On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more
In This Issue:
- Top News
..Congress Passes Omnibus Spending Package
..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options
..Supreme Court to Hear Challenge to ACA...more
12/22/2014
/ Affordable Care Act ,
Appropriations Bill ,
Centers for Medicare & Medicaid Services (CMS) ,
Halbig v Burwell ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
HRSA ,
King v Burwell ,
Legislative Agendas ,
Medicare ,
Medicare Shared Savings Program ,
Physicians ,
SCOTUS ,
Section 340B ,
Subsidies
Polsinelli presents Crisis Management: a multi-part series (culminating in a webinar on 11.20.2014) on what companies must know to stay ahead of external interruption that risks serious impact to their business concerns....more
In This Issue:
- Top News
..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections
..Physician Supervision Requirement for Small and Rural Hospitals
..CMS Offers Hospitals...more
9/29/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC
Enrollment in Health Plans under ACA Exceeds Projected Number of 7 Million -
The White House announced on April 1 that 7.1 million Americans had enrolled in health plans under the Affordable Care Act ("ACA"). ...more
In This Issue:
- Top News
..Sebelius: No More Health Law Delays; No Enrollment Extension
..CMS Announces Innovative Hospice Care Model
- State News
..17 States and D.C. Implementing SHOP Health Insurance...more
In This Issue:
- Top News
..Congress Approves Budget Deal with Short-Term ‘Doc Fix'
..CMS “Two-Midnight” Rule delayed until March 31, 2014
..Individuals with Canceled Insurance Policies May Apply for...more
1/24/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
EHR ,
Exempt Organizations ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Misbranding ,
OCR ,
OIG ,
Prescription Drugs ,
Tax Exemptions
In This Issue:
- Top News
..CMS Releases Payment Rules for the Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System, Renal Dialysis and Home Health
..President Signs the Drug Quality...more
In This Issue:
- Top News
..HHS Gives Mixed Messages Regarding Federal Health Care Program-Status of Qualified Health Care Plans (QHPs)
..HHS Issues Health Insurance Marketplace Enrollment Report...more
In This Issue:
- Top News
..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law
..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues
..Kaiser Study...more
11/1/2013
/ Abortion ,
Affordable Care Act ,
Debt Ceiling ,
Department of Health and Human Services (HHS) ,
Fraud ,
Government Shutdown ,
Health Insurance Exchanges ,
Healthcare ,
Healthcare.gov ,
Insurance Industry ,
Medicaid ,
Medical Devices ,
OIG ,
Premiums ,
Subsidies
In This Issue:
- Top News
..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations
..Glitches and Demand Lead to Marketplace Frustration
..HHS Delays Small...more
10/16/2013
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Insurance Exchanges ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
Open Enrollment ,
Pharmacies ,
Physician Medicare Reimbursements ,
Stark Law
In This Issue:
- Top News
..Obama Administration Delays Employer Mandate One Year
..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix
..CMS Proposes Payment Changes for Medicare...more
7/11/2013
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Contraceptive Coverage Mandate ,
Contraceptives ,
Delays ,
Department of Health and Human Services (HHS) ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Over-the-Counter Sales ,
Pay or Play ,
Pharmaceutical Industry ,
Prescription Drugs
In This Issue:
- Top News
..CMS Finalizes MLR Rule for Plans, Maintaining Application to Part D Sponsors
..Early State Filings Show Premium Reductions under ACA
..HHS Received More Than 830 Letters of...more
6/11/2013
/ Abortion ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Insurance Exchanges ,
Healthcare ,
Medicaid Expansion ,
Medicare ,
Preexisting Conditions ,
State Health Plans ,
Wellness Programs
In This Issue:
- Top News
..Tavenner Wins Senate Confirmation to Head CMS
..US Charges 89 in Nationwide Medicare Fraud Crackdown
- State News
..Vermont Becomes Fourth State to Allow Physician-Assisted...more
5/30/2013
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Labor (DOL) ,
Fraud ,
Healthcare ,
Medicaid ,
Medical Loss Ratio ,
Medicare ,
OIG ,
Physician-Assisted Suicide ,
Prescription Drugs ,
Supply Chain
In This Issue:
- Top News
..HHS Releases Hospital Pricing Data in Transparency Effort; Results Show Significant Variation
..States Divided on Medicaid Expansion
..CMS Issues FY 2014 Proposed Rules for...more
5/13/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Contraceptives ,
Department of Health and Human Services (HHS) ,
Health Insurance Exchanges ,
Hospice ,
Hospitals ,
Long-Term Care ,
Medicaid ,
Medicaid Expansion ,
Nurses ,
Proposed Regulation
In this Issue:
- Top News
..Large Hospital Systems Settles for $25.5 Million for False Claims Act Allegations
..Catholics’ Challenge to Contraceptive Coverage Mandate Dismissed As Not Ripe
- States...more
4/17/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Contraceptive Coverage Mandate ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
IRS ,
Medicaid Expansion ,
Medicare Advantage ,
Physician Payments ,
Physicians ,
Subcontractors ,
Sunshine Act ,
Supervision ,
Sustainability