The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed Rule was issued previously by the OIG in May 2014. The effective date of the Final Rule is February 13, 2017.
Noteworthy changes made by the Final Rule include the following key items:
The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final guidance. Rather, the Discussion Paper is the FDA’s “synthesis of all feedback” received, which the FDA hopes will “advance public discussion on future LDT oversight.” The Discussion Paper is not enforceable.
On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in Congress. Continue reading
Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for research, streamlined approvals for drugs and devices as well as funding to improve the Food and Drug Administration’s (FDA) ability to hire top quality scientific talent by increasing pay and improving the hiring process. The House of Representatives recently passed Cures by a similarly wide bipartisan margin of 392-26. The Senate vote marks a milestone victory for Cures champions including outgoing Energy and Commerce Committee Chairman Fred Upton (R-MI), Representative Diana DeGette (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN). Continue reading
Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT). First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs. This guidance marked a significant shift in the regulation of LDT as FDA has chosen not to exercise regulatory oversight or enforcement over LDTs. Continue reading
Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days per year must obtain a license, which includes completing an educational course determined by the Commissioner of Public Health (Commissioner), submitting a registration form to the Department, and paying a $750 licensure fee. Renewal applicants will be required to complete at least 5 hours of continuing education in the areas of ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing, and other areas that the Commissioner may designate by rule. Training courses may not be provided by the pharmaceutical representative’s employer. The ordinance takes effect on July 1, 2017.
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various HHS programs. For example:
- There are at least three new areas of review related to each skilled nursing facilities and hospice.
- OIG will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).
- OIG will conduct a review of the data reported to Open Payments under the Physician Payments Sunshine Act. Among other things, OIG intends to determine the volume and total dollar amount for drugs, devices and medical equipment ordered by physicians under Medicare Parts B and D who are contained in the Open Payments reports.
- OIG will conduct an analysis to determine the amount the federal government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B. This analysis builds on prior OIG analyses.
- OIG also will conduct an analysis to determine the amount the federal government could potentially save if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.
Pharmaceutical and medical device companies, clinical laboratories and other health care entities should carefully review the OIG 2017 Work Plan to determine areas of government focus. The Work Plan often serves as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring. Additionally, reports issued by the OIG after a review are a valuable resource regarding the OIG’s current analysis of industry activities.