CMS Posts January 2015 Update to Medicare Part B Drug Pricing Files

CMS has posted the January 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the first quarter of 2015. CMS notes that prices for the top Part B drugs decreased by 0.1 % on average this quarter, and prices changed 2% or less for 26 of the top 50 higher-volume drugs.

OIG: Compendia Publishers Comply with Transparency Rules for Evaluating Anticancer Drugs, Identifying Potential Conflicts

Under current law, Medicare Parts B and D cover anticancer drugs for indications not approved by the FDA only if the drugs are supported by one or more of four authorized compendia. Publishers of these compendia must comply with statutory requirements to maintain transparent processes for evaluating anticancer drug therapies and identifying potential conflicts of interest. In a recent report, the OIG concludes that each of the four authorized compendia publishers complied with these requirements, although the number and nature of disclosures of potential conflicts of interest varied across publishers.

FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

This post was written by Vicki Morris.

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.

The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.

Delays of Inspections: While the guidance acknowledges that delays may occur for many reasons – some of which are beyond the control of the facility – it explicitly states that where an owner, operator or agent causes the delay of an inspection, this may cause the drugs to be deemed adulterated. FDA provides examples of delaying a pre-announced inspection that include, but are not limited to:

  • A facility will not agree to a proposed inspection start date and does not give a reasonable explanation for its failure to do so
  • A facility, after scheduling an inspection, requests a later start date without giving a reasonable explanation
  • A facility fails to respond following the FDA’s attempt to contact the facility’s designated contact(s)

Delay During an Inspection: The guidance suggests that actions by a facility’s owner, operator, or agency before or after the beginning of an inspection, that impede an FDA investigator at the inspection site from performing the inspection in a reasonable manner, may be considered delaying the inspection. However, FDA notes that it will recognize minor delays from good faith efforts by the facility to comply with FDA requests as not unreasonable. FDA provides examples of delays during an inspection that may cause drugs to be adulterated:

  • A facility does not allow the FDA investigator access to an area of the facility until a specific future date or time, even though the area is operational and is an area of the inspection site that FDA has authority to inspect, without giving a reasonable explanation
  • A facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individual for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection

Delays in Producing Records: FDA emphasizes the importance of the Agency’s preparation for inspecting drug facilities in collecting and reviewing hardcopy and electronic records, files and papers. The guidance offers examples of delays in producing records that may cause drugs to be deemed adulterated that include, but are not limited to:

  • The FDA investigator, during an inspection, requests, within a specific, reasonable timeframe, records that it has authority to inspect, but the facility fails to produce the requested records within the timeframe requested by the Agency, without reasonable explanation
  • The FDA requests records under its legal authority to do so, but the facility fails to produce the requested records in a timely manner, without reasonable explanation

FDA emphasizes that in instances where the facility provides a reasonable explanation for delaying production of records, the facility should also ensure that the resulting delay is of a reasonable duration.

Limiting of Inspection: The guidance explains four circumstances where an owner, operator, or agent of a drug facility prevents an authorized FDA representative from conducting an inspection that constitutes a limitation that may cause drugs to be deemed adulterated:

  • Limiting access to facilities and/or manufacturing processes
  • Limiting photography
  • Limiting access to or copying of records
  • Limiting or preventing collection of samples

While the guidance suggests that impeding or resisting photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator to be necessary to effectively conduct that particular inspection, there is no mention of the Agency’s authority to regulate this activity in MAPPs, FDA’s internal guidelines.

Refusal to Permit Entry or Denials of Inspection: FDA interprets the term “refuses to permit entry or inspection” to include not only active, but also passive behavior and non-action by the owner, operator or agent of a drug facility, to prevent an authorized representative of the FDA from conducting an inspection, or to prevent the FDA from completing an inspection. Denials of inspection also include statements or physical actions intended to avoid inspection, or to mislead, deceive or impede the investigator. FDA provides examples that may constitute denying an inspection that may cause drugs to be adulterated:

