State Programs and Government Pricing

Guest Author: Katie Lapins
 
Keeping track of all of the reporting requirements associated with Government Pricing can be daunting. Is your product a brand, authorized generic, generic, injectable or otherwise administered in a clinic or doctor’s office? Not only are these important questions that dictate what reporting must be done on a monthly, quarterly, and/or annual basis, but manufacturers must also comply with various state reporting requirements, currently New Mexico (Q3 only), Vermont (Quarterly) and Texas (Monthly and Quarterly). Here’s a review of the current state reporting requirements:

New Mexico originally required quarterly reporting but this has changed to just the third quarter of each year, due by January 15 of the following year. New Mexico requires the following information for all Covered Outpatient Drugs from all manufacturers:

• - Quarterly Average Manufacturer Price (“AMP”),
• - Greatest wholesaler prompt pay discount percentage,
• - Lowest indirect price through a New Mexico wholesaler, and
• - Lowest prices to wholesalers, Pharmacy Benefits Managers and any other New Mexico entity that purchases directly from the manufacturer without the use of a wholesaler.

Vermont requires quarterly reporting within 30 days of the quarter end (January 30, May 1, August 1, and November 1). AMP and BP, if applicable, must be reported for each Covered Outpatient Drug. Additionally, manufacturers must report the undiscounted price paid by Vermont wholesalers for product received in Vermont during the quarter (the Vermont WAC). Vermont also requests that each manufacturer provide the methodology utilized to perform the calculations. For manufacturers, it may be worth including a note as to the confidentiality and proprietary nature of their methodology that is submitted.

Texas has two different reporting requirements. The first is simply that manufacturers must submit AMP on a quarterly basis. The second requirement is due by the 10th day of each month and must include the following information:

• - Direct Price to Chain Pharmacy
• - Direct Price to Long Term Care (“LTC”) Pharmacy
• - Direct Price to Pharmacy
• - Price to Wholesaler/Distributor

In the event a manufacturer reports a price range for these price points, they must also report a weighted average, based on unit sales. Texas also has requested that manufacturers submit pricing data for eligible pharmacies in Texas only. Last year, at IIR’s MDRP Summit, a Texas representative announced that this reporting requirement would most likely be going away and just this month, the Texas Health & Human Services Commission (“TX HHSC”) Vendor Drug Program announced that they will propose the following changes to the reporting requirement:

1. - If a manufacturer wants to place its products on the Texas Code Index, they would be required to submit AMP, AWP, Direct Price to LTC Pharmacy, Direct Price to Pharmacy, and Price to Wholesaler/Distributor
2. - No future prices would need to be submitted unless requested from the TX HHSC and at that point, the manufacturer would have 10 days to provide the information

Remember, these changes are proposed and as of today, pharmaceutical manufacturers should still be reporting to Texas the required data outlined above.

Also of note is New York’s EPIC and Pennsylvania’s PACE Programs. They also require quarterly submissions that contain the same information as your DDR submission.

And speaking of states, MDRP is the perfect time to bring your documentation to resolve any outstanding disputes with representatives from the following states who will be attending: Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Mississippi, Montana, Nevada, North Carolina, Oregon, Utah, Virginia, Wisconsin, and Wyoming.

If you need more information on the various state requirements or assistance in handling a dispute, please feel free to reach out to me. Katie Lapins, Government Pricing Specialists, LLC, 303.993.6466, K.Lapins@GP-Specialists.com. I look forward to seeing you in Chicago at MDRP!

Katie Lapins

Katie Lapins has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for 15 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, assisted manufacturers with voluntary disclosures/restatements, led audits and assessments, calculated and submitted statutory pricing requirements (AMP, BP, ASP, Non-FAMP, PHS and TRICARE), processed Medicaid/ SPAP/ Supplemental invoices, validated PHS eligibility, handled Class of Trade projects with over 100K entities, and created training for onsite and web-based instruction for 2 – 200 employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management.

A Message from Edward McAdam, Chairman, IIR’s MDRP Summit

Government rules and regulations affect every department at a pharmaceutical company. However, few areas are as directly—and as frequently—affected as the government pricing and reimbursement space. Those working in this segment need to be knowledgeable about several different government agencies whose updates impact the way manufacturers conduct their government-related operations.

We’re still thinking about Medicaid expansion and how many states will ultimately expand, thereby adding more weight to the Medicaid Drug Rebate Program. Along with HRSA’s 340B Proposed Mega Rule and CMS’ Final AMP Rule—both set to come out this year—this will fundamentally change how we do our calculations.

There’s only one event that I know that really addresses these questions providing a forum to debate and create a roadmap for manufacturers to follow—IIR’s Medicaid Drug Rebate Program Summit. I’m pleased to once again be chairing this industry-leading event—the largest in the country—taking place September 30-October 2 in Chicago.

I invite you to join us. 

The MDRP Chicago Summit has anticipated what manufacturers are dealing with on a day-to-day basis and provides essential content you won’t find anywhere else. It is THE largest MDRP event where industry, state and federal government professionals come to share information, get updated on regulatory issues, and have a good time doing it.

When you download the agenda, you’ll see why the MDRP Summit stands out: 

• Six pre-conference symposium including the all-new Town Hall between Manufacturers and States 
• The annual update on 340B Program Regulations and Processes from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA 
• The only event facilitating Dispute Resolution Meetings with at least 20 participating States 
• The all-new Pharmaceutical VA Contracting and Compliance Summit where you will get updates on FSS, NFAMP, FCP and more

There’s a reason 550+ MDRP executives (including myself!) come back year after year. Take a look at the agenda by downloading it here and register today!

I look forward to meeting you in Chicago. (I’ll be the guy up front introducing our opening keynote, Ezra Klein, Editor-in-Chief, Vox.com; Columnist, Bloomberg News, Policy Analyst/Contributor, MSNBC!)

Sincerely,

Edward J. McAdam, Sr. 
Daiichi Sankyo, Inc. 
Chairman, IIR’s Medicaid Drug Rebate Program Summit

Clinical Pathways, ACOs, COAs: Introducing 'Value' in Cancer Care

Below is an article from AJMC - a media partner for the upcoming Summit for Oncology Management. To learn more on topics like this, sign up for email updates. 

Via AJMC: Although advancements in medical science have greatly improved overall life expectancy and the ability for many to survive a cancer diagnosis, a recent study predicts that cancer care alone will cost the American health system $157 billion by 2020. It is well known that a major driver of these surmounting costs is the rising cost of chemotherapy and other treatments, in addition to the variation in how these treatments are used across the health care system.  However, there are several ways that providers, payers, and patients can work together to establish a more medically and financially effective cancer care model that also reduce costs and inefficiencies in the system.

Develop “clinical pathways” to reduce inappropriate use

For many cancers, there are multiple drugs that can be equally effective in treating a patient’s condition, but the price of these treatments can differ in cost by tens of thousands of dollars. Currently, oncologists are responsible for purchasing their own chemotherapy drugs, processing and maintaining them in a specialized pharmacy-like set up, and then administering them to their patients. Insurers then reimburse the oncologists for the cost of the drugs plus a margin to defray the price of maintenance and administration. Since oncologists receive a share of their income from the margins on the drugs they prescribe, insurers assert that there is an incentive to prescribe the pricier drugs, even when lower cost options of equal effectiveness exist.

Source: The Hill