Health Law Documents  

• January 6 - OIG report, Hospital Incident Reporting Systems Do Not Capture Most Patient Harm (OEI-06-09-0091).

• January 4 - HHS notice (77 Fed. Reg. 286) of a final core set of health quality measures recommended for Medicaid-eligible adults for voluntary use by state programs, health insurance issuers, and managed care entities that enter into contracts with Medicaid.

• January 4 - OIG report, Comparison of Second-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2011 (OEI-03-12-00020).

• December 30 - OIG report, Review of Excluded Providers in the Medicare Part D Program (A-07-10-06004).

• December 29 - OIG annual notice Federal Register (76 Fed. Reg. 81904) seeking proposals and recommendations for developing new and modifying existing safe harbor provisions under the Anti-Kickback Statute.

• December 28 - OIG report, Questionable Billing Patterns of Portable X-Ray Suppliers (OEI-12-10-00190).

• December 23 - OIG report, Program Integrity Problems with Newly Enrolled Medicare Equipment Suppliers (OEI-06-09-00230).

• December 20 - GAO report, Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting (GAO-12-225).

• December 20 - OIG Advisory Opinion No. 11-19 , saying Medigap policies may use a "preferred hospital" network without running afoul of federal fraud and abuse laws

• December 19 - CMS proposed rule on Physician Payments Sunshine Act provision of ACA (76 Fed. Reg. 78742).

• December 15 - GAO report, Drug Shortages: FDA’s Ability to Respond Should Be Strengthened (GAO-12-116).

• December 13 - GAO report, Pre-Existing Condition Insurance Plan: Comparison of Implementation and Early Enrollment with the Children’s Health Insurance Program (GAO-12-62R).

• December 13 - HHS final rule implementing CO-OP program (76 Fed. Reg. 77392).

• December 7 - CMS final rule (76 Fed. Reg. 76542) giving “qualified entities” access to Medicare claims data for purposes of aggregating the information with private sector data and publicly disseminating healthcare provider and supplier performance reports. 

• December 7 - CMS interim final rule with request for comments on MLR rebate requirements for non-federal governmental health plans (76 Fed. Reg. 76596).

• December 7 - CMS final rule with comment period on MLR requirements under ACA (76 Fed. Reg. 76574).

• December 7 - OIG Advisory Opinion No. 11-18, approving a proposal for an online service that would facilitate the exchange of information between healthcare practitioners, providers, and suppliers.

• December 5 - DOL proposed rules under the ACA related to MEWAs (76 Fed. Reg. 76222) and (76 Fed. Reg. 76235).

• December 5 - OIG report, Review of the Centers for Medicare & Medicaid Services' Audits of Part D Sponsors' Financial Records (A-03-10-00007).

• November 30 - GAO report, Private Health Insurance: Early Indicators Show That Most Insurers Would Have Met or Exceeded New Medical Loss Ratio Standards (GAO-12-90R).

• November 30 - CMS final rule on hospital OPPS for CY 2012 (76 Fed. Reg. 74122).

• November 30 - GAO report, Mental Health and Substance Abuse: Employers’ Insurance Coverage Maintained or Enhanced Since Parity Act, but Effect of Coverage on Enrollees Varied (GAO-12-63),

• November 30 - GAO report, Medicare Advantage: Enrollment Increased from 2010-2011 While Premiums Decreased and Benefit Packages Were Stable (GAO-12-93).

• November 29 -OIG Fall 2011 Semiannual Report to Congress.

• November 28 - CMS final rule on Medicare physician fee schedule for 2012 (76 Fed. Reg. 73026).

• November 23 - OIG Advisory Opinion No. 11-17 , saying an arrangement under which a laboratory services management company would furnish allergy testing and immunotherapy laboratory services within various primary care physicians’ medical offices could potentially generate prohibited remuneration under the Anti-Kickback Statute and would risk the imposition of sanctions.

• November 23 - GAO report, Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect Public Health (GAO-12-46).

• November 22 - OIG report, South Florida Medicare Comprehensive Outpatient Rehabilitation Facilities (OEI-05-10-00090).

• November 15 - OIG Advisory Opinion No. 11-16, finding a hospital’s domiciliary services program that provides transportation, lodging, and meal assistance to certain patients and their family members would not fun afoul of federal fraud and abuse laws and thus would not risk sanctions.

• November 14 - OIG report, Zone Program Integrity Contractors' Data Issues Hinder Effective Oversight (OEI-03-09-00520).

• November 14 - OIG report, Ensuring that Medicare Part D Reimbursement Is Limited to Drugs Provided for Medically Accepted Indications (OEI-07-08-00152).

• November 13 - OIG report, Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2010 (OEI-03-110410).

• November 10 - CMS final rule (76 Fed. Reg. 70228) on ESRD PPS and QIP for CY 2012.

• November 10 - GAO report, Medicaid: Prototype Formula Would Provide Automatic, Targeted Assistance to States during Economic Downturns (GAO-12-38).

• November 4 - CMS final rule (76 Fed. Reg. 68526) establishing Medicare payments and policies for HHAs for CY 2012.

• November 2 - CMS final rule (76 Fed. Reg. 67802) on Medicare Shared Savings Program.

• November 2 - CMS/OIG interim final rule (76 Fed. Reg. 67992) establishing waivers of physicial self-referall law, anti-kickback statute, and CMP to specified arrangements involving ACOs.

• November 2 - CMS notice (76 Fed. Reg. 68012) announcing the testing of the Advance Payment Model for certain ACOs in the MSSP.

• October 31 - OIG report, Adverse Events in Hospitals: Medicare's Responses to Alleged Serious Events (OEI-01-08-00590).

• October 31 - GAO report, Private Health Insurance: Implementation of the Early Retiree Reinsurance Program (GAO-11-875R).

• October 24 - GAO report, Health Care Price Transparency: Meaningful Price Information Is Difficult for Consumers to Obtain Prior to Receiving Care (GAO-11-791).

• October 24 - OIG report, Multi-State Review of Centers for Medicare & Medicaid Services Medicaid Drug Expenditure Controls (A-07-10-06003).

• October 24 - CMS final rule changes to ASC patient rights conditions of coverage (76 Fed. Reg. 655886).

• October 24 - CMS proposed rule to reform hospital and CAH conditions of participation (76 Fed. Reg. 65891).

• October 24 - CMS proposed rule identifyin reforms to streamline Medicare and Medicaid regulations and promote efficiency and transparency (76 Fed. Reg. 65909).

• October 20 - OIG report, Review of Drug Costs to Medicaid Pharmacies and Their Relation to Benchmark Prices (A-06-11-00002).

• October 18 - OIG Modification of Advisory Opinion No. 07-18, saying a charitable foundation could modify its previously approved patient assistance program to focus on expensive “specialty therapeutics” and to enroll “participating pharmacies” to process claims more efficiently without risking administrative sanctions.
  
   

• October 17 - GAO report, Long-Term Care Hospitals: CMS Oversight Is Limited and Should Be Strengthened (GAO-11-810).

• October 11 - OIG Advisory Opinion No. 11-15, finding proposed arrangement under which physicians would invest in a company that would provide pathology laboratory management services to a third party could potentially generate prohibited remuneration under the Anti-Kickback Statute and would risk administrative sanctions.

• October 11 - CMS/FDA notice on pilot program for parallel review of medical products (76 Fed. Reg. 62808).

• October 11 - CMS proposed rule on changes to MA and Medicare Prescription Drug Benefit Programs for CY 2013; Considering Changes of Participation for LTC Facilities (76 Fed. Reg. 63018).

• October 7 - OIG Advisory Opinion No. 11-14, finding an ophthalmology group practice’s proposal to co-manage cataract surgery patients with optometrists external to the group would not generate prohibited remuneration under the Anti-Kickback Statute

• October 6 - OIG Work Plan for Fiscal Year 2012.