  • A facility ignores or rejects the FDA’s attempt to schedule a pre-announced inspection
  • The facility does not allow the FDA investigator, upon arrival at the facility, to enter the facility or begin the inspection
  • A facility does not allow the FDA investigator to inspect the facility because certain staff members are not present, without a reasonable explanation, or
  • A facility sends staff home for the day and tells the FDA investigator that the facility is not producing any product

Although neither the FDA’s revised guidance nor the FD&C Act specifically define “reasonable,” FDA has long maintained that the inspectional authority under section 704 of the Act “extends to what is reasonably necessary to achieve the objective of the inspection.” Further, FDA contends that it will consider reasonable explanations for behavior that may otherwise be considered to be delaying, denying, limiting, or refusing an inspection under the revised guidance. The guidance’s vagueness reinforces the importance of taking the following key steps to ensure FDA inspection compliance:

  • Review FDA rules and guidance on how to conduct a good inspection
  • Assess facility’s existing plans for FDA inspection
  • Develop written internal procedures and systems that specifically address inspectional issues
  • Consider rationale for any delays, limits, or denials of inspection
  • Train and prepare staff for FDA inspections, including understanding the company’s positions and employees’ roles before, during, and after FDA investigations
  • Track what is stored at the facility and what is provided to the authorized FDA representative at inspection

Vicki Morris (Law Clerk) is a member of the firm’s Life Sciences Health Industry Group and is based in our Washington, D.C. office.

Update on Sunshine Act "Open Payments" Public Data Review and Data Correction Deadline

CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information.  The tool allows the public to search identified data for physicians, teaching hospitals, or companies.  CMS is also reminding applicable manufacturers and GPOs of an October 31, 2014 deadline for making corrections to any 2013 Open Payments disputed records for publication on or before December 31, 2014 (although data corrections can be performed at any time). Disputes that remain unresolved as of October 31, 2014 will display as disputed in the Open Payments database.

HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

This post was written by Robert Hill, Carol Loepere, and Joseph Metro

In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health care program beneficiaries from using the coupons. The OIG points out these coupon programs – which may take different forms, such as print coupons, electronic coupons, debit cards, and direct reimbursements – are remuneration offered to consumers to induce the purchase of specific items, and therefore implicate the criminal federal anti-kickback statute, 42 U.S.C § 1320a-7b(b). Where remuneration is knowingly and willfully paid with the intent to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated. The OIG goes on to observe that a claim that includes items or services resulting from a kickback violation would also constitute a false or fraudulent claim under the False Claims Act, 31 U.S.C. § 3729, and grounds for civil money penalties for beneficiary inducement if offer or acceptance of copayment coupons may induce a beneficiary to use a particular practitioner or pharmacy, 42 U.S.C § 1320a-7a(a)(5). While the SAB’s focus is on manufacturer coupon practices, in a footnote, the OIG states that pharmacies accepting coupons for Part D copayments may also be subject to these sanctions.

Notwithstanding the potential benefits of coupon programs to provide access to brand-name drugs and adherence to drug regimens, the OIG claims that such coupon programs may interfere with federal health care program cost-sharing requirements to promote prudent prescribing and purchasing choices by physicians and patients based on the “true costs” of drug and price competition in the market. As a result, the OIG writes, “[w]hile copayment coupons provide an immediate financial benefit to beneficiaries, they ultimately can harm both Federal health care programs and their beneficiaries.”

In the SAB, the OIG acknowledges that the pharmaceutical industry is aware of the potential anti-kickback concerns and generally has implemented a variety of controls to exclude federal health care program beneficiaries from these programs. The OIG’s concern seems to be that these controls don’t go far enough or don’t always work. In other words, the OIG sees the glass as “half empty.” The OIG does not seem to acknowledge that the glass may actually be half-full – i.e., the industry's attempt to have some controls (even if imperfect) evidences manufacturers’ intent to comply with the statute, making it difficult to show criminal liability.

