Health Law Documents  

2010

• 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).