HHS Announces Ebola Vaccine Project Agreements

Contracts to speed further development of two promising Ebola vaccines, known as rVSV-ZEBOV-GP and ChAd3 EBO-Z, could pave the way for commercial-scale production of millions of vaccine doses if clinical trials prove safety and efficacy, officials of the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced Dec. 23.

Development of both vaccines is being accelerated because of the public health emergency of international concern in West Africa. The funding was designated in the fiscal year 2015 continuing resolution for development of Ebola products.

Both contracts are sponsored by the ASPR’s Biomedical Advanced Research and Development Authority (BARDA). One contract is with GlaxoSmithKline in Philadelphia for 31 months and $12.9 million with options that would provide an additional $16,000. The other contract is with BioProtection Systems Corporation of Ames, Iowa, a wholly owned subsidiary of NewLink Genetics Corporation, for approximately 14 months and $30 million. It has options to extend the agreement 10 months and provide an additional $41 million.

“While we’re encouraged that traditional public health measures and supportive medical care are starting to control the outbreak in West Africa, the need for vaccines and therapeutics remains an urgent priority,” said BARDA Director Robin Robinson, Ph.D.


If you own or operate a small to medium-sized business, managing all your employees plus meeting federal labor laws and regulations can be daunting, especially with new rules being issued all the time. To help you understand your rights and responsibilities in every facet of running a business, please order a copy of Personnel Concepts’ All-On-One HR Compliance Program for Small Businesses.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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Court Voids DOL’s Home Health Care Minimum Wage Rule

The U.S. District Court for the District of Columbia on Monday struck down a Department of Labor (DOL) rule folding home health care workers into the wage provisions of the Fair Labor Standards Act (FLSA), calling the rule a “thinly-veiled effort to do through regulation what could not be done through legislation.”

The Wagner Act of 1938, or what’s now known as the FLSA, specifically exempted domestic workers from its purview. In 1974, Congress expanded the FLSA to cover domestic workers but included a carve-out for those who provide “care and fellowship” to the elderly and disabled in their homes.

In 2007, the Supreme Court ruled in a caregiver’s lawsuit review that the plaintiff was not entitled to overtime pay despite working long hours as a domestic caregiver.

In his opinion for the District Court, Judge Richard Leon wrote that the carve-out is not “an open question” that can be answered by administrative fiat. It can only be addressed by Congress.

The case was Home Care Association of America v. Weil.


If you own or operate a small to medium-sized business, managing all your employees plus meeting federal labor laws and regulations can be daunting, especially with new rules being issued all the time. To help you understand your rights and responsibilities in every facet of running a business, please order a copy of Personnel Concepts’ All-On-One HR Compliance Program for Small Businesses.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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HHS Says 6.4 Million Have Signed Up for Obamacare in Year Two

From Nov. 15 to Dec. 19, nearly 6.4 million consumers selected a plan in the Federally Facilitated Marketplace (FFM) or were automatically re-enrolled, with approximately 30 percent of this total comprised of people newly signing up for Marketplace coverage, according to statistics released today by the Department of Health and Human Services (HHS).

“We still have a lot of work to do before the Feb. 15 enrollment deadline, but this is an encouraging start. People shopped for coverage and signed up – finding more choices and greater competition,” HHS Secretary Sylvia Burwell said. “Thanks to the Affordable Care Act, so far nearly 6.4 million consumers, including about 1.9 million new consumers, have access to quality, affordable health coverage for 2015 through the federal Health Insurance Marketplace. This law is working, and families are better off as a result.”

HHS says it will produce more detailed reports that look at plan selection across the Federally Facilitated Marketplace and State-Based Marketplaces on a monthly basis.


For the full story on how the Affordable Care Act (ACA, or Obamacare) affects your business, no matter how large or small, please obtain a copy of our comprehensive yet easy-to-follow Affordable Care Act Compliance Kit.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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Proposed Rules on Excepted Benefits to Be Published

The Departments of Labor, Health and Human Services, and Treasury are seeking public comment on proposed rules that would amend the definition of excepted benefits to include certain limited wraparound coverage.

The proposed rules would allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to employees who are purchasing individual health insurance in the private market, including through the Health Insurance Marketplace. The rule proposes two pilot programs for wraparound coverage. One pilot would allow wraparound benefits only for Multi-State Plans in the Health Insurance Marketplace and another would allow wraparound benefits for part-time workers who could otherwise qualify for a flexible savings arrangement who enroll in individual market plan.