In fact, the OIG’s report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (OEI-05-12-00540) http://go.usa.gov/pdYQ, issued concurrently with the SAB, describes in detail mechanisms used by various manufacturers, most notably through claims processing and “switches,” to prevent use of the coupons for drugs paid for by Medicare Part D. The report identifies the principal shortcomings identified with these mechanisms as stemming from the fact that CMS does not permit manufacturers to submit Part D enrollment verification requests (“E1 transactions”) to the Part D Transaction Facilitator because of privacy concerns, so that manufacturers must use various “proxies” to attempt to determine whether the individual using the coupon is enrolled in a Part D plan. The report finds that these proxies, which may include elements as inexact as beneficiary age, may not be accurate enough to guarantee exclusion of Part D claims. Consequently, the OIG appears to be asserting that manufacturers may have liability for having imperfect controls, even though the current claims-processing system does not make a perfect solution available to them. The report did not identify any specific Part D claims for which coupons had in fact been used contrary to coupon terms and conditions.

The OIG recommends that CMS cooperate with industry stakeholders to improve the reliability of pharmacy claims edits, and make coupons transparent. CMS concurred with the recommendation.

CMS Updates Medicare Part B Drug Pricing Files

CMS has posted its October 2014 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the fourth quarter of 2014. CMS notes that prices for the top Part B drugs decreased by 0.4% on average this quarter. 

GAO Highlights Differences in Federal Program Drug Prices

The Government Accountability Office (GAO) has released data comparing retail prescription drug prices paid by the Department of Defense (DOD), Medicaid, and Medicare Part D for a sample of 78 high-utilization/high-expenditure drugs. In general, the GAO determined that Medicaid paid the lowest average net prices for both brand-name and generic drugs in the sample based on data for the third quarter of 2010. For the entire sample, Medicare Part D paid an estimated 32% higher average net price than Medicaid, while DOD paid 60% more than Medicaid (although Medicare Part D paid more for brand-name drugs than did DOD). Key factors affecting net prices paid by each program included the amount of any post-purchase price adjustments (e.g., refunds, rebates, or price concessions received by each program from drug manufacturers), which equaled approximately 15% of the gross price for Medicare Part D, 31% for DOD, and almost 53% for Medicaid across the entire sample.

FDA Meeting on Biomarker Development (Sept. 5)

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials). Public input from the meeting will be used to identify opportunities for biomarker-related regulatory guidance, improve understanding and consistency in regulatory review of therapeutic product applications that incorporate biomarkers in clinical trial designs, and identify potential strategies to facilitate scientific exchanges in regulatory and non-regulatory contexts. For more information on the meeting, which is being held in collaboration with Brookings Institution, and for early registration deadlines to attend the live meeting, see the FDA announcement.  FDA will also accept comments on this topic through November 5, 2014.

FDA Releases Drug/Device Industry Social Media Guidance Documents

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs and medical devices may: (1) communicate both benefit and risk information on Internet/social media platforms with character space limitations, and (2) correct independent third-party misinformation about a firm’s products.  For details, see Reed Smith's Client Alert posted on our Life Sciences Legal Update blog.

OIG Finds Drug Manufacturers' Medicaid AMP Determinations Follow Federal Rules

In a recent report, “Average Manufacturer Price Determinations by Selected Drug Manufacturers Generally Were Consistent With Federal Requirements,” the OIG has determined that the methodologies used by 20 selected (unnamed) drug manufacturers to determine average manufacturer price (AMP) for drugs reimbursed by Medicaid generally were consistent with federal requirements. In particular, the manufacturers consistently included transactions from retail community pharmacies rather than the more broadly-defined retail pharmacy class of trade. The OIG did note that manufacturers treated authorized generic sales to a secondary manufacturer differently, and suggested that CMS clarify this policy. The OIG also recommended that CMS permit a presumptive-inclusion methodology for wholesaler sales, since manufacturers would not have been able to calculate the AMP for a number of drugs without this methodology. Finally, the OIG recommended that CMS expand the use of a 12-month rolling average to estimate and remove indirect sales related to ineligible customers (in addition to using this for average for manufacturer price concessions).

