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Coming Week’s Highlights: Hearings on drug pricing, electronic health information and the FY2020 budget resolution.
- OMB Finishes Review of Final Medicaid Fraud Control Units Rule
- FDA: Modifications to Compliance Policy for Certain Deemed Tobacco Products
- CMS Seeks Recommendations That Allow Americans to Purchase Health Insurance Across State Lines
- FDA: Update on Nonproprietary Naming of Biological Products
- FDA: Quality Considerations for Continuous Manufacturing
- FDA: Competitive Generic Therapies Draft Guidance
- CMS Updates Overall Hospital Star Ratings, Asks for Feedback
- ONC/CMS: Interoperability; Exceptions to Information Blocking
- HHS Proposal Calls for Reforming Drug-Rebate System
- GAO: Private Health Insurance – Enrollment Remains Concentrated Among Few Issuers, Including in Exchanges
- GAO: Available Data Show Privately Insured Patients Are at Financial Risk
- MedPAC: March 2019 Report to Congress
- MACPAC: March 2019 Report to Congress
Tuesday, March 26, 2019
House Committee on the Budget: “Department of Health and Human Services FY2020 Budget”
The House Committee on the Budget will hold a hearing examining the proposed FY2020 budget for the Department of Health and Human Services (HHS) with Deputy Secretary of HHS Eric Hargan. Find a link to witness testimonies, member statements and the hearing live feed here.
Senate Committee on Health, Education, Labor and Pensions (HELP): “Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers”
The Senate Committee on Health, Education, Labor and Pensions will hold a hearing on making electronic health information available to patients and providers, a provision of the 21st Century Cures Act. Find a link to witness testimonies, member statements and the hearing live feed here.
Wednesday, March 27, 2019
Senate Committee on the Budget: “Fiscal Year 2020 Budget Resolution – Day 1”
The Senate Committee on the Budget will hold a two-part hearing to consider the FY 2020 Budget Resolution. The first part of the hearing includes opening statements.
Thursday, March 28, 2019
Senate Committee on the Budget: “Fiscal Year 2020 Budget Resolution – Day 2”
The Senate Committee on the Budget will hold a two-part hearing to consider the FY 2020 Budget Resolution. The second part of the hearing includes the consideration of amendments.
Tuesday, April 9, 2019
Senate Finance Committee: “TBA Drug Pricing Hearing with PBMs”
The Senate Finance Committee will continue its drug pricing series by inviting pharmacy benefit manager companies (PBMs) to testify before the committee. The invitation was extended on March 12 to Cigna, CVS Caremark and CVS Health, Humana, OptumRx and Prime Therapeutics—all have accepted to testify before the committee. The committee has not noticed the hearing officially—it has been rescheduled to April 9 due to NATO Secretary General Jens Stoltenberg’s joint address to Congress on the original date, April 3.
On March 21, House Oversight Committee Chairman Elijah Cummings (D-MD) and Rep. Mark DeSaulnier (D-CA) sent a letter to Purdue Pharma requesting documents related to how it has aggressively marketed OxyContin, a key player in the ongoing opioid crisis. The documents requested include the list of Sacklers, the family that owns the company, who worked for Purdue Pharma or served on the board, information about the drug manufacturer’s marketing strategies and communication between employees and family members.
Find the letter here.
On March 21, Sens. Chuck Grassley (R-IA) and Ron Wyden (D-OR) sent a letter to the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS), within the U.S. Department of Health and Human Services (HHS), seeking answers on their efforts to monitor medical suppliers that are partly owned by the physicians whose practices they supply.
The senators expressed their concern that some physician-owned distributorships might be disregarding the Physician Payments Sunshine Act, which requires them to disclose any physician’s ownership or investment interest. The letter notes that such financial relationships carried a possibility for wrongdoing. The senators also asked whether HHS had updated its compliance guidelines for hospitals, and what steps it took when it was told that a physician-owned distributorship failed to report a doctor’s ownership or investment interest.