• October 6 - OIG notice (76 Fed. Reg. 62074) seeking comments on revised standards for assessing the performance of the State Medicaid Fraud Control Units.

• September 30 - OIG Modified Advisory Opinion 07-06, concluding a nonprofit foundation’s request to modify its original arrangement to provide cost-sharing and premium subsidies for the chronically ill would not increase risk to federal healthcare programs and therefore would not change OIG’s original determination that the foundation’s program would not run afoul of federal fraud and abuse laws.

• September 23 - GAO report, Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement (GAO-11-836).

• September 19 - CMS notice (76 Fed. Reg. 58007) to establish a new system of records for personally identifiable information (PII) about certain individuals who participate in, or whose PII is used to determine eligibility of an ACO to participate in, a Medicare shared savings program.

• September 16 - CMS final rule on Medicaid RACs (76 Fed. Reg. 57808).

• September 16 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Contractors During Calendar Year 2009 (A-01-10-00516),

• September 16 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Contractors During Calendar Year 2008 (A-01-10-00513).

• September 14 - HHS proposed rule (76 Fed. Reg. 56712) allowing patients direct access to their lab results.  

• September 13 - OIG report, Use of Surety Bonds to Recover Overpayments Made to Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies: Early Findings (OIG-03-11-00351).

• September 6 - OIG Advisory Opinion No. 11-13, approving insurance only billing for county residents' EMS transport services.

• September 6 - OIG Advisory Opinion No. 11-12, saying neuro emergency telemedicine arrangement would not trigger sanctions. 

• September 6 - CMS final rule on changes to the e-prescribing incentive program (76 Fed. Reg. 54953).

• September 6 - CMS final rule on rate increase disclosure and review (76 Fed. Reg. 54969).

• September 1 - CMS final rule revising marketing and prompt pay requirements for MA and Part D plans mandated by MIPAA. (76 Fed. Reg. 54600).

• August 30 - GAO report, Private Health Insurance: Early Experiences Implementing New Medical Loss Ratio Requirements (GAO-11-711).

• August 29 - GAO report, Medicare Integrity Program: CMS Used Increased Funding for New Activities but Could Improve Measurement of Program Effectiveness (GAO-11-592).

• August 26 - GAO report, Pre-Existing Condition Insurance Plans: Program Features, Early Enrollment and Spending Trends, and Federal Oversight Activities (GAO-11-662).

• August 25 - HHS final rule on financial conflicts of interest(76 Fed. Reg. 53256 ).

• August 25 - CMS notice requesting applications for bundled payments for care improvement initiative (76 Fed. Reg. 53137).

• August 25 - CMS notice for three bundled payment models 76 Fed. Reg. 53137.

• August 25 - OIG report, Conflict-of-Interest Waivers Granted to HHS Employees in 2009 (OEI-04-10-00010).

• August 22 - DOL, HHS, IRS notice of proposed rulemaking on summary of benefits and coverage and the uniform glossary (76 Fed. Reg. 52442).

• August 22- DOL, HHS, IRS solicitation of comments on template for summary of benefits (76 Fed. Reg. 52475).

• August 18 - OIG report, Medicaid Brand-Name Drugs: Rising Prices Are Offset by Manufacturer Rebates (OEI-03-10-00260).

• August 18 - CMS final FY 2012 IPPS rule (76 Fed. Reg. 51476).

• August 18 - IRS temporary regulations (76 Fed. Reg. 51245) and proposed regulations (76 Fed. Reg. 51310)describing how the agency will implement new annual fees imposed on manufacturers and importers of brand-name prescription drugs under the ACA.

• August 17 - IRS proposed rule on premium tax credit under ACA (76 Fed. Reg. 50931).

• August 17 - HHS proposed rule establishing health insurance exchange eligibility and employer standards under ACA (76 Fed. Reg. 51202).

• August 17 - CMS proposed rule (76 Fed. Reg. 51148) expanding and simplifying Medicaid eligibility and coordinating Medicaid and CHIP with the new Exchanges per ACA.  

• August 17 - OIG report, Nationwide Rollup Report for Medicaid Drug Rebate Collections (A-06-10-00011).

• August 16 - GAO report, Private Investment Homes Sometimes Differed from Others in Deficiencies, Staffing, and Financial Performance (GAO-11-571).

• August 16 - OIG report, Higher Rebates for Brand-Name Drugs Result in Lower Costs for Medicaid Compared To Medicare Part D (OEI-03-10-00320).

• August 12 - GAO report, Medicare Physician Feedback Program: CMS Faces Challenges with Methodology and Distribution of Physician Reports (GAO-11-720).

• August 11 - OIG report, Medicaid Hospital Outlier Payment Followup for Fiscal Years 2004 Through 2006 (A-07-10-04160).

• August 11 - OIG report, Comparison of First-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2011 (OEI-03-11-00540).

• August 8 - CMS final rule on FY 2012 SNF PPS (76 Fed. Reg. 48486).

• August 5 - CMS final rule on payments for IRFs in FY 2012 (76 Fed. Reg. 47836).

• August 4 - CMS final hospice wage index for FY 2012,  (76 Fed. Reg. 47302).

• August 4 - OIG Advisory Opinion No. 11-11, finding two possible options for a medical supplier contract with a SNF to supply both items that are covered by Medicare Part B and items that are not covered could potentially generate prohibited remuneration under the Anti-Kickback Statute and trigger administrative sanctions.

• August 3 - Treasury, HHS, and DOL interim final rules with request for comments amending rules on coverage of preventive services under ACA (76 Fed. Reg. 46621).

• August 1 - OIG Advisory Opinion No. 11-10, finding a healthcare management services company may disburse pay-for-performance financial incentives on behalf of a state’s Medicaid program without risking sanctions. 

• August 1 - Medicare Part D Formularies: CMS Conducts Oversight of Mid-Year Changes; Most Mid-Year Changes Were Enhancements (GAO-11-366R).

• July 27 - OIG report, Comparison of Fourth-Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2011 (OEI-O3-11-00360).

• July 26 - GAO report, Key Information for Policymakers to Assess Efforts to Improve Quality While Reducing Costs (GAO-11-445).

• July 26 - HHS advanced notice of proposed rulemaking on human subject research protections (76 Fed. Reg. 44512).

• July 25 - Medicare Part D Changes in Utilization Similar for Randomly Reassigned and other Low-Income Subsidy Beneficiaries (GAO-11-546R).

• July 21 - OIG Advisory Opinion No. 11-09, saying Medigap plans may use preferred hospital network.

• July 20 - HHS proposed rule for establishing Consumer Operated and Oriented Plans (CO-OPs) (76 Fed. Reg. 43237).

• July 19 - OIG report, Medicare Hospices That Focus on Nursing Facility Residents (OEI-02-10-00070).

• July 19 - CMS proposed rule on CY 2012 Medicare physician fee schedule (76 Fed. Reg. 42772).

• July 18 - CMS proposed rule on OPPS for CY 2012 (76 Fed. Reg. 42170).

• July 18 - OIG report, Early Review of States’ Planned Medicaid Electronic Health Record Incentive Program Oversight (OEI-05-10-00080).

• July 15 - HHS NPRMs for state-based health insurance exchanges (76 Fed. Reg. 41866), and standards related to reinsurance, risk corridors, and risk adjustment to ensure premium stability for plans and enrollees in the newly established market (76 Fed. Reg. 41930). 

• July 15 - OIG report, Payments for Medicare Part B Services During Non-Part A Nursing Home Stays in 2008 (OEI-06-07-00580).

• July 12 - GAO report, Fraud Detection Systems: Centers for Medicare and Medicaid Services Needs to Do More to Ensure Widespread Use (GAO-11-475).

