In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to...more
8/27/2024
/ Abortion ,
Affordable Care Act ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Presidential Elections ,
Reproductive Healthcare Issues
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy. President-elect Biden has been clear that he wants to...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
California v Texas ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare Reform ,
Lame Duck Session ,
Legislative Agendas ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
Trump Administration
Welcome back. This week, the Senate Finance Committee is set to meet privately to discuss the drug pricing legislation being developed by the committee. All signs point to a deal being close with a few outstanding provisions,...more
This week, all is quiet in the Senate as stakeholders await the release of the highly anticipated cost-containment package that is being developed by the HELP and Finance committees. While the details are not yet public – a...more
This week, the full House is poised to take its first action on drug pricing, voting on a pair of bills that would improve access to drug patents. The first bill is H.R. 1520, the Purple Book Continuity Act of 2019, which...more
5/9/2019
/ Affordable Care Act ,
Congressional Budget Office ,
Drug Pricing ,
HELP ,
Legislative Agendas ,
Medicare Part D ,
Orange Book ,
Pharmaceutical Industry ,
Preexisting Conditions ,
Prescription Drugs ,
Purple Book
This week, the full House is poised to take its first action on drug pricing, voting on a pair of bills that would improve access to drug patents. The first bill is H.R. 1520, the Purple Book Continuity Act of 2019, which...more
5/8/2019
/ Affordable Care Act ,
Congressional Budget Office ,
Drug Pricing ,
Generic Drugs ,
Medicare Part D ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Agenda
This week, Congress is keeping its eye on drug pricing with a reported hearing in the House Ways & Means Committee. This comes on the heels of the full E&C Committee advancing six pieces of bipartisan legislation for full...more
As of June 2015, 24 states utilize a traumatic or acquired brain injury waiver,1 as provided under section 1915(c) of the Social Security Act, which are designed to help individuals with traumatic brain injury (TBI) live in...more
The next six weeks are shaping up to be the final work period before the summer recess, with both chambers scheduled to leave DC by July 15th for party conventions followed by the August recess. The National Defense...more
Senate HELP Committee Set for Second Mark Up on Cures Effort -
This week, the Senate Committee on Health, Education, Labor and Pensions (HELP) will hold its second legislative mark-up on its counterpart to the...more
3/8/2016
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug & Alcohol Abuse ,
EHR ,
Employee Retirement Income Security Act (ERISA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
GMO ,
HELP ,
Legislative Agendas ,
Medicaid ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Prescription Drugs ,
SCOTUS
Congress Expected to Vote on Opioid Legislation -
This week, Congress will consider the Comprehensive Addiction and Recovery Act (CARA). CARA would be the first step the Senate has taken in 2016 to address the opioid...more
What to Expect from Congress this Work Period -
The next Hill work period basically runs from February 22nd to March 23rd. As Congress returns, here’s a brief look at the pending health care issues on the radar for this...more
2/23/2016
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Hospitals ,
Justice Scalia ,
Legislative Agendas ,
Medicaid ,
Medicare Advantage ,
Physicians ,
Prescription Drug Coverage ,
Recovery Audit Contractors (RACs) ,
Substance Abuse
The Administration is Ramping Up Drug Pricing Response -
The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration,...more
2/17/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Committees ,
Drug Pricing ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Justice Scalia ,
Overpayment ,
Prescription Drugs ,
Proposed Legislation ,
SCOTUS ,
Substance Abuse ,
Zika
Martin Shkreli Not the Big Story on the Hill Last Week -
Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more
2/16/2016
/ Affordable Care Act ,
Biosimilars ,
BPCIA ,
Cancer ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Drug Pricing ,
GDUFA ,
Martin Shkreli ,
Mental Health ,
Prescription Drugs ,
Telemedicine ,