The senators requested answers to their questions by April 15, saying that they wanted to work together to make sure physician-owned distributorships were properly reporting under the disclosure law so that stakeholders could trust federal health care programs and patients could trust the quality of their care.
Find the letter here.
On March 19, the White House Office of Management and Budget (OMB) finished its review of a final rule, first proposed in 2016, that would update a number of policies for the Medicaid Fraud Control Units (MFCU). The proposed rule, from the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), is meant to create a unified timeline of statutory changes that occurred since 1977.
The budget includes a legislative proposal to allow MFCUs to receive federal matching funds for investigations or prosecution of beneficiary abuse and neglect in noninstitutional settings, such as home or community-based care.
On March 13, the Food and Drug Administration proposed an end to current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint- and menthol-flavored products), and prioritizing enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.
In addition, the FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint- and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This application date is one year earlier than the agency previously proposed.
Public release is TBD.
On March 6, the Centers for Medicare and Medicaid Services (CMS) issued a request for information (RFI) for recommendations on how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines. This announcement builds on President Trump’s Oct. 2017 executive order “Promoting Healthcare Choice and Competition Across the United States,” which intends to provide Americans relief from rising premiums by increasing consumer choice and competition.
In particular, CMS requests feedback on how states can take advantage of Section 1333 of the Patient Protection and Affordable Care Act, which provides for the establishment of a regulatory framework that allows two or more states to enter into a health care choice compact to facilitate the sale of health insurance coverage across state lines. CMS is primarily looking for input on how to expand access to health insurance coverage across state lines, effectively operationalize the sale of health insurance coverage across state lines and understand the financial impacts of selling health insurance coverage across state lines.
Comment period ends May 6, 2019.
Find the RFI and submit comments here.
On March 7, the Food and Drug Administration (FDA) issuing draft guidance that proposes to apply the naming convention only to new originator biologics and interchangeable biosimilars and to exempt currently licensed or approved biologics or products that are in the process of being licensed, including insulin. The draft guidance is a reversal of the FDA’s 2017 decision to require that all biologics follow a nonproprietary naming protocol.
The FDA cited brand-biologic industry concerns that changing the names of older biologics would impose costs on the health care system that could then be passed onto patients, and could create confusion among patients and health care providers.
Comment period ends on May 7, 2019; comments can be submitted here.
Find the draft guidance here.
On Feb. 26, the Food and Drug Administration (FDA) released a draft guidance on what factors brand and generic drug manufacturers should consider when setting up and using a continuous manufacturing system to produce their products. The guidance outlines the benefits of continuous manufacturing over traditional batch manufacturing, including the efficiency that comes with continuous manufacturing that could eventually lead to lower drug prices for consumers.
Comment period ends on May 28, 2019; comments can be submitted here.
Find the draft guidance here.
On Feb. 19, the Food and Drug Administration (FDA) published a draft guidance on how drug manufacturers can apply for the competitive generic therapy (CGT) pathway, intended for generic versions of drugs that have little-to-no competition in the market. This guidance encourages more generic drug manufacturing and explains how exclusivity would work under the CGT pathway, including exclusivity given to multiple CGT pathway-approved drugs that fit certain criteria.
Comment period ends on April 22, 2019; comments can be submitted here.
Find the draft guidance here.
On Feb. 28, the Centers for Medicare and Medicaid Service (CMS) updated the overall hospital star ratings, while announcing that it is looking at possible changes to how ratings are calculated for both the short and long term. Proposed changes help patients make more “like-to-like” comparisons, meaning they could compare similar hospitals. The CMS would accomplish this by placing hospitals into peer groups—meaning small rural hospitals would not be compared to larger, academic hospitals.
Comment period ends on March 29, 2019.
Find the proposed changes and submit comments here.