• July 12 - CMS proposed rule on face-to-face requirements for home health under Medicaid (76 Fed. Reg. 41032).

• July 12 - CMS proposed rule on home health PPS for CY 2012 (76 Fed. Reg. 40988).

• July 11 - OIG report, Changes in Skilled Nursing Facilities Billing in Fiscal Year 2011 (OEI-02-09-00204).

• July 8 - CMS proposed rule on ESRD PPS for CY 2012 and QIP Program for PY 2013 and PY 2014 (76 Fed. Reg. 40498).

• July 8 - HHS interim final rule with comment period on HIPAA administrative simplification, adoption of operating rules for eligibility for a health plan and healthcare claim status transactions (76 Fed. Reg. 40458).

• July 7 - OIG report, Most Power Wheelchairs in the Medicare Program Did Not Meet Medical Necessity Guidelines (OEI-04-09-00260).

• July 7 - HHS semi-annual agenda (76 Fed. Reg. 40052).

• June 30 - CMS proposed rule (76 Fed. Reg. 38342) that would retract the requirement in the calendar year 2011 Physician Fee Schedule final rule for the signature of a physician or qualified non-physician practitioner on a requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule.

• June 29 - GAO report, Patient Protection and Affordable Care Act: IRS Should Expand Its Strategic Approach to Implementation (GAO-11-719).

• June 29 - GAO report, Medicare: Issues for Manufacturer-Level Competitive Bidding for Durable Medical Equipment (GAO-11-337R).

• June 24 - HHS, Treasury, and DOL amended interim final regulations (76 Fed. Reg. 37208) concerning ACA-mandated internal claims and appeals and external review processes for group health plans and health insurance coverage.

• June 22 - GAO report, Medical Devices: FDA Should Enhance Its Oversight of Recalls (GAO-11-468).

• June 21 - OIG Advisory Opinion No. 11-08, existing and proposed contracts between DME supplier and IDTFs, pursuant to which IDTF staff members perform certain services on behalf of the DME supplier, could potentially generate prohibited remuneration under the Anti-Kickback Statute and trigger sanctions 
  

• June 17 - CMS proposed rule (76 Fed. Reg. 35684) that would establish Conditions of Participation (CoPs) for Community Mental Health Centers.

• June 15 - GAO report, HHS Research Awards: Use of Recovery Act and Patient Protection and Affordable Care Act Funds for Comparative Effectiveness Research (GAO-11-712R). proposed rule

• June 15 - OIG report, State Medicaid Policies and Oversight Activities Related to 340B-Purchased Drugs (OEI-05-09-00321).

• June 13 - GAO report, Private Health Insurance Waivers of Restrictions on Annual Limits on Health Benefits (GAO-11-725R).

• June 9 - GAO report, Health Care Fraud And Abuse Control Program: Improvements Needed in Controls over Reporting Deposits and Expenditures (GAO-11-446).

• June 8 - OIG Advisory Opinion No. 11-07 , approving vaccine reminder program.  

• June 8 - CMS proposed rule on the availability of Medicare data for performance management (76 Fed. Reg. 33566).

• June 6 - HHS request for information on reducing regulatory burdens (76 Fed. Reg. 32330).

• June 6 - CMS proposed notice on five-year review of physician work RVUs (76 Fed. Reg. 32410).

• June 6 - CMS final rule on Medicaid payment adjustments for provider-preventable conditions (76 Fed. Reg. 32816).

• June 3 - OIG Semiannual Report to Congress.

• June 1 - CMS proposed changes to electronic prescribing incentive program (76 Fed. Reg. 31547).

• May 31 - GAO report, Products Studied under Two Related Laws, but Improved Tracking Needed by FDA (GAO-11-457).

• May 31 - ONC proposed rule on permanent certification program for HIT (76 Fed. Reg. 31272).

• May 31 - OCR proposed rule on HIPAA accounting for disclosures under HITECH (76 Fed. Reg. 31426).

• May 26 - OIG report, Review of Medicare Payments to Prescription Drug Plans on Behalf of Deceased Enrollees (A-05-09-00027).

• May 26 - OIG Advisory Opinion 10-07, approving modifications to previously approved charitable assistance program.

• May 23 - CCIIO final rule rate increase disclosure and review (76 Fed. Reg. 29964).

• May 20 - OIG Advisory Opinion No. 11-06, saying charging providers to use an online referral service could violate Anti-Kickback Statute and trigger sanctions.    

• May 20 - OIG Advisory Opinion No. 11-05 , clearing charitable program to assist financially needy with obtaining genetic testing.

• May 20 - HHS proposed rule on orphan-drug exclusion from newly expanded 340B drug pricing program (76 Fed. Reg. 29183).

• May 17 - OIG report, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight (A-04-08-05069).

• May 17 - OIG report, Audit of Information Technology Security Included in Health Information Technology Standards (A-18-09-30160).

• May 13 - OIG Advisory Opinion No. 11-04 , finding military training affiliation agreement with hospital presented minimal risk of fraud and abuse.
  

• May 11 - GAO report, Hospital Emergency Departments: Health Center Strategies That May Help Reduce Their Use (GAO-11-414R).

• May 9 - OIG report, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents (OEI-07-08-00150).

• May 6 - GAO report, More Reliable Data and Consistent Guidance Would Improve CMS Oversight of State Complaint Investigations (GAO-11-280).

• CMS proposed rule on FY 2012 hospice wage index (76 Fed. Reg. 26806).

• May 6 - CMS proposed rule (76 Fed. Reg. 26342) providing guidance to states on how to assure that people with Medicaid have the same access to healthcare services as people with other types of health insurance in the face of state budget troubles.

• May 6 - CMS final rule (76 Fed. Reg. 26432) on the inpatient psychiatric facilities PPS for RY 2012.

• May 6 - CMS proposed rule (76 Fed. Reg. 26364) on PPS and consolidated billing for SNFs.

• May 6 - CMS final rule (76 Fed. Reg. 26490) on hospital inpatient value based purchasing program.

• May 5 - CMS final rule (76 Fed. Reg. 25550) revising the process hospitals and critical access hospitals use for credentialing and granting privileges to physicians and practitioners providing telemedicine services.

• May 5 - CMS proposed rule (76 Fed. Reg. 25788) on FY 2012 IPPS and LTCH PPS.

• April 29 - CMS proposed rule (76 Fed. Reg. 24214) on IRF PPS for FY 2012.

• April 26 - OIG report, Part D Plans Generally Cover Drugs Commonly Used By Dual Eligibles (OEI-05-10-00390).

• April 22 - OIG report, Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2009 (OEI-03-10-00380).

• April 19 - FTC/DOJ Proposed Statement of Antitrust Enforcement Policy on ACOs (76 Fed. Reg. 21894)

• April 19 - CMS final rule (76 Fed. Reg. 21950) concerning federal funding for Medicaid eligibility determination and enrollment activities.

• April 18 - OIG report, Medicare Payments for Diagnostic Radiology Services in Emergency Departments (OEI-07-09-00450).

• April 15 - CMS proposed rule (76 Fed. Reg. 21311) allowing states to target multiple groups in a single home and community based (HCBS) waiver demonstration.

• April 15 - CMS final rule (76 Fed. Reg. 21432) on changes to MA and Medicare Prescription Drug Benefit Program for CY 2012.

• April 14 -OIG Advisory Opinion No. 11-03, refusing to rule out sanctions in connection with a proposal in which LTC pharmacy joint venture. 

• April 7 - CMS proposed rule (76 Fed. Reg. 19528) on Medicare Shared Savings Program, ACOs.

• April 7 - CMS Notice (76 Fed. Reg. 19365) on hospital IPPS final wage indicies.

• April 7 - CMS/OIG Notice with Comment Period (76 Fed. Reg. 19655) on waivers in connection with Medicare Shared Savings Program.