Zika
Are Lawmakers and Stakeholders Ready for the Silver Tsunami? -
Last week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade...more
2/16/2016
/ ACOs ,
Affordable Care Act ,
Alternative Payment Models (APM) ,
Congressional Budget Office ,
Drug Pricing ,
Elder Issues ,
FCC ,
Food and Drug Administration (FDA) ,
Healthcare Costs ,
Medical Debt ,
Medicare ,
Mental Health ,
Prescription Drugs ,
Substance Abuse ,
TCPA ,
Telemedicine
ML Strategies Publishes 2016 Legislative Outlook -
The ML Strategies 2016 Legislation Outlook is now available! The first session of the 114th Congress marked a productive year for Congress, with passage of numerous...more
Cadillac Tax Repeal Garners Bipartisan Support; Prospects for Implementation Delay Increase -
Last week, the Senate passed its reconciliation package by a vote of 52-47, sending it back to the House for approval and...more
Drug Pricing Issues Heat Up Following HHS Forum -
Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more
FDA Hosts Genome Scientists For Next-Generation Sequencing Conference -
Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more
Ways & Means Leadership Changes – Health Policy Implications Looming:
As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
11/4/2015
/ 21st Century Cures Initiative ,
Affordable Care Act ,
Automatic Enrollment ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-Op ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Contraceptive Coverage Mandate ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Drug Pricing ,
E-Cigarettes ,
Federal Budget ,
Food and Drug Administration (FDA) ,
FTEs ,
Generic Drugs ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
ICD-10 ,
Medicare ,
Medicare Part B ,
MedPAC ,
Mental Health ,
New Legislation ,
Open Enrollment ,
OPPS ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Rulemaking Process ,
SCOTUS ,
Substance Abuse ,
Telehealth ,
Telemedicine ,
Tobacco Regulations ,
Two-Midnight Rule ,
U.S. Treasury
Senate Working Group Pressing Forward on Telehealth -
As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
10/29/2015
/ Affordable Care Act ,
Alternative Payment Models (APM) ,
Barack Obama ,
Cadillac Tax ,
Co-Op ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
E-Cigarettes ,
Elder Issues ,
Federal Trade Commission (FTC) ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Mental Health ,
Orphan Drugs ,
PACE ,
Prescription Drugs ,
SAMHSA ,
Section 340B ,
Social Security ,
State Health Insurance Exchanges ,
Substance Abuse ,
Telehealth ,
Telemedicine
Cuts in Mandatory Entitlement Programs Center of Budget Negotiations: As budget negotiators from both sides of the Hill come together to work out a two-year budget deal, determining how sequestration relief will be paid for...more
10/20/2015
/ Affordable Care Act ,
Barack Obama ,
Cadillac Tax ,
Co-Op ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Consumer Price Index ,
Cost-of-Living Adjustment (COLA) ,
Entitlements ,
Federal Budget ,
GAO ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare ,
Medicaid Expansion ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Proposed Legislation ,
Reconciliation ,
Social Security Act ,
Social Security Benefits ,
Undocumented Immigrants
Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more
8/11/2015
/ Affordable Care Act ,
Amarin ,
Caronia ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
FCC ,
First Amendment ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Care Providers ,
ICD-10 ,
Medicaid ,
Off-Label Promotion ,
OIG ,
OMB ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Regulatory Agenda
CMS Releases Final Payment Rules (IPPS, IRF, LTCHs, Hospice, and Psych): At the end of last week, the Centers for Medicare and Medicaid Services (CMS) released a set of final 2016 payment rules affecting acute care hospitals...more
8/4/2015
/ Affordable Care Act ,
Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
DSH ,
Electronic Medical Records ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Proposed Legislation ,
Psychiatric Hospitals ,
Regulatory Agenda ,
Two-Midnight Rule ,
Value-Based Purchasing
ACA Repeal Votes Continue: As part of a rare Senate Sunday session to consider a bill to replenish the highway trust fund for six years, Majority Leader Mitch McConnell (R-KY) brought up an amendment to repeal the ACA—in...more
7/29/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
Obama Administration ,
Proposed Legislation ,
Regulatory Agenda ,
Substance Abuse