Full Energy and Commerce Committee Approves Three Bipartisan Health Bills

On June 10, 2014, the full House Energy and Commerce Committee approved by voice vote three bipartisan public health bills:

  • H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for the use of controlled substances in clinical trials to allow treatments to get to patients in a more timely and predictable manner.
  • H.R. 4709, “Ensuring Patient Access and Effective Drug Enforcement Act,” which would amend the Controlled Substances Act to clarify definitions, allow parties to submit a corrective action plan prior to revocation or suspension of a registration, and require a report identifying how collaboration between agencies and stakeholders can benefit patient access to medications and prevent diversion and abuse of controlled substances.
  • H.R. 4631, the "Autism Collaboration, Accountability, Research, Education and Support (CARES) Act," which would continue autism-related federal research, early identification and intervention, education, and activities of the Interagency Autism Coordinating Committee.

OIG Issues Advisory Bulletin Impacting Independent Charity Patient Assistance Programs

On May 21, 2014, the OIG issued its “Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs” (SSAB) to address recently observed risks stemming from the conduct of Independent Charity Patient Assistance Programs (PAPs). The SSAB, which expands on previous OIG guidance from 2002 and 2005, specifically focuses on PAPs’ definitions of disease funds and the identification of eligible recipients, as well as the conduct of donors with relation to Independent Charity PAPs.   A Reed Smith Client Alert analyzing the bulletin is available here.

CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

On May 27, 2014, CMS published a final rule updating ACA Affordable Insurance Exchange and insurance market standards beginning in 2015. Among other things, the rule addresses standards related to: standardized consumer notices regarding insurance product discontinuation and renewal; Qualified Health Plan (QHP) quality data reporting to support quality ratings for plans on the insurance marketplace beginning in 2016; non-discrimination standards; employee choice in the Small Business Health Options Program (SHOP); enforcement remedies in federally-facilitated exchanges; the imposition of civil money penalties for providing false or fraudulent information to the Exchange and for improperly using or disclosing information; updated standards for “Navigators” and other consumer assistance programs; increases the risk corridor calculation ceiling on allowable administrative costs and the floor on profits by 2% “to account for uncertainty and changes in the market prior to and during benefit year 2015”; and modifies the allocation of reinsurance collections if those collections do not meet projections. The rule also provides for an expedited prescription drug exceptions process based on exigent circumstances (defined as when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee’s life, health, or ability to regain maximum function, or when an enrollee is undergoing a current course of treatment using a non-formulary drug). Under this provision, health plans must make coverage determinations within 24 hours after receiving the request; once an exception is granted, issuers must continue to provide the drug throughout the duration of the exigency. CMS states that it will continue to monitor this issue to consider whether it should propose additional standards.

House Energy and Commerce Subcommittee Approves Health Bills

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:

  • H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for the use of controlled substances in clinical trials to allow treatments to get to patients in a more timely and predictable manner.
  • H.R. 4709, “Ensuring Patient Access and Effective Drug Enforcement Act,” which would amend the Controlled Substances Act to clarify definitions, allow parties to submit a corrective action plan prior to revocation or suspension of a registration, and require a report identifying how collaboration between agencies and stakeholders can benefit patient access to medications and prevent diversion and abuse of controlled substances.
  • H.R. 4631, “Combating Autism Reauthorization Act of 2014,” which would continue autism-related federal research, early identification and intervention, education, and activities of the Interagency Autism Coordinating Committee.

Expedited Drug Development and Review: New FDA Resource Now Available

This post was written by Jennifer Pike.

A new guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” is now available from the Food and Drug Administration (FDA). The 40-page guidance is intended to serve as a single resource for information on FDA’s policies and procedures related to its four expedited drug development and review programs: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. The guidance also defines the threshold criteria generally applicable to each program, including when a condition is considered “serious,” when a therapy is “available therapy,” and when a medical need is “unmet.”   The guidance follows the 2012 passage of the Food and Drug Administration Safety and Innovation Act, which called for FDA to expand its efforts to expedite the development and review of drugs intended to treat serious conditions.  Comments regarding the guidance may be submitted at any time.