The proposed rules would give employees who otherwise may not be able to get generous employer-based benefits access to high level benefits. It responds to suggestions made on a proposed rule last December from a wide range of stakeholders, including business groups supportive of the idea. The proposed rule would give businesses, including small businesses, new flexibility to meet the unique needs of their workforces.

A notice of proposed rulemaking will be published in the Dec. 23 edition of the Federal Register and can also be viewed online here.


If you own or operate a small to medium-sized business, managing all your employees plus meeting federal labor laws and regulations can be daunting, especially with new rules being issued all the time. To help you understand your rights and responsibilities in every facet of running a business, please order a copy of Personnel Concepts’ All-On-One HR Compliance Program for Small Businesses.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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Patient Groups Want ACA ‘Discrimination’ Better Defined

A coalition of 279 patient advocacy groups calling itself “I Am (Still) Essential” has called on the Department of Health and Human Services (HHS) to better define what is considered discrimination under the Affordable Care Act (ACA).

“As part of the plan review process for 2015, we thought there would be a better review of the plans for discrimination, but we are finding that the 2015 plans are utilizing the same practices as they did in 2014,” the group’s letter to HHS reads in part.

By way of example, the group praised the Centers for Medicare and Medicaid Services (CMS), which is part of HHS, for saying that insurers who place most or all drugs for a specific condition on the highest cost tiers are “effectively” discriminating.

HHS is due in 2015 to issue a final “Notice of Benefit and Payment Parameters,” which could further define discrimination in health care coverage.


For the full story on how the Affordable Care Act (ACA, or Obamacare) affects your business, no matter how large or small, please obtain a copy of our comprehensive yet easy-to-follow Affordable Care Act Compliance Kit.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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HHS Partners with 8 Large Pharmacies to Promote Obamacare

The Department of Health and Human Services (HHS) is collaborating with eight of the nation’s largest pharmacies to encourage enrollment through the Health Insurance Marketplace at thousands of locations across the country. Ahold USA Companies, Bi-Lo Holdings, CVS Health, H-E-B, Kroger, Rite Aid, Walgreens and Walmart are playing an important role in providing information about the Health Insurance Marketplace to people across the country.

“Pharmacies and pharmacists are a trusted source of information for consumers who have health related questions, and they can provide information directly to consumers looking for quality and affordable health coverage on the Health Insurance Marketplace,” HHS Secretary Burwell said in announcing the partnerships. “These collaborations are integral to getting information directly to consumers from trusted health care providers in their communities.”

Pharmacists have been trained to answer basic questions about the Marketplace, and they know where to direct customers for enrollment assistance through HealthCare.gov, the call center, or through local in-person assistance, HHS said.

Special brochures, signage, circular advertisements, and other marketing materials have been and will be on display in many stores, providing consumers with information on health insurance and how to get enrolled. Many pharmacies have webpages dedicated to the Affordable Care Act and health insurance information. Pharmacy-based enrollment events are planned across the country and some pharmacies will have assisters available in stores to help enroll customers.


For the full story on how the Affordable Care Act (ACA, or Obamacare) affects your business, no matter how large or small, please obtain a copy of our comprehensive and easy-to-follow Affordable Care Act Compliance Kit.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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NLRB Files Complaints Against McDonald’s and Some Franchisees as Joint Employers

The National Labor Relations Board (NLRB) Office of the General Counsel has issued complaints against McDonald’s franchisees and their franchisor, McDonald’s USA, LLC, as joint employers.

The complaints allege that McDonald’s USA, LLC, and certain franchisees violated the rights of employees working at McDonald’s restaurants at various locations around the country by, among other things, making statements and taking actions against them for engaging in activities aimed at improving their wages and working conditions, including participating in nationwide fast food worker protests about their terms and conditions of employment during the past two years.

The Office of the General Counsel informed McDonald’s franchisees and their franchisor, McDonald’s USA, LLC, that, of 291 charges filed since November 2012, 86 cases have been found meritorious, and therefore, complaints would issue regarding those meritorious cases, absent settlement.

