Other HHS Developments

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On July 14, 2014, HHS announced a $100 million Medicaid Innovation Accelerator Program to assist state health system reform efforts designed to improve health care while reducing costs. The initiative, which is intended to complement other federal-state delivery system reform efforts, will “help jumpstart innovation” by providing data analytics, quality measurement, and other technical supports…

On July 21, 2014, the Health Resources and Services Administration (HRSA) released an “interpretive rule” reiterating that 340B-covered entities affected by the orphan drug exclusion may purchase orphan drugs at 340B prices when those orphan drugs are used for indications other than the rare disease or condition for which the drug received an orphan designation.…

HHS has released a report on premiums, tax credits, and health plan choices on the ACA federal Marketplace for plans operating in 2014.  In addition, CMS has launched an initiative, dubbed “From Coverage to Care,” designed to answer questions consumers may have about their new health coverage under the ACA and to help individuals…

In a recent website update, the Health Resources and Services Administration (HRSA) reaffirmed its current interpretation of the 340B discount drug program orphan drug exemption – despite a May 23, 2014 U.S. District Court ruling that vacated HRSA’s orphan drug regulation because of lack of the statutory authority to engage in such rulemaking. According to…

CMS plans to apply “Phase 2” ordering and referring denial edits to certifying physicians of Part A home health agency (HHA) services effective July 1, 2014. These edits, which currently apply only to the attending physician of an HHA, will ensure that the physician that certifies the patient’s eligibility to receive services under the…

On May 9, 2014, CMS announced it is implementing the first phase of its reforms to the Quality Improvement Organization (QIO) Program in an effort to “gain efficiencies, to eliminate any perceived conflicts of interest, and to better address the needs of Medicare beneficiaries.” Under this first phase, CMS has named two Beneficiary and Family-Centered…

CMS has provided additional guidance on its evolving hardship exemptions policy for individuals who had difficulty signing up for a qualified health plan (QHP) through an Affordable Insurance Exchange by the March 31, 2014 deadline. As previously reported, in March CMS announced it had established a “special enrollment period” for individuals who were “in…

Two more health care companies have settled potential violations of the HIPAA Privacy and Security Rules arising from the theft of unencrypted laptops by paying a total of almost $2 million and agreeing to continued oversight by the HHS Office for Civil Rights (OCR). In both instances, the breaches were self-reported and the settlements resulted…

On May 9, 2014, the Health Resources and Services Administration (HRSA) released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. Based on a review of 51 covered entities encompassing more than 410 outpatient facilities/sub-grantees and more than 860 contract pharmacy locations, HRSA identified “several recurring critical…

HHS has developed a Security Risk Assessment (SRA) tool to help providers comply with a Health Insurance Portability and Accountability Act (HIPAA) requirement that covered entities conduct a risk assessment to ensure compliance with HIPAA’s administrative, physical, and technical safeguards and to determine where electronic protected health information could be at risk. The SRA tool is…

On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015. Virtually all types of health care providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed – an unlikely scenario given the Republican House leadership’s reaction to the document. Nevertheless, the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) could resurface as spending offsets in the pending negotiations on Medicare physician fee schedule reform legislation or in future budget negotiations. Highlights of the Administration’s Medicare and Medicaid legislative proposals include the following (all savings estimates are for the 10-year period of FYs 2015-2024):
Continue Reading Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

Citing a “rapid and overwhelming increase in claim appeals,” the HHS Office of Medicare Hearings and Appeals (OMHA) has temporarily suspended the assignment of most new provider requests for an Administrative Law Judge (ALJ) hearing. In a memorandum to high-volume appellants dated December 24, 2013, Chief ALJ Nancy Griswold announced that the suspension, which…

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.…

President Obama announced on November 14, 2013 that HHS has adopted an administrative policy to allow insurers to continue to offer certain health insurance policies scheduled to be cancelled effective January 1, 2014 because of more stringent coverage requirements under the ACA. In short, under the“transitional” policy outlined in a letter to state insurance commissioners…

On November 13, 2013, HHS issued its first report on ACA Health Insurance Marketplace/Exchange enrollment statistics. According to the Administration, 106,185 individuals have selected health plans during the first 33 days of the open enrollment period (October 1 through November 2, 2013), although this figure also includes individuals who have not yet purchased a…

CMS has announced the names of 282 suppliers that have been awarded 3-year contracts under the Medicare DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program “Round 1 Recompete.” As discussed in our previous reports, this phase of bidding applies to nine geographic areas where competitive bidding contracts have been in effect since 2011, but…