PPACA Exchange Deadline Extended Indefinitely

The U.S. Department of Health and Human Services’ (HHS) Center for Consumer Information and Insurance Oversight (CCIIO) announced that “there is no deadline” for states to determine whether they will establish their own PPACA health insurance exchanges.  The February 15th deadline was also extended for states to declare whether they will “partner” with HHS to establish such an exchange.  The agency head said that “We are going to give final approval once states demonstrate that they are able to satisfy all the requirements and meet all the conditions of operating an exchange.”  A number of states have complained that they lack the information necessary to make a decision on whether or not to establish an exchange.  In this connection, HHS released a 474-page regulatory proposal intended to provide additional guidance to states and health insurers on the Medicaid expansion and the creation of exchanges, including guidance on: eligibility for federal premium tax credits; the imposition of increased cost-sharing; appeals of eligibility requirements; coordination between insurance exchanges and Medicaid/SCHIP; roles of counselors who will assist residents in applying for coverage; verification procedures for employer-sponsored coverage; and how to use updated Medicaid eligibility categories.  Comments on the proposed regulations are due by February 13th.  HHS Secretary Kathleen Sebelius announced that she and other senior HHS officials will tour the country to promote the PPACA and the establishment of and enrollment under health insurance exchanges, including the federally-run default exchange to be named the “Health Insurance Marketplace.”  To boost state-run exchanges, HHS announced that $1.5 billion in new PPACA grants were awarded to eleven states to establish online exchange markets.

PPACA Oversight and Implementation

Oversight of the PPACA by congressional committees will likely include close scrutiny of at least the following: the implementation of insurance exchanges and open enrollment beginning in October; the implementation of essential health benefits (EHB); the implementation of medical loss ratio (MLR) requirements; Medicaid expansion and the growing role of managed care; premium costs as implementation occurs; the development of accountable care organizations (ACOs); Medicare Advantage payments; the continued movement of dual-eligibles into managed care; employer decisions on maintaining coverage; and the possibility of PPACA implementation deadline delays.

Final HIPPA Regulations

The Department of Health and Human Services Office for Civil Rights (OCR) released four final regulations under an omnibus rule as follows: modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules mandated in the Health Information Technology for Economic and Clinical Health (HITECH) Act; changes to the HIPAA enforcement rules; final regulations concerning reporting of data breaches; and modifications to the Privacy Rule as required in the Genetic Information Nondiscrimination Act (GINA).  The effective date of the rule is March 26, 2013 while the compliance date for covered entities and their business associates is September 23, 2013.  HHS Secretary Kathleen Sebelius said the final rules are intended to protect patient data in “an ever expanding digital age.”  Of note, the reporting of a breach to affected individuals was changed so that the definition of a breach means “that an impermissible use or disclosure of protected health information is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised.”  The OCR also said that physicians can, without violating federal privacy rules, disclose a patient’s health care information to law enforcement or family members if the individual presents a serious danger to himself or others.  The final enforcement provisions include increased civil monetary penalties and a cap of $1.5 million on the maximum annual penalty, up from the existing $25,000 cap.

NIH Announces Funding of Alzheimer's Clinical Trials

The National Institute on Aging announced that $11 million will be awarded in FY 2013 and as much as $55 million over 5-years to the Alzheimer’s Disease Cooperative Study, a consortium of academic medical centers and clinics NIH founded in 1991 to collaborate on Alzheimer’s research.  The funds will be used in four clinical trials to help discover and develop treatments for Alzheimer’s disease.

Executive Actions to Stem Gun Violence Include Mental Health Provisions

In the wake of the Sandy Hook Elementary School mass shootings, on January 16th the President announced 23 executive actions intended to stem gun violence.  The White House said the following actions will focus on mental health: the issuance of final regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 to ensure mental health services are covered “at parity” with other covered health services; a directive to CDC to conduct research into the causes and prevention of gun violence; two directives attempting to clarify health care providers’ right to ask patients about gun ownership; and two directives intended to increase the information that states provide in connection with federal gun-purchase background checks.  The plan, developed by a group led by Vice President Biden, also is to include: efforts to train teachers to identify and respond to mental illness in children; innovative state-based strategies supporting people ages 16 to 25 with mental health or substance abuse issues; measures to offer students mental health services for trauma or anxiety and conflict-resolution programs; other school-based violence prevention strategies; and stipends and tuition reimbursement to educate and train more than 5,000 new social workers, counselors, and psychologists to work with young people in schools and communities.  Senator Charles Grassley (R-IA) expressed concern with the directive to CDC to study gun violence in that agency appropriations bills include language preventing the agency from using funds to “advocate or promote gun control.”  He also questioned the legality of the directives allowing providers to ask about gun ownership inasmuch as the PPACA contains a provision stating that the law does not grant the federal government the authority to collect “any information relating to the lawful ownership or possession of a firearm or ammunition.”  The Senate Committee on Health, Education, Labor and Pensions (HELP) is scheduled to hold hearings on the state of the mental health system with a focus on what needs to be done on early intervention.

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