• April 6 - CMS interim final rule (76 Fed. Reg. 18930) that revises the end-stage renal disease (ESRD) transition budget-neutrality adjustment.

• April 5, GAO report, Medicaid and CHIP: Reports for Monitoring Children’s Health Care Services Need Improvement (GAO-11-293R).

• April 4 - CMS proposed rule (76 Fed. Reg. 18472) making additional changes to final rule imposing stricter Medicare enrollment standards for DMEPOS suppliers.

• March 25 - GAO report, Private Health Insurance Coverage: Expert Views on Approaches to Encourage Voluntary Enrollment (GAO-11-392R).

• March 24 - OIG Advisory Opinion No. 11-02 , finding no sanctions for hospital's proposal to provide free transport to patients.

• March 24 - GAO report, End Stage Renal Disease: CMS Should Assess Adequacy Of Payment When Certain Oral Drugs Are Included and Ensure Availability of Quality Monitoring Data (GAO-11-365).

• March 21 - GAO report, Medicare Part D: CMS Conducted Fraud and Abuse Compliance Plan Audits, but All Audit Findings Are Not Yet Available (GAO-11-269R).

• March 18 - CMS final rule (76 Fed. Reg. 15601) revising and expanding Medicare and Medicaid regulations regarding the imposition and collection of CMPs against nursing homes not in compliance with federal participation requirements.

• March 17 - OIG proposed rule (76 Fed. Reg. 14637) that would allow state Medicaid Fraud Control Units (MFCUs) to use federal matching funds for certain data mining activities. 

• March 16 - OIG annual report, Compendium of Unimplemented Regulations.

• March 16 - GAO report, Private Health Insurance: Data on Application and Coverage Denials (GAO-11-268).

• March 14 - CMS interim final rule regarding the treatment of teaching hospitals that are members of the same Medicare GME affiliated groups for purposes of determining possble FTE resident cap reductions (76 Fed. Reg. 13515).

• March 14 - GAO report, Prescription Drugs: Trends in Usual and Customary Prices for Commonly Used Drugs (GAO-11-306r).

• March 4 - OIG report, Concerns with Rebates in the Medicare Part D Program (OEI-02-08-00050).

• February 23 - OIG final rule (76 Fed. Reg. 9968) concerning discrimination or retaliation against healthcare providers who refuse to perform (or participate in performing) abortion-related services based on their conscience objections. 

• February 18 - CMS interim final rule (76 Fed. Reg. 9503), amending the requirements that a LTC must meet to qualify to participate as a SNF in Medicare or NF in Medicaid.

• February 17 - GAO report, Electronic Prescribing: CMS Should Address Inconsistencies In Its Two Incentive Programs That Encourage The Use Of Health Information Technology (GAO-11-159).

• February 17 - CMS proposed rule (76 Fed. Reg. 9283) that would bar federal payment to states for amounts expended in providing medical assistance for healthcare-acquired conditions.

• February 15 - FDA final rule (76 Fed. Reg. 8637) exempting Medical Device Data Systems (MDDSs) from premarket notification requirements.

• February 14 - GAO report, Refining Payment Methodology Has Potential to Lower Program and Beneficiary Spending (GAO-11-56).

• February 14 - OIG report, Comparison of Second-Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2010  OEI-03-11-00030).

• February 11 - HHS proposed rule (76 Fed. Reg. 7767) clarifying that student insurance plans offered through colleges and universities will be defined as “individual health insurance coverage,” thus ensuring that students benefit from critical consumer protections created by PPACA. 

• February 5 - GAO report, Medicare Advantage: Comparison of Plan Bids to Fee-for-Service Spending by Plan and Market Characteristics (GAO-11-247R).

• February 4 - GAO report, Medicaid And CHIP: Given the Association between Parent and Child Insurance Status, New Expansions May Benefit Families (GAO-11-264).

• February 2 - CMS final rule (76 Fed. Reg. 5862) on Medicare, Medicaid, CHIP additional screening requirements, application fees, temporary enrollment moratoria, payment supsensions, and compliance plans for providers and suppliers.

• February 2 - OCIIO request for comments (76 Fed. Reg. 5774) on the establishment of the Consumer Operated and Oriented Plan program (CO–OP program).

• February 2 - CMS proposed rule (76 Fed. Reg. 5755) that would require most Medicare-participating providers and suppliers to give beneficiaries written notice about their right to contact a Medicare Quality Improvement Organization (QIO) with concerns about the quality of care they receive under the Medicare program.

• January - 27 - CMS proposed rule (76 Fed. Reg. 4998) on inpatient psychiatric facility PPS for rate year 2012.

• January 18 - OIG report, Rollup Review of Impact on Medicare Program for Investment Income That Medicare Advantage Organizations Earned and Retained From Medicare Funds in 2007 (A-07-10-01080).

• January 13 - CMS proposed rule (76 Fed. Reg. 2454) rule establishing a new hospital value-based purchasing program for hospitals paid under the Medicare IPPS.

• January 10 - OIG Advisory Opinion No. 11-01 , finding several proposals by a long-standing network of hospitals that provide charity care to sick children would not run afoul of federal fraud and abuse laws.

• January 10 -OIG report, Medicare Payments for Newly Available Generic Drugs (OEI-03-09-00510).

• January 7 - ONC final rul (76 Fed. Reg. 1262) establishing a permanent certification program for HIT.

• January 5 - CMS final rule (76 Fed. Reg. 628) establishing a Quality Incentive Program for ESRD facilities.

• January 4 - OIG report, Payments for Ambulatory Surgical Center Services Provided to Beneficiaries in Skilled Nursing Facility Stays Covered Under Medicare Part A in Calendar Years 2006 through 2008 (A-01-09-00521).

• January 1 - GAO report, Public Health Information Technology: Additional Strategic Planning Needed to Guide HHS’s Efforts to Establish Electronic Situational Awareness Capabilities (GAO-11-99).

2010

• December 30 - HHS notice (75 Fed. Reg. 82397) setting out an initial core set of health quality measures recommended for Medicaid-eligible adults for voluntary use by state programs, health insurance issuers, and managed care entities that enter into contracts with Medicaid.

• December 28 - OIG Advisory Opinion No. 10-26 finding payment plans for emergency and non-emergency transportation services provided for Medicaid-covered residents of SNFs could generate prohibited remuneration under the Anti-Kickback Statute.

• December 28 - request for information on how group health plans and health insurance issuers can employ value-based insurance design in the coverage of recommended preventive services.

• December 23- CMS advance notice of proposed rulemaking soliciting comments on the need to publish a proposed rule to address certain EMTALA policies (75 Fed. Reg. 80762).

• December 23 - OCIIO notice of proposed rulemaking (75 Fed. Reg. 81004) on implmenting rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases.

• December 22 - OIG report, Questionable Billing by Skilled Nursing Facilities (OEI-02-09-00202).

• December 22 - Questionable Billing for Medicare Outpatient Therapy Services (OEI-04-09-00540).

• December 22 - Questionable Billing for Brand-Name Inhalation Drugs in South Florida (OEI-03-09-00530).

• December 15 - OIG semiannual report.

• December 15 - OIG report, Inappropriate Claims for Medicaid Personal Care Services (OEI-07-08-00430).

• December 10 - HHS ONC request for information on President's Council of Advisors on Science and Technology Report entitled "Realizing the Full Potential of HIT to Improve Healthcare for Americans: The Path Forward" (75 Fed. Reg. 76986).

• December 7 - SSA interim final rule (75 Fed. Reg. 75884) setting forth the additional Medicare Part D premiums higher-income beneficiaries will pay starting in January 2011. 

• December 1 - HHS OCIIO interim final rule implementing MLR requirements (75 Fed. Reg. 74864).

• November 30 - CMS final rule (75 Fed. Reg. 73972) removing regulatory text pertaining to Medicaid state financing arrangements that was previously vacated by a federal district court.

