Pharmaspective

CMS Will Hold Three Separate Webinars to Provide a Regional-Level Overview of the Final Rules Implementing the Sunshine Act and the Open Payments Program

 

By Albert E. Cuccinello

On April 15th, April 16th, and April 22nd, the Centers for Medicare and Medicaid Services (CMS) will hold webinars to provide a regional-level overview of the final rules implementing the Sunshine Act, and the Open Payments program. The target audience for the webinars is association and medical society staff, physicians, practitioners, and practice managers.  Each webinar will include an overview of the final rule, information regarding the health care provider's role in the Open Payments program, resources available to health care providers, and key program dates.

 

The three regional webinars will be held as followed:

 

• CMS Regions 1, 2, 3, and 4
  • Date: Tuesday, April 15, 2014
  • Time: 1:00 p.m. - 2:00 p.m. EDT
  • Webinar link:  https://webinar.cms.hhs.gov/openpaymentsro1-4/  
  • Dial-in: (877) 267-1577
  • Meeting ID number (no password required):  997 848 185

 

• CMS Regions 5, 6, 7, and 8
  • Date: Wednesday, April 16, 2014
  • Time: 12:00 p.m. - 1:00 p.m. CDT
  • Webinar link:  https://webinar.cms.hhs.gov/openpaymentsro5-8/   
  • Dial-in: (877) 267-1577
  • Meeting ID number (no password required):  994 370 464

 

• CMS Regions 9 and 10
  • Date: Tuesday, April 22, 2014
  • Time: 11:00 a.m. - 12:00 p.m. PDT
  • Webinar link:  https://webinar.cms.hhs.gov/openpaymentsro9-10/   
  • Dial-in: (877) 267-1577
  • Meeting ID number (no password required):  990 170 990

 

To view the regional map, click here.  Any questions regarding these webinars or the Open Payments program may be submitted via e-mail to OpenPayments@cms.hhs.gov.

The D.C. Department of Health Releases the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2012" Report

 

By Kerry Miele

Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01], manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must be submitted to the D.C. Department of Health (Department) by July 1st of each year for those expenses incurred during the previous calendar year.

 

The Department recently released the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2012" Report ("Report"). According to the Report, 147 pharmaceutical manufacturers and labelers reported expending $97.5 million in 2012 for advertising, gift, and aggregate expenses in D.C. Of this total, companies reported $61.5 million for aggregate expenses, $30.5 million for gift expenses, and $5.4 million for advertising expenses. The report also notes that 15 companies each reported spending over $1 million in total aggregate expenditures, which represented 63.3% of total reported aggregate expenditures.

 

Click here to view the full report. 

Phase 1 vs. Phase 2: CMS Posts Chart Comparing Registration and Data Submission During Both Phases

 

By Brianna Pirmann

In an effort to assist reporting entities with Phase 1 registration and data submission, the Centers for Medicare and Medicaid Services (CMS) has posted on its Open Payments website a new table that provides a side-by-side comparison of Phases 1 and 2. Some of the topics covered in the comparison chart are:

 

• Registration procedures for entities located outside the United States;
• Information regarding the Remote Identity Proofing (RIDP) Process;
• User roles that are available in the Open Payments system;
• Information on how to handle registration for multiple entities;
• Data submission instructions;
• Assumption documents; and
• The attestation process.

 

Additionally, CMS has updated its Data Submission Instructions Document to include the following:

 

• Step-by-step screenshot instructions for creating a pipe-delimited CSV file in Microsoft Excel 2010;
• Specified categories to be used when entering registering entity business type;
• Specified required and optional data fields; and
• An example of how to enter aggregate data, using a payment or transfer of value scenario.

 

Phase 1 of the registration and data submission process will end on March 31, 2014. CMS has indicated that for the 2013 reporting year it will not enforce penalties for reporting non-compliance until after the close of Phase 2 registration and data submission. CMS has also indicated that it will announce additional information in the spring of 2014 regarding the review and correction phase, which is scheduled to begin on August 1, 2014. Please note that this phased approach to Open Payments registration and data submission is only for the 2013 reporting year, which includes data that was collected between August 1 and December 31, 2013.

 

CMS encourages industry users to review the data registration and submission resources and contact the help desk at OpenPayments@cms.hhs.gov with any follow-up questions.

DEA Schedules Eighth National Prescription Drug Take-Back Day for April 26, 2014

By Nancy A. Henshaw

In its continuing efforts to  provide a "safe, convenient, and responsible means of disposing of prescription drugs," the federal Drug Enforcement Administration (DEA) has scheduled its eighth National Prescription Drug Take-Back Day for Saturday, April 26, 2014. The DEA held its first Prescription Drug Take-Back event in September 2010. To date, the Take-Back events, which have collection sites across the United States and some U.S. territories, have removed over 3.4 million pounds of medication from circulation.

