April 2013

This post was also written by Andrew C. Bernasconi.

Yesterday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would dramatically increase the potential reward to an individual who provides a tip leading to the recovery of Medicare funds from a current maximum of $1,000 to a maximum of $9.9 million under the Medicare Incentive Reward Program.  Since 1998, an individual providing information regarding potential Medicare fraud and abuse to the Department of Health & Human Services’ Office of  Inspector General or the Medicare contractor with jurisdiction over the suspected fraudulent provider or supplier may be eligible to receive 10 percent of the Medicare funds ultimately collected from the tip, or $1,000, whichever is less.  Pursuant to the proposed rule CMS issued yesterday, an individual furnishing information that otherwise satisfies the requirements set forth in 42 C.F.R. § 420.405 would be eligible to receive 15 percent of a recovery up to $66 million.  Therefore, a tipster could receive up to a $9.9 million reward for any information provided regarding suspected Medicare fraud and abuse.Continue Reading Proposed Rule Would Reward Medicare Fraud Tipsters up to $9.9 Million, Revise Medicare Provider Enrollment Regulations

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs…

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

– Proposed FY 2014 Budget. The Obama Administration has released its proposed federal budget for fiscal year 2014, which includes proposals that would save $401 billion from federal health programs over 10 years. A Reed Smith alert on the proposal is available at https://www.healthindustrywashingtonwatch.com/2013/04/articles/regulatory-developments/obama-administrations-proposed-fy-2014-budget-includes-401-billion-in-health-program-savings/.

– Regulatory Developments. Recent CMS regulations have addressed federal funding for Medicaid expansion under the Affordable Care Act, Health Insurance Exchange “Navigators,” electronic health record (EHR) donation protections, and oversight rules for accreditation organizations. Reed Smith has issued a special alert regarding recent CMS policies on hospital Part B inpatient billing. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. The IRS has published hospital community health needs assessment regulations, and a HRSA rule addresses reporting to the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

– Other HHS Developments. CMS has: announced the winners of the Medicare DMEPOS competitive bidding round 2/national mail order competition; announced 2014 rates and policies for Medicare Advantage and Part D prescription drug plans; provided resources on EHR incentive program audits; released guidance on participation in Federally-Facilitated and State Partnership Exchanges; and launched a “Medicare Chronic Conditions Dashboard.” See https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. FDA has issued draft guidance on biosimilar product development (see https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/).

– Legislative Developments. Recent Congressional hearings have addressed a number of health policy issues; a Senate panel has approved the Mental Health Awareness and Improvement Act; and House committee leaders have released additional details on their Medicare physician fee schedule reform proposal (see https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

– OIG Developments. The OIG has issued reports on Medicare supplier surety bonds, private insurer reporting to the HealthCare.Gov plan finder portal, and the Medicaid Integrity Program (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

– Health Industry Events. Upcoming events include meetings/calls on EHR billing and coding, the Medicare ESRD low-volume payment adjustment, transitioning to ICD-10, HCPCS code applications, the comparative effectiveness data infrastructure, and medical device labeling (see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

On April 9, 2013, CMS announced the names of 799 suppliers that have been awarded 3-year contracts under Round 2 of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program, along with the 18 suppliers that accepted contracts under the national mail order competition for diabetic testing supplies. Under competitive bidding,…

On April 2, 2013, CMS published a final rule establishing increased Federal Medical Assistance Percentage (FMAP) rates for certain adult populations under states’ Medicaid programs effective January 1, 2014, as authorized by the Affordable Care Act (ACA). The rule sets forth the method states will use to claim the matching rate that is available for…

On April 5, 2013, the Internal Revenue Service published proposed regulations that provide additional guidance to charitable hospital organizations on the community health needs assessment (CHNA) requirements and related excise tax and reporting obligations under the ACA. The regulations address the requirement a hospital organization conduct a CHNA at least once every three years, taking…

CMS has released a letter providing operational and technical guidance for issuers seeking to offer Qualified Health Plans (QHPs) on Federally-facilitated and State Partnership Exchanges. The letter addresses, among other things, the QHP certification process; QHP performance and oversight; enrollment and premium payment; and consumer support. There is also an appendix with additional guidance…

Earlier this month, the Senate Finance Committee held a hearing on the nomination of Marilyn Tavenner to be CMS Administrator. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Mental Health Awareness and Improvement Act, legislation that reauthorizes and amends programs administered by both HHS and the Department of Education related to awareness,…

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in…

On April 5, CMS published a proposed rule that would revise the survey, certification, and enforcement procedures related to CMS oversight of national accreditation organizations (AOs). These revisions would implement certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 that removed legal distinctions between the Joint Commission hospital accreditation program and…

The Health Resources and Services Administration (HRSA) has published a final rule to incorporate ACA requirements that eliminate duplicative data reporting to the Healthcare Integrity and Protection Data Bank (HIPDB) and the National Practitioner Data Bank (NPDB). Among other things, the rule establishes a transition period to transfer all data in the HIPDB to…

All private health insurers in the individual and small group markets must submit data to the HealthCare.gov Plan Finder, an online portal created to help consumers compare health insurance coverage options. According to a recent OIG report, "Oversight of Private Health Insurance Submissions to the HealthCare.gov Plan Finder," while most private insurers reported…

On April 5, 2013, CMS published a proposed rule that would establish standards for “Navigators” in federally-facilitated and state partnership Affordable Insurance Exchanges under the ACA. Under prior CMS regulations, Exchanges must award grants to Navigators to provide impartial information to consumers about health insurance, the Exchange, Qualified Health Plans (QHPs), various insurance affordability programs…

On April 23, 2013, the Patient-Centered Outcomes Research Institute (PCORI) is hosting a roundtable discussion on “Building a National Data Infrastructure to Advance Patient-Centered Comparative Effectiveness Research.” The event will focus on the challenges and opportunities in creating such a research infrastructure and how PCORI’s investments can provide unique value. The registration deadline is April…