• November 29 - CMS final rule on Medicare physician fee schedule for CY 2011 (75 Fed. Reg. 73170).  

• November 24 - CMS final rule hospital OPPS and Calendar Year 2011 payment rates (75 Fed. Reg. 71800).

• November 24 - OIG report, FDA's Approval Status of Drugs Paid for by Medicaid (OEI-03-08-00500).

• November 22 - CMS proposed rule on MA and Medicare PDP proposed changes for contract year 2012 (75 Fed. Reg. 71190).

• November 19 - CMS final rule requiring hospitals to protect patients' right to choose their own visitors during a hospital stay (75 Fed. Reg. 70831).

• November 18 - OIG report, Medicare Part D Pharmacy Discounts for 2008 (OEI-02-10-00120).

• November 17 - CMS final rule on home health PPS for CY 2011 (75 Fed. Reg. 70372).

• November 17 - HHS and DOL request for information (75 Fed. Reg. 70160) soliciting input on conducting a market analysis for planning and developing a federal external review process for health plan denials and other decisions.

• November 17 - CMS - request for information (75 Fed. Reg. 70165) on policies and standards that will apply to ACOs participating in Medicare shared savings program.

• November 17 - HHS, DOL, and Treasury amendment to interim final regulation (75 Fed. Reg. 70114) on “grandfathered status” for group health plans and health insurance coverage in the group and individual markets.

• November 16 - HHS notice establishing the Independence Advisory Counsel (75 Fed. Reg. 70006).

• November 16 - CDC request for information (75 Fed. Reg. 70009) seeking public comment on the development of guidance on health risk assessments.

• November 16 - OIG report, Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries (OEI-06-09-00090).

• November 15 - CMS final notice announcing approval of Det Norske Veritas Healthcare as a national accreditation program for CAHs (75 Fed. Reg. 69682).

• November 15 - CMS final rule witdrawing Medicaid AMP, multiple source drug definition, and upper limits for multiple source drugs (75 Fed. Reg. 69591).

• November 12 - FDA notice (75 Fed. Reg. 69449) of draft guidance on “Dear Health Care Provider (DHCP) Letters.” 

• November 12 - OIG notice seeking comments on updating guidance on effects of exclusion (75 Fed. Reg. 69452).

• November 10 - CMS proposed rule on Medicaid RACs (75 Fed. Reg. 69037).

• November 10 - OIG Advisory Opinion No. 10-25, saying ambulance company may reimbruse city for dispatch, quality monitoring services.

• November 9 - CMS notice on Medicare Part A deductible (75 Fed. Reg. 68799).

• November 9 - CMS notice on Medicare Part A premiums (75 Fed. Reg. 68798).

• November 9 - CMS notice on Medicare Part B premiums (75 Fed. Reg. 68790).

• November 8 - GAO report, Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working With External Entities Were Recently Added (GAO-11-95). 

• November 5 - OIG roadmap for new physicians to guide them in learning how to comply with federal fraud and abuse laws.

• November 4 - OIG report, Comparison of First--Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2010 (OEI-03-10-00400).

• November 4 - OIG report, The Use of Payment Suspensions to Prevent Inappropriate Medicare Payments (OEI-01-09-00180).

• November 4 - OIG report, Oversight and Evaluation of the Fiscal Year 2008 Payment Error Rate Measurement Program (A-06-09-00037). 

• November 4 - OIG Advisory Opinion No. 10-23, finding sleep testing arrangement could trigger sanctions.

• November 4 - OIG Advisory Opinion No. 10-24, approving sleep testing arrangement.

• October 29 - GAO report, Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (GAO-10-961).

• October 29 - GAO report, Food And Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed (GAO-10-960).

• October 27 - OIG report, Payment for Drugs Under the Hospital Outpatient Prospective Payment System (OEI-03-09-00420).

• October 22 - CMS proposed rule adding written agreement requirement for LTC facilities that provide hospice care to residents (75 Fed. Reg. 652842).

• October 20 - OIG guidance for implementing its permissive exclusion authority under Section 1128(b)(15) of the Social Security Act. 

• October 19 - OIG report, Medicare and Medicaid Fraud and Abuse Training in Medical Education (OEI-01-10-00140).

• October 13 - ONC interim final rule (75 Fed. Reg. 62686) revising its final rule implementing EHR standards and specifications to remove a particular adopted implementation specification.

• October 13 - GAO report, Medicare Advantage, CMS Actions Regarding Health Plans' Health Reform Communications (GAO-10-953-R).

• October 13 - OIG report, Centers for Medicare & Medicaid Services’ Use of Medicare Fee-for-Service Error Rate Data to Identify and Focus on Error-Prone Providers (A-05-08-00080).  

• October 13 - OIG report, Quality Improvement Organizations' Final Responses to Beneficiary Complaints (OEI-01-09-00620).

• October 1 - OIG Fiscal Year 2011 Work Plan .

• September 29 - FDA final rule (75 Fed. Reg. 59935) clarifying what safety information must be reported during clinical trials of investigational drugs and biologics.

• September 28 - OIG Special Advisory Bulletin notifying pharmaceutical manufacturers that it intends to pursue enforcement actions against those that fail to comply with drug pricing and product information reporting requirements.

• September 28 - OIG report, Drug Manufacturers' Noncompliance with AMP Reporting Requirements (OEI-03-09-00060).

• September 28 - OIG Advisory Opinion No. 10-21, allowing use of preferred hospital network as part of Medigap policy. 

• September 28 - OIG Advisory Opinion No. 10-20, saying a radiology group may offer free insurance pre-authorization services to referring physicians.

• September 27 - OIG report, Review of Medicare Parts A and B Services Billed With Dates of Service After Beneficiaries' Deaths (A-01-09-00519).

September 27 - OIG Advisory Opinion No. 10-19, approving nonprofit organization’s proposal to receive donations of cash and DME to provide funding grants and DME to entities that serve individuals suffering from coagulation disorders and to provide DME directly to certain financially needy individuals.

• September 27 - OIG Advisory Opinion No. 10-18 , finding a health system’s proposal to provide pediatric patients who undergo a tonsillectomy at its outpatient surgery center and their families a free night’s stay in a nearby hotel following the procedure would not trigger administrative sanctions. 

• September 23 - CMS self-referral disclosure protocol (SRDP) for violations of the Stark Law.  

• September 23 - CMS proposed role (75 Fed. Reg. 58204), aimed at enhancing measures to prevent fraud and abuse in federal healthcare programs that ties various screening tools to the level of risk associated with different provider and supplier types.

• September 21 - OIG report CMS Reporting to the Healthcare Integrity and Protection Data Bank (OEI-07-09-00290).

• September 20 - OIG Advisory Opinion, No. 10-17  approving a proposed arrangement in which a children’s health system would donate funds to another health system’s programs for children and families as part of a private settlement of an administrative dispute involving the issuance of a CON.  

• September 16 - OIG report, End Stage Renal Disease Drugs: Facility Acquisition Costs and Future Medicare Payment Concerns (OEI-03-09-00280).

• September 17 - CMS proposed rule (75 Fed. Reg. 56946) to increase the transparency of Medicaid and CHIP demonstration applications and approved demonstration projects.

• September 17 - CMS and FDA notice seeking comments on establishing a process for parallel evaluations of premarket, FDA-regulated medical products (75 Fed. Reg. 57045).

• September 10 - OIG Advisory Opinion No. 10-16 saying a cochlear implant manufacturer’s proposal to reimburse providers for certain services rendered in connection with faulty external components while the product is still under warranty may trigger sanctions under AKS.

• September 9 - GAO legal opinion finding brochure sent by the HHS to Medicare beneficiaries describing changes in the program resulting from the newly enacted healthcare reform law did not violate the prohibition against using appropriated funds for publicity or propaganda.