OIG Examines Medicare Part B Payments for Compounded Drugs

The HHS OIG has examined Medicare Part B payments for compounded drugs and Medicare Administrative Contractors' (MAC) procedures for reviewing and processing claims for compounded drugs, in light of safety concerns involving a 2012 meningitis outbreak and increased scrutiny of compounded drugs. According to the OIG, neither CMS nor MACs tracked the number of Part B claims or payment amounts for compounded drugs, nor do Part B claims contain information that can be used to systematically identify claims for compounded drugs. The OIG observes that the current “inability to track claims for compounded drugs and identify the compounding pharmacies limits the ability of CMS and MACs to take steps that could stop payments for compounded drugs produced in violation of the [Federal Food, Drug, and Cosmetic] Act. The OIG therefore recommends that CMS (1) establish a method to identify Medicare Part B claims for compounded drugs, (2) explore the possibility of requiring providers to identify on Part B claims the pharmacy that produced the compounded drug, and (3) consider conducting descriptive analyses of Part B claims for compounded drugs.

CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

CMS is inviting comments on the Physician Payment Sunshine Act “Open Payments Program” dispute resolution and corrections process. As previously reported, the Physician Payment Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This financial data will be made publicly available on the CMS Open Payments website. On May 5, 2014, CMS published a notice soliciting additional feedback on the dispute resolution and corrections process, under which covered recipients and physician owners or investors have an opportunity to dispute certain information regarding a payment or other transfer of value. Comments will be accepted until June 2, 2014.

HRSA Releases 340B Audit Results

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 areas of non-compliance for hospitals and non-hospitals.” For non-hospitals, HRSA flagged the following major non-compliance areas: the covered entity’s inability to maintain accurate database information; billing contrary to the Medicaid Exclusion File (which may have resulted in duplicate discounts); and dispensing drugs to ineligible individuals (diversion) at the covered entity and contract pharmacies. For hospitals, the major area of non-compliance cited by HRSA was obtaining covered outpatient drugs through a Group Purchasing Organization (GPO) in violation of statutory restrictions. HRSA also identified best practices to minimize the risks of non-compliance by covered entities, including: development and documentation of comprehensive 340B Program policies and procedures; development of concrete methodologies for routine self-auditing; routine processes for internal corrective action; verification that contract pharmacy arrangements comply with the 340B requirements and are properly listed in the HRSA Office of Pharmacy Affairs database; and strong partnerships with state Medicaid agencies to meet state-specific requirements and prevent duplicate discounts.

Exploring the "Country of Origin" Question for Pharmaceutical Products

Because drugs and medical devices are often sourced, processed, and manufactured in multiple countries, manufacturers are often faced with difficult challenges in determining the country of origin for their products. As detailed in the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, a variety of factors must be taken into consideration when answering the country of origin question for a pharmaceutical product. The alert is available on our Life Sciences Legal Update blog.  

Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

This post was written by Jennifer Pike.

In a notice published in the Federal Register on May 7, 2014, the U.S. Food and Drug Administration (“FDA”) announced its intent to incentivize manufacturers to voluntarily update their prescription drug and biologics labels by using a government contractor.

FDA’s announcement stems from a January 2006 final rule in which FDA established revised content and format requirements for prescription drugs and biologics (the “Physician Labeling Rule” or “PLR”). The PLR required drugs and biologics approved after June 30, 2001 to adopt the new labels. A detailed implementation schedule under the PLR, which only resulted in only 15% of all drug and biologics being labeled in the PLR format, expired in November 2013. Therefore, moving forward, the only products which will be labeled in the PLR format will be new drugs and biologics and drugs that are voluntarily updated. To address this lack of labeling conversion, on February 6, 2013, FDA proposed the Prescription Drug Labeling Improvement and Enhancement Initiative. As part of the initiative, and as explained in detail in FDA’s notice, FDA plans to use a government contractor to provide PLR conversion resources and services, including preparation of draft PLR format labeling, in hopes of facilitating voluntary conversion.

The number of drugs and biologics affected by FDA’s initiative is staggering. FDA estimates that 375 manufacturers will be contacted over a 5 year period regarding 750 products. FDA will select the products for labeling conversion based on criteria that would maximize the benefit to public health, including volume of prescriptions, clinical relevance, and risk-based  considerations. Beyond the 750 products selected for PLR conversion, FDA further estimates that over 1,800 generic products will require labeling updates to reflect changes made to the corresponding brand-name products.

FDA is seeking public comment on its collection of information related to the initiative. Comments should be submitted in writing, or electronically at www.regulations.gov, on or before July 7, 2014.

