Check Out & Comment By 10/13 On FDA Proposed Food Labeling Rule Changes

August 20, 2015

Consumers, health care providers and others concerned about nutrition labeling should review proposed changes to the Food and Drug Administration (FDA) food labeling rules recently proposed by the FDA and submit any comments by the October 13, 2015 comment deadline.
With diet and lifestyle related diseases continuing to drive American disability and healthcare costs, American policymakers, business leaders, insurers, employers and consumers increasingly are looking to help Americans to eat better.  FDA issued two proposed rules and one supplemental proposed rule on updating the nutrition facts label.  Growing interest in promoting better health by helping Americans to eat smarter has prompted recurrent interest in improvements to food labels required by Food and Drug Administration (FDA) rules.

In response to these concerns, FDA now is considering final adoption of two proposed rules and one supplemental proposed rule on updating the nutrition facts label.  Interested parties can review these proposed rules and other related information here.

Concerned parties should review these proposed rules and other related information here.

About Project COPE: The Coalition On Patient Empowerment &  Coalition on Responsible Health Policy

Do you have ideas about how to improve the understandability of medication warnings or research findings for patients or other ideas about how to improve healthcare or health care policy?  Share your ideas in the  PROJECT COPE: Coalition On Patient Empowerment LinkedIn Group.  If you have knowledge, experience or other resources that could help patients, families, communities, or the government better understand or cope with  Asperger’s or other health care conditions, costs of care, or other challenges affecting Americans and the American health care system, we encourage you to get involved and share your insights.

As American leaders continue to struggle to deal with these and other mounting problems impacting the U.S. health care system, the input of individual Americans and businesses and community leaders is more critical than ever.  Get involved in helping to shape improvements and solutions to the U.S. health care system and the Americans it cares for by sharing your ideas and input through the Coalition For Responsible Health Care Policy  and exchanging information and ideas for helping American families deal with their family member’s illnesses, disabilities and other healthcare challenges through PROJECT COPE: Coalition On Patient Empowerment.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these  needs is the purpose of PROJECT COPE.

The Coalition and its PROJECT COPE arise and run on the belief that health care reform and policy must be patient centric and patient empowering.  The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans.  The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch.  Americans can best improve health care by not waiting for someone else to step up:  Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can.  Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process.  Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist.  The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye.  Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families.  While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining PROJECT COPE: Coalition On Patient Empowerment and by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

You also may be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here such as the following, our electronic Solutions Law Press Health Care Update publication available here, and/or our HR & Benefits Update electronic publication available here:

You also can get details about how to arrange for your employees or other communities to participate in training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here.

NOTE:  This article is provided for educational purposes.  It is does not provide legal advice, establish any attorney-client relationship or provide or serve as a substitute for legal advice to any individual or organization.  Readers must engage properly qualified legal counsel to secure legal advice about the rules discussed in light of specific circumstances. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, or (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.  ©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


10 Practical Pointers To Use Law To Better Strengthen The Legal Defensibility Of Your Business & Its Leaders

August 13, 2015

10 Practical Pointers To Use Law To Better Strengthen The Legal Defensibility Of Your Business & Its Leaders.

via 10 Practical Pointers To Use Law To Better Strengthen The Legal Defensibility Of Your Business & Its Leaders.


Check Defensibility Of Policies & Practices Given New HHS/DOJ Joint Disability Law Technical Assistance

August 10, 2015

Child welfare agencies, health care providers and their contactors and other service providers should evaluate the adequacy and defensibility of their existing practices for accommodating and providing other services to individuals with disabilities and their families in light of the new joint technical assistance to state and local child welfare agencies and courts on the requirements of Title II of the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act jointly announced by the Departments of Health & Human Services (HHS) and the Justice (DOJ) under a new HHS/DOJ partnership intended to help child welfare agencies protect the welfare of children and ensure compliance with nondiscrimination laws announced here August 10, 2015.