• September 8 - OIG Advisory Opinion No. 10-15 , approving joint venture between health system and physicians organization for ambulatory care center. 

• September 8 - OIG Advisory Opinion No. 10-14 , finding agreement between sleep testing provider, hospital posed low risk of fraud and abuse. 

• September 3 - CMS proposed rule (75 Fed. Reg. 54073) to withdraw certain challenged provisions of a Medicaid rule pertaining to AMP and FULs for multiple source drugs.

• August 31 - OIG Advisory Opinion No. 10-13, finding hospital could provide free pre-authorization services to patients and physicians.

• August 30 - OIG Advisory Opinion No. 10-12, saying organization could establish PAP to defray cost of drugs and devices for needy patients.

• August 30 - GAO report, FDA’s Consideration of Evidence from Certain Clinical Trials (GAO-10-798).

• August 27 - CMS final rule (75 Fed. Reg. 52629) setting forth more stringent enrollment standards for DMEPOS suppliers to help reduce fraud and protect beneficiaries.

• August 16 - OIG report, report, Review of Less-Than-Effective Drugs in the Medicare Part D Program (A-07-09-04138).

• August 16 - CMS final rules and interim final rule with comment period for hospital IPPS and LTCH PPS for FY 2011 (75 Fed. Reg. 50042).

• August 16 - GAO report, Consumer-Directed Health Plans: Health Status, Spending, and Utilization of Enrollees in Plans Based on Health Reimbursement Arrangements (GAO-10-616).

• August 12 - CMS final rule ESRD PPS (75 Fed. Reg. 49030).

• August 12 - CMS proposed rule ESRD Quality Incentive Program (75 Fed. Reg. 49215).

• August 12 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Carriers During Calendar Year 2007 (A-01-09-00503).

• August 11 - CMS final rule implementing MEQC and PERM for Medicaid and CHIP (75 Fed. Reg. 48816).

• August 10 - OIG report, A Review of Claims for Capped Rental Durable Medical Equipment (OEI-07-08-00550).

• August 4 - FDA notice of new FY 2011 fee rates for drug applications and establishments (75 Fed. Reg. 46952).

• August 4 - GAO report, Medicaid Managed Care: CMS’s Oversight of States’ Rate Setting Needs Improvement (GAO-10-810).

• August 4 - CMS final agreement drug manufacturers of applicable Part D drugs must sign to provide Medicare beneficiaries in the coverage gap a discount on their medications.

• August 4 - GAO report, Medicare Payments to Federally Qualified Health Centers (GAO-10-576R).

• August 3 - OCIIO request for comments on planning and establishing state-level exchanges (75 Fed. Reg. 45584).

• August 3 - CMS proposed rule updating payment rates for CY 2011 OPPS and ASC payment system (75 Fed. Reg. 46170).

• August 3 - CMS notice of final wage indices, hospital reclassifications, payment rates, impacts, and addenda for payments made under the OPPS for CY 2011 (75 Fed. Reg. 45769).

• July 30 - OIG Advisory Opinion No. 10-11, approving charitable contributions to encourage provider use of online scheduling program with drug makers.

• July 30 - HHS OCIIO interim final rule on Pre-Existing Condition Insurance Plan (75 Fed. Reg. 45014).

• July 28 - CMS final rule on Electronic Health Record Incentive Program (75 Fed. Reg. 44314).

• July 28 - ONC, HHS - final rule on HIT standards, specifications, and certification criteria for EHR technology (75 Fed. Reg. 44590).

• July 23 - HHS, DOL, Treasury interim final regulations (75 Fed. Reg. 43330) giving consumers in new health plans broad appeals rights provided for under the healthcare reform law.

• July 23 - CMS proposed rule (75 Fed. Reg. 43330) updating the home health PPS for CY 2011.

• July 22 - CMS Notice updating payment rates for IRFs for FY 20100 (75 Fed. Reg. 42836).

• July 22 - CMS notice (75 Fed. Reg. 42944) updating hospice payment rates for FY 2011.

• July 22 - CMS notice updating SNF payment rates for FY 2011.

• July 20 - FDA notice withdrawing rule requiring device makers to include information on pediatric studies (75 Fed. Reg. 41986).

• July 20 - OIG report, Review of Medicare Contractor Information Security Program Evaluations for Fiscal Year 2007 (A-18-07-30291).

• July 19 - Interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the PPACA (75 Fed. Reg. 41726).

• July 14 - OIG report, Analysis of Errors Identified in the Fiscal Year 2009 Comprehensive Error Rate Testing Program (A-01-10-01000).

• July 14 - GAO report, Health Care Quality Measurement: The National Quality Forum Has Begun a 4-Year Contract with HHS (GAO-10-737).

• July 14 - OCR notice of proposed rulemaking implementing modifications to HIPAA privacy, security, and enforcement rules under the HITECH Act (75 Fed. Reg. 40868).

• July 13 - CMS proposed rule to the physician fee schedule and other Part B payment policies for CY 2011 (75 Fed. Reg. 40040).

• July 12 - CMS Proposed Rule on CMPs for Nursing Homes (75 Fed. Reg. 39641).

• July 8 - OIG report, Medicare Part B Services During Non-Part A Nursing Home Stays: Mental Health (OEI-06-06-00580).

• July 6 - OIG report, Review of Inpatient Rehabilitation Facilities’ Compliance with Medicare’s Transfer Regulation During Fiscal years 2004 Through 2007 (A-04-09-00059).

• June 29 - OIG report, Invalid Prescriber Identifiers on Medicare Part D claims (OEI - 03-09-00140).

• June 28 - CMS proposed rule on changes to the hospital and critical access hospital COPs to ensure visitation rights for all patients (75 Fed. Reg. 36610).

• June 28 - IRS, EBSA, OCIIO, interim final rules with request for comments on PPACA preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (75 Fed. Reg. 37188).

• June 25 - OIG policy statement saying waiver of beneficiary cost-sharing amounts attributable to retroactive increases in payment rates resulting from the operation of new federal statutes or regulations will not be subject to administrative sanctions.

• June 24 - ONC final rule - establishing temporary certification program for HIT (75 Fed. Reg. 36158).

• June 24 - OIG report, Comparison of Fourth-Quarter 2009 Average Sales prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2010 (OEI-03-10-00350).

• June 22 - OIG report, Review of Medicaid Disproportionate Share Hospital Payment Distribution (A-07-09-04150).

• June 22 - OIG report, Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials (OEI-01-08-00510).

• June 18 - OIG Advisory Opinion No. 10-10 , clearing municipalities’ reciprocal waiver of cost-sharing for backup EMS transport. 

• June 18 - OIG Advisory Opinion No. 10-9, approving health service district’s proposal to transfer funds to county in which it owns hospital for new emergency communications center. 

• June 17 - IRS, EBSA, OCIIO interim final rules with request for comments relating to grandfathered status under PPACA for group health plans and health insurance coverage (75 Fed. Reg. 34538).

• June 7 - HHS proposed methodology for recalculating FMAP (75 Fed. Reg. 32182).

• June 3 - OIG Advisory Opinion No. 10-07 , saying it would not impose sanctions in connection with charity's proposal to help financially needy afford their medications.  

• June 1 - GAO report, Medicare Advantage: Relationship between Benefit Package Designs and Plans’ Average Beneficiary Health Status (GAO-10-403).

• May 28 - CMS final rule allowing states more flexibility to impose premiums and cost sharing on certain Medicaid recipients (75 Fed. Reg. 30244).

• May 27 - OIG Advisory Opinion No. 10-06, approving PAP that offers financial assistance to patients with co-payments. 

• May 27 - OIG Advisory Opinion No. 10-05, finding proposed rewards program for referrals of prospective residents to CCRCs by current residents and employees would not generate prohibited remuneration under the AKS. 