Older Entries

April 22, 2014 — CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (May 20)

April 10, 2014 — Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

April 8, 2014 — CMS Seeking Comments on Supervision Levels for Select Hospital Outpatient Services

April 8, 2014 — OIG Recommends Adjustments to Medicare ESRD Drug Payment Policies

March 14, 2014 — Drug Companies are Reminded - FDA is Following Facebook

March 5, 2014 — Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

February 24, 2014 — FDA to Overhaul an OTC System That "Isn't Working"

February 24, 2014 — Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

February 13, 2014 — House Panel, GAO Examine Drug Shortages

January 30, 2014 — Omnibus Government Spending Signed to Fund HHS, Other Departments

January 30, 2014 — CMS Call on Partnership to Improve Dementia Care in Nursing Homes (Feb. 26)

January 28, 2014 — FDA Provides Direction on "Dear Doctor" Letters

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

January 7, 2014 — DOJ Touts $3.8 Billion in FY 2013 False Claims Act Recoveries

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — Drug Distribution Security Legislation Signed into Law

November 11, 2013 — CMS Update on Medicare IVIG Demonstration (Nov. 22)

October 30, 2013 — CMS Call on Dementia Care in Nursing Homes (Nov. 25)

October 8, 2013 — HHS OCR Releases HIPAA Privacy Rule Guidance Documents

September 17, 2013 — HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

August 2, 2013 — FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

August 2, 2013 — New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

July 29, 2013 — CMS Issues Proposed OPPS, ASC Policies for 2014, Including Expanded OPPS Packaging Proposal

July 29, 2013 — CMS Proposed Rule Calls for 9.4% Cut in CY 2014 ESRD PPS Rates

July 29, 2013 — July Health Policy Hearings

July 29, 2013 — In Advance of Sunshine Act Reporting, CMS Releases Physician & Industry Resources

June 27, 2013 — Health Policy Hearings

June 25, 2013 — CMS Call on Improving Dementia Care in Nursing Homes (July 10)

June 20, 2013 — FDA Amends Orphan Drug Regulations

June 11, 2013 — OIG Recommends Changes to Medicare Dialysis Payments to Reflect Lower Drug Utilization

May 28, 2013 — FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

May 28, 2013 — OIG Report Examines High-Risk Compounded Sterile Preparations

May 10, 2013 — Congressional Health Policy Hearings & Markups

May 8, 2013 — Updated Draft Medicaid Federal Upper Limit (FUL) Files Posted

April 24, 2013 — Lawmakers Float Draft Drug Distribution Security Plan; Comment Opportunity

April 15, 2013 — CMS Letter to Issuers on Federally-Facilitated and State Partnership Exchanges

March 13, 2013 — CMS Plans to Include DME Infusion Drugs in Competitive Bidding in Response to OIG Findings

March 12, 2013 — FDA Issues New Guidance Documents

February 18, 2013 — CMS Proposes Medicare Advantage, Part D Drug Plan Medical Loss Ratio Rule and Advance 2014 Rate Information

February 18, 2013 — CMS Announces Dates for 2013 HCPCS Public Meetings

February 1, 2013 — CMS Releases Physician Payments Sunshine Act Final Rule

January 30, 2013 — CMS Proposes Changes to Medicaid Eligibility, Benefits, and Appeals Rules

January 29, 2013 — FDA Issues Final Rule on Current Good Manufacturing Practice Requirements for Combination Products

January 29, 2013 — FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

January 14, 2013 — Obama Administration's Regulatory Agenda Points to Busy 2013 for HHS

January 14, 2013 — CMS Call to Focus on Improving Dementia Care in Nursing Homes (Jan. 31)

January 11, 2013 — New Law Establishes IVIG Demonstration/Makes MSP Policy Revisions

January 11, 2013 — CMS Releases Updated Draft Medicaid FUL Files

January 11, 2013 — D.C. Circuit Decision Upholding DOD Rule May Leave Drug Manufacturers on the Hook for Refunds

January 11, 2013 — FDA Issues Final Guidance Documents on Drug and Medical Device Submissions

January 11, 2013 — FDA Releases Draft Guidance Documents on Providing Submissions in Electronic Format

