6/5/14 HHS/CMS published a notice under the Privacy Act of 1974 that announces the establishment of a new system of records titled "Open Payments" in order to implement ACA §6002, Sunshine Act Disclosures. The system will contain information about the following categories of individuals covered by the Open Payments program: (1) physicians and authorized representatives of physicians and teaching hospitals and (2) any applicable manufacturers and applicable group purchasing organization (GPO) system users.

ACA §6002 requires applicable manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report payments or other transfers of value (including gifts, consulting fees, research activities, speaking fees, meals, and travel) provided to physicians or teaching hospitals to CMS. Manufacturers and group purchasing organizations (GPOs) are also required to disclose/report annually to CMS physician ownership or investment interests. 

According to CMS, the increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers. Data must be reported in a required format so that CMS can release the data on a public website by September 30, 2014. CMS is developing an electronic system to facilitate the reporting process. GPOs, as well as the physicians and teaching hospitals, will have an opportunity to review and correct reported information prior to its publication. The ACA provides that violators of the reporting requirements will be subject to civil monetary penalties, capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report. 

§6002 also preempts any state or local laws requiring reporting of the same types of information regarding payments or other transfers of value made by applicable manufacturers to covered recipients. Under the requirement, no state or local government may require the separate reporting of any information regarding a payment or other transfer of value that is required to be reported under this statute, unless such information is being collected by a federal, state, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight. According to CMS, this creates the possibility of cost-savings, since a single reporting system for reporting this information is less burdensome than multiple programs.

CMS published a final rule in February 2013 to implement this program, which included several information collections subject to the Paperwork Reduction Act. This information collection request is to inform the public about information collected that is necessary for registration, attestation, dispute resolution and corrections, record retention, and submitting an assumptions document within Open Payments.

Comments are due July 7, 2014.

Read the notice at: http://www.gpo.gov/fdsys/pkg/FR-2014-06-05/pdf/2014-13012.pdf

6/3/14 IRS/Treasury issued a correction to the proposed regulations called "Minimum Essential Coverage and Other Rules Regarding the Shared Responsibility Payment for Individuals." The document makes technical additional corrections to the proposed regulations which were published in the Federal Register on January 27, 2014.

The proposed regulations contain guidance related to the ACA's individual shared responsibility provision and provide that coverage under certain government-sponsored programs is not minimum essential coverage, or MEC, (ACA§1501). Under the proposed regulations, the IRS stipulates that certain limited-benefit Medicaid and TRICARE health care coverage is not MEC. The proposed regulations also address the treatment of health reimbursement arrangements and wellness program incentives for purposes of determining the exemption for individuals who cannot afford employer-sponsored coverage.

Beginning earlier this year, the individual shared responsibility provision requires each nonexempt individual to have basic health insurance coverage known as MEC, qualify for an exemption, or make a shared responsibility payment when filing their federal income tax return. The requirement applies to adults, children (as tax dependents), seniors (most of whom will meet the coverage requirement through Medicare), and lawfully present immigrants.  

The comment period on the proposed regulations ended on April 28, 2014.

Read the correction at: http://www.gpo.gov/fdsys/pkg/FR-2014-06-03/pdf/2014-12754.pdf

6/2/14 HHS/CMS issued a notice under the Paperwork Reduction Act of 1995 (PRA) seeking comments on the revision of a currently approved information collection activity related to the Reporting Requirements for Grants to States for Rate Review Cycle I, Cycle II, Cycle III, and Cycle IV and Effective Rate Review Programs. According to CMS, the notice explains that the Rate Review Grant Program is required to assist states in the establishment of ''Data Centers'' that gather, evaluate, and publicize health care pricing data for the public.

Along with this information collection request, HHS announced the Cycle IV of the Rate Review Grant opportunity, ''Grants to States to Support Health Insurance Rate Review and Increase Transparency in the Pricing of Medical Services.'' As indicated by HHS/CMS, the purpose of Cycle IV of the Rate Review Grant Program is not only to continue the rate review successes of Cycles I- III but also and to offer enhanced support to the aforementioned Data Centers.

States and territories that are awarded funds under the Cycle IV funding opportunity are required to provide the HHS Secretary with rate review data, four quarterly reports, one annual report per year until the end of the grant period (as well as a final report) describing the state's development towards a more comprehensive and effective rate review process.

The rate review program under §1003 requires that insurers seeking rate increases of 10% or more for non-grandfathered plans in the individual and small group markets publicly and clearly disclose the proposed increases and the justification for them. Such increases are reviewed by either state or federal experts (in states that do not have a rate review program deemed effective by HHS) to determine whether they are unreasonable. Although the ACA does not grant HHS the authority to block a proposed rate increase, companies whose rates have been determined unreasonable must either reduce their rate hikes or post a justification on their website within 10 days of the rate review determination. CMS determined that both the individual and small-group markets in Massachusetts meet standards under §1003 and that the Commonwealth does have an effective rate review process.

Comments are due August 1, 2014.

Read the notice at:

Prior guidance can be found at: http://www.hhs.gov/healthcare/index.html