On Feb. 11, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) released proposed rules to support secure access, exchange and use of electronic health information. The Interoperability and Patient Access Proposed Rule from CMS outlines opportunities to make patient data more useful and transferable through open, secure, standardized and machine-readable formats while reducing restrictions on health care providers. The ONC rule calls on the health care industry to adopt standardized application programming interfaces (APIs), which will allow individuals to securely and easily access structured electronic health information (EHI) using smartphone applications.
In addition to the policy proposals, CMS released two requests for information (RFIs) to obtain feedback on interoperability and health information technology (health IT) adoption in post-acute care (PAC) settings, and the role of patient matching in interoperability and improved patient care.
Comment period ends on May 3, 2019.
Read the proposed rule and submit comments here.
Published on Feb. 6, a proposal by the Department of Health and Human Services (HHS) called for a ban on drug rebates, unless shared directly with seniors at the pharmacy counter, significantly lowering out-of-pocket retail drug spending for the minority of seniors on expensive drugs. The proposal would raise premiums for all Medicare beneficiaries. Part of the administration’s plan is set to take effect in a year and an anticipated legal challenge by pharmacy benefit managers (PBMs) could delay implementation.
The proposal cuts rebates tied to a percentage of list price that drug manufacturers pay to Part D plans, Medicaid managed care and PBMs by taking away the long-standing exemption for rebates in anti-kickback law. The administration proposed two new safe harbor protections: one that would allow rebates that are shared with patients at the point of sale and another that would let PBMs charge flat fees for their services.
Comment period ends on April 8, 2019.
Read the proposed rule here.
On March 18, the class action lawsuit led by Common Ground Healthcare Cooperative involving about 90 other exchange issuers, filed an amended complaint with the U.S. Court of Federal Claims and now seeks to collect cost-sharing reduction (CSR) reimbursements owed for plan years 2017, 2018 and 2019. Last week, the federal appeals court agreed to combine three other key CSR cases so that they can be heard by the same panel of judges. The court has not responded.
On March 21, the Government Accountability Office (GAO) released an updated report on private insurance data; previously, data showed that most people generally enroll with one of a few companies, meaning less competition and higher premiums in their region.
The updated report has a similar outcome—the three largest companies selling health insurance held 80 percent or more of the market in at least 37 states. Available data on the Affordable Care Act (ACA) insurance exchanges had similar trends—three or fewer companies held 80 percent or more of the market in at least 46 of 49 exchanges for individuals, and 42 of 46 exchanges for small employers.
Find the full report here.
On March 20, the Government Accountability Office (GAO) released a report that found privately insured patients transported by air ambulance providers outside of their insurers’ provider networks are at financial risk for balance bills—any balance bills are in addition to copayments or other types of cost-sharing typically paid by patients under their insurance coverage. The data reviewed by the GAO indicated that in 2017, about two-thirds of air ambulance transports for patients with private insurance were out-of-network, and almost all of the consumer complaints the GAO reviewed involved balance bills of over $10,000.
Find the full report here.
On March 15, the Medicare Payment Advisory Commission (MedPAC) released its March 2019 Report to Congress: Medicare Payment Policy. The report includes MedPAC’s analyses of payment adequacy in fee-for-service (FFS) Medicare and reviews the status of Medicare Advantage (MA) and the prescription drug benefit, Part D. MedPAC recommends that Congress replace the four current hospital quality payment programs with a single streamlined program—the hospital value incentive program (HVIP). As mandated by Congress, the report includes incentives for prescribing opioid and non-opioid pain treatment under Medicare’s hospital inpatient and outpatient payment systems.
Read the full report to Congress here.
On March 15, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its March 2019 Report to Congress on Medicaid and CHIP. This report addresses Medicaid hospital payment policy, which accounts for one-third of total Medicaid spending in fiscal year (FY) 2017. This year, MACPAC focused on disproportionate share hospital (DSH) and upper payment limit (UPL) supplemental payments.
Read the full report to Congress here.
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