December 20, 2012 — IRS Issues Notice on ACA Branded Prescription Drug Fee Parameters for 2013

December 19, 2012 — GAO Examines Medicare Dialysis Reimbursement

December 18, 2012 — FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

December 17, 2012 — OIG Releases 2012 Compendium of Unimplemented Recommendations

November 28, 2012 — Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

November 28, 2012 — CMS Posts Information on Medicaid Data and the ACA Branded Prescription Drug Fee Program

November 27, 2012 — Massachusetts Issues Final Drug/Device "Sunshine" Rules

November 12, 2012 — November Congressional Health Policy Hearings

November 5, 2012 — Massachusetts Approves Emergency Amendments on State "Sunshine Act" Drug/Device Manufacturer Reporting Requirements

October 30, 2012 — CMS Posts Updated Draft Medicaid Drug Pricing Files

October 16, 2012 — CMS Invites Comments on Draft Medicaid Drug Pricing Data (FULs, NARP, NADAC)

September 27, 2012 — State Collection of Medicaid Rebates for Drugs Paid Through Medicaid MCOs

September 27, 2012 — FDA Meetings on Patient-Focused Drug Development Initiative

September 6, 2012 — Vermont Offers Limited Amnesty to Device and Biologic Manufacturers who Failed to Report Payments to Health Care Providers

September 5, 2012 — FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

August 16, 2012 — IRS Schedules Nov. 9, 2012 Hearing on ACA Branded Prescription Drug Fee

July 31, 2012 — Congressional Health Policy Hearings

July 25, 2012 — CMS Webinar on Retail Community Pharmacy Consumer Prices Survey (July 26)

July 18, 2012 — OIG Examines Medicare Part D Drug Payments for Hospice Beneficiaries

July 18, 2012 — OIG Reviews Nursing Facility Compliance with Rules for Residents Receiving Atypical Antipsychotic Drugs

July 17, 2012 — Massachusetts Loosens Drug/Device Manufacturer Gift Ban and Disclosure Law, Allows Certain Drug Coupons and Vouchers

July 16, 2012 — FDA Small Entity Compliance Guidance: Toll Free Number Labeling for Drugs

July 16, 2012 — FDA Draft Guidances Describe Product-Specific Bioequivalence Recommendations

July 16, 2012 — FDA Guidance Addresses Genotoxicity Testing and Data Interpretation for Human Drugs

June 28, 2012 — Congress Clears FDA Safety & Innovation Act

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — House Approves Medical Product Counterfeiting Act

June 27, 2012 — GAO Examines HHS Action on Privacy and Security of Prescription Drug Data

June 23, 2012 — CMS Webinar on Medicaid National Average Drug Acquisition Cost Survey (June 28)

June 18, 2012 — House Panel Clears Legislation to Address Medical Product Theft, Counterfeiting

June 8, 2012 — CMS Accepting Comments on Draft Methodology for Calculating National Average Drug Acquisition Cost (NADAC)

May 30, 2012 — CMS Partnership Seeks to Improve Dementia Care In Nursing Homes

May 14, 2012 — Congressional Health Policy Hearings

May 11, 2012 — House Panel Unanimously Approves FDA User Fee Act

May 11, 2012 — FDA Reports on Post-Approval Drug Safety Monitoring

May 11, 2012 — International Collaboration Highlighted in FDA Global Engagement Report

May 10, 2012 — Updated Draft Medicaid Drug Payment FUL Files Posted

May 4, 2012 — CMS Announces Data Collection for the Physician Payments Sunshine Act Will Not Be Required Before 2013

April 23, 2012 — HHS Requests Input on Medication Non-Adherence

April 23, 2012 — HHS Issues its Open Government Plan Version 2.0

April 2, 2012 — OIG Release Report from Pharmaceutical Compliance Roundtable

March 30, 2012 — FDA Announces Delayed Enforcement of ACA Drug Sample Distribution Reporting Requirement

March 30, 2012 — Updated Draft Medicaid Drug Payment FUL Files Posted

March 29, 2012 — Congressional Health Policy Hearings

March 29, 2012 — Draft FDA Guidance Targets Direct-to-Consumer Television Marketing