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
In an exchange which has now gone viral, freshman U.S. Representative Katie Porter (D-Calif.) questioned former Celgene CEO Mark Alles about his 2017 compensation structure last week. Rep. Porter, who is now famous for...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
Last month, the House Energy and Commerce Committee (E&C) advanced eleven opioid-related pieces of legislation. While the House version of the Senate-passed Comprehensive Addiction and Recovery Act of 2016 (CARA) has yet to...more
This morning, the Senate HELP Committee will hold an executive session regarding the Mental Health Reform Act of 2016, a comprehensive mental health package negotiated in part by the Senate HELP Committee and the...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
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
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
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
Congress Slowly Works on Budget Reconciliation; ACA Reform Proposals Still Up in the Air -
The FY 2016 budget resolution, which was agreed to by Congress this past April, included broad reconciliation instructions...more
7/21/2015
/ Affordable Care Act ,
AHRQ ,
Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Electronic Medical Records ,
Federal Budget ,
Fraud Prevention ,
GAO ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare.gov ,
Home Health Care ,
ICD-10 ,
Legislative Agendas ,
Long Term Care Facilities ,
Medicaid ,
Medical Records ,
Medicare ,
Mental Health ,
Obama Administration ,
OMB ,
ONC ,
Pending Legislation ,
Prescription Drugs ,
Regulatory Agenda ,
Telehealth ,
Telemedicine
In This Issue:
- House Energy and Commerce Unanimously Advances 21st Century Cures Legislation
- Implementation of the Affordable Care Act
- Federal Regulatory Initiatives
- Congressional...more
In This Issue:
- 340B Drug Discount Program Guidance Nearing Finish Line
- Implementation of the Affordable Care Act
- Federal Regulatory Initiatives
- Congressional Initiatives
- Other...more
In This Issue:
- Stakeholders Urge FDA to Provide Clarity on Biosimilars
- Ebola Crisis Continues
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other...more
In This Issue:
- E&C continues to push for bipartisan efforts to improve drug pipeline
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Health Care...more
7/8/2014
/ Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Legislative Agendas ,
Legislative Committees ,
National Institute of Health (NIH) ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Telemedicine
In This Issue:
- Confusion Persists in Anticipation of 340B “Mega-Rule”
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and State Initiatives
- Other...more
In This Issue:
- Judge Rules Against 340B Drug Authority
- FDA Approves Skin Infection Drug
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other...more
In This Issue:
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and State Initiatives
- Other Health Care News
- Upcoming Hearings and...more