 

According to a DEA press release that was issued following the last National Prescription Drug Take-Back Day, the Take-Back events are necessary because the "Controlled Substances Act (CSA) as originally written didn't provide a way for patients, caregivers, and pet owners to dispose of such controlled substance (CS) medications such as painkillers, sedatives, tranquilizers, and stimulants like ADHD drugs. People were flushing their old meds down the toilet or throwing them in the trash, but in recent years medicines have been found in the nation’s water supplies, and medications were being retrieved from the trash by those who would abuse or sell them." The DEA also noted that  unused and expired prescription drugs that remain in home medicine cabinet are "highly susceptible to diversion, misuse, and abuse."

 

In 2010, the U.S. Congress passed the Secure and Responsible Drug Disposal Act of 2010, which amends the CSA to permit users of lawfully-obtained controlled substances to deliver the controlled substance to an authorized person for the purpose of disposal of the controlled substance. Regulations implementing this Act are being finalized by the DEA. 

 

The DEA will post of list of prescription drug collection sites beginning April 1, 2014.  

California Board of Pharmacy Issues Notice Stating That It Has Inactivated California's E-Pedigree Provisions

 

By Natasha Bobo

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act, which amends the Federal Food, Drug, and Cosmetic Act. Title II of this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved in the pharmaceutical distribution chain to implement a national track and trace system. Manufacturers and wholesale distributors that transfer ownership of a product will be required to provide the subsequent owner with transaction history, transaction information and a transaction statement in a single document in paper or electronic format. The Act includes requirements to implement an electronic track and trace system that will go into full effect ten years after the Act’s enactment. The Act preempts state pedigree laws.

 

In response to enactment of the Act, the California Board of Pharmacy (Board) has issued a public notice stating that California's e-Pedigree provisions have been inactivated. The Board also noted that it will sponsor legislation this year to repeal the e-Pedigree provisions that have been inactivated.

 

Click here to view the public notice.

The Office of Inspector General Releases 2014 Work Plan

 

By Kim C. Capone

The Office of Inspector General (OIG) has released its 2014 Work Plan. The Work Plan summarizes activities OIG plans to pursue with respect to the U.S. Department of Health and Human Services (HHS) programs and operations.

 

The Work Plan can be an important resource for identifying potential compliance risk areas. It is divided into the following sections: (1) Medicare Part A and Part B; (2) Medicare Part C and Part D; (3) Medicaid Program; (4) CMS-Related Legal and Investigative Activities; (5) Public Health Reviews; (6) Human Services Reviews; and (7) Other HHS-Related Reviews. It discusses OIG activities regarding hospitals, nursing homes, hospices, home health services and other community based care, medical equipment, prescription drugs, and other providers and suppliers.

 

Notably, the Legal and Investigative Activities section addresses exclusions from federal healthcare programs and the imposition of civil monetary penalties, pursuit of False Claims actions and assessment of compliance with Corporate Integrity Agreements, the advisory opinion process, and initiatives regarding provider compliance training and self-disclosure. It also describes the Health Care Fraud Prevention and Enforcement Action Team (HEAT), started in 2009, and the Medicare Fraud Strike Force teams, which coordinate efforts of federal, state and local law enforcement.

 

While there is similarity between the new Work Plan and the OIG’s previous Work Plans, OIG introduces several new areas that include, new inpatient admission criteria, analysis of salaries included in hospital cost reports, outpatient evaluation and management services billed at the new-patient rate, indirect medical education payments, oversight of hospital privileging, accuracy of the Physician Compare Web Site and hospice in assisted living facilities.

 

Click here to view the 2014 Work Plan.

Distributing Scientific and Medical Publications on Unapproved New Uses is the Subject of Revised FDA Draft Guidance

 

By Kim C. Capone

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices." The draft guidance recommends practices for pharmaceutical and medical device manufacturers when disseminating scientific and medical literature that include discussions of off-label uses for approved or cleared products. The scientific and medical literature addressed in the guidance include scientific or medical journal articles, scientific or medical reference texts, and clinical practice guidelines.

 

The revised draft guidance is a modification of the FDA's 2009 draft guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." The revised draft guidance contains many of the recommendations in the 2009 guidance, but provides more detailed definitions and examples. It also contains a comprehensive background discussion of prohibitions regarding off-label promotion and Section 401 of the Food and Drug Modernization Act (FDAMA).

 

Perhaps most significantly, the revised draft guidance includes a separate discussion of recommendations for distribution of reference texts and clinical practice guidelines. As stated in the guidance, "because … reference texts are considerably longer than journal articles, and generally address a wide range of topics, FDA believes that it is appropriate to make specific recommendations for distribution of reference texts that differ somewhat from the recommendations for journal articles." The FDA also sets forth separate recommendations for dissemination of clinical practice guidelines (CPG) because "a CPG may be much longer and often covers a wider range of topics than a journal article." With respect to CPGs, some of the FDA recommendations incorporate the Institute for Medicine's standards for CPG "trustworthiness."

 

Comments on the draft guidance (Docket No. FDA–2008–D–0053) are due by May 2, 2014. Interested persons may submit electronic comments regarding the revised draft guidance to http://www.regulations.gov,  or written comments to the Division of Dockets Management.