Federal child welfare and discrimination laws generally prohibit discrimination on the basis of disability, and require providers of government programs, services, and activities to make reasonable modifications to their policies and practices when necessary to avoid discrimination on the basis of disability, unless such modifications would fundamentally alter the nature of the program or the services.  The new joint technical assistance addresses disability discrimination complaints that HHS and DOJ say the agencies have received from parents who have had their children taken away or otherwise have not been given equal opportunities to become foster or adoptive parents.

The technical assistance provides an overview of Title II of the ADA and Section 504 and examples about how to apply them in the child welfare system, including child welfare investigations, assessments, guardianship, removal of children from their homes, case planning, adoption, foster care, and family court hearings, such as termination of parental rights proceedings.  It also underscores that Title II and Section 504 prohibit child welfare agencies from acting based on unfounded assumptions, generalizations, or stereotypes regarding persons with disabilities.

HHS and DOJ hope “[p]roviding this technical assistance to state and local agencies and courts will help ensure that families who have a member with a disability get equal access to vital child welfare services,” said Mark Greenberg, HHS’ Administration for Children and Families’ Acting Assistant Secretary.

The new child welfare technical assistance is part of a broader ongoing emphasis on investigation and enforcement of disability and other discrimination laws by HHS, DOJ and other agencies under the Obama Administration. Under the Obama Administration, HHS, DOJ and other agencies already have heavily sanctioned many child welfare, health care and other agencies and providers for alleged violation of these and other federal disability discrimination laws.  See, e.g., Health Care Employer’s Discrimination Triggers Medicare, EEOC Prosecutions; Hospital Will Pay $75K For Refusing To Hire Disabled Worker;  OCR Settlements Show Health Care & Disabled Housing Providers Face Growing Disability Discrimination RisksGenesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled.   In the face of this emphasis, child welfare, health care and other agencies and their legal counsel and other service providers should expect greater deference and enforcement to the needs of children and parents with disabilities in child custody, adoption, divorce and other proceedings, as well as continued investigation and enforcement of disability and other discrimination laws against child welfare, health care, and other social service agencies, their legal counsel and other advocates and others providing services.  These and other organizations and service providers should  evaluate the defensibility of the existing policies, practices and recordkeeping practices of their own organization, as well as those of their contractors and subcontractors in light of these and other disability discrimination laws, regulations and enforcement practices.

For More Advice, Assistance Or More Information

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Ms. Stamer is a highly regarded practicing attorney with extensive health industry legal and policy experience, also recognized as a knowledgeable and highly popular health industry thought and policy leader, who writes and publishes extensively  on health industry concerns. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, recognized as a “Top” lawyer in Health Care, Labor and Employment and Employee Benefits Law, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 27 years experience advising health industry clients about these and other matters. Her experience includes advising and defending hospitals, nursing home, home health, physicians and other health care professionals, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies and programs in response under CMS, OCR, HHS, FDA, IRS, DOJ, DEA, NIH, licensing, and other regulations; prevent, conduct and investigate, and respond to Board of Medicine, OIG, DOJ, DEA, DOD, DOL, Department of Health, Department of Aging & Disability, IRS, Department of Insurance, and other federal and state regulators; ERISA and private insurance, prompt pay and other reimbursement and contracting; peer review and other quality concerns; and other health care industry investigation, and enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. This experience includes extensive work advising and defending physicians, practices, hospitals and other health care organizations and others about Medicare and other health care billing and reimbursement practices,  as well as advising and defending providers against Medicare, Medicaid, Tricare and other audits, prepayment suspensions, provider exclusions and provider number revocation, and counseling and defending providers, medical staff and peer review committees, hospitals, medical practices and other health care organizations and others in relation to the conduct of audits and investigations, peer review investigations and discipline, employment, licensing board and other associated events.

The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights,  past Board President of the Richardson Development for Children and former Board Audit Committee Chair of the National Kidney Foundation of North Texas, Ms. Stamer has lead, advised, represented and conducted training and investigations of disability and other legal and operations risk management and compliance for early childhood intervention (ECI) and other childcare, health care, public and private schools, social service and other public and private organizations.  Ms. Stamer also  has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns.  Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.  In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans,  as well as  HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for  Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others. Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer such as the following, see here:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. ©2015 Cynthia Marcotte Stamer.  Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


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