• May 26 - GAO report, Nursing Homes: Some Improvement Seen in Understatement of Serious Deficiencies, but Implications for the Longer-Term Trend Are Unclear (GAO-10-434R).

• May 26 - CMS notice (75 Fed. Reg. 29555) of the draft model agreement that drug manufacturers of applicable Part D drugs will sign to participate in the coverage gap discount program.

• May 26 - CMS proposed rule (75 Fed. Reg. 29479) revising CoPs for both hospitals and CAHs to allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.

• May 19 - OIG report, Excluded Medicaid Providers: Analysis of Enrollment (OEI-09-08-00330).

• May 18 - OIG updated guidance on circumstances that might affect the independence or objectivity of an IRO that performs CIA reviews for an individual or an entity. 

• May 13 - DOJ Health Care Fraud and Abuse Control Program (HCFAC) Annual Report for Fiscal Year 2009.

• May 13 - HHS, DOL, Department of Treasury interim final rule implementing the requirements for group health plans and health insurance issuers in the group and individual markets under the provisions of the PPACA regarding dependent coverage of children under age 26 (75 Fed. Reg. 27122).

• May 12 - OIG report, Collection Status of Medicare overpayments Identified by Program Safeguard Contractors (OEI-03-00030).

• May 12 - OIG report, Medicare Overpayments Identified by Program Safeguard Contractors (OEI-03-08-0031).

• May 6 - OIG Advisory Opinion No. 10-04,  saying it would not impose administrative sanctions in connection with a proposal by several imaging providers to offer free insurance pre-authorization services to patients and physicians. 

• May 6 - GAO report, CMS Should Monitor Access to and Quality of Dialysis Care Promptly After Implementation of New Bundled Payment System (GAO-10-225).

• May 5 - HHS interim final rule with comment period (75 Fed. Reg. 24450) implementing the Early Retiree Reinsurance Program under the PPACA.

• May 5 - HHS interim final rule with comment period (75 Fed. Reg. 24470) as a first step to implementing a requirement mandated by the PPACA to establish a web portal that allows individuals and small businesses to access information about insurance coverage options.

• May 5 - CMS interim final rule with comment period implementing PPACA changes in provider and supplier enrollment, ordering, and referring and changes in provider agreements (75 Fed. Reg. 24437).

• May 4 - CMS proposed rule on IPPS and LTCH PPS for FY 2011 (75 Fed. Reg. 23852).

• April 30 - CMS final rule (75 Fed. Reg. 23068) giving states more flexibility in designing their Medicaid programs.

• April 30 - CMS notice (75 Fed. Reg. 23106) updating IPF PPS for rate year 2010 and 2011.  

• April 26 - GAO report, Medicare Contracting Reform: Agency Has Made Progress with Implementation, but Contractors Have Not Met All Performance Standards (GAO-10-71).

• April 26 - HHS semiannual regulatory agenda (75 Fed. Reg. 21782).

• April 23 - CMS proposed rule (75 Fed. Reg. 21207) that would allow ASCs to provide patients or the patients’ representative with required patient rights information on the day of the procedure when the procedure must be performed on the same day as the physician’s referral.

• April 23 - GAO report, Poorly Performing Nursing Homes: Special Focus Facilities Are Often Improving, but CMS’s Program Could be Strengthened (GAO-10-197).

• April 21 - FDA draft guidance that would expand transparency and disclosure when the agency grants a conflict-of-interest waiver to permit an individual’s participation in an FDA advisory committee meeting. 

• April 20 - FTC released a proposed revision to the Horizontal Merger Guidelines. 

• April 15 - CMS final rule (75 Fed. Reg. 19678) establishing a mandatory out-of-pocket limit, or MOOP, on overall cost-sharing for Parts A and B services (i.e., caps the amount MA plan enrollees will pay in deductibles and copayments).  

• April 14 - OIG report, Analysis of Improper Payments Identified During the Payment Error Rate Measurement Program Reviews in 2006 and 2007 (A-06-09-0070).

• April 14 - HHS request for information on premium review process (75 Fed. Reg. 19335).

• April 14 - HHS, DOL , IRS - Request for information (75 Fed. Reg. 19297) on medical loss ratios for purposes of PPACA.

• April 13 - OIG report, Medicare Payments for Medical Equipment and Supply Claims With Identical Referring Physician and Supplier National Provider Identifiers (OEI-04-10-00110).

• April 5 - CMS 2011 Rate Announcement and Call Letter.

• April 1 - FDA final rule and proposed rule requiring device makers to include information on pediatric populations (75 Fed. Reg. 16347 and 75 Fed. Reg. 16365).

• March 31 - DEA interim final rule on electronic prescribing for controlled substances (75 Fed. Reg. 16236).

• March 30 - GAO report, Medicare Recovery Audit Contracting: Weaknesses Remain in Addressing Vulnerabilities to Improper Payments, Although Improvements Made to Contractor Oversight (GAO-10-143).

• March 23 - GAO report, Food and Drug Administration: Opportunities Exist to Better Address Management Challenges (GAO-10-279).

• March 18 - OIG audit report, Review of Additional Rebates for Brand-Name Drugs With Multiple Versions (A-06-09-00033).

• March 11 - OIG annual compendium of unimplemented recommendations.

• March 10 - ONC proposed rule establishing certification programs for HIT (75 Fed. Reg. 11328).

• March 4 - GAO report, Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations (GAO-10-221).

• March 2 - GAO letter report, Group Purchasing Organizations: Research on Their Pricing Impact on Health Care Providers (GAO-10-323R).

• March 2 - OIG report, Beneficiaries Remain Vulnerable to Sales Agents' Marketing of Medicare Advantage Plans (OEI-05-09-0070).

• March 1 - GAO report, Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier (GAO-10-242).

• February 23 - OIG Advisory Opinions Nos. 10-01, 10-02, 10-03, saying Medigap plans may use preferred hospital networks.

• February 19 - OIG report, Recovery Audit Contractors’ Fraud Referrals (OEI-03-09-00130).

• February 17 - GAO report, Electronic Personal Health Information Exchange: Health Care Entities' Reported Disclosure Practices and Effects on Quality of Care (GAO-10-361). 

• February 12 - OIG report, Average Sales Prices: Manufacturer Reporting and CMS Oversight (OEI-03-08-00480).

• February 2 - IRS, DOL, HHS interim final rules implementing mental health parity law (75 Fed. Reg. 5410).

• January 29 - GAO report Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot Yet Be Evaluated (GAO-10-281).

• January 28 - HHS final rule on NPDB reporting requirements (75 Fed. Reg. 4656).

• January 26 - CMS notice approving three national accreditation organizations to participate in Advanced Diagnostic Imaging Supplier Accreditation Program (75 Fed. Reg. 4088).

• January 20 - OIG report, A Comparison Of Medicaid Federal Upper Limit Amounts To Acquisition Costs, Medicare Payment Amounts, And Retail Prices (OEI-03-08-00490).

• January 20 - OIG report, Outlier Average Manufacturer Prices In The Federal Upper Limit Program (OEI-03-07-00740).

• January 19 - GAO report, Medicare Advantage: CMS Assists Beneficiaries Affected by Inappropriate Marketing but Has Limited Data on Scope of Issue (GAO-10-36).

• January 19 - GAO report, Medicaid and CHIP: Enrollment, Benefits, Expenditures, and Other Characteristics of State Premium Assistance Programs (GAO-10-258R).

• January 13 - CMS proposed rule on HITECH Act incentive payments to eligible providers to adopt EHRs (75 Fed. Reg. 1844).

• January 13 - HHS interim final rule adopting initial set of standards, implementation specifications, and certification criteria (75 Fed. Reg. 2014).

• January 13 - OIG fraud alert to DME suppliers about telemarkting prohibition.

