Congress — Big Agenda & Little Time -
With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
1/12/2024
/ Artificial Intelligence ,
China ,
DEA ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Department of Transportation (DOT) ,
Environmental Protection Agency (EPA) ,
FCC ,
Federal Aviation Administration (FAA) ,
Federal Highway Administration ,
Federal Trade Commission (FTC) ,
FERC ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labor Shortage ,
Legislative Agendas ,
NHTSA ,
Notice of Proposed Rulemaking (NOPR) ,
Popular ,
Primary Elections ,
Proposed Legislation ,
Regulatory Agenda ,
Research and Development ,
Tariffs ,
Tax Incentives ,
U.S. Commerce Department ,
U.S. Treasury
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
FDA Reform Tops Spring Work Period Agenda -
The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will...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
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 next Hill work period basically runs from February 22 to March 18. As Congress returns, here’s a brief look at the pending health care issues on the radar for this work period....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
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
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
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
In This Issue:
- Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck
- Implementation of the Affordable Care Act
- Federal Regulatory Initiatives
- Congressional Initiatives
- Other...more
7/8/2015
/ Affordable Care Act ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Ebola ,
ESRD ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Exchanges ,
Home Health Agencies ,
Hospitals ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Payment Reform ,
OIG ,
OPPS ,
Physician Fee Schedule ,
Premiums ,
Regulatory Agenda ,
Reinsurance ,
SAMHSA ,
Unique Device Identifiers
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:
- House E&C Proceeds with Cures Initiative this Week
- Congress Continues Budget Considerations; Health Care Playing Leading Role
- Implementation of the Affordable Care Act
- Other Federal...more
In This Issue:
- Senate HELP Begins Innovation for Healthier Americans Hearings
- 340B Hearing Postponed; Written Testimonies Shed Light on Agenda
- Implementation of the Affordable Care Act
-...more
In This Issue:
- Introduction
- Agriculture, Food Safety, and Nutrition
- Appropriations, Budget, and Debt Ceiling
- Defense and National Security
- Education
- Energy and Environment
- Financial...more
1/21/2015
/ Appropriations Bill ,
Defense Sector ,
Department of Transportation (DOT) ,
Energy Policy ,
Environmental Policies ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Foreign Policy ,
Healthcare ,
Immigration ,
Immigration Reform ,
Infrastructure ,
Legislative Agendas ,
Legislative Committees ,
Obama Administration ,
Political Parties ,
Tax Reform ,
Telecommunications
In This Issue:
- SGR Already Strong Focus of 114th Congress:
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other Health...more
In This Issue:
- FDA Releases Menu Labeling Rule
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Upcoming Congressional Hearings
- Excerpt from FDA...more
12/3/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fast-Food Industry ,
Food and Drug Administration (FDA) ,
Food Safety ,
Health Insurance ,
Health Insurance Exchanges ,
Labeling ,
Legislative Agendas ,
Medicare Part D ,
Restaurant Industry
In This Issue:
- Ebola Response Taking a Multifaceted Approach
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional Initiatives
- Other...more
In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more
9/5/2014
/ Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
FSMB ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
ICD Codes ,
ICD-10 ,
Legislative Agendas ,
Medicaid ,
Medical Devices ,
Medicare ,
PHSA ,
Physicians ,
Proposed Legislation ,
Telemedicine
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:
- First Guidance following Hobby Lobby released
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and State...more
7/23/2014
/ Affordable Care Act ,
Burwell v Hobby Lobby ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Closely Held Businesses ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
EHR ,
Employer Mandates ,
Food and Drug Administration (FDA) ,
Healthcare ,
National Institute of Health (NIH) ,
ONC ,
Opt-Outs ,
PHRMA ,
Religious Freedom Restoration Act (RFRA) ,
SCOTUS