drug regimens to effectively prevent HIV infection. This type of regimen is known as PrEP.

Numerous human PrEP trials have confirmed that, when used as directed, the PrEP regimens invented by CDC are 99% effective in preventing HIV infection in at-risk patients. Hundreds of millions of taxpayer dollars funded many of these trials.

The United States Patent and Trademark Office granted four patents to HHS that protect CDC’s work and the taxpayers’ investment. These patents entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use. Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS.

The claims asserted against Gilead are allegations only, there has been no determination of liability.



Wed, 06 Nov 2019 21:00:00 -0500