While representatives of the Office of the General Counsel have been engaged in efforts to settle the matter with the parties, thus far, those efforts have largely been unsuccessful.  Therefore, the Regional Offices, where meritorious charges were filed and not settled, issued complaints against the alleged joint employers today.  General Counsel representatives will continue efforts to settle the meritorious charges, notwithstanding issuance of the complaints.  Additionally, of the 291 charges filed, 11 cases were resolved and 71 cases remain under investigation.


If you own or operate a small to medium-sized business, managing all your employees plus meeting federal labor laws and regulations can be daunting, especially with new rules being issued all the time. To help you understand your rights and responsibilities in every facet of running a business, please order a copy of Personnel Concepts’ All-On-One HR Compliance Program for Small Businesses.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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Get Ready for New OSHA Reporting Requirements Coming Jan. 1

For employers under federal jurisdiction of the Occupational Safety and Health Administration (OSHA), New Year’s means more than just making resolutions; employers will also need to comply with new reporting requirements going into effect Jan. 1, 2015.

Employers will now be required to report all work-related fatalities within 8 hours and all in-patient hospitalizations, amputations, and losses of an eye within 24 hours of finding about the incident. Previously, employers were required to report all workplace fatalities and when three or more workers were hospitalized in the same incident.

There will be three options for employers to report. They will be able to call their nearest area office during normal business hours, using the 24-hour OSHA hotline at 1-800-321-OSHA (1-800-321-6742), or they can report online.


OSHA has also updated the list of industries required to keep injury and illness records, meaning more companies will be required to report and keep injury and illness records. Fortunately, we at Personnel Concepts have created the perfect compliance companion for these new reporting requirements. Get a copy of our OSHA Recordkeeping and Reporting Compliance Kit, which is brand new and up to date with all the expanded requirements.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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HHS Partners With Tech Companies to Spread the Obamacare Word

Following its pact with PayNearMe, the Department of Health and Human Services (HHS) has now partnered with tech companies Monster.com, Peers.org and higi to help spread the word on signing up for insurance coverage on HealthCare.gov.

“These innovative companies help us to reach our consumers where they are with the information they need to sign up and reenroll in quality, affordable care through the Health Insurance Marketplace,” said HHS Secretary Sylvia M. Burwell. “With these partnerships, we are using digital platforms to get Open Enrollment information in front of consumers who need it.”

Monster is a job seeking, career management, recruitment and talent management website. Peers claims it hosts “the world’s largest independent sharing economy community, whose mission is to make the sharing economy work for the people who power it.”

Higi, a kiosk-based health engagement platform, has placed engaging Marketplace Open Enrollment messaging on the overhead screens of its interactive stations tracking key health vitals (e.g., blood pressure, BMI, weight, body fat, etc.) located in the pharmacy areas of 2,000 Kroger, 1,000 Super Valu/Albertson’s, and 250 Meijer stores nationally.


For the full story on how the Affordable Care Act (ACA, or Obamacare) affects your business, no matter how large or small, please obtain a copy of our comprehensive and easy-to-follow Affordable Care Act Compliance Kit.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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CMS Proposes to Afford Same-Sex Spouses Equal Rights

The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule to fold the United States v. Windsor decision on marriage into the two medical programs it oversees by allowing same-sex spouses to participate in and administer “patient rights and services.”

“Specifically, we propose to revise certain definitions and patient’s rights provisions, in order to ensure that same-sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities,” the final rule says.

This proposed rule would revise regulations governing Medicare and Medicaid participating providers and suppliers by proposing to clarify that, where state law or facility policy provides or allows certain rights or privileges to a patient’s opposite-sex spouse under certain provisions, a patient’s same-sex spouse must be afforded equal treatment if the marriage is valid in the jurisdiction in which it was celebrated.

“These revisions would promote equality and ensure the recognition of the validity of same-sex marriages when administering the patient rights and services at issue,” the CMS announcement read.

The final rule was published in the Federal Register on Dec. 12. Comments on the issue are due to the CMS no longer than 5 p.m. ET on Feb. 10, 2015.


If you own or operate a small to medium-sized business, managing all your employees plus meeting federal labor laws and regulations can be daunting, especially with new rules being issued all the time. To help you understand your rights and responsibilities in every facet of running a business, please order a copy of Personnel Concepts’ All-On-One HR Compliance Program for Small Businesses.


NOTE: The details in this blog are provided for informational purposes only. All answers are general in nature and do not constitute legal advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought. The author specifically disclaims any and all liability arising directly or indirectly from the reliance on or use of this blog.
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