• January 11 - GAO report, Corporate Crime: DOJ Has Taken Steps to Better Track Its Use of Deferred and Non-Prosecution Agreements, But Should Evaluate Effectiveness (GAO-10-110).

• January 11 - GAO report, Brand-Name Prescription Drug Pricing: Lack of Therapeutically Equivalent Drugs and Limited Competition May Contribute to Extraordinary Price Increases (GAO-10-201).

• January 5 - OIG report, Adverse Events in Hospitals: Public Disclosure of Information About Events (OEI-06-09-00360).

• December 30 - OIG report, Medicare Power Wheelchair Claims Frequently Did Not Meet Documentation Requirements (OEI-04-07-00401).

• December 28 - GAO report, Nursing Homes: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment (GAO-10-70) and questionnaire.

• December 28 - GAO report, Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs (GAO-10-118R).

• December 28 - GAO report, Medicare Managed Care: Observations about Medicare Cost Plans (GAO-10-185).

• December 22 - GAO report, Ongoing Federal Oversight of Payments to Offset Uncompensated Hospital Care Costs Is Warranted (GAO-10-69).

• December 18 - Midyear Formulary Changes in Medicare Prescription Drug Plans (OEI-01-08-00540).

• December 9 - CMS final rule on Medicare claims appeal procedures  (74 Fed. Reg. 65296).

• December 9 - CMS final rule on Medicare Part D claims appeals (74 Fed. Reg. 65340).

• December 9 - GAO report, Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed (GAO-10-68).

• December 7 - GAO report, CMS Working to Address Problems from Round 1 of the Durable Medical Equipment Competitive Bidding Program (GAO-10-27).

• December 7 - OIG report, Aberrant Medicare Home Health Outlier Payment Patterns in Miami-Dade County and other Geographic Areas in 2008 (OEI-04-08-00570).

• December 3 - OIG semiannual report, April 1, 2009 - September 30, 2009.

• November 30 - CMS final rule delaying the effective date of two Medicaid rules that would have given states more flexibility in designing Medicaid benefit packages (74 Fed. Reg. 62501).

• November 27 - Federal Matching Shares for Medicaid, SCHIP for October 1, 2010 through September 30, 2011 (74 Fed. Reg. 62315).

• November 25 - Payment Policies Under the Physician Fee Schedule for CY 2010 (74 Fed. Reg. 61738).

• November 24 - GAO report, Centers for Medicare and Medicaid Services: Deficiencies in Contract Management Internal Control Are Pervasive (GAO-10-60).

• November 23 - CMS notice withdrawing proposed rule withdrew on definition of Medicaid “rehabilitative services” (74 Fed. Reg. 61096).

• November 20 - CMS final rule with comment period on the CY 2010 OPPS (74 Fed. Reg. 60316).

• November 2 - OIG report, Medicare Drug Integrity Contractors’ Identification of Potential Part D Fraud and Abuse (OEI-03-08-00420).

• November 2 - OIG report, Reassignment of Medicare Benefits (OEI-07-08-00180).

• October 30 - HHS interim final rule implementing increasing penalty amounts for violating HIPAA in accordance with HITECH Act (74 Fed. Reg. 56123). 

• October 26 - GAO report, New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints (GAO-09-866).

• October 26 - GAO report, Medicare: Per Capita Method Can Be Used to Profile Physicians and Provide Feedback on Resource Use (GAO-09-802).

• October 23 - OIG Health Care Fraud and Abuse Control annual report (HCFAC report).

• October 23 - OIG report, Adverse Event Reporting For Medical Devices (OEI-01-08-00110).

• October 22 - Beneficiary Appeals in Medicare Advantage (OEI-01-08-00280).

• October 22 - CMS proposed rule revising MA and Part D programs to clarify various participation requirements, specify changes to strengthen beneficiary protections, ensure plan offerings to beneficiaries include meaningful differences, improve plan payment rules and processes, and implement new policies (74 Fed. Reg. 54634).

• October 22 - GAO report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators (GAO-09-807).

• October 20 - OIG report, Medicare Part D Plan Sponsor Electronic Prescribing Initiatives (OEI-05-08-00322).

• October 14 - OIG report, Medicare Part D E-Prescribing Standards: Early Assessment Shows Partial Connectivity (OEI-05-08-00320).

• October 7 - OCR proposed rule modifying HIPAA privacy rule to implement Genetic Information Nondiscrimination Act of 2008 (74 Fed. Reg. 51698).

• October 7 - IRS, DOL, HHS interim final rules with request for comments implementing Genetic Information Nondiscrimination Act of 2008 (74 Fed. Reg. 51644).

• October 1 - FDA proposed rule on postmarketing safety reporting for combination products (74 Fed. Reg. 50744).

• October 1 - OIG FY 2010 Work Plan.

• September 30 - GAO report, Medicare Physician Services: Utilization Trends Indicate Sustained Beneficiary Access with High and Growing Levels of Service in Some Areas of the Nation (GAO-09-559).

• September 30 - GAO report, Nursing Homes: CMS’s Special Focus Facility Methodology Should Better Target the Most Poorly Performing Homes, Which Tended to Be Chain Affiliated and For-Profit (GAO-09-689).

• September 30 - GAO report, Medicaid: Fraud and Abuse Related to Controlled Substances Identified in Selected States (GAO-09-957).

• September 29 - CMS proposed rule for ESRD PPS (74 Fed. Reg. 49922).

• September 24 - OIG Advisory Opinion No. 09-16 , allowing proposed network between professional organization and referral service.

• September 23 - FDA proposed rule on current good manufacturing practice requirements for combination products (74 Fed. Reg. 48423).

• September 16 - CMS final rule limiting Medicare recoupments of provider and supplier overpayments (74 Fed. Reg. 47458).

• September 16 - CMS proposed rule on states' CHIP allotments for FY 2009 through 2013 (74 Fed. Reg. 47517).

• September 14 - GAO report, Medicaid Preventive Services: Concerted Efforts Needed To Ensure Beneficiaries Receive Services (GAO-09-578).

• September 8 - OIG report, Medicare Part D Reconciliation Payments for 2006 and 2007 (OEI-02-08-00460).

• September 8 - OIG reports, Medicare Hospice Care: Services Provided to Beneficiaries Residing in Nursing Facilities (OEI-02-06-00223) and Medicare Hospice Care for Beneficiaries in Nursing Facilities: Compliance With Medicare Coverage Requirements (OEI-02-06-00221).  

• September 3 - OIG Advisory Opinion No. 09-14 and Advisory Opinion No. 09-15 approving local governments' exclusive contracts for ambulance transport services.

• September 1 - OIG report, MSIS Data Usefulness for Detecting Fraud, Waste, and Abuse (OEI-04-07-00240).

• August 31 - GAO report, Private Health Insurance: Research on Competition in the Insurance Industry (GAO-09-864R).

• August 31 - GAO report, Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together (GAO-09-647).

• August 27 - CMS final rule and interim final rule on hospital IPPS for FY 2010 and changes to LTCH PPS for Rate Years 2010 and 2009 (74 Fed. Reg. 43754).

• August 25 - FTC final rule on health breach notification (74 Fed. Reg. 42962).

• August 21 - GAO report, Health Insurance: Enrollment, Benefits, Funding, and other Characteristics of State High-Risk Health Insurance Pools (GAO-09-730R).

• August 18 - Advisory Opinion No. 09-13 (Dep’t of Health and Human Servs. Office of Inspector Gen. Aug. 11, 2009) (saying hospital may subsidies affiliated ambulance cooperative).

• August 14, 2009 - Advisory Opinion No. 09-12, (Dept. of Health and Human Servs. Office of Inspector Gen. Aug. 7, 2009) (allowing copayment subsidies for Medicare Part D enrollees).